Completed PHASE3 INTERVENTIONAL 3-arm NCT00284856

Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)

A Multicenter, Randomized, Double-Blind, Parallel-Group 6-Month Study to Evaluate the Efficacy and Safety of Oral Montelukast Sodium, Fluticasone Propionate and Placebo in Patients With Chronic Asthma Who Smoke Cigarettes

Sponsor: Organon and Co

Conditions Asthma

Interventions Comparator: Placebo Comparator: fluticasone montelukast sodium

Updated 8 times since 2017 Last updated: May 7, 2024 Started: May 31, 2006 Primary completion: Apr 30, 2010 Completion: Apr 30, 2010

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Asthma and is currently completed. Organon and Co leads this study, which shows 8 recorded versions since 2006 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

8 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jun 2024 — Jul 2024 [monthly]

Completed PHASE3
Mar 2022 — Jun 2024 [monthly]

Completed PHASE3
Jan 2021 — Mar 2022 [monthly]

Completed PHASE3

▶ Show 3 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

May 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Organon and Co

Data source: Organon and Co

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.