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Frederick County faces a possible landmark year in 2013, as already controversial issues play out and perennial battles repeat themselves, with new conflicts and progress emerging as the year unfolds.
Growth will continue to be on the front burner this year, with developer agreements locking the county into projects already in the pipeline for years to come, while the battle over a county incinerator could reach critical mass.
Meanwhile, the county must find a way to fill a $30 million budget hole, as a new school board resumes its annual battle for increased funding.
Frederick will try to find a new top cop to replace longtime Police Chief Kim Dine, and seven municipalities, including the city, will hold elections this year as the county prepares for the historic arrival of charter government in 2014.
On the state front, county lawmakers will try to get a pile of local legislation passed, including a statewide ban on synthetic marijuana, and Frederick County Board of Commissioners' President Blaine R. Young (R) will decide whether he has the financial backing and recognition to run for the GOP nomination for governor.
Here is a look at what could be the top 10 stories of the coming year:
Door open to continued county growth
Development in Frederick County will continue on pace this year, bringing new homes and businesses as a result of agreements made during 2012.
Since April, the five-member Frederick County Board of Commissioners has entered into six agreements with developers.
The binding pacts — known as Developers Rights and Responsibilities Agreements — will remain intact for 25 years, so future boards will be unable to overturn them. It gives the developer the right to build while stipulating infrastructure improvements the builder must make to accommodate the new growth.
"There are other ones coming," commissioners' President Blaine R. Young (R) said. "It puts the predictability and stability that we need, based on our [growth plan] going forward, and it takes these matters and no longer makes them political."
Young has said he predicts that in total 25 agreements will be signed and under way at the end of the board's four-year term in 2014.
The five commissioners have already approved two agreements — the Landsdale Planned Unit Development, which will bring 1,100 homes to the west side of McClain Road, north of Md. 80 in Monrovia, and the Jefferson Technology Park, which will bring 850 homes, a 250-bed hotel, 7,100 permanent jobs and 1.37 million square feet of business to the U.S. 340 and Md. 180 corridor in Frederick.
Two more agreements are currently being formulated, including the Eaglehead/Linganore Planned Unit Development for new homes and businesses on 1,354 acres in the Lake Linganore/New Market area, and the Urbana Town Center, which will bring 600 homes to the southwest side of Md. 355, adjacent to the Urbana Community Park.
A fifth agreement is also in the works for Westview South, which is slated to bring 615 homes and 122,480-square-feet of commercial space to the east side of New Design Road and west of Md. 85 in Frederick.
And the sixth agreement is for the planned Monrovia Town Center. Developers want to build 1,510 homes on 457.3 acres of farmland in Monrovia.
The mayor and the Frederick Board of Aldermen has also approved the construction of 2,050 homes on 555.43 acres of annexed farmland north of the city of Frederick.
The Crum property sits west of U.S. 15, south of Sundays Lane and north of Willowbrook Road. About 537 acres are slated for the construction of 1,200 homes and a mix of businesses.
The 302.67-acre Keller property sits at the intersection of Yellow Springs, Rocky Springs and Walter Martz roads. The developers want to build 850 homes.
Friends of Frederick County, a land preservation group, has filed several unsuccessful lawsuits trying to stop much of the development in the county and the city. Their most recent lawsuit alleges that the county commissioners had no legal authority to rezone almost 9,000 acres of farmland from agriculture and resource conservation to residential and commercial.
County faces tough budget decisions
Frederick County officials will face tough decisions this year as they develop the county's fiscal 2014 budget, including how to deal with a $31.6 million structural deficit.
The county projects revenues of $476 million for the fiscal year that begins July 1, up from $430 million the previous year, while expenditures are projected at $510 million, up from $470 last year, according to the county budget office.
Part of the increase in both figures is because of a decision by the Frederick County Board of Commissioners to eliminate the tax paid for fire and rescue service, and move those costs into the general fund.
Commissioner Billy Shreve has indicated that all areas of the county's budget, with the likely exceptions of public safety and water and sewer spending, are susceptible to cuts to help close the budget gap.
The county's budget committee will begin meeting this month, County Manager Lori Depies said.
That's also when the county will begin to get updated information from the state on revenue projections from state income tax, aid for public safety and highway user revenues, Depies said.
The city of Frederick does not have a forecast for its fiscal 2014 budget because it doesn't have revenue estimates from the state, according to city officials.
City preparing to search for a new police chief
With the departure of popular longtime Police Chief Kim Dine, one of the biggest tasks the city of Frederick faces in 2013 is to find a replacement for him.
