Skip to main content
OpenTrials
Completed

NCT Number: NCT00140946

A Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients (0476-075)

A study to assess the clinical effect of montelukast sodium with concomitant administration of inhaled budesonide in asthmatic patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females between the ages of 18 and 70 with asthma

Treatment and study plan

MK0476; montelukast sodium/Duration of Treatment: 16 weeks

Drug

Comparator: placebo / Duration of Treatment: 16 weeks

Drug

Primary outcomes

  1. Percentage of days of asthma exacerbations

Secondary outcomes

  1. Percentage of asthma free days

  2. Percentage of nocturnal awakenings

  3. Beta agonist use

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Two-Period, Parallel-group Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients.

Important dates

Study start
1998
Primary completion
2000
Study completion
2000
First posted
Sep 1, 2005
Registry last updated
Feb 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.