Comparison of Two Bronchodilator Inhalers in Adolescents and Adults With Exercise-Induced Asthma

NCT ID: NCT00085774

Last Updated: 2021-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2004-09-30

Brief Summary

This study was designed to examine the effectiveness of two bronchodilator inhalers in patients who have exercise-induced asthma.

Conditions

Exercise-induced Bronchospasm

Keywords

albuterol; aerosol inhaler; metered-dose inhaler; breath-actuated inhaler; exercise-induced bronchospasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Albuterol HFA BOI

Group Type: EXPERIMENTAL

albuterol aerosol by HFA BOI

Intervention Type: DRUG

albuterol HFA BOI 160 mcg

Albuterol HFA MDI

Group Type: EXPERIMENTAL

albuterol aerosol by HFA MDI

Intervention Type: DRUG

albuterol HFA MDI 160 mcg

Placebo

Group Type: PLACEBO_COMPARATOR

placebo aerosol by HFA

Intervention Type: DRUG

placebo HFA

Interventions

albuterol aerosol by HFA MDI

albuterol HFA MDI 160 mcg

Intervention Type: DRUG

albuterol aerosol by HFA BOI

albuterol HFA BOI 160 mcg

Intervention Type: DRUG

placebo aerosol by HFA

placebo HFA

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Provide written informed consent
• Male or non-pregnant, non-nursing females aged 12 40 years, inclusive, at the first screening visit
• Have exercise-induced bronchospasm (EIB), with or without asthma, as demonstrated by a ≥15% decrease in pre-challenge absolute FEV1 observed up to 60 minutes following an exercise challenge conducted at the first screening visit
• Predicted FEV1 ≥70% for age, height, gender, and, where applicable, race following an 8 hour period without [beta]2 agonist use
• Have no contraindications for exercising maximally
• Ability to perform spirometry reproducibly (i.e., the difference between the two highest FEV1 values out of a minimum of three and a maximum of eight values obtained at the first screening visit must not exceed 0.2 L)
• Ability to self-perform PEF (peak expiratory flow) determinations with a handheld peak flow meter
• Can tolerate withdrawal of applicable medications for qualification at both screening visits
• Normal chest X ray, or, if abnormal, is consistent with asthma and shows no evidence of other active disease
• Otherwise healthy individuals with clinically acceptable medical history, physical examination, vital signs, and 12 lead ECG (electrocardiogram; with 30 second Lead II rhythm strip)
• Body mass index (BMI) of 19 29 kg/m2 (BMI = weight [kg] / height2 [m])
• Non-smokers for at least one year prior to the first screening visit and have maximum smoking histories of ten-pack years (i.e., equivalent to 20 cigarettes per day for 10 years).

Exclusion Criteria

• Allergy or sensitivity to albuterol or to other components of the formulations used in the drug
• Exposure to investigational drugs within 30 days prior to the first screening visit
• Require continuous treatment with [beta] blockers (administered by any route), MAO (monoamine oxidase) inhibitors, tricyclic antidepressants, cromones (by any route), antileukotrienes, and/or systemic corticosteroids
• Treated with oral or injectable corticosteroids within the 12 weeks prior to the first screening visit
• The prescribed dose regimen of any required inhaled corticosteroids has not been stable for at least four weeks prior to the first screening visit NOTE: Patients requiring subsequent dosage adjustment of these drug products must be discontinued from the study.
• Inability to tolerate or unwillingness to comply with required washout periods for all applicable medications and xanthine-containing foods and beverages prior to the screening visit
• Treatment in an emergency room for asthmatic symptoms or hospitalization for asthmatic symptoms within twelve months prior to the first screening visit
• Experienced an upper respiratory tract infection and/or sinusitis associated with exacerbation of asthmatic symptoms not requiring emergency room treatment and/or hospitalization and/or treatment with oral or injected corticosteroids that has not resolved within four weeks prior to the screening visit
• History and/or presence of any clinically-significant acute or chronic disease, including but not limited to bronchitis, emphysema, active tuberculosis, bronchiectasis, cystic fibrosis, clinically significant cardiovascular disease (including cardiac arrhythmias and uncontrolled hypertension), clinically significant hepatic, renal, or endocrine dysfunction, stroke, uncontrolled diabetes, hyperthyroidism, convulsive disorders, and neoplastic disease other than basal cell carcinoma of the skin
• Known or suspected substance abuse (e.g., alcohol, marijuana, etc.) and/or presence of any other medical or psychological conditions that in the investigator's opinion should preclude study enrollment.
• Are employees of this study site or have a family member associated with the conduct of this study at this site
• Previous enrollment in an IVAX Research-sponsored Albuterol HFA aerosol asthma study.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David S Pearlman, MD

Role: PRINCIPAL_INVESTIGATOR

Colorado Allergy and Asthma Centers, PC

Locations

Colorado Allergy and Asthma Centers, PC

Denver, Colorado, United States

Colorado Allergy and Asthma Centers, PC

Englewood, Colorado, United States

Colorado Allergy and Asthma Centers, PC

Lakewood, Colorado, United States

Countries

United States

Other Identifiers

IXR-302-4-167

Identifier Type: -

Identifier Source: org_study_id