Evaluation of Two Doses of QVAR Versus Placebo by Breath Operated and Metered Dose Inhalers in Moderate Asthmatic Adolescents and Adults on a Stable Regimen of Inhaled Corticosteroids
NCT ID: NCT00109668
Last Updated: 2021-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
415 participants
INTERVENTIONAL
2004-07-31
2006-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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beclomethasone dipropionate (QVAR)
Eligibility Criteria
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Inclusion Criteria
* Asthma (FEV1 60-85% predicted)
* Ability to perform acceptable and reproducible spirometry
* Ability to perform PEF determinations
* Reversible bronchoconstriction as verified by a greater than or equal to 12% increase in FEV1 following inhalation of albuterol. Historical reversibility will be allowed
* Patients must be on a stable regimen of daily-inhaled corticosteroids at low to medium doses for at least 30 days prior to screening.
* Otherwise healthy individuals with clinically-acceptable medical history, physical examination, vital signs, 12 lead ECG, and clinical laboratory parameters within the acceptable ranges for asthma patients.
* Non-smoker for at least one year prior to the screening visit and maximum smoking history of ten-pack years
* The patient must be willing to give written informed consent and be able to adhere to the dose and visit schedules. If applicable, parent or guardian must also provide consent.
Exclusion Criteria
* Patients demonstrating an increase or decrease in FEV1 \>20% between the screening and baseline visit.
* Patients requiring the use of \>12 puffs per day of albuterol for any 3 consecutive days between the screening and baseline visits.
* Patients who are unable to use an MDI without a spacer device. (Use of spacers is prohibited during the course of the study.)
* Patients who have been treated with methotrexate, cyclosporin, gold or other cytotoxic agents for the control of asthma or for a concurrent condition within the last 3 months.
* Patients who are receiving escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy for rhinitis.
* Patients with evidence of oropharyngeal candidiasis.
* Exposure to investigational drugs within 30 days prior to the screening visit
* Require continuous treatment with beta blockers (administered by any route), MAO inhibitors, leukotriene modifiers, tricyclic antidepressants, anticholinergics, inhaled nedocromil or cromolyn, or nebulized therapy (excluding sponsor provided albuterol MDI) following the screening visit.
* Patients who have received any of the following treatments or met any of the following conditions within six weeks prior to the screening visit: \*oral or injectable corticosteroids; \*an upper respiratory tract infection and/or sinusitis associated with exacerbation of asthmatic symptoms; \*emergency room treatment or hospitalization for asthmatic symptoms
* Inability to tolerate or unwillingness to comply with required washout periods for all applicable medications
* Treatment at any time for life-threatening asthmatic episodes
* History or presence of any non-asthmatic acute or chronic lung disease
* History of glaucoma, ocular hypertension or cataracts
* Presence of systemic fungal, bacterial, viral or parasitic infections and/or ocular herpes simplex
* Known or suspected substance abuse (e.g., alcohol, marijuana, etc.)
* Patients who are known to be HIV positive
* Unlikely to be compliant, take study medication as directed, complete the diary cards, or attend scheduled clinic visits as required.
12 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Locations
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Alabama Allergy and Asthma
Birmingham, Alabama, United States
Allergy and Asthma Specialists
Huntington Beach, California, United States
West Coast Clinical Trials
Long Beach, California, United States
Allergy Research Foundation
Los Angeles, California, United States
UCLA David Geffen School of Medcine
Los Angeles, California, United States
Clinical Trials of Orange County, Inc.
Orange, California, United States
Allergy Associates Medical Group
San Diego, California, United States
Allergy and Asthma Medical Group
Walnut Creek, California, United States
Boulder Medical Center
Boulder, Colorado, United States
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, United States
Colorado Allergy and Asthma Center
Denver, Colorado, United States
Asthma and Allergy Research Center
Sarasota, Florida, United States
Allergy and Asthma DTC
Tallahassee, Florida, United States
Aero Allergy Research Labs of Savannah, Inc
Savannah, Georgia, United States
Pulmonary Consultants of North Idaho
Coeur d'Alene, Idaho, United States
Sneeze, Wheeze and Itch Associates
Normal, Illinois, United States
Family Allergy and Asthma Research Center
Louisville, Kentucky, United States
Bendel Medical Research
Lafayette, Louisiana, United States
Northeast Medical Research Associates
North Dartmouth, Massachusetts, United States
The Clinical Research Center
St Louis, Missouri, United States
Dr. Alan Kaufman
The Bronx, New York, United States
Regional Allergy and Asthma Consultants
Asheville, North Carolina, United States
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, United States
Allergy, Asthma & Dermatology Research Center
Lake Oswego, Oregon, United States
Allergy Associates Research Center
Portland, Oregon, United States
National Allergy and Asthma and Urticaria Centers of Charleston, PA
Charleston, South Carolina, United States
Allergy and Asthma Associates
Houston, Texas, United States
Dr. Emory Robinette
Abingdon, Virginia, United States
Belligham Asthma and Allergy
Bellingham, Washington, United States
Pulmonary Consultants
Tacoma, Washington, United States
Morgantown Pulmonary Associates
Morgantown, West Virginia, United States
Ponce School of Medicine
Ponce, , Puerto Rico
Countries
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Other Identifiers
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IXR-301-4-197
Identifier Type: -
Identifier Source: org_study_id