Evaluation of Two Doses of QVAR by Breath Operated and Metered Dose Inhalers in Asthmatic Children
Safety and Efficacy Evaluation of Two Doses of HFA-Propelled Beclomethasone Dipropionate (QVAR) Versus Placebo by Breath Operated and Metered Dose Inhalers in Mild to Moderate Asthmatic Children
1 other identifier
interventional
440
2 countries
39
Brief Summary
The primary objective of this study is to compare the QVAR-Easi-Breathe 100 mcg/day and QVAR-Easi-Breathe 200 mcg/day with placebo relative to changes in forced expiratory volume in 1 second (FEV1) results following 12 weeks of treatment. Secondary objectives such as daily asthma symptoms scores (per week), morning peak expiratory flow (PEF) values, nocturnal awakening and utilization of rescue medication per day also will be evaluated. In addition, an exploratory evaluation will assess the comparability of the two devices (i.e., QVAR-Easi-Breathe versus QVAR-MDI) at the same dose levels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Oct 2004
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2004
CompletedFirst Posted
Study publicly available on registry
October 11, 2004
CompletedStudy Start
First participant enrolled
October 31, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2006
CompletedNovember 23, 2021
November 1, 2021
1.7 years
October 8, 2004
November 19, 2021
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Male or female children aged 5 through 11 years at the screening visit
- 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.
You may not qualify if:
- Patients who have used inhaled corticosteroids within 30 days prior to the screening visit.
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Allergy and Asthma Specialists
Huntington Beach, California, 92647, United States
Pediatric Care Medical Group
Huntington Beach, California, 92647, United States
West Coast Clinical Trials
Long Beach, California, 90806, United States
Southern California Research
Mission Viejo, California, 92691, United States
Clinical Trials of Orange County, Inc.
Orange, California, 92868, United States
California Allergy & Asthma
Palmdale, California, 93551, United States
Center for Clinical Trials, LLC
Paramount, California, 90723, United States
Integrated Research Group
Riverside, California, 92506, United States
Allergy Associates Medical Group
San Diego, California, 92120, United States
Allergy and Asthma Medical Group
Walnut Creek, California, 94598, United States
Allergy & Asthma Care of Florida
Ocala, Florida, 34471, United States
New Horizon's Health Research
Atlanta, Georgia, 30309, United States
AeroAllergy Research Labs of Savanna, Inc
Savannah, Georgia, 31406, United States
Sneeze, Wheeze and Itch Associates
Normal, Illinois, 61761, United States
Family Allergy & Asthma Research Institute
Louisville, Kentucky, 40215, United States
Perez-Betancourt Medical Clinic
Metairie, Louisiana, 70001, United States
NorthEast Medical Research Associates
North Dartmouth, Massachusetts, 02747, United States
Clinical Research Institute
Plymouth, Minnesota, 55441, United States
The Asthma and Allergy Center
Papillion, Nebraska, 68046-4194, United States
Asthma and Allergy Associates, PC
Ithaca, New York, 14850, United States
St.Elizabeth's Children's Health Center
Utica, New York, 13502, United States
Regional Allergy and Asthma Consultants
Asheville, North Carolina, 28805, United States
Allergy & Respiratory Center
Canton, Ohio, 44718, United States
Dayton Clinical Research Center
Dayton, Ohio, 45406, United States
Dr. Santiago Reyes
Oklahoma City, Oklahoma, 73112, United States
Allergy and Asthma Clinical Research Center
Oklahoma City, Oklahoma, 73120, United States
Allergy and Asthma Research Groups
Eugene, Oregon, 97401, United States
Allergy, Asthma & Dermatology Research Center
Lake Oswego, Oregon, 97035, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504, United States
Allergy Associates Research Center
Portland, Oregon, 97213, United States
Allergy & Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241, United States
The Allergy Asthma and Sinus Center
Knoxville, Tennessee, 37922, United States
Pediatric Allergy/Immunology Assoc.
Dallas, Texas, 75230, United States
Pharmaceutical Research and Consulting, Inc.
Dallas, Texas, 75231, United States
Allergy and Asthma Associates
Houston, Texas, 77054, United States
Virginia Adult & Pediatric Allergy & Asthma
Richmond, Virginia, 23229, United States
Spokane Allergy and Asthma Clinical Research
Spokane, Washington, 99204, United States
Centro Neumologia Pediatrica
Hato Rey, 00917, Puerto Rico
Ponce School of Medicine
Ponce, 00732, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2004
First Posted
October 11, 2004
Study Start
October 31, 2004
Primary Completion
June 30, 2006
Study Completion
June 30, 2006
Last Updated
November 23, 2021
Record last verified: 2021-11