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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00094016
• Other study ID #: IXR-302-25-197
• Status: Completed
• Phase: Phase 3
• Start date: October 31, 2004
• Est. completion date: June 30, 2006

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: June 30, 2006
• Est. primary completion date: June 30, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• beclomethasone dipropionate

Locations

Country	Name	City	State
Puerto Rico	Centro Neumologia Pediatrica	Hato Rey
Puerto Rico	Ponce School of Medicine	Ponce
United States	Regional Allergy and Asthma Consultants	Asheville	North Carolina
United States	New Horizon's Health Research	Atlanta	Georgia
United States	Allergy & Respiratory Center	Canton	Ohio
United States	Pediatric Allergy/Immunology Assoc.	Dallas	Texas
United States	Pharmaceutical Research and Consulting, Inc.	Dallas	Texas
United States	Dayton Clinical Research Center	Dayton	Ohio
United States	Allergy and Asthma Research Groups	Eugene	Oregon
United States	Allergy and Asthma Associates	Houston	Texas
United States	Allergy and Asthma Specialists	Huntington Beach	California
United States	Pediatric Care Medical Group	Huntington Beach	California
United States	Asthma and Allergy Associates, PC	Ithaca	New York
United States	The Allergy Asthma and Sinus Center	Knoxville	Tennessee
United States	Allergy, Asthma & Dermatology Research Center	Lake Oswego	Oregon
United States	West Coast Clinical Trials	Long Beach	California
United States	Family Allergy & Asthma Research Institute	Louisville	Kentucky
United States	Clinical Research Institute of Southern Oregon, PC	Medford	Oregon
United States	Perez-Betancourt Medical Clinic	Metairie	Louisiana
United States	Southern California Research	Mission Viejo	California
United States	Sneeze, Wheeze and Itch Associates	Normal	Illinois
United States	NorthEast Medical Research Associates	North Dartmouth	Massachusetts
United States	Allergy & Asthma Care of Florida	Ocala	Florida
United States	Allergy and Asthma Clinical Research Center	Oklahoma City	Oklahoma
United States	Dr. Santiago Reyes	Oklahoma City	Oklahoma
United States	Clinical Trials of Orange County, Inc.	Orange	California
United States	California Allergy & Asthma	Palmdale	California
United States	The Asthma and Allergy Center	Papillion	Nebraska
United States	Center for Clinical Trials, LLC	Paramount	California
United States	Allergy & Clinical Immunology Associates	Pittsburgh	Pennsylvania
United States	Clinical Research Institute	Plymouth	Minnesota
United States	Allergy Associates Research Center	Portland	Oregon
United States	Virginia Adult & Pediatric Allergy & Asthma	Richmond	Virginia
United States	Integrated Research Group	Riverside	California
United States	Allergy Associates Medical Group	San Diego	California
United States	AeroAllergy Research Labs of Savanna, Inc	Savannah	Georgia
United States	Spokane Allergy and Asthma Clinical Research	Spokane	Washington
United States	St.Elizabeth's Children's Health Center	Utica	New York
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,