Completed PHASE3 INTERVENTIONAL 2-arm NCT00127166

Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)

A Multicenter, Double-Blind, Randomized, Crossover Design Study to Evaluate the Effect of Montelukast Vs. Salmeterol on the Inhibition of Exercise-Induced Bronchoconstriction in Asthmatic Patients Aged 6-14 Years

Sponsor: Organon and Co

Conditions Exercise Induced Asthma

Interventions Fluticasone propionate Montelukast matching placebo Montelukast sodium Salmeterol matching placebo Salmeterol xinafoate

Updated 8 times since 2017 Last updated: May 7, 2024 Started: Dec 31, 2005 Primary completion: Nov 30, 2008 Completion: Nov 30, 2008

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

Listed as NCT00127166, this PHASE3 trial focuses on Exercise Induced Asthma and remains completed. Sponsored by Organon and Co, it has been updated 8 times since 2005, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

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

Dec 2005

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.