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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 30, 2014