Montelukast as a Controller of Atopic Syndrome

Asthma Clinical Trial

— MONTAS  

Official title:

Montelukast as a Controller of Atopic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559546
• Other study ID #: HUS7/E5/07
• Status: Completed
• Phase: Phase 4
• First received: November 15, 2007
• Last updated: November 15, 2007
• Start date: March 2007
• Est. completion date: July 2007

Study information

• Verified date: November 2007
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to find out if montelukast can be used to treat the various symptoms of allergic syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Asthma
• Atopic Eczema
• Conjunctivitis
• Conjunctivitis, Allergic
• Dermatitis, Atopic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• montelukast
10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner

Locations

Country	Name	City	State
Finland	Skin and Allergy Hospital, Helsinki University Hospital	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Allergic symptoms		3 weeks
Secondary	Need for antihistamines or inhaled beta-2-agonists to relieve symptoms		3 weeks
Secondary	Exhaled nitric oxide concentration		3 weeks