Inhaled Albuterol Sulfate For Acute Wheezing Due To Obstructive Airways Disease In Children

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: albuterol sulfate inhalation aerosol

• Registration Number: NCT00144846
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study evaluates the effect of cumulative dose administration of albuterol sulfate inhalation aerosol delivered with valved holding chamber and facemask. This is a four week study in birth to 23 month old subjects who are experiencing acute wheezing due to obstructive airways disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-05
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	albuterol sulfate inhalation aerosol	-

Primary Outcome Measures

Name	Time	Method
To evaluate safety (adverse events, vital signs, physical exams, ECG monitoring etc.) of cumulative dosing of albuterol sulfate inhalation aerosol

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy measures (percent change from baseline over entire treatment period in the TAL score, respiratory rate, wheezing etc.) of cumulative dosing of albuterol sulfate inhalation aerosol.

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇷 Ponce, Puerto Rico