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

Asthma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109668
• Other study ID #: IXR-301-4-197
• Status: Completed
• Phase: Phase 3
• Start date: July 31, 2004
• Est. completion date: September 30, 2006

Study information

• Verified date: December 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: September 30, 2006
• Est. primary completion date: September 30, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• beclomethasone dipropionate (QVAR)

Locations

Country	Name	City	State
Puerto Rico	Ponce School of Medicine	Ponce
United States	Dr. Emory Robinette	Abingdon	Virginia
United States	Regional Allergy and Asthma Consultants	Asheville	North Carolina
United States	Belligham Asthma and Allergy	Bellingham	Washington
United States	Alabama Allergy and Asthma	Birmingham	Alabama
United States	Boulder Medical Center	Boulder	Colorado
United States	Dr. Alan Kaufman	Bronx	New York
United States	National Allergy and Asthma and Urticaria Centers of Charleston, PA	Charleston	South Carolina
United States	Pulmonary Consultants of North Idaho	Coeur d'Alene	Idaho
United States	Asthma and Allergy Associates, PC	Colorado Springs	Colorado
United States	Colorado Allergy and Asthma Center	Denver	Colorado
United States	Allergy and Asthma Associates	Houston	Texas
United States	Allergy and Asthma Specialists	Huntington Beach	California
United States	Bendel Medical Research	Lafayette	Louisiana
United States	Allergy, Asthma & Dermatology Research Center	Lake Oswego	Oregon
United States	West Coast Clinical Trials	Long Beach	California
United States	Allergy Research Foundation	Los Angeles	California
United States	UCLA David Geffen School of Medcine	Los Angeles	California
United States	Family Allergy and Asthma Research Center	Louisville	Kentucky
United States	Morgantown Pulmonary Associates	Morgantown	West Virginia
United States	Sneeze, Wheeze and Itch Associates	Normal	Illinois
United States	Northeast Medical Research Associates	North Dartmouth	Massachusetts
United States	Allergy, Asthma & Clinical Research Center	Oklahoma City	Oklahoma
United States	Clinical Trials of Orange County, Inc.	Orange	California
United States	Allergy Associates Research Center	Portland	Oregon
United States	The Clinical Research Center	Saint Louis	Missouri
United States	Allergy Associates Medical Group	San Diego	California
United States	Asthma and Allergy Research Center	Sarasota	Florida
United States	Aero Allergy Research Labs of Savannah, Inc	Savannah	Georgia
United States	Pulmonary Consultants	Tacoma	Washington
United States	Allergy and Asthma DTC	Tallahassee	Florida
United States	Allergy and Asthma Medical Group	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico,