Evaluation of Nasal Inflammatory Biomarkers

NCT03450031 | Completed

• 1 other identifier: 17-13 XOBIO Pilot
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Interleukin-4

  Interlukin- 4 \[pg/ml\] using ELISA assays

  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

Study Arms (2)

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)

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

Other: NAC (no drug/no device)

Interventions

NAC (no drug/no device) OTHER

Nasal allergen challenge (NAC) with mixed grass pollen: a bolus NAC with mixed grass pollen will be conducted

NAC (no drug/no device) and NFP; NAC (no drug/no device) and NFP AND NLF

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to give written informed consent.
• Male or female, age 18-65 years.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fraunhofer-Institute of Toxicology and Experimental Medicine: lead
• UCB Pharma: collaborator

Study Sites (1)

Fraunhofer ITEM im CRC

Hanover, Lower Saxony, 30165, Germany

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jens Hohlfeld

  Fraunhofer-Institute of Toxicology and Experimental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: March 1, 2018
• Study Start: February 8, 2018
• Primary Completion: April 26, 2018
• Study Completion: October 30, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)