Dine headed the Frederick Police Department from 2002 until Dec. 5, 2012, after announcing on Nov. 14 that he was leaving the department to become chief of the U.S. Capitol Police. He began work at his new position on Dec. 17.
Capt. Thomas Ledwell has been named acting chief of the department.
Ledwell, 44, who was appointed to the rank of captain in July, has spent about 20 years as an officer with the city, the last 13 of which as a member of the command staff.
Mayor Randy McClement said recently that he didn't have a date for when a search for Dine's replacement would begin because the city's human resources staff is currently examining the best way to do it. He said the city was researching companies that conduct law-enforcement employment searches and their costs.
"This is an opportunity that doesn't happen a lot," McClement said. "It's not a matter of if, it's a matter of how more than anything. It's not like I'm pushing it off — it's not as easy to go out and do this as you would hire any regular employee."
McClement said the search could take up to six months, but he hoped it would be a time frame of two to three months, starting sometime in early 2013. He acknowledged that the search could take longer if candidates from a larger area are sought, although he hasn't decided on the search parameters yet.
"If those people aren't here locally, you have to get them in," he said. "You have to look at their schedule — it's more scheduling than anything."
Seven county towns to hold elections
The period for candidates to file to run for mayor of Frederick city officially opened on Wednesday, but speculation about who might vie for the office has been circulating for months.
Mayor Randy McClement and all five seats on the Frederick Board of Aldermen will be up for possible re-election to four-year terms in the November 2013 general election.
No one has officially announced their candidacies but several names have surfaced for mayor.
Rick Weldon, the city manager of Brunswick who also has served as a county commissioner, state delegate and executive assistant to McClement, said he'd be "the most surprised person in Frederick" if McClement didn't run for a second term.
Weldon also mentioned current Aldermen Shelley Aloi (R) and Karen Young (D) as possible mayoral candidates, as well as Del. Galen Clagett (D-Dist. 3A), who will not seek a re-election as delegate, and county Commissioner Billy Shreve (R).
He also said former Mayor Jennifer Dougherty, who served between 2001-2005 and ran in 2009 but lost in the primary, might consider another run for the seat.
"I don't think you can ever rule out Mayor Dougherty," he said. "My gut's telling me that's an unfinished book — there are chapters that haven't been written yet."
Dougherty said she hadn't made a decision on a possible run but acknowledged that it was possible.
She also mentioned Aloi, Clagett and Young as possible candidates, as well as Gary Brooks, the owner of Barley and Hops restaurant.
Regardless of who runs, she said she hoped to see an ambitious mayor in office.
"When people decide they're going to run, from my perspective as a voter, I want people who have ideas, not just who want to be mayor," she said.
Six other county municipalities will also hold elections in 2013.
New Market Mayor Winslow Burhans III's term will expire in the coming year, along with all five of the members of the current town council. General elections for the town will be held in May. New Market town officials are elected for four-year terms.
Rosemont will also have its elections in May, when the town's burgess and four commissioners will be elected for two-year terms.
Emmitsburg will have its general election in September to fill two town commissioner seats currently held by Glenn Blanchard and Patrick Joy. Town officials are elected for three-year terms.
And Woodsboro Burgess Gary Smith and two commissioners — Scott Brakebill and William Rittlemeyer — will also be up for re-election to four-year terms.
Burkittsville is slated to have elections in June for mayor, currently held by Deborah Burgoyne, and three council members for three-year terms, while Thurmont will elect three council members in October for four-year terms, according to a state website.
Most of the towns do not have any nominations yet for any of their soon-to-be open seats.
Mount Airy, Brunswick, Middletown and Myersville are not holding their town elections until 2014, with Walkersville scheduled to hold theirs in 2015.
New county school board faces busy year
The Frederick County Board of Education — which now includes two brand new members — will have a lot on its plate in the coming year.
And Joy Schaefer and Zakir Bengali — the two new board members who were elected along with incumbent Kathryn "Katie" Groth in November — will have to learn fast as the school system makes steps to finish implementing the new Common Core Standard Curriculum this year and prepare to start a new system of teacher evaluations in 2013-14.
The new teacher evaluation system, which is part of a state mandate, will for the first time be partially based on student performance.
Under the new system, 20 percent of a teacher's evaluation will depend on student progress. The rest of the evaluation will assess planning and instruction skills, classroom environment and professional responsibilities, all based on classroom observation.
The new school board will also have to help the system prepare for a new system of standardized tests known as the Partnership for Assessment of Readiness for College and Careers, which will replace the existing Maryland School Assessments in 2014-15.
