Montelukast as a controller of atopic syndrome - MONTAS-study - MONTAS

Phase 1

Conditions: Allergic symptoms (rhinitis, conjunctivits, asthma, oral symptoms and atopic eczema) caused by pollen allergy to birch or timothy.
MedDRA version: 20.0Level: LLTClassification code 10001709Term: Allergic conjunctivitisSystem Organ Class: 100000004853
MedDRA version: 20.0Level: LLTClassification code 10003641Term: Atopic eczemaSystem Organ Class: 100000004858
MedDRA version: 20.0Level: LLTClassification code 10001723Term: Allergic rhinitisSystem Organ Class: 100000004855
MedDRA version: 20.0Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 100000004855

Registration Number: EUCTR2007-000047-99-FI

Lead Sponsor: Tari Haahtela

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

The inclusion criteria are:
·18 – 40 years of age
·Wheal diameter over 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:
oAllergic conjunctivitis
oAtopic eczema
oOral symptoms from vegetables or fruits by cross reactivity to birch
oUrticaria in allergen exposure

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The exclusion criteria are:
•Need for regular treatment with glucocorticoids
•Current smoking
•Other major disease or need for regular drug treatment
oCardiovascular diseases
oDiabets
oRheumatic or other immunological diseases
•Pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test if montelukast could be used as an easy systemic controller of various aspects of atopic syndrome (rhinitis, conjunctivitis, asthma, eczema, oral symptoms).;Secondary Objective: ;Primary end point(s): The main outcome parameter is allergic symptoms assessed with a written questionnaire.

Secondary Outcome Measures