A Study to Compare Effectiveness of Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics (0476-329)

A Randomized, Open Label, Cross-Over Study Comparing Effectiveness for the Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00157937

Enrollment

Registered

2005-09-12

Start date

2003-02-28

Completion date

2005-06-30

Last updated

2024-08-15

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

Conditions

Allergic Rhinitis, Asthma

Brief summary

Subjects have 8-week with montelukast sodium or comparator drug administration period, 2-week wash-out period and 8-week comparator drug or the drug administration period (with cross-over design) for assessment of the drug efficacy, safety and tolerability.

Interventions

DRUGMK0476; montelukast sodium/Duration of Treatment: 16 weeks

DRUGComparator: theophylline ER/Duration of Treatment: 16 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Males or females between the ages of 18 and 60 with mild to moderate asthma

Design outcomes

Primary

Measure	Time frame
FEV1	—

Secondary

Measure	Time frame
AM-PEFR; daytime symptom score; treatment frequency of beta agonist; global assessment investigator's symptom assessment; Quality of Life Questionnaire for Adult Korean Asthmatics; QLQAKA	—

Outcome results

None listed

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