"The need for professional development for our staff, given the many new demands of the Common Core implementation, PARCC assessments and evaluation model, is another item we would like to fund," said county schools Superintendent Theresa Alban in an email. "We also began to address our need for competitive salaries last year and would like to continue to move forward in that area."
That is why balancing the school system's fiscal 2014 budget will be one of the biggest challenges the board will face, Alban said.
Although state and county funding for schools is expected to remain flat, expenses in the coming year will continue to increase, school board member Brad Young said.
"I expect it to be tougher than last year," Young said.
The Frederick County Board of Commissioners, which dedicates more than 50 percent of the county budget to public education, plans to give back $1.6 million that the school system contributed to cover the county deficit two years ago. But the commissioners have no intention of giving the school system more than $240.3 million, the minimum educational funding required by state law.
The county does not project an increase in students, which means no increase in state funding, Young said.
"We will definitely have an increased cost in the budget," he said. "It will definitely mean that we have to reallocate money from different categories."
That may be difficult for new board members who will have to dive into the budget discussions and balance their priorities with the needs of the system,Young said.
"They will have to learn that anything new comes at the price of something existing," Young said.
However, Schaefer said her goal will be to advocate for the true needs of the school system. With so many mandates being imposed every year, it is unrealistic to expect that the school system can continue to function successfully on the same level of funding, she said.
"The status quo in education is not enough," she said. "We would have to say there is a cost to maintenance-of-effort funding. There may not be a monetary cost but somebody somewhere is paying the price."
Permits key to future of county incinerator
Residents early this year will have another opportunity to offer their input on how a long-planned and controversial waste-to-energy incinerator will impact Frederick County's air, water and land.
The Maryland Department of the Environment will hold a public hearing at 6 p.m. Jan. 30 at Tuscarora High School, 5312 Ballenger Creek Pike in Frederick. In the event of snow, the hearing will be held on Feb. 6 at the same location and time, officials said.
The MDE held a hearing in November of 2011 on the environmental impact of the facility, which will burn trash to produce electricity. The agency held another hearing in August on the incinerator's water permits.
The hearings are part of the incinerator's multilayered state-permitting process.
The incinerator is a long-planned project between Frederick and Carroll counties. It is estimated to cost $527 million to build, with Frederick's share set at $316 million — about 60 percent — and Carroll County picking up the remainder.
Carroll County commissioners have said they want to pull out of the incinerator deal.
Frederick County Board of Commissioners' President Blaine R. Young (R) said several other jurisdictions in Maryland have expressed interest in partnering with the county if Carroll exits.
"My personal opinion, Carroll County will not make any decision until all the permits are issued," Young said.
The MDE is expected to complete the permitting process this year.
The county wants to build an incinerator because its landfill is at capacity, forcing trash to be trucked to landfills in Virginia and Pennsylvania.
County, city send wish lists to Annapolis
Local legislators in the General Assembly in Annapolis will take up 13 bills requested by the Frederick County Board of Commissioners, including one that would allow local charitable clubs and organizations to use video slot machines to help raise funds, and another that would increase the number of raffles that such organizations can hold.
A bill proposed by the five commissioners supports adding Frederick to the list of nine other counties that allow nonprofit fraternal, religious and veterans' organizations to operate up to five slot machines.
Another bill would increase the number of fundraising raffles that organizations are allowed to hold, from a maximum of six per year. The measure would allow the commissioners to pass an ordinance that sets the limit on how many raffles each organization can hold.
Del. Kelly Schulz (R-Dist. 4A) said she strongly supports the raffles bill to give organizations more ways to raise money that they desperately need.
Other proposed bills expected to be introduced when the 90-day legislative session starts on Jan. 9 call for the removal of state-imposed stormwater management fees, changing erosion controls for construction projects and giving a tax rebate to all county property owners.
The eight-member delegation is not expected to introduce a bill proposed by commissioners' President Blaine R. Young (R) that would have required county residents to show identification when voting.
While the city doesn't need the delegation's authority to pass local legislation, Mayor Randy McClement (R) and the Frederick Board of Aldermen also met with the delegation to discuss priorities for 2013.
In addition to legislation to ban synthetic marijuana on a statewide level, the city is also hoping for more highway user revenues, electronic advertising in lieu of newspaper advertisements for business, legislation to help with blighted and vacant properties, and funding for an additional alcoholic beverage inspector to focus on the city's restaurants and bars.
Citing much-needed road repairs, the city has asked for more highway revenues — which are collected by the state via transportation-related state taxes or fees such as the gas tax or car title fees and distributed by the state to municipalities to be used for road maintenance — for several years.
McClement said the city's ban on synthetic drugs that began Nov. 1 made it necessary to push for statewide legislation, otherwise the problem will just move to other areas.
"We know that just drives it out of our borders, and the county said the same thing — 'We want state legislation to ban this stuff,'" McClement said. "It's one of those things we believe its good for us, but, in our case, we've started the ball rolling for us to support our region."
County sets stage for a new era
This month, a group of Frederick County government employees will take the first steps in the jurisdiction's first change in a form of government since its founding in 1748.
The transition team will help address some of the issues surrounding the county's change from a government with a five-member board of commissioners to one headed by a county executive and a seven-member county council.
The team will review the county code page by page, looking for things that need to be changed, including website content and organizational charts, said County Manager Lori Depies, who is overseeing the effort.
They've also asked division directors to examine the policies and procedures that pertain to their areas for anything that requires approval by the Frederick County Board of Commissioners or the county manager, Depies said.
Voters approved the proposed charter with 62 percent of the vote in November's election, culminating a decades-long effort by the measure's supporters.
With the vote, Frederick became the 12th Maryland jurisdiction to establish charter government, joining 10 other counties and Baltimore city.
The county executive and council are scheduled to take office in December 2014.
'Spice' could be banned statewide
Several members of the Frederick County delegation to the Maryland General Assembly are expected to introduce bills banning the sale and use of synthetic marijuana known as "spice" during the legislative session, which begins Jan. 9.
Sen. Ronald Young (D-Dist. 3) of Frederick said that lawmakers are working on legislation to ban spice both statewide and in the county, in the event a Maryland bill fails.
Frederick County Board of Commissioners' President Blaine R. Young (R) also said that state lawmakers are also drafting emergency legislation to ban synthetic drugs that could move quickly through the General Assembly and be signed into law by the governor by mid-February.
The town of Walkersville is the most recent municipality to enact legislation, voting in December to ban the sale, purchase, manufacture, distribution, transportation, trade or consumption of spice. A violation is a criminal misdemeanor carrying a penalty of up to $1,000, 30 days in jail or both.
The new law is similar to the city of Frederick's, which was enacted on Nov. 1, although under Walkersville's charter, a violation can only carry 30 days in jail instead of the 90 days imposed in the city.
The town of Thurmont was the first to pass a ban on Oct. 23. Having spice in Thurmont carries a $250 fine but no jail time because it is a civil violation.
Lawmakers across the state are also looking to crack down on the sale of spice. A prefiled bill sponsored by Del. Kevin Kelly (D-Dist. 1B) of Cumberland would add spice to Maryland's roster of controlled dangerous substances.
Blaine Young's gubernatorial bid still alive
Frederick County Board of Commissioners' President Blaine R. Young said he will make a formal decision late this year on whether to continue a campaign for the Republican nomination for governor in 2014.
Young said he's continuing to do polling, outreach and fundraising, and will work throughout the year to lay the groundwork for a possible gubernatorial campaign.
Young's fledgling campaign has drawn attention in various parts of the state, as have his travels in a large recreational vehicle emblazoned with "Blaine Young For Maryland" banners on all four sides.
With the gubernatorial primaries scheduled for June 2014, Young has joined a speculative list of hopefuls in the Republican field that includes Harford County Executive David Craig, former Lt. Gov. Michael Steele and Larry Hogan, who was the appointment secretary for former Gov. Robert Ehrlich.
Meanwhile, Young has continued to attend events and speak to groups around the state to generate money and supporters.
Young said he has raised more than the $300,000 he had set as a threshold to reach by the end of this year to continue his efforts.
Campaign finance reports must be filed by Jan. 16.
Young said people also continue to ask him if he'll run for county executive after voters approved a move to charter government in 2014. But he said he is focusing on the gubernatorial campaign for now.
"This is the opportunity that I'm investing my time and energy to explore," he said.


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Art of Submission
During the Korean War, a grudge was born between an American soldier and his captor, General Kang. Fifty years later Tiago Sanchez is forced to use his skills as a fighter to settle their feud and save his family.
Cast: Ving Rhames, Ernie Reyes Jr., Robert Almodovar, Mario Aguja, Sara Downing
Produced by:
Directed by: Adam Boster, Kenneth Chamitoff
Written by: Kenneth Chamitoff
Running time: 1hr 45min
Opens: Sep 21, 2012 Limited
|Theaters for Today
Pick a day
on this day.

