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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795496
• Other study ID #: 232685
• Status: Completed
• Phase: N/A
• First received: November 20, 2008
• Last updated: April 19, 2011
• Start date: November 2008
• Est. completion date: August 2010

Study information

• Verified date: November 2008
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Atopic Dermatitis
• Bronchial Hyperreactivity
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.
• Skin prick tests
Skin prick testing will be performed for: birch, timothy, mugwort, alder, pine, cat, dog, horse, house dust mite, Cladosporium herbarum.
• Serum IgE blood testing
One blood test to measure total serum IgE
• Mantoux-testing
Tuberculin (2 TU) s.c. on the forearm. The test is read after 72 hours.

Locations

Country	Name	City	State
Finland	Skin- and Allergy Hospital, Department of Dermatology	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University

Country where clinical trial is conducted

Finland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bronchial hyperreactivity		10 year follow-up	No
Secondary	Skin prick tests		10 year follow-up	No
Secondary	Serum-IgE		10-year follow-up	No
Secondary	Mantoux-test		72 hours	No