Montelukast as a Controller of Atopic Syndrome - Full Text View

Sponsor:	Helsinki University
Collaborator:	Merck
Information provided by:	Helsinki University
ClinicalTrials.gov Identifier:	NCT00559546

Purpose

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

Condition	Intervention	Phase
Seasonal Allergic Rhinitis Allergic Conjunctivitis Atopic Eczema Asthma	Drug: montelukast	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Montelukast as a Controller of Atopic Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Asthma Eczema Hay Fever Pinkeye

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Helsinki University:

Primary Outcome Measures:

Allergic symptoms [ Time Frame: 3 weeks ]

Secondary Outcome Measures:

Need for antihistamines or inhaled beta-2-agonists to relieve symptoms [ Time Frame: 3 weeks ]
Exhaled nitric oxide concentration [ Time Frame: 3 weeks ]

Enrollment:	61
Study Start Date:	March 2007
Study Completion Date:	July 2007

Arms	Assigned Interventions
1: Active Comparator 3 weeks of Montelukast and 3 weeks of placebo treatment	Drug: montelukast 10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner
2: Active Comparator 3 weeks of placebo and 3 weeks of montelukast treatment	Drug: montelukast 10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559546

Locations

Finland
Skin and Allergy Hospital, Helsinki University Hospital
Helsinki, Finland, 00029 HUS

Sponsors and Collaborators

Helsinki University

Merck

Investigators

Principal Investigator:

Tari Haahtela, Professor

Skin and Allergy Hospital, Helsinki University Hospital

More Information

No publications provided by Helsinki University

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Lehtimäki L, Petäys 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. Epub 2009 Jan 6.

Study ID Numbers:	HUS7/E5/07
Study First Received:	November 15, 2007
Last Updated:	November 15, 2007
ClinicalTrials.gov Identifier:	NCT00559546 History of Changes
Health Authority:	Finland: Finnish Medicines Agency

Additional relevant MeSH terms:

Respiratory System Agents
Dermatitis, Atopic
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Rhinitis
Leukotriene Antagonists
Hypersensitivity
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Syndrome
Skin Diseases, Eczematous
Skin Diseases, Genetic

Dermatitis
Otorhinolaryngologic Diseases
Disease
Immune System Diseases
Conjunctivitis, Allergic
Skin Diseases
Eye Diseases
Anti-Asthmatic Agents
Conjunctivitis
Pharmacologic Actions
Conjunctival Diseases
Nose Diseases
Montelukast
Genetic Diseases, Inborn
Rhinitis, Allergic, Seasonal

ClinicalTrials.gov processed this record on February 08, 2010