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

Primary Purpose

Exercise-induced Bronchospasm

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
albuterol aerosol by HFA MDI
albuterol aerosol by HFA BOI
placebo aerosol by HFA
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise-induced Bronchospasm focused on measuring albuterol, aerosol inhaler, metered-dose inhaler, breath-actuated inhaler, exercise-induced bronchospasm

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Colorado Allergy and Asthma Centers, PC
  • Colorado Allergy and Asthma Centers, PC
  • Colorado Allergy and Asthma Centers, PC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Albuterol HFA BOI

Albuterol HFA MDI

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean maximum percent change in the baseline percent predicted FEV1 value observed up to one hour post-challenge
Mean maximum absolute change in the baseline absolute FEV1 value observed up to one hour post-challenge
Mean percent change in the baseline absolute FEV1 value at each post-challenge time point
Mean absolute change in the baseline absolute FEV1 value at each post-challenge time point
Mean percent change in the baseline percent-predicted FEV1 value at each post-challenge time point
Mean largest negative (or mean smallest positive) percent change in the baseline absolute FEV1 value observed up to one hour post-challenge
Mean largest negative (or mean smallest positive) percent change in the average test-day pre-dose baseline percent predicted FEV1 value observed up to one hour post-challenge
Time to recovery (in minutes) measured from time of completion of exercise challenge to time FEV1 returns to 10% or less of baseline value during the recovery phase
Total changes in FEV1 expressed as the baseline-adjusted area-under-the-effect curve of the percent-predicted FEV1 versus time over 60 minutes (AUEC0 60)
Percentage of patients who are "protected" (maximum percent decrease in the baseline absolute FEV1 <10%), "partially protected" (10 20%), and "unprotected" (>20%).

Full Information

First Posted
June 14, 2004
Last Updated
November 19, 2021
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00085774
Brief Title
Comparison of Two Bronchodilator Inhalers in Adolescents and Adults With Exercise-Induced Asthma
Official Title
A Single-Dose Efficacy Comparison of Albuterol Hydrofluoroalkane (HFA) Breath-operated Inhaler (BOI) (Volare Easi-Breathe™) and Albuterol HFA Meter Dose Inhaler (MDI) (Volare™) in Adolescents and Adults With Exercise-Induced Bronchospasm
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 30, 2004 (Actual)
Primary Completion Date
September 30, 2004 (Actual)
Study Completion Date
September 30, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise-induced Bronchospasm
Keywords
albuterol, aerosol inhaler, metered-dose inhaler, breath-actuated inhaler, exercise-induced bronchospasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Albuterol HFA BOI
Arm Type
Experimental
Arm Title
Albuterol HFA MDI
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
albuterol aerosol by HFA MDI
Intervention Description
albuterol HFA MDI 160 mcg
Intervention Type
Drug
Intervention Name(s)
albuterol aerosol by HFA BOI
Intervention Description
albuterol HFA BOI 160 mcg
Intervention Type
Drug
Intervention Name(s)
placebo aerosol by HFA
Intervention Description
placebo HFA
Primary Outcome Measure Information:
Title
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.
Time Frame
Three doses 2-7 days apart
Secondary Outcome Measure Information:
Title
Mean maximum percent change in the baseline percent predicted FEV1 value observed up to one hour post-challenge
Time Frame
exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Title
Mean maximum absolute change in the baseline absolute FEV1 value observed up to one hour post-challenge
Time Frame
exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Title
Mean percent change in the baseline absolute FEV1 value at each post-challenge time point
Time Frame
exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Title
Mean absolute change in the baseline absolute FEV1 value at each post-challenge time point
Time Frame
exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Title
Mean percent change in the baseline percent-predicted FEV1 value at each post-challenge time point
Time Frame
exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Title
Mean largest negative (or mean smallest positive) percent change in the baseline absolute FEV1 value observed up to one hour post-challenge
Time Frame
exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Title
Mean largest negative (or mean smallest positive) percent change in the average test-day pre-dose baseline percent predicted FEV1 value observed up to one hour post-challenge
Time Frame
exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Title
Time to recovery (in minutes) measured from time of completion of exercise challenge to time FEV1 returns to 10% or less of baseline value during the recovery phase
Time Frame
exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Title
Total changes in FEV1 expressed as the baseline-adjusted area-under-the-effect curve of the percent-predicted FEV1 versus time over 60 minutes (AUEC0 60)
Time Frame
exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Title
Percentage of patients who are "protected" (maximum percent decrease in the baseline absolute FEV1 <10%), "partially protected" (10 20%), and "unprotected" (>20%).
Time Frame
exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Pearlman, MD
Organizational Affiliation
Colorado Allergy and Asthma Centers, PC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado Allergy and Asthma Centers, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Colorado Allergy and Asthma Centers, PC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Colorado Allergy and Asthma Centers, PC
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States

12. IPD Sharing Statement

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

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