Montelukast as a Controller of Atopic Syndrome

Phase 4

Completed

• Conditions: Seasonal Allergic Rhinitis; Allergic Conjunctivitis; Asthma; Atopic Eczema
• Interventions: Drug: montelukast

• Registration Number: NCT00559546
• Lead Sponsor: University of Helsinki

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 available

Study Timeline

• Study Start: 2007-03
• Study Completion: 2007-07
• Status Verified: 2007-11
• Study First Submitted: 2007-11-15
• Study First Submitted QC: 2007-11-15
• Last Update Submitted: 2007-11-15
• Study First Posted: 2007-11-16
• Last Update Posted: 2007-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	montelukast	3 weeks of Montelukast and 3 weeks of placebo treatment
2	montelukast	3 weeks of placebo and 3 weeks of montelukast treatment

Primary Outcome Measures

Name	Time	Method
Allergic symptoms	3 weeks

Secondary Outcome Measures

Name	Time	Method
Need for antihistamines or inhaled beta-2-agonists to relieve symptoms	3 weeks
Exhaled nitric oxide concentration	3 weeks

Trial Locations

Locations (1)

Skin and Allergy Hospital, Helsinki University Hospital; 🇫🇮 Helsinki, Finland