subset: commoncrawl


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In the name of ICOMOS, President Gustavo Araoz conveyed a message to ICOMOS Japan, expressing condolences for the many deaths and solidarity at this dark hour for their country.
Documentation Centre
Welcome to UNESCO-ICOMOS Documentation Centre! Our collections specialize in the conservation and restoration of cultural heritage, and more specifically in the built heritage, historic monuments and sites .


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On 1 April 2012, the winegrowers from the Fellbach vineyards near Stuttgart are hosting their annual wine festival at the Alter Kelter in Fellbach. Guests will be joined by the Württemberg wine queen Petra Hammer and the Fellbach vintners as they enjoy wines from the Württemberg wine region in the salubrious surroundings of the vinothek.
Suchen, Nachschlagen, Informieren. Hier finden Sie alles, damit Sie immer "auf dem Laufenden" sind.


text:
Hover to zoom
Essential Light 2S
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1-17 International sizes
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Sponsored by Amoena: an educational website created to help breast cancer survivors reclaim a positive body image.


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Obsolescence is a measure of tech progress. That's why the gadgets we couldn't imagine living without ten years ago – that old Walkman, your black brick of a beeper, and camera with multiple rolls of film – are laughably out-of-date today. Yet oddly, some products which ought to be dead and buried are still being actively manufactured and sold as new. Believe it or not, you can still walk or log into a store and buy a new cassette boom box to use for your breakdancing routine.
Sprint recently revealed it would be offering the Lenovo IdeaPad S205s WiMAX mini notebook for $199.99 on a two-year contract, the bizarre announcement that spurred this list. The company just affirmed weeks ago that it was done with WiMAX phones, but evidently it thinks WiMAX notebooks stand a whole class apart.
In case you've always wanted a subsidized notebook that uses an archaic wireless standard, or you fancy the idea of being stuck with the device for two years, here's your chance. Hiding beneath the no-frills 11.6-inch (1366x768) display, a 1.33 GHz dual-core Intel U5600 processor runs the show, and the machine comes with 2GB of RAM and 250GB of storage onboard. You can grab the IdeaPad S205s right now, either in-store or at Sprint's website.
The 56K modem's reason for continued existence is revealed by the choice of clipart. Most home users do not have a cash drawer attached to the bottom of their workstation–this modem is meant for POS systems, in stores that do not have broadband. In fact, if you want to relive the days of AOL discs in an auditory sense, you often can catch a snatch of a carrier tone after swiping your credit card at a small retailer, if they have the modem volume turned up.
The ISP that I work for still has quite a few people on dial up accounts. They still use the old dial up modems. I guess they just don't offer broadband everywhere.
You are beeing unfair. More than half of the object are not just useful, but almost vital for some legacy systems. What if I have all my childhood VHS? What if I have some old data on a floppy disk? And so on. The same is true for companies. Well, some other stuff is really fun
WiMax isn't archaic.
I am a career computer technician and constantly learning about or buying the latest and greatest technology. I have too many negative things to say about this article to list. the only object that possibly belongs on this list is perhaps the serial modem not because of what it is but the COST 89 dollars WTF. P.S. After reading this poor excuse for an article I demand to be paid for my wasted time………just kidding……………But seriously you don't know what you are talking about. I will not be revisiting this website again this article was so bad. Hope your boss doesn't read this because you've lost a first time visitor. Fire this Hack.
USR Modems are used for what is called "Out Of Band" connections for darn near every access level router deployed. I'm not going to explain more since an ostensibly "tech" blog should shoudn't have needed more than "OOB" to know what I was referring to in the first place.
two years ago i searched the internet for a plain VCR to replace one that kicked the bucket. Luckily I found a website hat still had them available and I bought two (one is still in the box in case something happens to the other two I am using). i love being able to tape TV shows and play them back on different VCRs. Yes- i have a Blu-ray player that streams, but i still like watching TV shows since the networks often have good shows running at the same time.
Typewriters, such as the Brother shown, are still used where carbon copies or NCR paper copies are needed.


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Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations (PROSE)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
While the increase in the prevalence of asthma has abated, levels of asthma morbidity and mortality remain near record highs. An asthma exacerbation is a major factor contributing to morbidity, and even mortality in patients with asthma. Although current approaches to treatment have reduced these risks, asthma exacerbations are major problems for inner-city patients and their families, and prevention of these events continues to be a significant challenge. In children with asthma, there are predictable seasonal epidemics of exacerbations, especially during the fall season, otherwise known as the "September epidemic." The purpose of this trial is to compare the efficacy of 4 to 5 months of three treatments ― omalizumab, corticosteroid therapy boost, and placebo ― in reducing fall exacerbations in inner-city children and adolescents with allergic persistent asthma when initiated approximately 4 -6 weeks prior to the start of the first day of each participant's school year.
