Exercise-induced BronchospasmPhase 3NCT00085774
Comparison of Two Bronchodilator Inhalers in Adolescents and Adults With Exercise-Induced Asthma
A Phase 3 study testing albuterol aerosol by HFA MDI and albuterol aerosol by HFA BOI in people with Exercise-induced Bronchospasm, run by Teva Branded Pharmaceutical Products R&D, Inc. at 3 sites in United States.
Trial summary
This study was designed to examine the effectiveness of two bronchodilator inhalers in patients who have exercise-induced asthma. Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Exercise-induced Bronchospasm
- What is being tested?
- albuterol aerosol by HFA MDI and albuterol aerosol by HFA BOI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jun 2004to 30 Sep 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
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- 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).
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Colorado Allergy and Asthma Centers, PC
Denver, Colorado, 80230
Colorado Allergy and Asthma Centers, PC
Englewood, Colorado, 80112
Colorado Allergy and Asthma Centers, PC
Lakewood, Colorado, 80401
About this study
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
This study was designed to examine the effectiveness of two bronchodilator inhalers in patients who have exercise-induced asthma.
- Conditions
- Exercise-induced Bronchospasm
- Being tested
- albuterol aerosol by HFA MDI, albuterol aerosol by HFA BOI, placebo aerosol by HFA
- Keywords
- albuterol, aerosol inhaler, metered-dose inhaler, breath-actuated inhaler, exercise-induced bronchospasm
- Medical subject headings
- Asthma, Exercise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albuterol aerosol by HFA MDIDrug
albuterol HFA MDI 160 mcg
albuterol aerosol by HFA BOIDrug
albuterol HFA BOI 160 mcg
placebo aerosol by HFADrug
placebo HFA
| Study group | Role | What they receive |
|---|---|---|
| Albuterol HFA BOI | Experimental | Not described Receives: Drug: albuterol aerosol by HFA BOI |
| Albuterol HFA MDI | Experimental | Not described Receives: Drug: albuterol aerosol by HFA MDI |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo aerosol by HFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Mean largest negative (or mean smallest positive) percent change in the baseline absolute FEV1 value observed up to one hour post-challenge
Measured: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
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
Measured: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
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
Measured: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
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)
Measured: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Percentage of patients who are "protected" (maximum percent decrease in the baseline absolute FEV1 <10%), "partially protected" (10 20%), and "unprotected" (>20%).
Measured: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2004 (estimated)
- Study start30 Jun 2004
- Primary completion30 Sep 2004
- Study completion30 Sep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise-induced BronchospasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David S Pearlman, MD, Principal investigator, Colorado Allergy and Asthma Centers, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00085774
- Sponsor's protocol ID
- IXR-302-4-167
- Status last verified
- Nov 2021
- First submitted
- 14 Jun 2004
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00085774
- Acronym / sponsor ID
- IXR-302-4-167
- Conditions
- Exercise-induced Bronchospasm
- Keywords
- albuterol, aerosol inhaler, metered-dose inhaler, breath-actuated inhaler, exercise-induced bronchospasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2004 (actual)
- Primary completion
- 30 Sep 2004 (actual)
- Study completion
- 30 Sep 2004 (actual)
- First posted
- 17 Jun 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to examine the effectiveness of two bronchodilator inhalers in patients who have exercise-induced asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| albuterol aerosol by HFA MDIalbuterol HFA MDI 160 mcg | Drug | Albuterol HFA MDI |
| albuterol aerosol by HFA BOIalbuterol HFA BOI 160 mcg | Drug | Albuterol HFA BOI |
| placebo aerosol by HFAplacebo HFA | Drug | Placebo |
Primary outcome
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
10 secondary outcomes
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Pearlman, MD principal investigator
Colorado Allergy and Asthma Centers, PC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing albuterol aerosol by HFA MDI and albuterol aerosol by HFA BOI in people with Exercise-induced Bronchospasm, run by Teva Branded Pharmaceutical Products R&D, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.