Comparative Effectiveness of a Breath-operated Albuterol Inhaler in Asthma Patients With Poor Inhaler Technique
Comparison of Single-dose Efficacy of Albuterol-HFA-BOI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 asthma
Started Mar 2003
Shorter than P25 for phase_2 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2003
CompletedFirst Posted
Study publicly available on registry
February 17, 2003
CompletedStudy Start
First participant enrolled
March 31, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2003
CompletedNovember 30, 2021
November 1, 2021
5 months
February 14, 2003
November 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change in SGaw (A measure of the change in specific airway conductance - how hard it is to get air into the lungs)
Pre-dose and +120 minutes
Secondary Outcomes (3)
The area-under-the-effect curve of change in SGaw from basline over time
Pre-dose and +120 minutes
The maximum increase in SGaw from baseline over two hours
Baseline through +120 minutes
Time in hours to the maximum increase in SGaw from baseline
Baseline through +120 minutes post-dose
Study Arms (2)
Albuterol HFA-BOI
EXPERIMENTALAlbuterol HFA-MDI
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Jewish Medical and Research Ceter
Denver, Colorado, 80206, United States
Related Publications (1)
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.
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harold Nelson, MD
National Jewish Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2003
First Posted
February 17, 2003
Study Start
March 31, 2003
Primary Completion
August 31, 2003
Study Completion
August 31, 2003
Last Updated
November 30, 2021
Record last verified: 2021-11