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

Tracking Information
First Submitted Date ICMJE	February 14, 2003
First Posted Date ICMJE	February 17, 2003
Last Update Posted Date	February 6, 2017
Study Start Date ICMJE	March 2003
Actual Primary Completion Date	August 2003 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 12, 2011)	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 ]
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; (submitted: December 12, 2011)	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 ]
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; Intervention Model: Crossover Assignment; Masking: None (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 Arms	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
Actual Enrollment ICMJE; (submitted: December 12, 2011)	14
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	August 2003
Actual 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
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	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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
PRS Account	Teva Pharmaceutical Industries
Verification Date	February 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP