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Table 1 Inclusion and exclusion criteria, including required washouts for restricted medications

From: The Allergic Rhinitis Clinical Investigator Collaborative (AR-CIC): verification of nasal allergen challenge procedures in a study utilizing an investigational immunotherapy for cat allergy

Inclusion criteria  
Male or female aged 18–65 years Willing and able to provide written consent
Minimum 1-year documented history of AR on exposure to cats Willing and able to participate in all study visits, treatment plans, and provide all samples
Positive SPT to cat allergen ≥ 3 mm than negative control TNSS ≥ 8/12 or PNIF reduction ≥ 50% on screening allergen challenge
Regular exposure to a cat in their normal living or working environment, on at least 2 separate occasions for a total duration of at least 8 h per week Participants of childbearing age must practice an acceptable form of contraception and have a negative urine pregnancy test at screening
Exclusion criteria  
Diagnosis of asthma Clinically relevant physical examination abnormalities (in the investigator’s opinion)
Laboratory values outside of normal limits except if deemed not of clinical relevance by the investigator Vital signs outside of normal limits, except if deemed not of clinical relevance by the investigator
FEV1 < 80% of predicted FEV1/FVC < 70%
History of anaphylaxis Significant history of alcohol and drug abuse
Receipt of any allergen immunotherapy within the last 10 years, or in the last 3 years for non-adjuvant, or non-sublingual pre-seasonal immunotherapy treatments History of any significant disease or disorder such as autoimmune, cardiovascular, pulmonary, which in the opinion of the investigator would either put the participant at risk, or affect the study results, or the participant’s ability to take part in the study
If epinephrine administration is contra-indicated History of vaso-vagal reaction in response to needles and blood donation
Clinically relevant illness, in the investigator’s opinion, within the previous 6 weeks Previous participation in this or previous study of Cat-PAD
Participants who are pregnant, lactating, or planning a pregnancy History of severe drug allergy, severe angioedema, or anaphylactic reaction to food
Received treatment with an investigational drug within 3 months Unable to communicate or to understand the requirements of the study
Known allergy to thioglycerol History of immune-pathological diseases
History of positive test results to Hepatitis B, Hepatitis C, HIV, or tuberculosis other than anticipated due to vaccination Smoker or quit smoking in the past 3 months
In the opinion of the investigator, the participant is unlikely to complete all of the study Must abide with washout periods to certain medications
Medication Washout period prior to Screening Visit and NAC Visits
Depot corticosteroids 90 days
Tricyclic antidepressant 14 days
Monoamine oxidase inhibitors (MAOI) 14 days
Beta-blockers Investigator’s decision
Alpha-adrenoceptor blocker Investigator’s decision
Tranquillizers or psychoactive drugs, except benzodiazepines and zopiclone on a PRN basis (no more than twice per month) 14 days
Treatment of minor affective disorders with stable doses of non-tricyclic anti-depressants such as serotonin antagonists and reuptake inhibitors, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors and norepinephrine-dopamine reuptake inhibitors Dose administered must remain constant from 6 weeks prior to enrolment
Corticosteroids (systemic, dermatological*, inhalational, intranasal, ocular) 30 days
Anti-histamines (nasal, long acting) once daily dosing oral 10 days
Anti-histamines (nasal, short acting) more than once daily dosing, oral or ocular 7 days
Anticholinergics 7 days
Alpha-adrenergic agonists 7 days
Cromones 30 days
Leukotriene inhibitors 10 days
Non-steroidal anti-inflammatory drugs (NSAIDs) 3 days prior to NAC
  1. * Topical hydrocortisone (≤ 1%) was permitted for use on < 10% body surface area