AsthmaPhase 4NCT00530062
Comparison of Single-Dose Efficacy of an Albuterol Breath-Actuated Inhaler (Albuterol-HFA-BAI) Versus an Albuterol Metered-Dose Inhaler (Albuterol-HFA-MDI) in Participants With Asthma
A Phase 4 study testing Albuterol-HFA-MDI and Albuterol-HFA-BAI in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 5 sites in United States.
Trial summary
This is a research study designed to compare the single-dose efficacy of albuterol-hydrofluoroalkane-breath-actuated inhaler (HFA-BAI) and albuterol-HFA-metered-dose inhaler (MDI) in asthmatics with poor inhaler coordinating abilities. Read more about this study
- Who is it for?
- Ages 7 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Albuterol-HFA-MDI and Albuterol-HFA-BAI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Jul 2007to 24 Oct 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Asthma of a minimum of 6 months duration
- Participants who demonstrate poor inhalation/actuation coordination when evaluated at screening utilizing the Aerosol Inhalation Monitor (AIM, Vitalograph) prior to any training and following training in 3 consecutive attempts
- Reversible bronchoconstriction of >12% increase in FEV1 with a cumulative dose of 450 mcg of albuterol
- The reversibility (FEV1) of ≤70% following administration of the initial 90 mcg of albuterol
- Ability to perform spirometry reproducibly
- Ability to self-perform peak expiratory flow (PEF) determinations and report scores on diaries
Show all 9Show fewer
- Can tolerate withdrawal of applicable medications for qualification at screening
- Otherwise healthy individuals
- Non-smokers for at least 2 years prior to the screening visit
Who cannot join
- Allergy or sensitivity to albuterol
- Exposure to investigational drugs within 30 days prior to the screening visit
- Continuous treatment with beta-blockers, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, and/or systemic corticosteroids
- Treated with oral or injectable corticosteroids within the 6 weeks prior to the screening visit
- The prescribed dose regimen of any required antileukotrienes, inhaled corticosteroids and/or inhaled cromolyn and/or nedocromil had not been stable for at least 4 weeks prior to the screening visit
- Inability to tolerate or unwillingness to comply with required washout periods for all applicable medications
Show all 12Show fewer
- Hospitalization for acute exacerbation of asthma more than twice in past year
- Treatment in an emergency room or hospitalization for asthmatic symptoms within 3 months prior to the screening visit
- An upper respiratory tract infection and/or sinusitis associated with exacerbation of asthma that is unresolved 3 weeks prior to the screening visit
- History and/or presence of any clinically significant non-asthmatic acute or chronic disease
- Known or suspected substance abuse
- Previous enrollment in an IVAX Research-sponsored Albuterol-HFA asthma study Note: Other inclusion and exclusion criteria may apply.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Clinical Study Site
Huntington Beach, California, 92647
Clinical Study Site
Lake Oswego, Oregon, 97035
Teva Clinical Study Site
Lakewood, Colorado, 80401
Clinical Study Site
Minneapolis, Minnesota, 55402
Clinical Study Site
Oklahoma City, Oklahoma, 73120
About this study
Official title: Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability
This is a research study designed to compare the single-dose efficacy of albuterol-hydrofluoroalkane-breath-actuated inhaler (HFA-BAI) and albuterol-HFA-metered-dose inhaler (MDI) in asthmatics with poor inhaler coordinating abilities.
- Conditions
- Asthma
- Being tested
- Albuterol-HFA-MDI, Albuterol-HFA-BAI
- Keywords
- Asthma and Poor Coordinators of Asthma Inhalers
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albuterol-HFA-MDIDrug
Also called Albuterol, ProAir
Inhalation Aerosols, 90 mcg, 1 dose per treatment period
Albuterol-HFA-BAIDrug
Also called Albuterol
Inhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Albuterol-HFA-BAI | Experimental | Participants will receive single actuation of albuterol 90 micrograms (mcg), administered using BAI in treatment period 1 or 2. Receives: Drug: Albuterol-HFA-BAI |
| Albuterol-HFA-MDI | Active comparator | Participants will receive single actuation of albuterol 90 mcg, administered using MDI in treatment period 1 or 2. Receives: Drug: Albuterol-HFA-MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area-Under-the-Effect Curve of Percent Change in Test-Day Baseline Forced Expiratory Volume in 1 Second (FEV1) Versus Time (up to 2 Hours Postdose), %FEV1 AUEC0-2
The %FEV1 AUEC0-2 was calculated using the linear trapezoidal rule. The baseline value consisted of the average of the two predose FEV1 measurements. The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.
Measured: Baseline, Up to 2 hours postdose
Secondary outcomes (8)
Percent Change From Baseline in FEV1 Within 30 Minutes Postdose
The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.
Measured: Baseline up to 30 minutes postdose
Percent Change From Baseline in FEV1 up to 2 Hours Postdose
The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.
Measured: Baseline up to 2 hours postdose
Area-Under-the-Effect Curve of Change in Test-Day Baseline FEV1 Versus Time (up to 2 Hours Postdose), FEV1 AUEC0-2
The %FEV1 AUEC0-2 was calculated using the linear trapezoidal rule. The test-day baseline consisted of the average of the two predose FEV1 measurements. The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.
