Atopic DermatitisNCT00795496
Bronchial Hyperreactivity in Atopic Dermatitis Patients - a 10 Year Follow-up
An observational study of Atopic Dermatitis, run by University of Helsinki at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Histamine provocation, Skin prick tests and Serum IgE blood testing
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2008to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Skin- and Allergy Hospital, Department of Dermatology
Helsinki, 00250
About this study
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Histamine provocation, Skin prick tests, Serum IgE blood testing, Mantoux-testing
- Keywords
- Atopic dermatitis, Bronchial hyperreactivity, Skin prick tests, Serum IgE, Mantoux test
- Medical subject headings
- Dermatitis, Atopic, Bronchial Hyperreactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histamine provocationProcedure or surgery
A dosimetric histamine challenge test in which the provocative dose of inhaled histamine producing a decrease of 15% in FEV1 is measured.
Skin prick testsProcedure or surgery
Skin prick testing will be performed for: birch, timothy, mugwort, alder, pine, cat, dog, horse, house dust mite, Cladosporium herbarum.
Serum IgE blood testingProcedure or surgery
One blood test to measure total serum IgE
Mantoux-testingProcedure or surgery
Tuberculin (2 TU) s.c. on the forearm. The test is read after 72 hours.
| Study group | Role | What they receive |
|---|---|---|
| AD patients | AD patients who fulfill the inclusion criteria for the study Receives: Procedure: Histamine provocation; Procedure: Skin prick tests; Procedure: Serum IgE blood testing; Procedure: Mantoux-testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchial hyperreactivity
Measured: 10 year follow-up
Secondary outcomes (3)
Skin prick tests
Measured: 10 year follow-up
Serum-IgE
Measured: 10-year follow-up
Mantoux-test
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionApr 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Investigators
- Sakari Reitamo, MD, PhD, Principal investigator, Skin- and Allergy Hospital, Dep. of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795496
- Sponsor's protocol ID
- 232685
- Status last verified
- Nov 2008
- First submitted
- 20 Nov 2008
- Last updated
- 20 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Virtanen H, Remitz A, Malmberg P, Rytila 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. doi: 10.1016/j.jaci.2007.08.021. Epub 2007 Oct 1. No abstract available.
PubMed 17910892
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchial Hyperreactivity in Atopic Dermatitis Patients - a 10 Year Follow-up
- ClinicalTrials.gov ID
- NCT00795496
- Acronym / sponsor ID
- 232685
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Bronchial hyperreactivity, Skin prick tests, Serum IgE, Mantoux test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AD patients | – | Procedure: Histamine provocation, Procedure: Skin prick tests, Procedure: Serum IgE blood testing, Procedure: Mantoux-testingAD patients who fulfill the inclusion criteria for the study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Histamine provocationA dosimetric histamine challenge test in which the provocative dose of inhaled histamine producing a decrease of 15% in FEV1 is measured. | Procedure or surgery | AD patients |
| Skin prick testsSkin prick testing will be performed for: birch, timothy, mugwort, alder, pine, cat, dog, horse, house dust mite, Cladosporium herbarum. | Procedure or surgery | AD patients |
| Serum IgE blood testingOne blood test to measure total serum IgE | Procedure or surgery | AD patients |
| Mantoux-testingTuberculin (2 TU) s.c. on the forearm. The test is read after 72 hours. | Procedure or surgery | AD patients |
Primary outcome
Bronchial hyperreactivity
Time frame: 10 year follow-up
3 secondary outcomes
Skin prick tests
Time frame: 10 year follow-up
Serum-IgE
Time frame: 10-year follow-up
Mantoux-test
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2011.
- Background: PubMed 17910892Virtanen H, Remitz A, Malmberg P, Rytila 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. doi: 10.1016/j.jaci.2007.08.021. Epub 2007 Oct 1. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sakari Reitamo, MD, PhD principal investigator
Skin- and Allergy Hospital, Dep. of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchial hyperreactivity (time frame: 10 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00795496, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2011.