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

NCT ID: NCT00795496

Last Updated: 2011-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atopic Dermatitis

Study Design

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Observational Model Type

COHORT

Study Groups

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AD patients

AD patients who fulfill the inclusion criteria for the study

Histamine provocation

Intervention Type PROCEDURE

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

Skin prick tests

Intervention Type PROCEDURE

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

Serum IgE blood testing

Intervention Type PROCEDURE

One blood test to measure total serum IgE

Mantoux-testing

Intervention Type PROCEDURE

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

Interventions

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Histamine provocation

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

Intervention Type PROCEDURE

Skin prick tests

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

Intervention Type PROCEDURE

Serum IgE blood testing

One blood test to measure total serum IgE

Intervention Type PROCEDURE

Mantoux-testing

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Helsinki

OTHER

Sponsor Role lead

Responsible Party

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Helsinki University Central Hospital, Department of Dermatology

Principal Investigators

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Sakari Reitamo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Skin- and Allergy Hospital, Dep. of Dermatology

Locations

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Skin- and Allergy Hospital, Department of Dermatology

Helsinki, , Finland

Site Status

Countries

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Finland

References

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Virtanen H, Remitz A, Malmberg P, Rytila 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. doi: 10.1016/j.jaci.2007.08.021. Epub 2007 Oct 1. No abstract available.

Reference Type BACKGROUND
PMID: 17910892 (View on PubMed)

Other Identifiers

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232685

Identifier Type: -

Identifier Source: org_study_id

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