Measured: Baseline up to 2 hours postdose
Percentage of Participants With a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose
Measured: Baseline up to 2 hours postdose
Percentage of Participants With a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose
Measured: Baseline up to 2 hours postdose
Time to a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose
The number of minutes required for the baseline FEV1 to increase by at least 12% within the 2-hour observation period. Median time and corresponding confidence intervals (CIs) were obtained via the Kaplan-Meier estimate.
Measured: Baseline up to 2 hours postdose
Time to a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose
The number of minutes required for the baseline FEV1 to increase by at least 15% within the 2-hour observation period. Median time and corresponding CIs were obtained via the Kaplan-Meier estimate.
Measured: Baseline up to 2 hours postdose
Time to Maximum Increase in FEV1
Each calculation for FEV1 took several minutes in order to obtain the highest of 3 measurements. The total collection time exceeded the 120 mins post-dose time frame for some participants.
Measured: Baseline up to 2 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study start25 Jul 2007
- Primary completion24 Oct 2008
- Study completion24 Oct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530062
- Sponsor's protocol ID
- IXR-404-04-167
- Status last verified
- Aug 2022
- First submitted
- 14 Sep 2007
- Last updated
- 7 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability
- ClinicalTrials.gov ID
- NCT00530062
- Acronym / sponsor ID
- IXR-404-04-167
- Conditions
- Asthma
- Keywords
- Asthma and Poor Coordinators of Asthma Inhalers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2007 (actual)
- Primary completion
- 24 Oct 2008 (actual)
- Study completion
- 24 Oct 2008 (actual)
- First posted
- 17 Sep 2007 (estimated)
- Results
- Posted 31 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study designed to compare the single-dose efficacy of albuterol-hydrofluoroalkane-breath-actuated inhaler (HFA-BAI) and albuterol-HFA-metered-dose inhaler (MDI) in asthmatics with poor inhaler coordinating abilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albuterol-HFA-BAI | Experimental | Drug: Albuterol-HFA-BAIParticipants will receive single actuation of albuterol 90 micrograms (mcg), administered using BAI in treatment period 1 or 2. |
| Albuterol-HFA-MDI | Active comparator | Drug: Albuterol-HFA-MDIParticipants will receive single actuation of albuterol 90 mcg, administered using MDI in treatment period 1 or 2. |
Who may qualify
- Ages
- 7 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Asthma of a minimum of 6 months duration
- Participants who demonstrate poor inhalation/actuation coordination when evaluated at screening utilizing the Aerosol Inhalation Monitor (AIM, Vitalograph) prior to any training and following training in 3 consecutive attempts
- Reversible bronchoconstriction of >12% increase in FEV1 with a cumulative dose of 450 mcg of albuterol
- The reversibility (FEV1) of ≤70% following administration of the initial 90 mcg of albuterol
- Ability to perform spirometry reproducibly
Key exclusion criteria (12 listed)
- Allergy or sensitivity to albuterol
- Exposure to investigational drugs within 30 days prior to the screening visit
- Continuous treatment with beta-blockers, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, and/or systemic corticosteroids
- Treated with oral or injectable corticosteroids within the 6 weeks prior to the screening visit
- The prescribed dose regimen of any required antileukotrienes, inhaled corticosteroids and/or inhaled cromolyn and/or nedocromil had not been stable for at least 4 weeks prior to the screening visit
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-HFA-MDIAlso: Albuterol, ProAirInhalation Aerosols, 90 mcg, 1 dose per treatment period | Drug | Albuterol-HFA-MDI |
| Albuterol-HFA-BAIAlso: AlbuterolInhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period. | Drug | Albuterol-HFA-BAI |
Primary outcome
Area-Under-the-Effect Curve of Percent Change in Test-Day Baseline Forced Expiratory Volume in 1 Second (FEV1) Versus Time (up to 2 Hours Postdose), %FEV1 AUEC0-2
Time frame: Baseline, Up to 2 hours postdose
The %FEV1 AUEC0-2 was calculated using the linear trapezoidal rule. The baseline value consisted of the average of the two predose FEV1 measurements. The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.
8 secondary outcomes
Percent Change From Baseline in FEV1 Within 30 Minutes Postdose
Time frame: Baseline up to 30 minutes postdose
Percent Change From Baseline in FEV1 up to 2 Hours Postdose
Time frame: Baseline up to 2 hours postdose
Area-Under-the-Effect Curve of Change in Test-Day Baseline FEV1 Versus Time (up to 2 Hours Postdose), FEV1 AUEC0-2
Time frame: Baseline up to 2 hours postdose
Percentage of Participants With a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose
Time frame: Baseline up to 2 hours postdose
Percentage of Participants With a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose
Time frame: Baseline up to 2 hours postdose
Time to a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose
Time frame: Baseline up to 2 hours postdose
Time to a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose
Time frame: Baseline up to 2 hours postdose
Time to Maximum Increase in FEV1
Time frame: Baseline up to 2 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Albuterol-HFA-MDI and Albuterol-HFA-BAI in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 5 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 9 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 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Area-Under-the-Effect Curve of Percent Change in Test-Day Baseline Forced Expiratory Volume in 1 Second (FEV1) Versus Time (up to 2 Hours Postdose), %FEV1 AUEC0-2 (time frame: Baseline, Up to 2 hours postdose). 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 7 Sep 2022.