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

What is being tested

albuterol aerosol by HFA MDI

+ albuterol aerosol by HFA BOI

+ placebo aerosol by HFA

Drug

Who is being recruted

Exercise-induced Bronchospasm

From 12 to 40 Years

+24 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled

Phase 3

Interventional

Study Start: June 2004

See protocol details

Summary

Principal SponsorTeva Branded Pharmaceutical Products R&D, Inc.

Last updated: November 24, 2021

Sourced from a government-validated database.Claim as a partner

Study start date: June 30, 2004Actual date on which the first participant was enrolled.

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

Official TitleA 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

Principal SponsorTeva Branded Pharmaceutical Products R&D, Inc.

Last updated: November 24, 2021

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

24 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, outcome assessors, and care providers do not know which treatment is being given. This is the most complete way to prevent bias and keep the study as neutral as possible.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sexBiological sex of participants that are eligible to enroll.

From 12 to 40 YearsRange of ages for which participants are eligible to join.

Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Exercise-induced Bronchospasm

Criteria

12 inclusion criteria required to participate

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

Show More Criteria

12 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups

are designated in this study

33.333% chance

of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Colorado Allergy and Asthma Centers, PCDenver, United StatesSee the location

Suspended

Colorado Allergy and Asthma Centers, PCEnglewood, United States

Suspended

Colorado Allergy and Asthma Centers, PCLakewood, United States

Completed3 Study Centers

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

albuterol aerosol by HFA MDI

+ albuterol aerosol by HFA BOI

+ placebo aerosol by HFA

Exercise-induced Bronchospasm

Treatment Study

Summary

Protocol

Randomized Allocation

Parallel Assignment

Placebo-Controlled Study

Quadruple-Blind Study

Eligibility

Conditions

Criteria

Study Plan

Treatment Groups

Study Objectives

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.

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%).

Study Centers

This study has 3 locations