Clinical trial NCT00109668: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-05-03
Enrollment: 415
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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.

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