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Completed

NCT Number: NCT00795496

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

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.

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Key information

Conditions

Atopic Dermatitis Bronchial Diseases Bronchial Hyperreactivity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Respiratory Tract Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Skin- and Allergy Hospital, Department of Dermatology

Helsinki, 00250, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Histamine provocation

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

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

Procedure

One blood test to measure total serum IgE

Mantoux-testing

Procedure

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

Primary outcomes

  1. Bronchial hyperreactivity

    Time frame: 10 year follow-up

Secondary outcomes

  1. Skin prick tests

    Time frame: 10 year follow-up

  2. Serum-IgE

    Time frame: 10-year follow-up

  3. Mantoux-test

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 21, 2008
Registry last updated
Apr 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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