Seasonal Allergic RhinitisNCT01192386
Eosinophil Markers and Development of Disease in Allergic Rhinitis
An observational study of Seasonal Allergic Rhinitis, run by University of Aarhus.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Seasonal Allergic Rhinitis
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- May 2010to May 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: Follow-up on participants in Allergic Rhinitis study 1995.
Who may be able to join
- Participant in earlier study (1995)
Who cannot join
- Treatment with any kind of corticosteroid within two months will exclude from study of inflammatory parameters
About this study
Official title: Eosinophil Markers and Development of Disease in Allergic Rhinitis. A 15-year Follow-up of Patients With Grass Pollen Induced Hayfever.
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.
Read the 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.
- Conditions
- Seasonal Allergic Rhinitis
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma morbidity
Patients are asked whether they have experienced asthmatic symptoms or have been disgnosed with asthma within the latest 15 years
Measured: Single measurement - May 2010
Secondary outcomes (1)
Rhinitis morbidity
Patients are asked for current hayfever symptoms
Measured: Single measurement - May 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Investigators
- Lars Peter Nielsen, MD, Principal investigator, Department of Respiratory Research, Aarhus University Hospital, DK-8000 Aarhus C, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192386
- Sponsor's protocol ID
- RHINO2010
- Status last verified
- Aug 2010
- First submitted
- 30 Aug 2010
- Last updated
- 1 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eosinophil Markers and Development of Disease in Allergic Rhinitis. A 15-year Follow-up of Patients With Grass Pollen Induced Hayfever.
- ClinicalTrials.gov ID
- NCT01192386
- Acronym / sponsor ID
- RHINO2010
- Conditions
- Seasonal Allergic Rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- May 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 1 Sep 2010 (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.
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Follow-up on participants in Allergic Rhinitis study 1995.
Key inclusion criteria (1 listed)
- Participant in earlier study (1995)
Key exclusion criteria (1 listed)
- Treatment with any kind of corticosteroid within two months will exclude from study of inflammatory parameters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Asthma morbidity
Time frame: Single measurement - May 2010
Patients are asked whether they have experienced asthmatic symptoms or have been disgnosed with asthma within the latest 15 years
1 secondary outcome
Rhinitis morbidity
Time frame: Single measurement - May 2010
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 1 Sep 2010.
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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.
Lars Peter Nielsen, MD principal investigator
Department of Respiratory Research, Aarhus University Hospital, DK-8000 Aarhus C, Denmark
Questions about this trial
What is this clinical trial studying?
An observational study of Seasonal Allergic Rhinitis, run by University of Aarhus.
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 1 inclusion and 1 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 1 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Asthma morbidity (time frame: Single measurement - May 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2010.