Seasonal Allergic RhinitisNCT00297843
A Pilot Monocenter Study to Assess Cellular and Soluble Biomarkers in Nasal Secretions
An observational study of Seasonal Allergic Rhinitis and Healthy Subjects, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial summary
Allergic Rhinitis is an inflammatory disease which causes an influx of inflammatory cells and cytokines into the nasal mucosa. These biomarkers can also be found in the nasal secretions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Seasonal Allergic Rhinitis, Healthy Subjects
- What is being tested?
- allergen challenge (grass pollen), nasal lavage
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2006to May 2006
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects, aged 18-55 years.
- Women will be considered for inclusion if they are: Not pregnant or nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and have been amenorrhoeic for more than 1 year prior to the screening visit).Of childbearing potential and using an appropriate method of contraception (Oral contraceptive pill or double barrier).
- FEV1 > 80% of predicted at screening.
- Absence of any structural nasal abnormalities or nasal polyps on examination, a history of frequent nose bleeding or recent nasal surgery.
- Absence of conditions or factors, which would make the subject unlikely to be able to stay in the Fraunhofer ECC for 4 hours.
- Non smoker or smokers with a history of less than 10 pack years.
Show all 17Show fewer
- Able and willing to give written informed consent to take part in the study.
- Available to complete all study measurements.
- For subjects with allergic rhinitis:
- History of allergic rhinitis to grass pollen and a positive skin prick test for Dactylis glomerata pollen at or within 12 months prior to the screening visit.
- Subject must exhibit a moderate response upon 4.000 Dactylis glomerata pollen grains/m3 during 4 hours in the ECC on visit 2, which is defined as a Total Nasal Symptom Score of at least 6. (TNSS is the sum of obstruction, rhinorrhea, itch, and sneeze, each of which has been scored on a scale from 0 to 3).
- Subjects with mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function may be included also.
- Total Nasal Symptom Score (TNSS) of < 3 and a score < 2 for each symptom, i.e. obstruction, rhinorrhea, itch, and sneeze prior to entering the pollen chamber.
- for healthy subjects:
- No history of allergic rhinitis and a negative skin prick test including Dactylis glomerata at or within 12 months prior to the screening visit.
- Total Nasal Symptom Score (TNSS) prior to and during pollen exposition of < 3 and a score < 2 for each symptom, i.e. obstruction, rhinorrhea, itch, and sneeze.
- Absence of any respiratory disease
Who cannot join
- History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the informed consent and during the study.
- Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxic seizures.
- Administration of oral, injectable or dermal corticosteroids within 8 weeks or intranasal and/or inhaled corticosteroids within 4 weeks of the screening visit.
- Unable to abstain from other medications including non-steroidal anti-inflammatory drugs (NSAIDS), anti-depressant drugs, anti-histamines and anti-asthma, anti-rhinitis or hay fever medication (other than short acting inhaled beta-agonists) and paracetamol (up to 1g paracetamol per day is permitted for the treatment of minor ailments e.g. headache) for 1 week prior to screening and throughout the course of the study.
- Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- Subject is undergoing allergen desensitisation therapy
- There is a risk of non-compliance with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Monocenter Study to Assess the Reproducibility and Specificity of Cellular and Soluble Biomarkers in Nasal Secretions in Patients With Allergic Rhinitis and Healthy Volunteers Following Pollen Exposure in the Fraunhofer Environmental Challenge Chamber (ECC)
Allergic Rhinitis is an inflammatory disease which causes an influx of inflammatory cells and cytokines into the nasal mucosa. These biomarkers can also be found in the nasal secretions. The evaluation of these inflammatory biomarkers is of great interest as this could lead to a concept of measuring the efficacy of anti-allergic treatments by assessing the changes in nasal biomarkers after allergen challenge. To use this model as an assessment of pharmacodynamics it is crucial to evaluate the specificity and reproducibility of cellular and cytokine levels in the nasal secretions after allergen provocations.
In a 2 part repeated measurement design 20 patients with allergic rhinitis and 20 healthy subjects will undergo two 4-hour pollen exposures in an interval of 21 days.
The aim of this study is to explore the cellular and cytokine levels this allergen challenge will induce in nasal secretions and to assess if an increase in those inflammatory biomarkers is specific to the patient subgroup and whether the results are reproducible after the second allergen challenge.
