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.

Condition	Treatment or Intervention	Phase
Asthma	Drug: beclomethasone dipropionate	Phase III

Further Study Details: 

Expected Total Enrollment:  440

Ages Eligible for Study:  5 Years   -   11 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 * 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.

Arizona
      Arizona Asthma and Allergy Institute, Glendale,  Arizona,  85304,  United States; Recruiting
California
      Southern California Research, Mission Viejo,  California,  92691,  United States; Recruiting
      Allergy and Asthma Medical Group, Walnut Creek,  California,  94598,  United States; Recruiting
      Clinical Trials of Orange County, Inc., Orange,  California,  92868,  United States; Recruiting
      Integrated Research Group, Riverside,  California,  92506,  United States; Recruiting
      Allergy Associates Medical Group, San Diego,  California,  92120,  United States; Recruiting
      California Allergy & Asthma, Palmdale,  California,  93551,  United States; Recruiting
      Allergy and Asthma Specialists, Huntington Beach,  California,  92647,  United States; Recruiting
      West Coast Clinical Trials, Long Beach,  California,  90806,  United States; Recruiting
Illinois
      Sneeze, Wheeze and Itch Associates, Normal,  Illinois,  61761,  United States; Recruiting
Kentucky
      Family Allergy & Asthma Research Institute, Lousiville,  Kentucky,  40215,  United States; Recruiting
Massachusetts
      NorthEast Medical Research Associates, North Dartmouth,  Massachusetts,  02747,  United States; Recruiting
New York
      AAIR Research Center, Rochester,  New York,  14618,  United States; Recruiting
      Dr. Alan Kaufman, Bronx,  New York,  10465,  United States; Recruiting
      Asthma and Allergy Associates, PC, Ithaca,  New York,  14850,  United States; Recruiting
North Carolina
      Allergy and Asthma Center of NC PA, High Point,  North Carolina,  27262,  United States; Recruiting
      Regional Allergy and Asthma Consultants, Asheville,  North Carolina,  28805,  United States; Recruiting
Oklahoma
      Dr. Santiago Reyes, Oklahoma City,  Oklahoma,  73112,  United States; Recruiting
      Allergy and Asthma Clinical Research Center, Oklahoma City,  Oklahoma,  73120,  United States; Recruiting
Oregon
      Allergy, Asthma & Dermatology Research Center, Lake Oswego,  Oregon,  97035,  United States; Recruiting
      Allergy and Asthma Research Groups, Eugene,  Oregon,  97401,  United States; Recruiting
      Allergy Associates Research Center, Portland,  Oregon,  97213,  United States; Recruiting
Tennessee
      The Allergy Asthma and Sinus Center, Knoxville,  Tennessee,  37922,  United States; Recruiting
Texas
      Pharmaceutical Research and Consulting, Inc., Dallas,  Texas,  75231,  United States; Recruiting
      Allergy and Asthma Associates, Houston,  Texas,  77054,  United States; Recruiting
      Pediatric Allergy/Immunology Assoc., Dallas,  Texas,  75230,  United States; Recruiting
Washington
      Spokane Allergy and Asthma Clinical Research, Spokane,  Washington,  99204,  United States; Recruiting
Puerto Rico
      Ponce School of Medicine, Ponce,  00732,  Puerto Rico; Recruiting
      Centro Neumologia Pediatrica, Hato Rey,  00917,  Puerto Rico; Recruiting

Study ID Numbers:  IXR-302-25-197
Record last reviewed:  October 2004
Last Updated:  October 13, 2004
Record first received:  October 8, 2004
ClinicalTrials.gov Identifier:  NCT00094016
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08