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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00140946

Enrollment

546

Registered

2005-09-01

Start date

1998-03-31

Completion date

2000-10-31

Last updated

2022-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

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

Interventions

DRUGMK0476; montelukast sodium/Duration of Treatment: 16 weeks

DRUGComparator: placebo / Duration of Treatment: 16 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Percentage of days of asthma exacerbations	—

Secondary

Measure	Time frame
Percentage of asthma free days	—
Percentage of nocturnal awakenings	—
Beta agonist use	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026