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Changes in Adaptive Immune Responses and Effector Cell Responses Upon Nasal Allergen Exposure - a Pilot Study

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ClinicalTrials.gov Identifier: NCT03644680
Recruitment Status : Completed
First Posted : August 23, 2018
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Ass.Prof.Dr.med. Josef Toth, Medical University of Vienna

Brief Summary:

IgE-associated allergy is a hypersensitivity disease affecting more than 25% of the population in industrialised countries. The recognition of allergen by immunoglobulin E (IgE) plays a central role in the cause of allergic diseases. Both seasonal and nasal provocation studies have demonstrated the rise in specific IgE after allergen exposure. Additionally changes in other clinical and immunological parameters (e.g. nasal blockage, mast cell and basophil sensitivity, various cytokines or T cell profiles) in response to allergen exposure have been described. However the time sensitive interplay of these various factors such as the relationship between rise in IgE levels and change in basophils sensitivity or cytokine profiles is not yet fully understood. Clarifying how these various factors interact and contribute to immunological responses to allergen, is crucial for the development of new therapeutic approaches.

The investigators aim to address these questions through a study following 36 Birch allergic patients after provocation with allergen or placebo over a peroid of 6 weeks to 1 year.


Condition or disease Intervention/treatment Phase
Allergic Rhinitis Allergic Inflammation Diagnostic Test: Nasal Provocation with Birch Extract Other: Nasal Provocation with NaCl 0.9% Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In this single-center, randomized, placebo-controlled, double-blind study a total of 36 patients will be recruited into this study on a voluntary basis and will be randomised to receive a nasal challenge with either birch pollen extract or placebo.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Changes in Adaptive Immune Responses and Effector Cell Responses Upon Nasal Allergen Exposure - a Pilot Study
Actual Study Start Date : September 24, 2018
Actual Primary Completion Date : October 4, 2019
Actual Study Completion Date : October 4, 2019

Arm Intervention/treatment
Experimental: Nasal Provocation with Birch Extract
Birch allergic patient receiving 3 consecutive nasal challenges with birch extract (Allergopharma). Total dose of 1.5ug of Bet v 1 per challenge
Diagnostic Test: Nasal Provocation with Birch Extract
Nasal spray containing birch extract from Allergopharma

Placebo Comparator: Nasal Provocation with NaCl 0.9%
Birch allergic patient receiving 3 consecutive nasal challenges with sterile NaCl 0.9%. Total dose of 100ul per nostril per challenge
Other: Nasal Provocation with NaCl 0.9%
Nasal spray containing sterile sodium chloride 0.9%




Primary Outcome Measures :
  1. Allergen Specific IgE Rise [ Time Frame: 1 Year ]
    To assess changes of allergen specific IgE levels after challenge with Birch pollen extract


Secondary Outcome Measures :
  1. IgE Levels in Nasal Secretions [ Time Frame: 1 Year ]
    To assess changes in allergen-specific IgE levels in nasal secretions after nasal provocation with birch pollen extract

  2. Total IgE Levels [ Time Frame: 1 Year ]
    To assess changes in total IgE levels after nasal provocation with birch pollen extract

  3. Assessing Immunoglobin Isotypes [ Time Frame: 1 Year ]
    To assess changes in allergen-specific and total IgA, IgD, IgG (including subtypes) and IgM levels in sera and nasal secretions after nasal provocation with birch pollen extract by ELISA

  4. Changes in TH2 Cytokine patterns. [ Time Frame: 1 Year ]
    To assess changes in TH2 cytokine patterns in sera and nasal secretions after nasal provocation with birch pollen extract. This we be determined by ELISA or Luminex assay which will mean cytokine measurements will have the same units of measure.

  5. IgE Production [ Time Frame: 1 Year ]
    To assess presence and changes in IgE production (i.e., by RT-PCR with primers specific for IgE) in nasal mucosa

  6. Subjective Symptom Assessment [ Time Frame: 1 Year ]
    To assess changes in nasal symptoms using the validated scoring system, Total Nasal Symptom Score (TNSS). On this scale 4 nasal symptoms are assessed namely sneezing, rhinorrhea, nasal itching and nasal blockage on a scale of 0 (no symptoms) 1 (mild symptom burden), 2 (moderate symptom burden) or 3 (severe symptom burden). The scores a totaled and a score out of 12 is produced. Higher values represent greater allergic symptom burden.

  7. Nasal Blockage [ Time Frame: 1 Year ]
    To objectively assess the degree of change in nasal blockage by PNIF

  8. Skin Response [ Time Frame: 1 Year ]
    To assess the changes in skin reactivity to allergen in a titrated skin prick test to birch pollen extract



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female
  • 18 to 60 years of age
  • Birch pollen sensitized subjects
  • Moderate to severe allergic rhinitis to birch pollen for at least two seasons according to medical history
  • Sensitization to Bet v 1 (3.5 kU/L Bet v 1 specific IgE or higher as determined by UniCAP-FEIA)
  • CD203c or CD63 upregulation or histamine release upon challenge with Bet v 1 in basophil activation tests (at least 20% increase in upregulated CD63 or CD203c expression or histamine release on basophils upon stimulation compared to unstimulated controls measured by flow cytometry)
  • Willingness to comply with the study protocol and written informed consent
  • Subjects must have a standard health care insurance
  • Subjects must be available during the study period to complete all treatments and assessments

Exclusion Criteria:

  • History of anaphylaxis
  • Any severe chronic, malignant or general disease
  • Treatment with systemic or topical (intranasal, inhaled, external) corticosteroids within the previous 2 months before the start of the study
  • Treatment with antihistamines 3 days prior to the screening visit of the study
  • Treatment with other immunosuppressant drugs within the previous 6 months prior to the start of the study
  • Arterial hypertension or use of anti-hypertensive therapy, including beta-blockers
  • Contra-indications to skin prick testing such as: skin inflammation in the test area, urticaria facticia
  • Sensitisation to an allergen which is relevant during the birch pollen season (e.g., ash tree pollen, house dust mite etc)
  • Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method
  • A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude
  • Participation in another clinical trial within one month prior to the study; however participation during the previous month solely in the form of blood donation and/or without other interventions will be accepted
  • Known alcohol or drug addiction or abuse
  • Risk of non-compliance with the study procedure
  • Active asthma currently necessitating treatment
  • Previous immunotherapy with birch pollen
  • Nasal polyps, history of chronic sinusitis or substantial deviation of the nasal septum

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644680


Locations
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Austria
8H1.02, ENT Lab, Department of Otorhinolaryngology, Vienna General Hospital
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Josef Toth, MD ENT Specialist

Publications:

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Responsible Party: Ass.Prof.Dr.med. Josef Toth, Associate Professor, Doctor of Medicine, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03644680     History of Changes
Other Study ID Numbers: MUViennaIK18
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Inflammation
Pathologic Processes
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases