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Evaluation of Nasal Inflammatory Biomarkers

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
NAC (no drug/no device)
Sponsored by
Fraunhofer-Institute of Toxicology and Experimental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Seasonal Allergic Rhinitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Able and willing to give written informed consent.
  2. 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)
  3. 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.
  4. Absence of significant current symptoms of allergic rhinitis consistent with being out of season for their principal allergen (eg grass).
  5. Skin prick test positive for mixed grass pollen allergen at Visit 1 or within one year prior to screening.

Exclusion criteria

  1. Asthma requiring more than inhaled short-acting beta-2 agonists.
  2. Spirometry showing FEV1 <80% predicted
  3. Subjects who have smoked more than 5 cigarettes in the last 6 months or have a smoking history of ≥10 pack years.
  4. Upper or lower respiratory tract infection in the prior 4 weeks.
  5. Nasal or lung provocation procedure (eg, allergen challenge) conducted in the prior 4 weeks.
  6. Significant nasal deformity, recent nasal surgery or obstructing nasal polyps.
  7. History of anaphylaxis (any cause), or previous severe hypersensitivity reaction to any of the test agents for SPT or NAC.
  8. Recent participation in a study of an investigational medicinal product (IMP) which could interfere with markers evaluated in this research
  9. Use of any medications according to section 5.2 in the period indicated before Visit 1

Sites / Locations

  • Fraunhofer ITEM im CRC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

NAC (no drug/no device) and NFP

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

Arm Description

NAC with mixed grass pollen will be conducted. Nasal mucosal inflammatory mediators will be collected via nasal filter paper (NFP)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 30, 2018
Last Updated
February 13, 2019
Sponsor
Fraunhofer-Institute of Toxicology and Experimental Medicine
Collaborators
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT03450031
Brief Title
Evaluation of Nasal Inflammatory Biomarkers
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
April 26, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fraunhofer-Institute of Toxicology and Experimental Medicine
Collaborators
UCB Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NAC (no drug/no device) and NFP
Arm Type
Experimental
Arm Description
NAC with mixed grass pollen will be conducted. Nasal mucosal inflammatory mediators will be collected via nasal filter paper (NFP)
Arm Title
NAC (no drug/no device) and NFP AND NLF
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
NAC (no drug/no device)
Intervention Description
Nasal allergen challenge (NAC) with mixed grass pollen: a bolus NAC with mixed grass pollen will be conducted
Primary Outcome Measure Information:
Title
Interleukin-4
Description
Interlukin- 4 [pg/ml] using ELISA assays
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Hohlfeld
Organizational Affiliation
Fraunhofer-Institute of Toxicology and Experimental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fraunhofer ITEM im CRC
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30165
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Nasal Inflammatory Biomarkers

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