AsthmaPhase 3NCT00308685

Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI in Pediatric Asthmatics

A Phase 3 study testing Albuterol in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to evaluate the repeat-dose safety and effectiveness of a bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11 years with asthma. The dosing period lasts three weeks and starts following a three-week run-in period. Read more about this study

Who is it for?: Ages 4 to 11 years
Conditions the study is for: Asthma
What is being tested?: Albuterol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 95 participants
Where: 14 sitesUnited States
Study dates: 10 Jun 2006to 4 Dec 2006
Phase: Phase 3
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 4 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Persistent asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening
Male and female children aged 4-11 years, inclusive, with predicted forced expiratory volume in 1 second (FEV1) 60-90%
Ability to perform spirometry
Demonstrate 12% airways reversibility

Who cannot join

Require continuous treatment with beta-blockers, monoamine oxidase inhibitors, tricyclic antidepressants, anticholinergics, and/or systemic corticosteroids
Presence of any non-asthmatic clinically-significant acute or uncontrolled chronic diseases

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Allergy and Respiratory Center
Canton, Ohio, 44718
William Storms Medical Research
Colorado Springs, Colorado, 80907
Pediatric Pulmonary Associates of North Texas
Dallas, Texas, 75230
Colorado Allergy and Asthma Centers, PC
Denver, Colorado, 80230
Colorado Allergy and Asthma Centers, PC
Englewood, Colorado, 80112
Allergy & Asthma Specialist Medical Group
Huntington Beach, California, 92647
Colorado Allergy and Asthma Centers, PC
Lakewood, Colorado, 80401
Little Rock Allergy and Asthma
Little Rock, Arkansas, 72205-4565
Clinical Research Institute
Minneapolis, Minnesota, 55402
Sneeze, Wheeze & Itch Associates, Inc.
Normal, Illinois, 61761
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120
The Asthma & Allergy Center, PC
Papillion, Nebraska, 68046
Allergy & Asthma Associates of Santa Clara Valley Research Center
San Jose, California, 95117
Southern Allergy & Asthma, PC
Savannah, Georgia, 31405

Other trials in United States

About this study

Official title: Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI (PROAIR™ HFA (Albuterol Sulfate) Breath Actuated Inhalation Aerosol) in Pediatric Asthmatics

Conditions: Asthma
Being tested: Albuterol, Placebo
Keywords: Asthma, Pediatric asthma
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlbuterolDrug
Albuterol 90mcg
PlaceboDrug
Placebo

Study groups in NCT00308685
Study group	Role	What they receive
Albuterol-HFA-BAI	Experimental	ProAir(TM) HFA, Breath Actuated Inhalation Aerosol Receives: Drug: Albuterol
Placebo-HFA-BAI	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Observed up to 2 Hours Following Completion of Dosing (FEV1max%0-2) at Day 22
The baseline FEV1 was defined as the average of the two predose measurements ( at -0.5 and 0.0 hour) on the test day (Day 22). The mean was obtained from the analysis of covariance (ANCOVA) adjusted for baseline FEV1 and the pooled investigational center.
Measured: Baseline (Predose at Day 22), 2 hours postdose at Day 22

Secondary outcomes (1)

Baseline-Adjusted Area Under the Percent-Predicted FEV1 Versus Time Curve Over 6 Hours (PPFEV1 AUEC0-6) at Day 22
Baseline-adjusted PPFEV1 AUEC0-6 on Study Day 22 was determined using both the Day 1 and Day 22 baselines.
Measured: Predose (30 and 5 minutes) and 15, 30, 45, 60, 120, 240, and 360 minutes postdose at Day 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 20064 Dec 2006

First posted30 Mar 2006 (estimated)
Study start10 Jun 2006
Primary completion4 Dec 2006
Study completion4 Dec 2006

