Montelukast as a Controller of Atopic Syndrome
Overview[ - collapse ][ - ]
Purpose | The purpose of the study is to find out if montelukast can be used to treat the various symptoms of allergic syndrome. |
---|---|
Condition | Seasonal Allergic Rhinitis Allergic Conjunctivitis Atopic Eczema Asthma |
Intervention | Drug: montelukast |
Phase | Phase 4 |
Sponsor | Helsinki University |
Responsible Party | Helsinki University |
ClinicalTrials.gov Identifier | NCT00559546 |
First Received | November 15, 2007 |
Last Updated | November 15, 2007 |
Last verified | November 2007 |
Tracking Information[ + expand ][ + ]
First Received Date | November 15, 2007 |
---|---|
Last Updated Date | November 15, 2007 |
Start Date | March 2007 |
Estimated Primary Completion Date | July 2007 |
Current Primary Outcome Measures | Allergic symptoms [Time Frame: 3 weeks] |
Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
Brief Title | Montelukast as a Controller of Atopic Syndrome |
---|---|
Official Title | Montelukast as a Controller of Atopic Syndrome |
Brief Summary | The purpose of the study is to find out if montelukast can be used to treat the various symptoms of allergic syndrome. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment |
Condition |
|
Intervention | Drug: montelukast 10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
---|---|
Estimated Enrollment | 61 |
Estimated Completion Date | July 2007 |
Estimated Primary Completion Date | Not Provided |
Eligibility Criteria | Inclusion Criteria: - Wheal diameter at least 4 mm in skin-prick test for both birch and timothy - Allergic symptoms in both upper airways (allergic rhinitis) and lower airways (asthma-like symptoms or diagnosed asthma) and at least one of the following: - Allergic conjunctivitis - Atopic eczema - Oral symptoms from vegetables or fruits by cross reactivity to birch - Urticaria in allergen exposure Exclusion Criteria: - Need for regular treatment with glucocorticoids - Current smoking - Other major disease or need for regular drug treatment - Pregnancy |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Finland |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00559546 |
---|---|
Other Study ID Numbers | HUS7/E5/07 |
Has Data Monitoring Committee | No |
Information Provided By | Helsinki University |
Study Sponsor | Helsinki University |
Collaborators | Merck Sharp & Dohme Corp. |
Investigators | Principal Investigator: Tari Haahtela, Professor Skin and Allergy Hospital, Helsinki University Hospital |
Verification Date | November 2007 |
Locations[ + expand ][ + ]
Skin and Allergy Hospital, Helsinki University Hospital | Helsinki, Finland, 00029 HUS |
---|