Seasonal Allergic RhinitisNCT03450031
Evaluation of Nasal Inflammatory Biomarkers
A study testing NAC (no drug/no device) in people with Seasonal Allergic Rhinitis, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial summary
This research aims to establish a panel of inflammatory biomarkers of the early (Histamine, Tryptase, ProstaglandineD2) and late (Interleukin-4, Interleukin-5, Interleukin-6, Interleukin-13, Eotaxin, Tumor necrosis factor-a (TNF), (Macrophage Inflammatory Protein-1beta (MIP1ß)) phase response to nasal bolus allergen… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- NAC (no drug/no device)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 8 Feb 2018to 30 Oct 2018
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to give written informed consent.
- Male or female, age 18-65 years.
- Women will be considered for inclusion if they are:
- Not pregnant, as confirmed by pregnancy test, and not nursing.
- Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchal, or post-menopausal with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit).
- Of childbearing potential and using a highly effective method of contraception during the entire study, as defined by at least one of the following
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- vasectomised partner
- sexual abstinence (the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to Visit 2 procedures until at least 72 hours after NAC)
- implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods (i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap)
- History of seasonal allergic rhinitis to grass pollen with symptoms during the 2016 and 2017 allergen season requiring treatment with anti-histamines, nasal corticosteroids or leukotriene antagonists.
- Absence of significant current symptoms of allergic rhinitis consistent with being out of season for their principal allergen (eg grass).
- Skin prick test positive for mixed grass pollen allergen at Visit 1 or within one year prior to screening.
Who cannot join
- Asthma requiring more than inhaled short-acting beta-2 agonists.
- Spirometry showing FEV1 <80% predicted
- Subjects who have smoked more than 5 cigarettes in the last 6 months or have a smoking history of ≥10 pack years.
- Upper or lower respiratory tract infection in the prior 4 weeks.
- Nasal or lung provocation procedure (eg, allergen challenge) conducted in the prior 4 weeks.
- Significant nasal deformity, recent nasal surgery or obstructing nasal polyps.
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- History of anaphylaxis (any cause), or previous severe hypersensitivity reaction to any of the test agents for SPT or NAC.
- Recent participation in a study of an investigational medicinal product (IMP) which could interfere with markers evaluated in this research
- Use of any medications according to section 5.2 in the period indicated before Visit 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Nasal Inflammatory Biomarkers During the Early and Late Phase Response to Nasal Volus Allergen Challenge in in Subjects With Seasonal Allergic Rhinitis (Out-of-season)
This research aims to establish a panel of inflammatory biomarkers of the early (Histamine, Tryptase, ProstaglandineD2) and late (Interleukin-4, Interleukin-5, Interleukin-6, Interleukin-13, Eotaxin, Tumor necrosis factor-a (TNF), (Macrophage Inflammatory Protein-1beta (MIP1ß)) phase response to nasal bolus allergen challenge (NAC) in subjects with out-of-season seasonal allergic rhinitis, suitable for future application in drug intervention studies of novel anti-allergy therapeutics.
Read the detailed description
Biomarkers will be sampled by nasal filter paper (NFP) adsorption and lavage (NLF) prior to and following NAC. Samples from initial subjects (Cohort A; n~6) will be used primarily for validation of biomarker assays in nasal filter paper eluates. Validated biomarker assays will be applied to analyze biomarker changes in a further cohort of subjects (Cohort B; n~12) with the aim of fully defining the optimum panel and sampling time points for future studies.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- NAC (no drug/no device)
- 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.
NAC (no drug/no device)Other
Nasal allergen challenge (NAC) with mixed grass pollen: a bolus NAC with mixed grass pollen will be conducted
| Study group | Role | What they receive |
|---|---|---|
| NAC (no drug/no device) and NFP | Experimental | NAC with mixed grass pollen will be conducted. Nasal mucosal inflammatory mediators will be collected via nasal filter paper (NFP) Receives: Other: NAC (no drug/no device) |
| NAC (no drug/no device) and NFP AND NLF | Experimental | NAC with mixed grass pollen will be conducted. Nasal filter paper (NFP)sampling will be conducted from one nostril per time point. Subjects in Cohort B will also undergo nasal lavage (NLF) pre-NAC and at serial time points thereafter up to 8 hours Receives: Other: NAC (no drug/no device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-4
Interlukin- 4 [pg/ml] using ELISA assays
Measured: Change from baseline at time points: 1 minutes (min), 4 min, 7 min, 10 min, 15 min, 30 min, 60 min, 120 min, 240 min, 360 min, 480 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start8 Feb 2018
- Primary completion26 Apr 2018
- Study completion30 Oct 2018
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Sponsor
- Investigators
- Jens Hohlfeld, Principal investigator, Fraunhofer-Institute of Toxicology and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450031
- Sponsor's protocol ID
- 17-13 XOBIO Pilot
- Status last verified
- Feb 2019
- First submitted
- 30 Jan 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nasal Inflammatory Biomarkers During the Early and Late Phase Response to Nasal Volus Allergen Challenge in in Subjects With Seasonal Allergic Rhinitis (Out-of-season)
- ClinicalTrials.gov ID
- NCT03450031
- Acronym / sponsor ID
- 17-13 XOBIO Pilot
- Conditions
- Seasonal Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 26 Apr 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 1 Mar 2018 (actual)
- 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.
