Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT05378594
Eligibility Criteria:
Inclusion Criteria:
* Inclusion criteria (HDM allergic volunteers):
1. Adults aged 18 to 65 years
2. A clinical history of perennial allergic rhinitis for at least 2 years with house dust mite allergen a potential cause of symptoms
3. Positive skin prick test response, defined as wheal diameter ≥ 5 mm, to house dust mite allergen extract
4. For women of childbearing age, a negative urine pregnancy test at the time of screening and willingness to use an effective form of contraception for the duration of involvement in the study.
5. The ability to give informed consent and comply with study procedures.
Inclusion criteria (SB allergic volunteers):
1. Adults aged 18 to 65 years.
2. A clinical history of seasonal allergic rhinitis in February-May for at least 2 years.
3. Positive skin prick test response, defined as wheal diameter ≥ 5 mm, to silver birch pollen allergen extract.
4. For women of childbearing age, a negative urine pregnancy test at the time of screening and willingness to use an effective form of contraception for the duration of involvement in the study.
5. The ability to give informed consent and comply with study procedures.
Inclusion criteria for non-atopic controls
1. Adults aged 18 to 65 years.
2. The ability to give informed consent and comply with study procedures.
Exclusion Criteria:
* Exclusion criteria (allergic volunteers):
1. History of previous allergen immunotherapy to the relevant allergen being tested in the past 10 years
2. Pre-bronchodilator FEV1 \< 70% of predicted value at screening.
3. Perennial asthma requiring regular inhaled corticosteroids.
4. History of emergency visit or hospital admission for asthma in the previous 12 months.
5. History of chronic obstructive pulmonary disease
6. History of significant recurrent acute sinusitis, defined as 2 episodes per year for the last 2 years, all of which required antibiotic treatment.
7. History of chronic sinusitis, defined as sinus symptoms lasting greater than 12 weeks that includes 2 or more major factors or 1 major factor and 2 minor factors. Major factors are defined as facial pain or pressure, nasal obstruction or blockage, nasal discharge or purulence or discolored postnasal discharge, purulence in nasal cavity, or impaired or loss of smell. Minor factors are defined as headache, fever, halitosis, fatigue, dental pain, cough, ear pain, pressure, or fullness.
8. At screening visit, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media, or other relevant infectious process; serous otitis media is not an exclusion criterion. Participants may be re-evaluated for eligibility after symptoms resolve.
9. History of life-threatening anaphylaxis or angioedema.
10. Ongoing systemic immunosuppressive treatment.
11. The use of any investigational drug within 30 days of the screening visit.
12. The presence of any medical condition that the investigator deems incompatible with participation in the study.
Exclusion criteria for non-atopic controls
1. A history of hay fever, chronic rhinitis/rhinosinusitis other than symptoms experienced during viral colds or other respiratory tract infections.
2. A positive skin prick test to any of a panel of common aeroallergens including grass pollen (Timothy grass), silver birch (Betula verrucosa), house dust mite (Dermatophagoides pteronyssinus), cat hair (Felis domesticus), dog hair (Canis familiaris), and common moulds (Aspergillus fumigatus., Cladosporium sp., Alternaria sp.), with adequate positive and negative controls.
3. Pre-bronchodilator FEV1 \< 70% of predicted value at screening.
4. Perennial asthma requiring regular inhaled corticosteroids.
5. History of emergency visit or hospital admission for asthma in the previous 12 months.
6. History of chronic obstructive pulmonary disease
7. At screening visit, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media, or other relevant infectious process; serous otitis media is not an exclusion criterion. Participants may be re-evaluated for eligibility after symptoms resolve.
8. History of life-threatening anaphylaxis or angioedema.
9. Ongoing systemic immunosuppressive treatment.
10. The use of any investigational drug within 30 days of the screening visit.
11. The presence of any medical condition that the investigator deems incompatible with participation in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05378594
Study Brief:
Protocol Section:
NCT05378594