Montelukast as a Controller of Atopic Syndrome

NCT00559546 | Completed Phase 4

• 1 other identifier: HUS7/E5/07
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Seasonal Allergic Rhinitis; Allergic Conjunctivitis; Atopic Eczema; Asthma

Outcome Measures

Primary Outcomes (1)

• Allergic symptoms

  3 weeks

Secondary Outcomes (2)

• Need for antihistamines or inhaled beta-2-agonists to relieve symptoms

  3 weeks

• Exhaled nitric oxide concentration

  3 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

3 weeks of Montelukast and 3 weeks of placebo treatment

Drug: montelukast

2

ACTIVE COMPARATOR

3 weeks of placebo and 3 weeks of montelukast treatment

Drug: montelukast

Interventions

montelukast DRUG

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

1; 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Need for regular treatment with glucocorticoids
• Current smoking
• Other major disease or need for regular drug treatment
• Pregnancy

Sponsors & Collaborators

• University of Helsinki: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Skin and Allergy Hospital, Helsinki University Hospital

Helsinki, 00029 HUS, Finland

Location

Related Publications (1)

• Lehtimaki L, Petays T, Haahtela T. Montelukast is not effective in controlling allergic symptoms outside the airways: a randomised double-blind placebo-controlled crossover study. Int Arch Allergy Immunol. 2009;149(2):150-3. doi: 10.1159/000189198. Epub 2009 Jan 6.

  PMID: 19127072 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic; Dermatitis, Atopic; Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Tari Haahtela, Professor

  Skin and Allergy Hospital, Helsinki University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: March 1, 2007
• Study Completion: July 1, 2007
• Last Updated: November 16, 2007

Record last verified: 2007-11

Locations

FI (1)