This research aims to establish a panel of inflammatory biomarkers of the early (Histamine, Tryptase, ProstaglandineD2) and late (Interleukin-4, Interleukin-5, Interleukin-6, Interleukin-13, Eotaxin, Tumor necrosis factor-a (TNF), (Macrophage Inflammatory Protein-1beta (MIP1ß)) phase response to nasal bolus allergen challenge (NAC) in subjects with out-of-season seasonal allergic rhinitis, suitable for future application in drug intervention studies of novel anti-allergy therapeutics.
Detailed description
Biomarkers will be sampled by nasal filter paper (NFP) adsorption and lavage (NLF) prior to and following NAC. Samples from initial subjects (Cohort A; n~6) will be used primarily for validation of biomarker assays in nasal filter paper eluates. Validated biomarker assays will be applied to analyze biomarker changes in a further cohort of subjects (Cohort B; n~12) with the aim of fully defining the optimum panel and sampling time points for future studies.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAC (no drug/no device) and NFP | Experimental | Other: NAC (no drug/no device)NAC with mixed grass pollen will be conducted. Nasal mucosal inflammatory mediators will be collected via nasal filter paper (NFP) |
| NAC (no drug/no device) and NFP AND NLF | Experimental | Other: NAC (no drug/no device)NAC with mixed grass pollen will be conducted. Nasal filter paper (NFP)sampling will be conducted from one nostril per time point. Subjects in Cohort B will also undergo nasal lavage (NLF) pre-NAC and at serial time points thereafter up to 8 hours |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Able and willing to give written informed consent.
- Male or female, age 18-65 years.
- History of seasonal allergic rhinitis to grass pollen with symptoms during the 2016 and 2017 allergen season requiring treatment with anti-histamines, nasal corticosteroids or leukotriene antagonists.
- Absence of significant current symptoms of allergic rhinitis consistent with being out of season for their principal allergen (eg grass).
- Skin prick test positive for mixed grass pollen allergen at Visit 1 or within one year prior to screening.
Key exclusion criteria (9 listed)
- Asthma requiring more than inhaled short-acting beta-2 agonists.
- Spirometry showing FEV1 <80% predicted
- Subjects who have smoked more than 5 cigarettes in the last 6 months or have a smoking history of ≥10 pack years.
- Upper or lower respiratory tract infection in the prior 4 weeks.
- Nasal or lung provocation procedure (eg, allergen challenge) conducted in the prior 4 weeks.
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 |
|---|---|---|
| NAC (no drug/no device)Nasal allergen challenge (NAC) with mixed grass pollen: a bolus NAC with mixed grass pollen will be conducted | Other | NAC (no drug/no device) and NFP, NAC (no drug/no device) and NFP AND NLF |
Primary outcome
Interleukin-4
Time frame: Change from baseline at time points: 1 minutes (min), 4 min, 7 min, 10 min, 15 min, 30 min, 60 min, 120 min, 240 min, 360 min, 480 min
Interlukin- 4 [pg/ml] using ELISA assays
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 15 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Jens Hohlfeld principal investigator
Fraunhofer-Institute of Toxicology and Experimental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAC (no drug/no device) in people with Seasonal Allergic Rhinitis, 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 12 inclusion and 9 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 15 Feb 2019. 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.
What does the primary outcome measure?
Interleukin-4 (time frame: Change from baseline at time points: 1 minutes (min), 4 min, 7 min, 10 min, 15 min, 30 min, 60 min, 120 min, 240 min, 360 min, 480 min). 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 15 Feb 2019.