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
- Conditions
- Asthma
- Registration Number
- NCT00109668
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
QVAR in a standard press and breath inhaler (QVAR-MDI) has been approved by the Food and Drug Administration (FDA) for use in the United States. The purpose of this study is to determine the level of asthma control when comparing the safety and effectiveness of QVAR in two different devices, a metered dose inhaler (MDI) and a breath operated inhaler (BOI).
- Detailed Description
This investigation is a multicenter, randomized, placebo and active controlled, double-blind, double-dummy, parallel-group study to evaluate the safety and efficacy of two doses of QVAR-BOI in adolescents and adults.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 415
- Male or non-pregnant, non-nursing female at least 12 years of age at the screening visit. NOTE: Females of childbearing potential may be included if they are practicing an acceptable method of contraception for at least 2 months and have a negative urine pregnancy test at the screening visit.
- 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.
- Allergy or sensitivity to BDP (beclomethasone dipropionate) or to other components of the formulations used in the CTM
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Allergy Research Foundation
🇺🇸Los Angeles, California, United States
Asthma and Allergy Research Center
🇺🇸Sarasota, Florida, United States
Aero Allergy Research Labs of Savannah, Inc
🇺🇸Savannah, Georgia, United States
Regional Allergy and Asthma Consultants
🇺🇸Asheville, North Carolina, United States
Morgantown Pulmonary Associates
🇺🇸Morgantown, West Virginia, United States
Alabama Allergy and Asthma
🇺🇸Birmingham, Alabama, United States
Colorado Allergy and Asthma Center
🇺🇸Denver, Colorado, United States
Allergy Associates Medical Group
🇺🇸San Diego, California, United States
Allergy, Asthma & Clinical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
Allergy Associates Research Center
🇺🇸Portland, Oregon, United States
Allergy and Asthma Associates
🇺🇸Houston, Texas, United States
Allergy and Asthma Specialists
🇺🇸Huntington Beach, California, United States
West Coast Clinical Trials
🇺🇸Long Beach, California, United States
Allergy and Asthma Medical Group
🇺🇸Walnut Creek, California, United States
Clinical Trials of Orange County, Inc.
🇺🇸Orange, California, United States
Northeast Medical Research Associates
🇺🇸North Dartmouth, Massachusetts, United States
Asthma and Allergy Associates, PC
🇺🇸Colorado Springs, Colorado, United States
The Clinical Research Center
🇺🇸Saint Louis, Missouri, United States
Allergy and Asthma DTC
🇺🇸Tallahassee, Florida, United States
Allergy, Asthma & Dermatology Research Center
🇺🇸Lake Oswego, Oregon, United States
Dr. Emory Robinette
🇺🇸Abingdon, Virginia, United States
Boulder Medical Center
🇺🇸Boulder, Colorado, United States
Bendel Medical Research
🇺🇸Lafayette, Louisiana, United States
UCLA David Geffen School of Medcine
🇺🇸Los Angeles, California, United States
Dr. Alan Kaufman
🇺🇸Bronx, New York, United States
Ponce School of Medicine
🇵🇷Ponce, Puerto Rico
Family Allergy and Asthma Research Center
🇺🇸Louisville, Kentucky, United States
National Allergy and Asthma and Urticaria Centers of Charleston, PA
🇺🇸Charleston, South Carolina, United States
Belligham Asthma and Allergy
🇺🇸Bellingham, Washington, United States
Sneeze, Wheeze and Itch Associates
🇺🇸Normal, Illinois, United States
Pulmonary Consultants
🇺🇸Tacoma, Washington, United States
Pulmonary Consultants of North Idaho
🇺🇸Coeur d'Alene, Idaho, United States