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

NCT03644680 | Completed DMC

• 1 other identifier: MUViennaIK18
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis; Allergic Inflammation

Outcome Measures

Primary Outcomes (1)

• Allergen Specific IgE Rise

  To assess changes of allergen specific IgE levels after challenge with Birch pollen extract

  1 Year

Secondary Outcomes (8)

• IgE Levels in Nasal Secretions

  1 Year

• Total IgE Levels

  1 Year

• Assessing Immunoglobin Isotypes

  1 Year

• Changes in TH2 Cytokine patterns.

  1 Year

• IgE Production

  1 Year

Study Arms (2)

Nasal Provocation with Birch Extract

EXPERIMENTAL

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 Provocation with NaCl 0.9%

PLACEBO COMPARATOR

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%

Interventions

Nasal Provocation with Birch Extract DIAGNOSTIC_TEST

Nasal spray containing birch extract from Allergopharma

Nasal Provocation with Birch Extract

Nasal Provocation with NaCl 0.9% OTHER

Nasal spray containing sterile sodium chloride 0.9%

Nasal Provocation with NaCl 0.9%

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

8H1.02, ENT Lab, Department of Otorhinolaryngology, Vienna General Hospital

Vienna, 1090, Austria

Location

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MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Josef Toth, MD

  ENT Specialist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Doctor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 23, 2018
• Study Start: September 24, 2018
• Primary Completion: October 4, 2019
• Study Completion: October 4, 2019
• Last Updated: October 10, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)