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

NCT00109668 | Completed Phase 3

• 1 other identifier: IXR-301-4-197
• Study Type: interventional
• Target: 415
• Locations: 2 countries
• Sites: 32

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).

Conditions

Asthma

Interventions

beclomethasone dipropionate (QVAR) DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (32)

Alabama Allergy and Asthma

Birmingham, Alabama, 35209, United States

Location

Allergy and Asthma Specialists

Huntington Beach, California, 92647, United States

Location

West Coast Clinical Trials

Long Beach, California, 90806, United States

Location

Allergy Research Foundation

Los Angeles, California, 90025, United States

Location

UCLA David Geffen School of Medcine

Los Angeles, California, 90095, United States

Location

Clinical Trials of Orange County, Inc.

Orange, California, 92868, United States

Location

Allergy Associates Medical Group

San Diego, California, 92120, United States

Location

Allergy and Asthma Medical Group

Walnut Creek, California, 94598, United States

Location

Boulder Medical Center

Boulder, Colorado, 80304, United States

Location

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, 80907, United States

Location

Colorado Allergy and Asthma Center

Denver, Colorado, 80230, United States

Location

Asthma and Allergy Research Center

Sarasota, Florida, 34233, United States

Location

Allergy and Asthma DTC

Tallahassee, Florida, 32308, United States

Location

Aero Allergy Research Labs of Savannah, Inc

Savannah, Georgia, 31406, United States

Location

Pulmonary Consultants of North Idaho

Coeur d'Alene, Idaho, 83814, United States

Location

Sneeze, Wheeze and Itch Associates

Normal, Illinois, 61761, United States

Location

Family Allergy and Asthma Research Center

Louisville, Kentucky, 40215, United States

Location

Bendel Medical Research

Lafayette, Louisiana, 70503, United States

Location

Northeast Medical Research Associates

North Dartmouth, Massachusetts, 02747, United States

Location

The Clinical Research Center

St Louis, Missouri, 63141, United States

Location

Dr. Alan Kaufman

The Bronx, New York, 10465, United States

Location

Regional Allergy and Asthma Consultants

Asheville, North Carolina, 28805, United States

Location

Allergy, Asthma & Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

Allergy, Asthma & Dermatology Research Center

Lake Oswego, Oregon, 97035, United States

Location

Allergy Associates Research Center

Portland, Oregon, 97213, United States

Location

National Allergy and Asthma and Urticaria Centers of Charleston, PA

Charleston, South Carolina, 29407, United States

Location

Allergy and Asthma Associates

Houston, Texas, 77054, United States

Location

Dr. Emory Robinette

Abingdon, Virginia, 24210, United States

Location

Belligham Asthma and Allergy

Bellingham, Washington, 98225, United States

Location

Pulmonary Consultants

Tacoma, Washington, 98405, United States

Location

Morgantown Pulmonary Associates

Morgantown, West Virginia, 26505, United States

Location

Ponce School of Medicine

Ponce, 00732, Puerto Rico

Location

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2005
• First Posted: May 3, 2005
• Study Start: July 31, 2004
• Primary Completion: September 30, 2006
• Study Completion: September 30, 2006
• Last Updated: December 8, 2021

Record last verified: 2021-12

Locations

PR (1); US (31)