Biological: Omalizumab
Drug: Fluticasone
Biological: Placebo omalizumab
Biological: Placebo fluticasone
Phase 4
|Study Type:
|Study Design:
|Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:
|Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations (ICAC-20)
- Occurrence of one or more asthma exacerbations [ Time Frame: 4-5 months ] [ Designated as safety issue: Yes ]Asthma exacerbation defined as a prescription of a course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥ 20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥ 10mg per day for ≥ 1 day.
- Virus-induced exacerbations as measured by an exacerbation that is associated with a virus detected using the nasal mucus samples. [ Time Frame: 4-5 month ] [ Designated as safety issue: Yes ]
- Severity of asthma symptoms associated with a viral infection [ Time Frame: 4-5 months ] [ Designated as safety issue: Yes ]defined as the highest value among the following 3 variables: number of days with wheezing, tightness in the chest, or cough; number of nights with disturbed sleep as a result of asthma; and number of days on which the participant had to slow down or discontinue play/physical activities over a two-week period
- Number of exacerbations evaluated monthly with and without viral respiratory infections [ Time Frame: 4-5 months ] [ Designated as safety issue: Yes ]
- Composite Asthma Severity Index [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
- Spirometry measurements [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
- Asthma control measurements [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]Measurements based on scores obtained from Asthma Control Test (ACT) and Childhood Asthma Control Test (CACT)questionnaire
- Economic outcomes [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
- School absences [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
- Estimates of treatment adherence [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
- Safety data (adverse events and serious adverse events) [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
- Home allergen levels [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
|Study Start Date:
|September 2011
|Study Completion Date:
|March 2014
|Primary Completion Date:
|March 2014 (Final data collection date for primary outcome measure)
|Assigned Interventions
Experimental: Omalizumab
Participants will receive active omalizumab (Xolair®) injections and a placebo inhaler. Each participant will receive omalizumab (Xolair®) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants will receive standardized specialist asthma care.
Biological: Omalizumab
Other Name: Xolair®Biological: Placebo fluticasone
Each placebo blister for fluticasone will contain 13mg fill of lactose powder.
Other Name: Placebo Flovent® Diskus®
Experimental: Inhaled corticosteroid boost therapy (ICS)
Participants in the Inhaled Corticosteroid (ICS) boost arm will receive active ICS and placebo injections of omalizumab (Xolair®). Self-administered fluticasone (Flovent ® Diskus) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone will used. All participants will receive standardized specialist asthma care.
Drug: Fluticasone
Other Name: Flovent® Diskus®Biological: Placebo omalizumab
The composition of the placebo omalizumab is the same as the active study drug without the omalizumab.
Other Name: Placebo Xolair®
Placebo Comparator: Placebo
The placebo group will receive placebo injection and placebo inhaler. All participants will receive standardized specialist asthma care.
Biological: Placebo omalizumab
The composition of the placebo omalizumab is the same as the active study drug without the omalizumab.
Other Name: Placebo Xolair®Biological: Placebo fluticasone
Each placebo blister for fluticasone will contain 13mg fill of lactose powder.
Other Name: Placebo Flovent® Diskus®
|Ages Eligible for Study:
|6 Years to 17 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Inclusion Criteria
- combined body weight (as measured at the screening visit) and total serum IgE (immunoglobulin E) level (as measured within 3 months of the screening visit) suitable for omalizumab (Xolair®) dosing.
- a diagnosis of asthma by a clinician made more than 1 year prior to recruitment; participants who received an asthma diagnosis by a clinician less than 1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment.
- having a requirement for at least 100mcg fluticasone 100 mcg twice a day or equivalent at the Assumption of Care Visit and meet at least one of the following criteria: i. One or more asthma-related exacerbations, separated by at least two weeks, requiring treatment with a systemic corticosteroid course in the previous 12 months.
ii. One or more asthma-related overnight hospitalizations in the past 12 months.
- a positive prick skin-test to at least one perennial allergen (i.e. dust mite, cockroach, mold, cat, dog, rat, mouse) documented at the screening visit or at a ICAC study visit within 12 months of the screening visit.
- primary place of residence is in one of the pre-selected recruitment census tracts.
- able to perform spirometry.
- parent or legal guardian is willing to sign the written informed consent (age appropriate) prior to initiation of any study procedure.
- willing to sign the assent form, if age appropriate.
