Comparative Effectiveness of a Breath-operated Albuterol Inhaler in Asthma Patients With Poor Inhaler Technique

This study has been completed.

Sponsor:

Information provided by:

Teva Pharmaceutical Industries

ClinicalTrials.gov Identifier:

NCT00054964

First received: February 14, 2003

Last updated: March 19, 2015

Last verified: March 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

February 14, 2003

Last Updated Date

March 19, 2015

Start Date ^ICMJE

March 2003

Primary Completion Date

August 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00054964 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The area-under-the-effect curve of change in SGaw from basline over time [ Time Frame: Pre-dose and +120 minutes ] [ Designated as safety issue: No ]
The maximum increase in SGaw from baseline over two hours [ Time Frame: Baseline through +120 minutes ] [ Designated as safety issue: No ]
Time in hours to the maximum increase in SGaw from baseline [ Time Frame: Baseline through +120 minutes post-dose ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparative Effectiveness of a Breath-operated Albuterol Inhaler in Asthma Patients With Poor Inhaler Technique

Official Title ^ICMJE

Comparison of Single-dose Efficacy of Albuterol-HFA-BOI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability

Brief 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.

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Albuterol HFA-BOI
Albuterol HFA breath operated inhaler, 90 mcg/sprau
Drug: Albuterol HFA-MDI
Albuterol HFA multi-dose inhaler

Other Name: Proair HFA-MDI

Study Arm (s)

Experimental: Albuterol HFA-BOI
Intervention: Drug: Albuterol HFA-BOI
Active Comparator: Albuterol HFA-MDI
Intervention: Drug: Albuterol HFA-MDI

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2003

Primary Completion Date

August 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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)

Exclusion Criteria:

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

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00054964

Other Study ID Numbers ^ICMJE

IXR-202-4-167

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Teva Study Physician, Teva Pharmaceutials

Study Sponsor ^ICMJE

Teva Branded Pharmaceutical Products, R&D Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Harold Nelson, MD

National Jewish Medical Center

Information Provided By

Teva Pharmaceutical Industries

Verification Date

March 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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