Evaluation of Two Doses of QVAR by Breath Operated and Metered Dose Inhalers in Asthmatic Children
NCT ID: NCT00094016
Last Updated: 2021-11-23
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
440 participants
INTERVENTIONAL
2004-10-31
2006-06-30
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
Eligibility Criteria
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Inclusion Criteria
* Documented clinical evidence of asthma (FEV1 = 65-90%)
* Ability to perform acceptable and reproducible spirometry per ATS guidelines
* Ability to perform PEF determinations
* Reversible bronchoconstriction as verified by \>12% increase in FEV1
* Otherwise healthy children with clinically-acceptable medical history, physical examination, vital signs and clinical laboratory parameters within the acceptable ranges for asthma patients
* The parent or guardian must be willing to give written informed consent as well as the patient assent and be able to adhere to the dose and visit schedule.
Exclusion Criteria
* Allergy or sensitivity to beclomethasone dipropionate (BDP) 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 who are unable to use a metered dose inhaler (MDI) without a spacer device.
* Patients requiring the use of \>12 puffs per day of albuterol for any 3 consecutive days between the screening and baseline visits.
* Patients with evidence of growth retardation
* 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 (on physical exam) of oropharyngeal candidiasis.
* Exposure to investigational drugs within 30 days prior to the screening visit
* Require continuous treatment with beta blockers MAO inhibitors, tricyclic antidepressants, anticholinergics, inhaled nedocromil or cromolyn, or nebulized therapy (excluding sponsor provided albuterol MDI)
* Inability to tolerate or unwillingness to comply with required washout periods for all applicable medications
* Treatment at any time for life-threatening asthmatic episodes (e.g., episodes requiring intubation and/or associated with the development of hypercapnia, hypoxia and seizures, etc.)
* Patients that 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.
* History and/or presence of any non-asthmatic acute or chronic lung disease, including but not limited to bronchitis (within the previous 6 months), emphysema, active tuberculosis, bronchiectasis or cystic fibrosis.
* Presence of any clinically-significant cardiovascular disease (including cardiac arrhythmias and uncontrolled hypertension), clinically-significant hepatic, renal, or endocrine dysfunction, stroke, uncontrolled diabetes, hyperthyroidism, convulsive disorders, neoplastic disease other than basal cell carcinoma, and significant psychiatric disease.
* History of glaucoma or cataracts
* Presence of systemic fungal, bacterial, viral or parasitic infections and/or ocular herpes simplex
* Unlikely to be compliant, take study medication as directed, complete the diary cards, or attend scheduled clinic visits as required.
5 Years
11 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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Allergy and Asthma Specialists
Huntington Beach, California, United States
Pediatric Care Medical Group
Huntington Beach, California, United States
West Coast Clinical Trials
Long Beach, California, United States
Southern California Research
Mission Viejo, California, United States
Clinical Trials of Orange County, Inc.
Orange, California, United States
California Allergy & Asthma
Palmdale, California, United States
Center for Clinical Trials, LLC
Paramount, California, United States
Integrated Research Group
Riverside, California, United States
Allergy Associates Medical Group
San Diego, California, United States
Allergy and Asthma Medical Group
Walnut Creek, California, United States
Allergy & Asthma Care of Florida
Ocala, Florida, United States
New Horizon's Health Research
Atlanta, Georgia, United States
AeroAllergy Research Labs of Savanna, Inc
Savannah, Georgia, United States
Sneeze, Wheeze and Itch Associates
Normal, Illinois, United States
Family Allergy & Asthma Research Institute
Louisville, Kentucky, United States
Perez-Betancourt Medical Clinic
Metairie, Louisiana, United States
NorthEast Medical Research Associates
North Dartmouth, Massachusetts, United States
Clinical Research Institute
Plymouth, Minnesota, United States
The Asthma and Allergy Center
Papillion, Nebraska, United States
Asthma and Allergy Associates, PC
Ithaca, New York, United States
St.Elizabeth's Children's Health Center
Utica, New York, United States
Regional Allergy and Asthma Consultants
Asheville, North Carolina, United States
Allergy & Respiratory Center
Canton, Ohio, United States
Dayton Clinical Research Center
Dayton, Ohio, United States
Dr. Santiago Reyes
Oklahoma City, Oklahoma, United States
Allergy and Asthma Clinical Research Center
Oklahoma City, Oklahoma, United States
Allergy and Asthma Research Groups
Eugene, Oregon, United States
Allergy, Asthma & Dermatology Research Center
Lake Oswego, Oregon, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States
Allergy Associates Research Center
Portland, Oregon, United States
Allergy & Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States
The Allergy Asthma and Sinus Center
Knoxville, Tennessee, United States
Pediatric Allergy/Immunology Assoc.
Dallas, Texas, United States
Pharmaceutical Research and Consulting, Inc.
Dallas, Texas, United States
Allergy and Asthma Associates
Houston, Texas, United States
Virginia Adult & Pediatric Allergy & Asthma
Richmond, Virginia, United States
Spokane Allergy and Asthma Clinical Research
Spokane, Washington, United States
Centro Neumologia Pediatrica
Hato Rey, , Puerto Rico
Ponce School of Medicine
Ponce, , Puerto Rico
Countries
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Other Identifiers
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IXR-302-25-197
Identifier Type: -
Identifier Source: org_study_id