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Evaluation of Two Doses of QVAR by Breath Operated and Metered Dose Inhalers in Asthmatic Children

Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00094016
Collaborator
(none)
440
Enrollment
39
Locations
19.9
Actual Duration (Months)
11.3
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 11 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Allergy and Asthma Specialists Huntington Beach California United States 92647
    2 Pediatric Care Medical Group Huntington Beach California United States 92647
    3 West Coast Clinical Trials Long Beach California United States 90806
    4 Southern California Research Mission Viejo California United States 92691
    5 Clinical Trials of Orange County, Inc. Orange California United States 92868
    6 California Allergy & Asthma Palmdale California United States 93551
    7 Center for Clinical Trials, LLC Paramount California United States 90723
    8 Integrated Research Group Riverside California United States 92506
    9 Allergy Associates Medical Group San Diego California United States 92120
    10 Allergy and Asthma Medical Group Walnut Creek California United States 94598
    11 Allergy & Asthma Care of Florida Ocala Florida United States 34471
    12 New Horizon's Health Research Atlanta Georgia United States 30309
    13 AeroAllergy Research Labs of Savanna, Inc Savannah Georgia United States 31406
    14 Sneeze, Wheeze and Itch Associates Normal Illinois United States 61761
    15 Family Allergy & Asthma Research Institute Louisville Kentucky United States 40215
    16 Perez-Betancourt Medical Clinic Metairie Louisiana United States 70001
    17 NorthEast Medical Research Associates North Dartmouth Massachusetts United States 02747
    18 Clinical Research Institute Plymouth Minnesota United States 55441
    19 The Asthma and Allergy Center Papillion Nebraska United States 68046-4194
    20 Asthma and Allergy Associates, PC Ithaca New York United States 14850
    21 St.Elizabeth's Children's Health Center Utica New York United States 13502
    22 Regional Allergy and Asthma Consultants Asheville North Carolina United States 28805
    23 Allergy & Respiratory Center Canton Ohio United States 44718
    24 Dayton Clinical Research Center Dayton Ohio United States 45406
    25 Dr. Santiago Reyes Oklahoma City Oklahoma United States 73112
    26 Allergy and Asthma Clinical Research Center Oklahoma City Oklahoma United States 73120
    27 Allergy and Asthma Research Groups Eugene Oregon United States 97401
    28 Allergy, Asthma & Dermatology Research Center Lake Oswego Oregon United States 97035
    29 Clinical Research Institute of Southern Oregon, PC Medford Oregon United States 97504
    30 Allergy Associates Research Center Portland Oregon United States 97213
    31 Allergy & Clinical Immunology Associates Pittsburgh Pennsylvania United States 15241
    32 The Allergy Asthma and Sinus Center Knoxville Tennessee United States 37922
    33 Pediatric Allergy/Immunology Assoc. Dallas Texas United States 75230
    34 Pharmaceutical Research and Consulting, Inc. Dallas Texas United States 75231
    35 Allergy and Asthma Associates Houston Texas United States 77054
    36 Virginia Adult & Pediatric Allergy & Asthma Richmond Virginia United States 23229
    37 Spokane Allergy and Asthma Clinical Research Spokane Washington United States 99204
    38 Centro Neumologia Pediatrica Hato Rey Puerto Rico 00917
    39 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:
    NCT00094016
    Other Study ID Numbers:
    • IXR-302-25-197
    First Posted:
    Oct 11, 2004
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Nov 1, 2021
    Additional relevant MeSH terms:
    Asthma
    Beclomethasone

    Study Results

    No Results Posted as of Nov 23, 2021