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:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-24 @ 1:17 PM
NCT ID:
NCT01388595
Eligibility Criteria:
Inclusion Criteria:
1. Persistent allergic rhinitis without asthma.
2. Atopy to at least 1 allergen on SPT.
3. ≥ 20% drop in PNIF following nasal AMP challenge
4. Male to female aged 18-65
5. Informed Consent
6. Ability to comply with the protocol
Exclusion Criteria:
1. Severe allergic rhinitis as defined by those in whom there are symptoms which significantly impair day to day activities on QOL questionnaire.
2. Nasal Polyposis grade 2/3, deviated nasal septum ≥ 50%
3. PNIF \< 60 litres/min
4. The use of oral corticosteroids within the last 3 months.
5. Recent respiratory tract / sinus infection (2 months).
6. Significant concomitant respiratory disease such as COPD, CF, ABPA, bronchiectasis and active pulmonary tuberculosis.
7. Any other clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA/ CVA,that may endanger the health or safety of the participant, or jeopardise the protocol.
8. Any significant abnormal laboratory result as deemed by the investigators
9. Pregnancy, planned pregnancy or lactation
10. Known or suspected contra-indication to any of the IMP's
11. Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01388595
Study Brief:
Protocol Section:
NCT01388595