Montelukast in Chronic Asthma
February 7, 2022 updated by: Organon and Co
Montelukast in Chronic Asthma: Non-interventional Study With Montelukast 10 mg
Treatment of patients insufficiently treated with ICS or ICS + LABA.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
2000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Mild to moderate adult asthmatics (≥18 years of age) insufficiently treated with ICS or ICS + LABA
Description
Inclusion Criteria:
- Patients Insufficiently Treated With ICS Or ICS + LABA.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
1
Mild to moderate adult asthmatics (≥18years of age) insufficiently treated with ICS or ICS + LABA.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Documentation of asthma control via ACT (Asthma Control Test).
Time Frame: 6 months (12 months optional)
|
6 months (12 months optional)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mini Asthma Quality of Life Questionnaire (Mini AQLQ).
Time Frame: 6 months (12 months optional)
|
6 months (12 months optional)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
December 4, 2008
First Submitted That Met QC Criteria
December 4, 2008
First Posted (Estimate)
December 5, 2008
Study Record Updates
Last Update Posted (Actual)
February 18, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0476-421
- 2008_031 (Other Identifier: Merck)
- MK-0476-421
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.