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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

Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00109668
Collaborator
(none)
415
Enrollment
32
Locations
26
Actual Duration (Months)
13
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: beclomethasone dipropionate (QVAR)
 Phase 3

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 Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Actual Study Start Date :
Jul 31, 2004
Actual Primary Completion Date :
Sep 30, 2006
Actual Study Completion Date :
Sep 30, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alabama Allergy and Asthma Birmingham Alabama United States 35209
    2 Allergy and Asthma Specialists Huntington Beach California United States 92647
    3 West Coast Clinical Trials Long Beach California United States 90806
    4 Allergy Research Foundation Los Angeles California United States 90025
    5 UCLA David Geffen School of Medcine Los Angeles California United States 90095
    6 Clinical Trials of Orange County, Inc. Orange California United States 92868
    7 Allergy Associates Medical Group San Diego California United States 92120
    8 Allergy and Asthma Medical Group Walnut Creek California United States 94598
    9 Boulder Medical Center Boulder Colorado United States 80304
    10 Asthma and Allergy Associates, PC Colorado Springs Colorado United States 80907
    11 Colorado Allergy and Asthma Center Denver Colorado United States 80230
    12 Asthma and Allergy Research Center Sarasota Florida United States 34233
    13 Allergy and Asthma DTC Tallahassee Florida United States 32308
    14 Aero Allergy Research Labs of Savannah, Inc Savannah Georgia United States 31406
    15 Pulmonary Consultants of North Idaho Coeur d'Alene Idaho United States 83814
    16 Sneeze, Wheeze and Itch Associates Normal Illinois United States 61761
    17 Family Allergy and Asthma Research Center Louisville Kentucky United States 40215
    18 Bendel Medical Research Lafayette Louisiana United States 70503
    19 Northeast Medical Research Associates North Dartmouth Massachusetts United States 02747
    20 The Clinical Research Center Saint Louis Missouri United States 63141
    21 Dr. Alan Kaufman Bronx New York United States 10465
    22 Regional Allergy and Asthma Consultants Asheville North Carolina United States 28805
    23 Allergy, Asthma & Clinical Research Center Oklahoma City Oklahoma United States 73120
    24 Allergy, Asthma & Dermatology Research Center Lake Oswego Oregon United States 97035
    25 Allergy Associates Research Center Portland Oregon United States 97213
    26 National Allergy and Asthma and Urticaria Centers of Charleston, PA Charleston South Carolina United States 29407
    27 Allergy and Asthma Associates Houston Texas United States 77054
    28 Dr. Emory Robinette Abingdon Virginia United States 24210
    29 Belligham Asthma and Allergy Bellingham Washington United States 98225
    30 Pulmonary Consultants Tacoma Washington United States 98405
    31 Morgantown Pulmonary Associates Morgantown West Virginia United States 26505
    32 Ponce School of Medicine Ponce Puerto Rico 00732

    Sponsors and Collaborators

    • Teva Branded Pharmaceutical Products R&D, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Teva Branded Pharmaceutical Products R&D, Inc.
    ClinicalTrials.gov Identifier:
    NCT00109668
    Other Study ID Numbers:
    • IXR-301-4-197
    First Posted:
    May 3, 2005
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Dec 1, 2021
    Additional relevant MeSH terms:
    Beclomethasone

    Study Results

    No Results Posted as of Dec 8, 2021