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

NCT ID: NCT00054964

Last Updated: 2021-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2003-08-31

Brief Summary

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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

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Albuterol HFA-BOI

Group Type EXPERIMENTAL

Albuterol HFA-BOI

Intervention Type DRUG

Albuterol HFA breath operated inhaler, 90 mcg/sprau

Albuterol HFA-MDI

Group Type ACTIVE_COMPARATOR

Albuterol HFA-MDI

Intervention Type DRUG

Albuterol HFA multi-dose inhaler

Interventions

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Albuterol HFA-BOI

Albuterol HFA breath operated inhaler, 90 mcg/sprau

Intervention Type DRUG

Albuterol HFA-MDI

Albuterol HFA multi-dose inhaler

Intervention Type DRUG

Other Intervention Names

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Proair HFA-MDI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harold Nelson, MD

Role: PRINCIPAL_INVESTIGATOR

National Jewish Medical Center

Locations

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National Jewish Medical and Research Ceter

Denver, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT

Other Identifiers

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IXR-202-4-167

Identifier Type: -

Identifier Source: org_study_id