Status:
COMPLETED
Evaluation of Nasal Inflammatory Biomarkers
Lead Sponsor:
Fraunhofer-Institute of Toxicology and Experimental Medicine
Collaborating Sponsors:
UCB Pharma
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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, ...
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 b...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- 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.
- Exclusion criteria
- 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.
- 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
Exclusion
Key Trial Info
Start Date :
February 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03450031
Start Date
February 8 2018
End Date
October 30 2018
Last Update
February 15 2019
Active Locations (1)
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1
Fraunhofer ITEM im CRC
Hanover, Lower Saxony, Germany, 30165