Bronchial Hyperreactivity in Atopic Dermatitis Patients - a 10 Year Follow-up - Full Text View

Sponsored by:	Helsinki University
Information provided by:	Helsinki University
ClinicalTrials.gov Identifier:	NCT00795496

Purpose

The investigators will contact 64 patients with atopic dermatitis (AD) who participated in a long-term tacrolimus ointment trial in Helsinki 10 years ago, and ask them to participate in this follow-up study. The investigators will do the same tests as 10 years ago, i.e. bronchial hyperreactivity, skin prick tests, serum-IgE, Mantoux-test (2 TU), and questionnaires about asthma and allergic rhinitis symptoms. The investigators also collect data about their AD medication during the last 10 years.

The investigators hypothesis is that when the skin condition improves in patients with AD the brochial hyperreactivity improves. The investigators also want to study whether different treatments play a role in the development or resolution of bronchial hyperreactivity.

Condition	Intervention
Atopic Dermatitis	Procedure: Histamine provocation Procedure: Skin prick tests Procedure: Serum IgE blood testing Procedure: Mantoux-testing

Drug Information available for: Tuberculin Purified Protein Derivative Histamine Histamine dihydrochloride Histamine phosphate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort
Official Title:	Bronchial Hyperreactivity in Atopic Dermatitis Patients - a 10 Year Follow-up

Further study details as provided by Helsinki University:

Primary Outcome Measures:

Bronchial hyperreactivity [ Time Frame: 10 year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Skin prick tests [ Time Frame: 10 year follow-up ] [ Designated as safety issue: No ]
Serum-IgE [ Time Frame: 10-year follow-up ] [ Designated as safety issue: No ]
Mantoux-test [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Serum is collected for measurement of IgE

Estimated Enrollment:	64
Study Start Date:	November 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
AD patients AD patients who fulfill the inclusion criteria for the study	Procedure: Histamine provocation A dosimetric histamine challenge test in which the provocative dose of inhaled histamine producing a decrease of 15% in FEV1 is measured. Procedure: Skin prick tests Skin prick testing will be performed for: birch, timothy, mugwort, alder, pine, cat, dog, horse, house dust mite, Cladosporium herbarum. Procedure: Serum IgE blood testing One blood test to measure total serum IgE Procedure: Mantoux-testing Tuberculin (2 TU) s.c. on the forearm. The test is read after 72 hours.

Groups/Cohorts

Assigned Interventions

AD patients

AD patients who fulfill the inclusion criteria for the study

Procedure: Histamine provocation

A dosimetric histamine challenge test in which the provocative dose of inhaled histamine producing a decrease of 15% in FEV1 is measured.

Procedure: Skin prick tests

Skin prick testing will be performed for: birch, timothy, mugwort, alder, pine, cat, dog, horse, house dust mite, Cladosporium herbarum.

Procedure: Serum IgE blood testing

One blood test to measure total serum IgE

Procedure: Mantoux-testing

Tuberculin (2 TU) s.c. on the forearm. The test is read after 72 hours.

Detailed Description:

We will by letters and telephone contact all patients (n=64) who fulfill the inclusion criteria for this study.

The testing in the study (bronchial hyperreactivity, skin prick testing, serum IgE) is cross-sectional, but we retrospectively collect data from the last 10 years about the skin condition and medication for atopic diseases.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

The investigators invite all patients who participated in the FG-506-06-21 tacrolimus ointment study, and who at baseline in that study were tested for bronchial hyperreactivity.

Criteria

Inclusion Criteria:

Patient has participated in the FG-506-06-21 study in Helsinki
Patient was tested for bronchial hyperreactivity in the years 1998-2000
Patient gives signed informed consent to participate in this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795496

Locations

Finland
Skin- and Allergy Hospital, Department of Dermatology
Helsinki, Finland, 00250

Sponsors and Collaborators

Helsinki University

Investigators

Principal Investigator:

Sakari Reitamo, MD, PhD

Skin- and Allergy Hospital, Dep. of Dermatology

More Information

Publications:

Virtanen H, Remitz A, Malmberg P, Rytilä P, Metso T, Haahtela T, Reitamo S. Topical tacrolimus in the treatment of atopic dermatitis--does it benefit the airways? A 4-year open follow-up. J Allergy Clin Immunol. 2007 Dec;120(6):1464-6. Epub 2007 Oct 1. No abstract available.

Responsible Party:	Helsinki University Central Hospital, Department of Dermatology ( Sakari Reitamo, MD, PhD, Specialist in Dermatology, Acting Professor )
Study ID Numbers:	232685
Study First Received:	November 20, 2008
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00795496
Health Authority:	Finland: Ministry of Social Affairs and Health

Keywords provided by Helsinki University:

Atopic dermatitis
Bronchial hyperreactivity
Skin prick tests
Serum IgE
Mantoux test

Study placed in the following topic categories:

Hypersensitivity
Dermatitis, Atopic
Respiratory Tract Diseases
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate

Histamine phosphate
Skin Diseases, Eczematous
Bronchial Hyperreactivity
Skin Diseases, Genetic
Histamine
Dermatitis

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine Agonists
Bronchial Diseases

Immune System Diseases
Physiological Effects of Drugs
Histamine Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009