Back to resultsEosinophil Markers and Development of Disease in Allergic Rhinitis
Primary Purpose
Seasonal Allergic Rhinitis
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Seasonal Allergic Rhinitis
Eligibility Criteria
Inclusion Criteria:
- Participant in earlier study (1995)
Exclusion Criteria:
- Treatment with any kind of corticosteroid within two months will exclude from study of inflammatory parameters
Sites / Locations
Outcomes
Primary Outcome Measures
Asthma morbidity
Patients are asked whether they have experienced asthmatic symptoms or have been disgnosed with asthma within the latest 15 years
Secondary Outcome Measures
Rhinitis morbidity
Patients are asked for current hayfever symptoms
Full Information
NCT ID
NCT01192386
First Posted
August 30, 2010
Last Updated
August 31, 2010
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01192386
Brief Title
Eosinophil Markers and Development of Disease in Allergic Rhinitis
Official Title
Eosinophil Markers and Development of Disease in Allergic Rhinitis. A 15-year Follow-up of Patients With Grass Pollen Induced Hayfever.
Study Type
Observational
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Inflammatory proteins from eosinophil granulocytes in blood from patients with seasonal allergic hayfever have been shown to predict development of asthma at a six-year follow-up. This study is a 15-year follow-up of the same patients to verify earlier results and study disease development.
Detailed Description
The study consists of a single visit at which patients fill in a questionnaire on actual hayfever and asthma symptoms as well as current treatment. Blood samples and nasal lavages are drawn and analysed for eosinophils as well as eosinophil cationic protein and tryptase. Spirometry is performed.
If patients use drugs which can interfere with results, ie. corticosteroids or beta-agonists, biochemistry and/or spirometry are omitted.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
7. Study Design
Enrollment
29 (Actual)
Primary Outcome Measure Information:
Title
Asthma morbidity
Description
Patients are asked whether they have experienced asthmatic symptoms or have been disgnosed with asthma within the latest 15 years
Time Frame
Single measurement - May 2010
Secondary Outcome Measure Information:
Title
Rhinitis morbidity
Description
Patients are asked for current hayfever symptoms
Time Frame
Single measurement - May 2010
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant in earlier study (1995)
Exclusion Criteria:
Treatment with any kind of corticosteroid within two months will exclude from study of inflammatory parameters
Study Population Description
Follow-up on participants in Allergic Rhinitis study 1995.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Peter Nielsen, MD
Organizational Affiliation
Department of Respiratory Research, Aarhus University Hospital, DK-8000 Aarhus C, Denmark
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Eosinophil Markers and Development of Disease in Allergic Rhinitis
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