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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: beclomethasone dipropionate

• Study Type: Interventional
• Enrollment: 440
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • Hato Rey, Puerto Rico, 00917
    • Centro Neumologia Pediatrica
  • Ponce, Puerto Rico, 00732
    • Ponce School of Medicine
• United States
  • California
    • Huntington Beach, California, United States, 92647
      • Pediatric Care Medical Group
    • Huntington Beach, California, United States, 92647
      • Allergy and Asthma Specialists
    • Long Beach, California, United States, 90806
      • West Coast Clinical Trials
    • Mission Viejo, California, United States, 92691
      • Southern California Research
    • Orange, California, United States, 92868
      • Clinical Trials of Orange County, Inc.
    • Palmdale, California, United States, 93551
      • California Allergy & Asthma
    • Paramount, California, United States, 90723
      • Center for Clinical Trials, LLC
    • Riverside, California, United States, 92506
      • Integrated Research Group
    • San Diego, California, United States, 92120
      • Allergy Associates Medical Group
    • Walnut Creek, California, United States, 94598
      • Allergy and Asthma Medical Group
  • Florida
    • Ocala, Florida, United States, 34471
      • Allergy & Asthma Care of Florida
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • New Horizon's Health Research
    • Savannah, Georgia, United States, 31406
      • AeroAllergy Research Labs of Savanna, Inc
  • Illinois
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze and Itch Associates
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • Family Allergy & Asthma Research Institute
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • Perez-Betancourt Medical Clinic
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Northeast Medical Research Associates
  • Minnesota
    • Plymouth, Minnesota, United States, 55441
      • Clinical Research Institute
  • Nebraska
    • Papillion, Nebraska, United States, 68046-4194
      • The Asthma and Allergy Center
  • New York
    • Ithaca, New York, United States, 14850
      • Asthma and Allergy Associates, PC
    • Utica, New York, United States, 13502
      • St.Elizabeth's Children's Health Center
  • North Carolina
    • Asheville, North Carolina, United States, 28805
      • Regional Allergy and Asthma Consultants
  • Ohio
    • Canton, Ohio, United States, 44718
      • Allergy & Respiratory Center
    • Dayton, Ohio, United States, 45406
      • Dayton Clinical Research Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Dr. Santiago Reyes
    • Oklahoma City, Oklahoma, United States, 73120
      • Allergy and Asthma Clinical Research Center
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Allergy and Asthma Research Groups
    • Lake Oswego, Oregon, United States, 97035
      • Allergy, Asthma & Dermatology Research Center
    • Medford, Oregon, United States, 97504
      • Clinical Research Institute of Southern Oregon, PC
    • Portland, Oregon, United States, 97213
      • Allergy Associates Research Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15241
      • Allergy & Clinical Immunology Associates
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • The Allergy Asthma and Sinus Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Pediatric Allergy/Immunology Assoc.
    • Dallas, Texas, United States, 75231
      • Pharmaceutical Research and Consulting, Inc.
    • Houston, Texas, United States, 77054
      • Allergy and Asthma Associates
  • Virginia
    • Richmond, Virginia, United States, 23229
      • Virginia Adult & Pediatric Allergy & Asthma
  • Washington
    • Spokane, Washington, United States, 99204
      • Spokane Allergy and Asthma Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2004
• Primary Completion (Actual): June 30, 2006
• Study Completion (Actual): June 30, 2006

Study Registration Dates

• First Submitted: October 8, 2004
• First Submitted That Met QC Criteria: October 8, 2004
• First Posted (Estimate): October 11, 2004

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Beclomethasone
• Other Study ID Numbers: IXR-302-25-197