NCT00756418 is a Phase 4 clinical trial of montelukast in Asthma, sponsored by Organon and Co.

Who is sponsoring NCT00756418?

NCT00756418 is sponsored by Organon and Co.

What drugs are being tested in NCT00756418?

Interventions in NCT00756418: montelukast, Theophylline.

Is NCT00756418 still recruiting?

NCT00756418 is currently completed. Last updated 15 August 2024.

Last reviewed 2024-08-15 · How we verify

NCT00756418

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Montelukast Post-marketing Comparative Study With Theophyline Added to Inhaled Corticosteroid (0476-396)

Completed Phase 4 Last updated 15 August 2024

What this trial tests

Phase 4 trial testing montelukast in Asthma in 84 participants. Completed in 28 August 2004.

Timeline

1 June 2003

Primary endpoint
28 August 2004

28 August 2004

Quick facts

Lead sponsor	Organon and Co
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	84
Start date	1 June 2003
Primary completion	28 August 2004
Estimated completion	28 August 2004

Drugs / interventions tested

montelukast (montelukast) — full drug profile →
Theophylline — full drug profile →

Conditions studied

Asthma — all drugs for Asthma →

Sponsor

Organon and Co — full company profile →

Who can join

Adults 6 to 14, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A clinical study explores the safety and efficacy of montelukast and to compare the safety and efficacy of montelukast with those of theophylline in pediatric bronchial asthma patients when they are used in conjunction with inhaled steroids.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Anti-leukotriene agents compared to inhaled corticosteroids in the management of recurrent and/or chronic asthma in adults and children.
Chauhan BF, Ducharme FM. · · 2012 · cited 80× · PMID 22592685 · DOI 10.1002/14651858.cd002314.pub3
Packaging and Delivery of Asthma Therapeutics.
Mathis BJ, Kusumoto M, Zaboronok A, Hiramatsu Y. · · 2021 · cited 9× · PMID 35056988 · DOI 10.3390/pharmaceutics14010092

Verify or expand the search:

Other trials of montelukast

Trials testing the same drug.

NCT02410278 — Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving T · Phase 4 · completed

Other recruiting trials for Asthma

Currently open trials in the same condition.

NCT07525375 — A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared t · Phase 2 · recruiting
NCT07536256 — Community Connections Through Native Hawaiian Cultural Values to Strengthen Youth Resilience, Health, and Well-Being · NA · recruiting
NCT07556159 — A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice · recruiting
NCT07282886 — VENTURI (VENTilation Using Respiratory Imaging) · Phase 2 · recruiting
NCT07433569 — A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Differ · Phase 1 · recruiting

Other Organon and Co trials

Trials by the same sponsor.

NCT05761444 — Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients · Phase 4 · completed
NCT05789576 — A Study to Investigate Efficacy and Safety of VTAMA® (Tapinarof) Cream, 1% in Plaque Psoriasis in the Head and Neck Regi · Phase 4 · completed
NCT05680740 — A Study to Investigate Efficacy and Safety of VTAMA (Tapinarof) Cream, 1% in Intertriginous Plaque Psoriasis · Phase 4 · completed
NCT05560646 — A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo in Participants Aged 18 · Phase 2 · completed
NCT05264506 — Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive · Phase 3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00756418 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Organon and Co
Last refreshed: 15 August 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00756418.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing