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NCT00755794 Clinical Trial

The Singulair® add-on Study Effectiveness of Adding Montelukast to Inhaled Corticosteroids in Adult Subjects With Uncontrolled Asthma (0476-384)

Asthma Clinical Trial

— SAS  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00755794
Other study ID # 0476-384
Secondary ID 2008_548
Status Completed
Phase Phase 3
First received
Last updated
Start date June 2006
Est. completion date September 2007

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 800
Est. completion date September 2007
Est. primary completion date September 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Patient Is Well Controlled, Adherent And Satisfied With Current Controller Therapy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• montelukast sodium
Montelukast Tablet, 10 mg, 8 weeks, daily

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

Outcome
Type Measure Description Time frame Safety issue
Primary 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 To evaluate the safety and tolerability of montelukast 8 weeks
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