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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 Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier:
NCT00054964
First received: February 14, 2003
Last updated: December 12, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Asthma
 Drug: Albuterol HFA-BOI
Drug: Albuterol HFA-MDI
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Single-dose Efficacy of Albuterol-HFA-BOI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Teva Branded Pharmaceutical Products, R&D Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 14
Study Start Date: March 2003
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Albuterol HFA-BOI Drug: Albuterol HFA-BOI
Albuterol HFA breath operated inhaler, 90 mcg/sprau
Active Comparator: Albuterol HFA-MDI Drug: Albuterol HFA-MDI
Albuterol HFA multi-dose inhaler
Other Name: Proair HFA-MDI

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054964

Locations
United States, Colorado
National Jewish Medical and Research Ceter
Denver, Colorado, United States, 80206
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Principal Investigator: Harold Nelson, MD National Jewish Medical Center
  More Information

No publications provided

Responsible Party: Teva Study Physician, Teva Pharmaceutials
ClinicalTrials.gov Identifier: NCT00054964     History of Changes
Other Study ID Numbers: IXR-202-4-167
Study First Received: February 14, 2003
Last Updated: December 12, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 22, 2013