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

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ClinicalTrials.gov Identifier: NCT00054964
Recruitment Status : Completed
First Posted : February 17, 2003
Last Update Posted : February 6, 2017
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Albuterol HFA-BOI Drug: Albuterol HFA-MDI Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : March 2003
Actual Primary Completion Date : August 2003
Actual Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The area-under-the-effect curve of change in SGaw from basline over time [ Time Frame: Pre-dose and +120 minutes ]
  2. The maximum increase in SGaw from baseline over two hours [ Time Frame: Baseline through +120 minutes ]
  3. Time in hours to the maximum increase in SGaw from baseline [ Time Frame: Baseline through +120 minutes post-dose ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
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.

Responsible Party: Teva Study Physician, Teva Pharmaceutials
ClinicalTrials.gov Identifier: NCT00054964     History of Changes
Other Study ID Numbers: IXR-202-4-167
First Posted: February 17, 2003    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017

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