Bronchial Hyperreactivity in Atopic Dermatitis Patients - a 10 Year Follow-up
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00795496|
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : April 20, 2011
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 or disease||Intervention/treatment|
|Atopic Dermatitis||Procedure: Histamine provocation Procedure: Skin prick tests Procedure: Serum IgE blood testing Procedure: Mantoux-testing|
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 Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||Bronchial Hyperreactivity in Atopic Dermatitis Patients - a 10 Year Follow-up|
|Study Start Date :||November 2008|
|Primary Completion Date :||April 2010|
|Study Completion Date :||August 2010|
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 IgEProcedure: Mantoux-testing
Tuberculin (2 TU) s.c. on the forearm. The test is read after 72 hours.
- Bronchial hyperreactivity [ Time Frame: 10 year follow-up ]
- Skin prick tests [ Time Frame: 10 year follow-up ]
- Serum-IgE [ Time Frame: 10-year follow-up ]
- Mantoux-test [ Time Frame: 72 hours ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795496
|Skin- and Allergy Hospital, Department of Dermatology|
|Helsinki, Finland, 00250|
|Principal Investigator:||Sakari Reitamo, MD, PhD||Skin- and Allergy Hospital, Dep. of Dermatology|