- Conditions
- Seasonal Allergic Rhinitis, Healthy Subjects
- Being tested
- allergen challenge (grass pollen), nasal lavage
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allergen challenge (grass pollen), nasal lavageProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2006 (estimated)
- Study startMar 2006
- Study completionMay 2006
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 Seasonal Allergic RhinitisStudies 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
- Time perspective
- Other
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Norbert Krug, MD, Principal investigator, Fraunhofer ITEM, Nikolai-Fuchs-Str. 1, 30625 Hannover, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297843
- Sponsor's protocol ID
- 06/01 Nabio ITEM
- Status last verified
- Jun 2007
- First submitted
- 28 Feb 2006
- Last updated
- 19 Jun 2007
- Results posted
- No
Publications
Badorrek P, Muller M, Koch W, Hohlfeld JM, Krug N. Specificity and reproducibility of nasal biomarkers in patients with allergic rhinitis after allergen challenge chamber exposure. Ann Allergy Asthma Immunol. 2017 Mar;118(3):290-297. doi: 10.1016/j.anai.2017.01.018.
PubMed 28284536
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Monocenter Study to Assess the Reproducibility and Specificity of Cellular and Soluble Biomarkers in Nasal Secretions in Patients With Allergic Rhinitis and Healthy Volunteers Following Pollen Exposure in the Fraunhofer Environmental Challenge Chamber (ECC)
- ClinicalTrials.gov ID
- NCT00297843
- Acronym / sponsor ID
- 06/01 Nabio ITEM
- Conditions
- Seasonal Allergic Rhinitis, Healthy Subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- May 2006
- First posted
- 1 Mar 2006 (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.
Allergic Rhinitis is an inflammatory disease which causes an influx of inflammatory cells and cytokines into the nasal mucosa. These biomarkers can also be found in the nasal secretions. The evaluation of these inflammatory biomarkers is of great interest as this could lead to a concept of measuring the efficacy of anti-allergic treatments by assessing the changes in nasal biomarkers after allergen challenge. To use this model as an assessment of pharmacodynamics it is crucial to evaluate the specificity and reproducibility of cellular and cytokine levels in the nasal secretions after allergen provocations.
In a 2 part repeated measurement design 20 patients with allergic rhinitis and 20 healthy subjects will undergo two 4-hour pollen exposures in an interval of 21 days.
The aim of this study is to explore the cellular and cytokine levels this allergen challenge will induce in nasal secretions and to assess if an increase in those inflammatory biomarkers is specific to the patient subgroup and whether the results are reproducible after the second allergen challenge.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Male and female subjects, aged 18-55 years.
- Women will be considered for inclusion if they are: Not pregnant or nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and have been amenorrhoeic for more than 1 year prior to the screening visit).Of childbearing potential and using an appropriate method of contraception (Oral contraceptive pill or double barrier).
- FEV1 > 80% of predicted at screening.
- Absence of any structural nasal abnormalities or nasal polyps on examination, a history of frequent nose bleeding or recent nasal surgery.
- Absence of conditions or factors, which would make the subject unlikely to be able to stay in the Fraunhofer ECC for 4 hours.
Key exclusion criteria (7 listed)
- History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the informed consent and during the study.
- Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxic seizures.
- Administration of oral, injectable or dermal corticosteroids within 8 weeks or intranasal and/or inhaled corticosteroids within 4 weeks of the screening visit.
- Unable to abstain from other medications including non-steroidal anti-inflammatory drugs (NSAIDS), anti-depressant drugs, anti-histamines and anti-asthma, anti-rhinitis or hay fever medication (other than short acting inhaled beta-agonists) and paracetamol (up to 1g paracetamol per day is permitted for the treatment of minor ailments e.g. headache) for 1 week prior to screening and throughout the course of the study.
- Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
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 |
|---|---|---|
| allergen challenge (grass pollen), nasal lavage | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 19 Jun 2007.
- Derived from this study: PubMed 28284536Badorrek P, Muller M, Koch W, Hohlfeld JM, Krug N. Specificity and reproducibility of nasal biomarkers in patients with allergic rhinitis after allergen challenge chamber exposure. Ann Allergy Asthma Immunol. 2017 Mar;118(3):290-297. doi: 10.1016/j.anai.2017.01.018.
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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.
Norbert Krug, MD principal investigator
Fraunhofer ITEM, Nikolai-Fuchs-Str. 1, 30625 Hannover, Germany
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 Seasonal Allergic Rhinitis and Healthy Subjects, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
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 17 inclusion and 7 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 19 Jun 2007. 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 Germany. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00297843, 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 19 Jun 2007; AzTrials last refreshed its copy on 6 Nov 2026.