Completed

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

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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 Allergies
+7

+ Asthma
+ Asthma, Exercise-Induced
From 12 to 40 Years
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: January 18, 2026
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 
NCT00085774
Principal SponsorTeva Branded Pharmaceutical Products R&D, Inc.
Last updated: January 18, 2026
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 Allergies
Asthma
Asthma, Exercise-Induced
Bronchial Diseases
Bronchial Spasm
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
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.

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

albuterol HFA MDI 160 mcg
Group II
Experimental

albuterol HFA BOI 160 mcg
Group III
Placebo

placebo HFA
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