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