Study of an Approved Drug in Patients With Asthma (0476-289)(COMPLETED)

Phase 3

Completed

• Conditions: Asthma

• Registration Number: NCT00092144
• Lead Sponsor: Organon and Co

Brief Summary

The purpose of this study is to assess the efficacy and safety of an approved drug on asthma symptoms in patients with chronic asthma which is also active during the allergy season.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02-26
• Primary Completion: 2004-06-15
• Study Completion: 2004-06-15
• Study First Submitted: 2004-09-21
• Study First Submitted QC: 2004-09-23
• Study First Posted: 2004-09-24
• Status Verified: 2022-01
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Asthma symptoms brought on by allergies

Exclusion Criteria

• Patient has any lung disease
• Currently have a sinus infection or cold symptoms

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To assess daytime asthma symptoms as measured by daily diaries over a 3-week treatment period

Secondary Outcome Measures

Name	Time	Method
To assess the following over a 3-week treatment period:
nighttime symptoms
AM PEFR
B-agonist use
PM PEFR
discontinuations due to asthma
asthma attacks