Working… Menu

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. Identifier: NCT00795496
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : April 20, 2011
Information provided by:
Helsinki University

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.

Condition or disease Intervention/treatment
Atopic Dermatitis Procedure: Histamine provocation Procedure: Skin prick tests Procedure: Serum IgE blood testing Procedure: Mantoux-testing

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Official Title: Bronchial Hyperreactivity in Atopic Dermatitis Patients - a 10 Year Follow-up
Study Start Date : November 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Histamine

Group/Cohort Intervention/treatment
AD patients
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 IgE

Procedure: Mantoux-testing
Tuberculin (2 TU) s.c. on the forearm. The test is read after 72 hours.

Primary Outcome Measures :
  1. Bronchial hyperreactivity [ Time Frame: 10 year follow-up ]

Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
Serum is collected for measurement of IgE

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The investigators invite all patients who participated in the FG-506-06-21 tacrolimus ointment study, and who at baseline in that study were tested for bronchial hyperreactivity.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00795496

Layout table for location information
Skin- and Allergy Hospital, Department of Dermatology
Helsinki, Finland, 00250
Sponsors and Collaborators
Helsinki University
Layout table for investigator information
Principal Investigator: Sakari Reitamo, MD, PhD Skin- and Allergy Hospital, Dep. of Dermatology

Layout table for additonal information
Responsible Party: Sakari Reitamo, MD, PhD, Specialist in Dermatology, Acting Professor, Helsinki University Central Hospital, Department of Dermatology Identifier: NCT00795496     History of Changes
Other Study ID Numbers: 232685
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: April 20, 2011
Last Verified: November 2008
Keywords provided by Helsinki University:
Atopic dermatitis
Bronchial hyperreactivity
Skin prick tests
Serum IgE
Mantoux test
Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchial Hyperreactivity
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Bronchial Diseases
Respiratory Tract Diseases
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs