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

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).

Study Overview

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

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.

• Study Type: Interventional
• Enrollment: 415
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • Ponce, Puerto Rico, 00732
    • Ponce School of Medicine
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Alabama Allergy and Asthma
  • California
    • Huntington Beach, California, United States, 92647
      • Allergy and Asthma Specialists
    • Long Beach, California, United States, 90806
      • West Coast Clinical Trials
    • Los Angeles, California, United States, 90025
      • Allergy Research Foundation
    • Los Angeles, California, United States, 90095
      • UCLA David Geffen School of Medcine
    • Orange, California, United States, 92868
      • Clinical Trials of Orange County, Inc.
    • San Diego, California, United States, 92120
      • Allergy Associates Medical Group
    • Walnut Creek, California, United States, 94598
      • Allergy and Asthma Medical Group
  • Colorado
    • Boulder, Colorado, United States, 80304
      • Boulder Medical Center
    • Colorado Springs, Colorado, United States, 80907
      • Asthma and Allergy Associates, PC
    • Denver, Colorado, United States, 80230
      • Colorado Allergy and Asthma Center
  • Florida
    • Sarasota, Florida, United States, 34233
      • Asthma and Allergy Research Center
    • Tallahassee, Florida, United States, 32308
      • Allergy and Asthma DTC
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Aero Allergy Research Labs of Savannah, Inc
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • Pulmonary Consultants of North Idaho
  • Illinois
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze and Itch Associates
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • Family Allergy and Asthma Research Center
  • Louisiana
    • Lafayette, Louisiana, United States, 70503
      • Bendel Medical Research
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Northeast Medical Research Associates
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • The Clinical Research Center
  • New York
    • Bronx, New York, United States, 10465
      • Dr. Alan Kaufman
  • North Carolina
    • Asheville, North Carolina, United States, 28805
      • Regional Allergy and Asthma Consultants
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Allergy, Asthma & Clinical Research Center
  • Oregon
    • Lake Oswego, Oregon, United States, 97035
      • Allergy, Asthma & Dermatology Research Center
    • Portland, Oregon, United States, 97213
      • Allergy Associates Research Center
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • National Allergy and Asthma and Urticaria Centers of Charleston, PA
  • Texas
    • Houston, Texas, United States, 77054
      • Allergy and Asthma Associates
  • Virginia
    • Abingdon, Virginia, United States, 24210
      • Dr. Emory Robinette
  • Washington
    • Bellingham, Washington, United States, 98225
      • Belligham Asthma and Allergy
    • Tacoma, Washington, United States, 98405
      • Pulmonary Consultants
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Morgantown Pulmonary Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 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): July 31, 2004
• Primary Completion (Actual): September 30, 2006
• Study Completion (Actual): September 30, 2006

Study Registration Dates

• First Submitted: May 2, 2005
• First Submitted That Met QC Criteria: May 2, 2005
• First Posted (Estimate): May 3, 2005

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: December 1, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: 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-301-4-197