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00308685
Sponsor's protocol ID: IXR-303-25-167
Status last verified: Mar 2022
First submitted: 28 Mar 2006
Last updated: 1 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI (PROAIR™ HFA (Albuterol Sulfate) Breath Actuated Inhalation Aerosol) in Pediatric Asthmatics
ClinicalTrials.gov ID: NCT00308685
Acronym / sponsor ID: IXR-303-25-167
Conditions: Asthma
Keywords: Asthma, Pediatric asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
Study start: 10 Jun 2006 (actual)
Primary completion: 4 Dec 2006 (actual)
Study completion: 4 Dec 2006 (actual)
First posted: 30 Mar 2006 (estimated)
Results: Posted 24 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Albuterol-HFA-BAI	Experimental	Drug: AlbuterolProAir(TM) HFA, Breath Actuated Inhalation Aerosol
Placebo-HFA-BAI	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 4 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Persistent asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening
Male and female children aged 4-11 years, inclusive, with predicted forced expiratory volume in 1 second (FEV1) 60-90%
Ability to perform spirometry
Demonstrate 12% airways reversibility

Key exclusion criteria (2 listed)

Require continuous treatment with beta-blockers, monoamine oxidase inhibitors, tricyclic antidepressants, anticholinergics, and/or systemic corticosteroids
Presence of any non-asthmatic clinically-significant acute or uncontrolled chronic diseases

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
AlbuterolAlbuterol 90mcg	Drug	Albuterol-HFA-BAI
PlaceboPlacebo	Drug	Placebo-HFA-BAI

Primary outcome

Maximum Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Observed up to 2 Hours Following Completion of Dosing (FEV1max%0-2) at Day 22
Time frame: Baseline (Predose at Day 22), 2 hours postdose at Day 22
The baseline FEV1 was defined as the average of the two predose measurements ( at -0.5 and 0.0 hour) on the test day (Day 22). The mean was obtained from the analysis of covariance (ANCOVA) adjusted for baseline FEV1 and the pooled investigational center.

1 secondary outcome

Baseline-Adjusted Area Under the Percent-Predicted FEV1 Versus Time Curve Over 6 Hours (PPFEV1 AUEC0-6) at Day 22
Time frame: Predose (30 and 5 minutes) and 15, 30, 45, 60, 120, 240, and 360 minutes postdose at Day 22

Results and safety

Results posted to the registry on 24 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Albuterol-HFA-BAI	50	47
Placebo-HFA-BAI	45	40

Primary outcome: Maximum Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Observed up to 2 Hours Following Completion of Dosing (FEV1max%0-2) at Day 22

Time frame: Baseline (Predose at Day 22), 2 hours postdose at Day 22. Mean (Standard Error). Unit: percent change

Measure	Albuterol-HFA-BAI n = 50	Placebo-HFA-BAI n = 45
Value	13.807 (0.954)	8.644 (1.044)

Albuterol-HFA-BAI vs Placebo-HFA-BAI: Difference in adjusted means: 5.163 (95% CI 2.478 to 7.847), p = 0.0002, ANCOVA

Population analysed: Intent-to-treat (ITT) population included all randomized participants who took at least 1 dose of the assigned study medication and had at least 1 postdose spirometry measurement.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Day 1 up to Day 22. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Albuterol-HFA-BAI	0 of 50 (0%)	0 of 50 (0%)	0 of 50
Placebo-HFA-BAI	0 of 45 (0%)	0 of 45 (0%)	0 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingPhase 1
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RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
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Active, not recruitingPhase 2/3
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RecruitingPhase 2
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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.

Teva Medical Expert, M.D. study director

Teva Branded Pharmaceutical Products R&D, Inc.

14 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 in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 14 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 4 inclusion and 2 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 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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?

Yes. Results are posted in the registry (first posted 24 Feb 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?

Maximum Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Observed up to 2 Hours Following Completion of Dosing (FEV1max%0-2) at Day 22 (time frame: Baseline (Predose at Day 22), 2 hours postdose at Day 22). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00308685.

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 1 Apr 2022.