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

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Albuterol HFA-BOI (Drug); Albuterol HFA-MDI (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Teva Branded Pharmaceutical Products, R&D Inc.

Official(s) and/or principal investigator(s):
Harold Nelson, MD, Principal Investigator, Affiliation: National Jewish Medical Center

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.

Clinical Details

Official title: Comparison of Single-dose Efficacy of Albuterol-HFA-BOI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percent change in SGaw (A measure of the change in specific airway conductance - how hard it is to get air into the lungs)

Secondary outcome:

The area-under-the-effect curve of change in SGaw from basline over time

The maximum increase in SGaw from baseline over two hours

Time in hours to the maximum increase in SGaw from baseline

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

National Jewish Medical and Research Ceter, Denver, Colorado 80206, United States
Additional Information

Starting date: March 2003
Last updated: March 19, 2015

Page last updated: August 23, 2015

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