The Singulair® add-on Study Effectiveness of Adding Montelukast to Inhaled Corticosteroids in Adult Subjects With Uncontrolled Asthma (0476-384)
SAS
An 8 Week Multicenter, Open-label, Observational Study to Evaluate the Effectiveness of Adding Montelukast Sodium 10 mg Per Day to Inhaled Corticosteroids in Adult Subjects With Uncontrolled Asthma
2 other identifiers
interventional
800
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the effectiveness of adding Montelukast Sodium (singulair®) 10 mg per day to inhaled corticosteroids in adult subjects with uncontrolled asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Jun 2006
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 18, 2008
CompletedFirst Posted
Study publicly available on registry
September 19, 2008
CompletedJune 7, 2024
February 1, 2022
1.3 years
September 18, 2008
June 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
To describe the percentage of patients with asthma who will be controlled after 8 weeks of treatment with montelukast used in combination with inhaled corticosteroids
8 weeks
Secondary Outcomes (1)
To evaluate the safety and tolerability of montelukast
8 weeks
Study Arms (1)
1
EXPERIMENTALMontelukast
Interventions
Eligibility Criteria
You may qualify if:
- Patients Is 18 Years Old
- Note 1: Regulatory Requirements Necessitate The Following Criterion. It May Not Be Appropriate For Your Patients. Female Patients Of Childbearing Potential Should Be Informed Not To Become Pregnant During The Study By Using The Appropriate Contraceptive Methods (Oral Or Long-Acting Contraceptive Injections (Depo Provera), Intrauterine Device (Iud), Or Barrier Methods (E.G. Condom Or Diaphragm Plus Spermicide) Or To Be Abstinent (No Sexual Intercourse)) Beginning At Least 7 Days Before Visit 1 And Continuing At Least 14 Days After Visit 4 Or A Discontinuation Visit
- Note 2: For Alberta: Investigators Who Will Recruit In Private Office, No Patients Can Be Recruited In The Study Until Approval From The College Of Physicians And Surgeons Of Alberta Ethics Committee Is Obtained
You may not qualify if:
- Patient Is Well Controlled, Adherent And Satisfied With Current Controller Therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (1)
FitzGerald JM, Foucart S, Coyle S, Sampalis J, Haine D, Psaradellis E, McIvor RA. Montelukast as add-on therapy to inhaled corticosteroids in the management of asthma (the SAS trial). Can Respir J. 2009 May-Jun;16 Suppl A(Suppl A):5A-14A. doi: 10.1155/2009/593753.
PMID: 19557206DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2008
First Posted
September 19, 2008
Study Start
June 1, 2006
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
June 7, 2024
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share