NCT00442338 is a Phase 3 clinical trial of montelukast sodium in Asthma, sponsored by Organon and Co.

Who is sponsoring NCT00442338?

NCT00442338 is sponsored by Organon and Co.

What drugs are being tested in NCT00442338?

Interventions in NCT00442338: montelukast sodium, montelukast sodium, aminophylline hydrate.

Is NCT00442338 still recruiting?

NCT00442338 is currently completed. Last updated 31 January 2022.

Are results published for NCT00442338?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-01-31 · How we verify

NCT00442338

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

MK-476 IV Formulation Phase III Open Label Exploratory Comparative Study - Acute Exacerbations of Asthma -

Completed Phase 3 Results posted Last updated 31 January 2022

What this trial tests

Phase 3 trial testing montelukast sodium in Asthma in 91 participants. Completed in 1 August 2007.

Timeline

1 March 2007

Primary endpoint
1 August 2007

1 August 2007

Quick facts

Lead sponsor	Organon and Co
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	91
Start date	1 March 2007
Primary completion	1 August 2007
Estimated completion	1 August 2007

Drugs / interventions tested

montelukast sodium — full drug profile →
montelukast sodium — full drug profile →
aminophylline hydrate — full drug profile →

Conditions studied

Asthma — all drugs for Asthma →

Sponsor

Organon and Co — full company profile →

Who can join

Adults 15 to 75, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration
Time frame: Baseline and 60 minutes after study drug administration
The time weighted average change from Baseline in Forced Expiratory Volume in One Second (FEV1) over the first 60 minutes after study drug administration (average change FEV1 (0-60 min)). Baseline (pre-allocation) was the last measurement obtained during the screening period.

Sponsor's own description

The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult participants with acute asthma.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Efficacy and side effects of intravenous theophylline in acute asthma: a systematic review and meta-analysis.
Mahemuti G, Zhang H, Li J, Tieliwaerdi N, et al · · 2018 · cited 20× · PMID 29391776 · DOI 10.2147/dddt.s156509

Verify or expand the search:

Other trials of montelukast sodium

Trials testing the same drug.

NCT00545844 — Singulair(R) In Asthma And Allergic Rhinitis (0476-383) · 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 NCT00442338 (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: 31 January 2022

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/NCT00442338.

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