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

Completed

• Conditions: Atopic Dermatitis
• Interventions: Procedure: Histamine provocation; Procedure: Skin prick tests; Procedure: Serum IgE blood testing; Procedure: Mantoux-testing

• Registration Number: NCT00795496
• Lead Sponsor: University of Helsinki

Brief Summary

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

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.

Study Timeline

• Status Verified: 2008-11
• Study Start: 2008-11
• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Primary Completion: 2010-04
• Study Completion: 2010-08
• Last Update Submitted: 2011-04-19
• Last Update Posted: 2011-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AD patients	Histamine provocation	AD patients who fulfill the inclusion criteria for the study
AD patients	Serum IgE blood testing	AD patients who fulfill the inclusion criteria for the study
AD patients	Mantoux-testing	AD patients who fulfill the inclusion criteria for the study
AD patients	Skin prick tests	AD patients who fulfill the inclusion criteria for the study

Primary Outcome Measures

Name	Time	Method
Bronchial hyperreactivity	10 year follow-up

Secondary Outcome Measures

Name	Time	Method
Skin prick tests	10 year follow-up
Serum-IgE	10-year follow-up
Mantoux-test	72 hours

Trial Locations

Locations (1)

Skin- and Allergy Hospital, Department of Dermatology; 🇫🇮 Helsinki, Finland