AsthmaPhase 2NCT00054964
Comparative Effectiveness of a Breath-operated Albuterol Inhaler in Asthma Patients With Poor Inhaler Technique
A Phase 2 study testing Albuterol HFA-BOI and Albuterol HFA-MDI in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in United States.
Trial summary
This study was designed to examine the effectiveness of a breath-operated albuterol inhaler in asthma patients who have difficulty using their standard "press-and-breathe" inhaler. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Albuterol HFA-BOI and Albuterol HFA-MDI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2003to 31 Aug 2003
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asthma diagnosed ≥6 months prior and stable for 4 weeks prior to screening
- Poor inhaler coordination as assessed at screening
- Reversible bronchoconstriction (≥ 12% increase in FEV1)
Who cannot join
- Albuterol allergy
- Investigational drug within 30 days
- Injected corticosteroid within 6 weeks
- Requires beta-blockers, MAO inhibitors, tricyclic antidepressants, long-acting beta-blockers, steroids other than those inhaled
- Other criterial apply
Trial locations and contacts
1 site in 1 country.
United States1 site
National Jewish Medical and Research Ceter
Denver, Colorado, 80206
About this study
Official title: Comparison of Single-dose Efficacy of Albuterol-HFA-BOI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability
This study was designed to examine the effectiveness of a breath-operated albuterol inhaler in asthma patients who have difficulty using their standard "press-and-breathe" inhaler.
Read the detailed description
This was a single-center, randomized, open-label, active-controlled, 2-period, 2-sequence, single dose-dose, crossover comparison of the ability of Albuterol BOI-HFA to produce bronchodilation relative to that produced by to albuterol MDI-HFA in at least 12 asthmatics with poor inhaler coordinating ability.
- Conditions
- Asthma
- Being tested
- Albuterol HFA-BOI, Albuterol HFA-MDI
- 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-BOIDrug
Albuterol HFA breath operated inhaler, 90 mcg/sprau
Albuterol HFA-MDIDrug
Also called Proair HFA-MDI
Albuterol HFA multi-dose inhaler
| Study group | Role | What they receive |
|---|---|---|
| Albuterol HFA-BOI | Experimental | Not described Receives: Drug: Albuterol HFA-BOI |
| Albuterol HFA-MDI | Active comparator | Not described Receives: Drug: Albuterol HFA-MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in SGaw (A measure of the change in specific airway conductance - how hard it is to get air into the lungs)
Measured: Pre-dose and +120 minutes
Secondary outcomes (3)
The area-under-the-effect curve of change in SGaw from basline over time
Measured: Pre-dose and +120 minutes
The maximum increase in SGaw from baseline over two hours
Measured: Baseline through +120 minutes
Time in hours to the maximum increase in SGaw from baseline
Measured: Baseline through +120 minutes post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2003 (estimated)
- Study start31 Mar 2003
- Primary completion31 Aug 2003
- Study completion31 Aug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harold Nelson, MD, Principal investigator, National Jewish Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00054964
- Sponsor's protocol ID
- IXR-202-4-167
- Status last verified
- Nov 2021
- First submitted
- 14 Feb 2003
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Nelson HS, Wenzel SE, Weisfeld L, Llorens L, Atkinson DC, Stahl EG. Comparison of single-dose efficacy of albuterol-hydrofloroalkane breath-activated inhaler and Nelson HS, Wenzel SE, Weisfeld L, Llorens L, Atkinson DC, Stahl EG. Comparison of single-dose efficacy of albuterol-hydrofloroalkane metered-dose inhaler in asthma patients with poor inhaler coordinating ability. Chest 2008;134:92003S (Abstracts, ACCP Annual Meeting, October 25-30, 2008, Philadelphia, Pennsylvania, USA.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Single-dose Efficacy of Albuterol-HFA-BOI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability
- ClinicalTrials.gov ID
- NCT00054964
- Acronym / sponsor ID
- IXR-202-4-167
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2003 (actual)
- Primary completion
- 31 Aug 2003 (actual)
- Study completion
- 31 Aug 2003 (actual)
- First posted
- 17 Feb 2003 (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 a breath-operated albuterol inhaler in asthma patients who have difficulty using their standard "press-and-breathe" inhaler.
Detailed description
This was a single-center, randomized, open-label, active-controlled, 2-period, 2-sequence, single dose-dose, crossover comparison of the ability of Albuterol BOI-HFA to produce bronchodilation relative to that produced by to albuterol MDI-HFA in at least 12 asthmatics with poor inhaler coordinating ability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albuterol HFA-BOI | Experimental | Drug: Albuterol HFA-BOI |
| Albuterol HFA-MDI | Active comparator | Drug: Albuterol HFA-MDI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Asthma diagnosed ≥6 months prior and stable for 4 weeks prior to screening
- Poor inhaler coordination as assessed at screening
- Reversible bronchoconstriction (≥ 12% increase in FEV1)
Key exclusion criteria (5 listed)
- Albuterol allergy
- Investigational drug within 30 days
- Injected corticosteroid within 6 weeks
- Requires beta-blockers, MAO inhibitors, tricyclic antidepressants, long-acting beta-blockers, steroids other than those inhaled
- Other criterial apply
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-BOIAlbuterol HFA breath operated inhaler, 90 mcg/sprau | Drug | Albuterol HFA-BOI |
| Albuterol HFA-MDIAlso: Proair HFA-MDIAlbuterol HFA multi-dose inhaler | Drug | Albuterol HFA-MDI |
Primary outcome
Percent change in SGaw (A measure of the change in specific airway conductance - how hard it is to get air into the lungs)
Time frame: Pre-dose and +120 minutes
3 secondary outcomes
The area-under-the-effect curve of change in SGaw from basline over time
Time frame: Pre-dose and +120 minutes
The maximum increase in SGaw from baseline over two hours
Time frame: Baseline through +120 minutes
Time in hours to the maximum increase in SGaw from baseline
Time frame: Baseline through +120 minutes post-dose
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 30 Nov 2021.
- Results publicationNelson HS, Wenzel SE, Weisfeld L, Llorens L, Atkinson DC, Stahl EG. Comparison of single-dose efficacy of albuterol-hydrofloroalkane breath-activated inhaler and Nelson HS, Wenzel SE, Weisfeld L, Llorens L, Atkinson DC, Stahl EG. Comparison of single-dose efficacy of albuterol-hydrofloroalkane metered-dose inhaler in asthma patients with poor inhaler coordinating ability. Chest 2008;134:92003S (Abstracts, ACCP Annual Meeting, October 25-30, 2008, Philadelphia, Pennsylvania, USA.
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.
Harold Nelson, MD principal investigator
National Jewish Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Albuterol HFA-BOI and Albuterol HFA-MDI in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site 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 3 inclusion and 5 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 30 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 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percent change in SGaw (A measure of the change in specific airway conductance - how hard it is to get air into the lungs) (time frame: Pre-dose and +120 minutes). 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 NCT00054964, which also lists 1 linked publication.
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 30 Nov 2021.