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

NCT00085774 | Completed Phase 3

• 1 other identifier: IXR-302-4-167
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• The primary endpoint was mean maximum % change in the baseline absolute forced expiratory volume in 1 second (FEV1) value observed up to 1 hour post-challenge.

  Three doses 2-7 days apart

Secondary Outcomes (10)

• Mean maximum percent change in the baseline percent predicted FEV1 value observed up to one hour post-challenge

  exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes

• Mean maximum absolute change in the baseline absolute FEV1 value observed up to one hour post-challenge

  exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes

• Mean percent change in the baseline absolute FEV1 value at each post-challenge time point

  exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes

• Mean absolute change in the baseline absolute FEV1 value at each post-challenge time point

  exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes

• Mean percent change in the baseline percent-predicted FEV1 value at each post-challenge time point

  exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes

Study Arms (3)

Albuterol HFA BOI

EXPERIMENTAL

Drug: albuterol aerosol by HFA BOI

Albuterol HFA MDI

EXPERIMENTAL

Drug: albuterol aerosol by HFA MDI

Placebo

PLACEBO COMPARATOR

Drug: placebo aerosol by HFA

Interventions

albuterol aerosol by HFA MDI DRUG

albuterol HFA MDI 160 mcg

Albuterol HFA MDI

albuterol aerosol by HFA BOI DRUG

albuterol HFA BOI 160 mcg

Albuterol HFA BOI

placebo aerosol by HFA DRUG

placebo HFA

Placebo

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Colorado Allergy and Asthma Centers, PC

Denver, Colorado, 80230, United States

Location

Colorado Allergy and Asthma Centers, PC

Englewood, Colorado, 80112, United States

Location

Colorado Allergy and Asthma Centers, PC

Lakewood, Colorado, 80401, United States

Location

MeSH Terms

Conditions

Asthma, Exercise-Induced

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Exercise-Induced Allergies; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• David S Pearlman, MD

  Colorado Allergy and Asthma Centers, PC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2004
• First Posted: June 17, 2004
• Study Start: June 30, 2004
• Primary Completion: September 30, 2004
• Study Completion: September 30, 2004
• Last Updated: November 24, 2021

Record last verified: 2021-11

Locations

US (3)