Status:
COMPLETED
Kinetics of Nasal Cytokine Responses to Mechanical Stimulation
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
AstraZeneca
Conditions:
Allergic Rhinitis Due to Grass Pollen
Allergic Asthma
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
IgE-associated allergy is a hypersensitivity disease affecting more than 40% of the population in industrialised countries. Recently the kinetics of change of clinical and immunological parameters (e....
Detailed Description
Allergic rhinitis (AR) and allergic asthma are a common manifestations of Type I allergy, an IgE-mediated hypersensitivity disease estimated to affect as much as 40% of the global population . IgE is ...
Eligibility Criteria
Inclusion
- All groups
- Male or female
- 18 to 50 years of age
- 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
- Allergic Rhinitis
- Moderate to severe allergic rhinitis to grass pollen for at least two seasons according to medical history
- Skin prick test positive to grass pollen extract
- Blood ImmunoCAP sensitisation to grass pollen (\>0.35 kU/L grass pollen extract specific IgE or higher as determined by UniCAP-FEIA)
- No history of Asthma
- Allergic Asthma
- Clinical history of asthma
- Spirometry reversibility or PC20 methacholine/histamine \<8mg
- Skin prick test positive to grass extract
- Blood ImmunoCAP sensitisation to grass pollen (\>0.35 kU/L grass pollen extract specific IgE or higher as determined by UniCAP-FEIA)
- Non-Allergics
- No history of Asthma
- No history of allergy
- Negative skin prick test to a common skin prick test panel including grass pollen
- No ImmunoCAP sensitisation to to grass pollen (\<0.35 kU/L grass pollen extract specific IgE or higher as determined by UniCAP-FEIA)
Exclusion
- Older than 50 or younger than 18 years
- Active smoker
- 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
- 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
- Previous immunotherapy with grass pollen
- Nasal polyps, history of chronic sinusitis or substantial deviation of the nasal septum
Key Trial Info
Start Date :
March 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04878237
Start Date
March 25 2021
End Date
May 31 2021
Last Update
August 13 2021
Active Locations (1)
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1
8H1.02, ENT Lab, Department of Otorhinolaryngology, Vienna General Hospital
Vienna, Austria, 1090