- a history of chickenpox or received the chickenpox vaccine.
- insurance which covers costs of medications.
- have not used and do not plan to restart the following medications in the 7 days prior to the first visit: tricyclic antidepressants, ketaconazole, or beta adrenergic blocker drugs (both oral and topical).
Exclusion Criteria:
Participants who meet any of the following criteria are not eligible for enrollment but may be reassessed:
- assigned to a treatment of less than 100mcg fluticasone twice a day or equivalent at the Assumption of Care Visit.
- pregnant or lactating. Females of child-bearing potential (post-menarche) must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral, subcutaneous, mechanical, or surgical contraception).
- clinically significant laboratory abnormalities (not associated with the study indication) at the screening visit.
- platelet counts less than 100 x 109/L at the screening visit.
- currently participating in another asthma-related pharmaceutical study or intervention study or who have participated in another asthma-related pharmaceutical study or intervention study in the month prior to Recruitment.
- live with a foster parent; not applicable if participant is able to provide consent.
- do not have access to a phone (needed for scheduling appointments).
- plan to move from the area during the study period.
- have previously been treated with omalizumab (Xolair®) within 1 year of recruitment.
- currently receiving or have received hyposensitization therapy to any allergen in the past year prior to recruitment.
- received hyposensitization therapy to dust mite, Alternaria or cockroach for ≥ 6 months in the past 3 years prior to Recruitment.
- a life-threatening asthma exacerbation in the last 2 years requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure.
- home schooled or in year round school.
- Who are currently taking or who have taken any of the following medications within 4 weeks of the Screening Visit: Monoamine oxidase inhibitors (phenelzine, tranylcypromine); Tricyclic and tetracyclic antidepressants; beta adrenergic blocker drugs (both oral and topical); Anticonvulsants(carbamazepine, phenobarbital, phenytoin, mephobarbital, primidone, ethosuximide, methsuximide, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, tiagabine, topiramate, valproic acid, divalproex sodium, zonisamide); Protease inhibitors(ritonavir, indinavir, nelfinavir); Calcium channel blockers (verapamil, diltiazem); Modafinil; Tamoxifen; non-nucleoside reverse transcriptase inhibitors; Macrolide antibiotics*(erythromycin, clarithromycin, dirithromycin, troleandomycin); chloramphenicol; nefazodone; aprepitant; St Johns Wort; Rifampin*; Azole antifungals* (ketoconazole, fluconazole,itraconazole); Sibutramine*; bergamottin* (constituent of grapefruit juice).*may be rescreened if this therapy is short-lived
- will not allow the study clinician, an asthma specialist, to manage their disease for the duration of the study or who are not willing to change their asthma medications to follow the protocol.
Participants who meet any of the following criteria are not eligible for assumption of care and may not be reassessed except where noted:
- a current severe hypersensitivity to milk.
- Who were enrolled in the previous ICAC trial, Inner-City Anti-IgE (immunoglobulin E) Therapy for Asthma (ICATA,ICAC-08/09).
- Who have any medical illnesses that in the opinion of the investigators would a.) increase the risk the subject would incur by participating in the study; b.) interfere with the measured outcomes of the study; or c.) interfere with the performance of the study procedures. Examples of such diseases are: cystic fibrosis, bronchiectasis, type 1 diabetes, hemophilia, Von Willebrands disease, sickle cell disease, cerebral palsy, rheumatoid arthritis, lupus, psoriasis, hyperimmunoglobulin E syndrome, parasite infections, Wiskott-Aldrich Syndrome or allergic bronchopulmonary aspergillosis.
- known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study medication or drugs related to omalizumab (e.g. monoclonal antibodies, polyclonal gamma globulin) or fluticasone.
- currently have diagnosed cancer, are currently being investigated for possible cancer, or who have a history of cancer.
- do not primarily speak English (or Spanish at centers with Spanish speaking staff).
- The participant's caretaker does not primarily speak English (or Spanish at centers with Spanish speaking staff); not applicable if participant is able to provide consent.
