Eosinophil Markers and Development of Disease in Allergic Rhinitis
This study has been completed.
Sponsor:
University of Aarhus
Collaborator:
Aarhus University Hospital
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01192386
First received: August 30, 2010
Last updated: August 31, 2010
Last verified: August 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 30, 2010 | ||||
| Last Updated Date | August 31, 2010 | ||||
| Start Date ICMJE | May 2010 | ||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Asthma morbidity [ Time Frame: Single measurement - May 2010 ] [ Designated as safety issue: No ] Patients are asked whether they have experienced asthmatic symptoms or have been disgnosed with asthma within the latest 15 years |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01192386 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Rhinitis morbidity [ Time Frame: Single measurement - May 2010 ] [ Designated as safety issue: No ] Patients are asked for current hayfever symptoms |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Eosinophil Markers and Development of Disease in Allergic Rhinitis | ||||
| Official Title ICMJE | Eosinophil Markers and Development of Disease in Allergic Rhinitis. A 15-year Follow-up of Patients With Grass Pollen Induced Hayfever. | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Not Provided | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Follow-up on participants in Allergic Rhinitis study 1995. |
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| Condition ICMJE | Seasonal Allergic Rhinitis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 29 | ||||
| Completion Date | May 2010 | ||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01192386 | ||||
| Other Study ID Numbers ICMJE | RHINO2010 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Ass. professor Lars Peter Nielsen, Department of Respiratory Research, Aarhus University Hospital | ||||
| Study Sponsor ICMJE | University of Aarhus | ||||
| Collaborators ICMJE | Aarhus University Hospital | ||||
| Investigators ICMJE |
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| Information Provided By | University of Aarhus | ||||
| Verification Date | August 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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