- a history of severe(grade 3)anaphylactoid or anaphylactic reaction(s).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430403
|United States, Colorado
|National Jewish Health
|Denver, Colorado, United States, 80206
|United States, District of Columbia
|Children's National Medical Center
|Washington, District of Columbia, United States, 20010
|United States, Illinois
|Children's Memorial Hospital - Department of Allergy
|Chicago, Illinois, United States, 60614-3363
|United States, Massachusetts
|Boston University School of Medicine
|Boston, Massachusetts, United States, 02118
|United States, Michigan
|Henry Ford Health System
|Detroit, Michigan, United States, 48202
|United States, New York
|Columbia University Medical Center
|New York, New York, United States, 10032
|United States, Ohio
|Cincinnati Children's Hospital
|Cincinnati, Ohio, United States, 45229
|United States, Texas
|University of Texas Southwestern Medical Center
|Dallas, Texas, United States, 75235
|Study Chair:
|Stanley Szefler, MD
|National Jewish Health
|Study Chair:
|Stephen Teach, MD, MPH
|Children's Research Institute
Additional Information:
No publications provided
|Responsible Party:
|National Institute of Allergy and Infectious Diseases (NIAID)
|ClinicalTrials.gov Identifier:
|NCT01430403 History of Changes
|Other Study ID Numbers:
|Study First Received:
|September 1, 2011
|Last Updated:
|June 5, 2014
|Health Authority:
|United States: Food and Drug Administration
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Flovent® Diskus®
Inhaled Corticosteroid Therapy
Anti-IgE Therapy
Anti-immunoglobulin E Therapy
Additional relevant MeSH terms:
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses
ClinicalTrials.gov processed this record on September 03, 2015


text:
- Independent
- The Enterprise
- The Recorder
Hunters found the body of a missing Waldorf man Thursday night.
According to information provided by the Charles County Sheriff�s Office, a group of hunters discovered the body of Paul Vincent Knobel, 49, of Waldorf around 9 p.m. Nov. 1 while hunting in a wooded area between Woodville Road and Poplar Hill Road in Waldorf.
Knobel was reported missing on Oct. 25 by family members and was last seen around 5 p.m. Oct. 23 at his home in the 15000 block of Woodville Road.
Family members indicated in a item published in the Maryland Independent on Wednesday that Knobel left on foot and might have been hunting.
Spokeswoman for the sheriff�s office, Diane Richardson, said it appeared Knobel had a self-inflicted gunshot wound.
His body was sent to the Office of the Chief Medical Examiner in Baltimore for an autopsy.


text:
Great Time at the Mustangs Game
The first game is in the books. I had a better than expected time last night at my first ever Billings Mustangs game.
If you are looking for a fun, affordable event for the family –consider a Mustangs game! Even if you are not a huge fan of baseball, I am pretty sure you will still enjoy yourself at a game


text:
Hi all!
Thanx for any help in advance! Ive got a problem emailing variables from a form (file1.php). In file2.php is this mail()-function: // it mal()functions!
mail ("firstname.lastname@example.com",
"Contacting from http://www.mydomain.xx:",
"The User submitted:
Name: $name
Firma: $firma
e-Mail: $email
Website: $website
Telefon: $telefon
Job: $job
Stunden: $hours
Lohn: $lohn
Wochenende: $wochenende") // This is line X (see below)
Then I get this error:
Warning: Failed to Connect in c:\path\file2.php on line X // <--
Why? My php.ini isset
[mail function]
; For Win32 only.
SMTP = localhost
; For Win32 only.
sendmail_from = localhost
; For Unix only. You may supply arguments as well
(default: "sendmail -t -i").
;sendmail_path =
I say thanx to everybody helping me! Greets,


text:
This contemporary plug-in wall lamp from Robert Sonneman features a modified pharmacy lamp design and gloss black finish. Ideal anywhere you need more light for reading or other tasks. The head rotates 350 degrees and the shade rotates 180 degrees. A high/low switch lets you choose your light level.
One of the most acclaimed designers in the lighting industry, Robert Sonneman has received scores of international accolades for sleek, contemporary designs. From bath bars to sconces and wall lights, Robert Sonneman's passion for quality and cutting-edge style shines through in each and every design. If your home deserves the best European inspired lighting creations, it deserves Sonneman.
Shipping and Delivery Information - For item EUX2994 if ordered by 1 pm Pacific Time


text:
The Community of Disc Golfers and About All Things Disc Golf
Here are the pre-emptive answers to all your questions:
1) Yes we are playing.
2) We are playing at redmond.
3) We tee off at 5pm
1) Yes we are playing.
2) We are playing at MLT.
3) We tee off at 5pm.
But it's raining! Are you still playing?
1) Yes.
I hear if I play Juel, it will make me unconsistant.
1) You are right, by not playing Juel I will consistantly throw less discs every week.
I hope this clears up any and all confusion on the matter with this official and definitive stance. =)
Views: 11
Replies are closed for this discussion.
© 2015 Created by Terry "the Pirate" Calhoun.


text:
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