Seasonal Allergic Rhinitis MedDRA version: 12.1 Level: LLT Classification code 10039776 Term: Seasonal allergic rhinitis
Conditions
Interventions
Product Name: RV568
Product Code: RV568
Pharmaceutical Form: Nasal drops, suspension
Current Sponsor code: RV568
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentrati
Sponsors
RespiVert Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. The subject is healthy (healthy is defined as individuals who are free from clinically-significant illness or disease as determined by the Investigator from their medical history, physical examination, laboratory studies, and other tests) 2. Males aged between 18 and 55 years inclusive. 3. Body weight >= 50 kg and BMI within the range 19 – 29 kg/m2 (inclusive). 4. The subject has a history of seasonal allergic rhinitis. 5. The subject exhibits a moderate response to approximately 1,500 grass pollen grains/m3 after 4 hours in the Vienna Challenge Chamber, defined as a nasal symptom score of >= 6. 6. The subject has a positive skin prick test (wheal >= 4mm) for grass pollen at, or within the 12 months preceding, the screening visit. 7. The subject has a positive total IgE result (RAST >= class 2) for grass pollen at or within the 12 months preceding the screening visit. 8. The subject is a current non-smoker who has not used any tobacco products in the 6 months preceding the screening visit with a pack history of = 80% and a baseline FEV1/FVC >= 70% (maximum recorded values) of the predicted value using the ECCS guidelines. 10. There are no conditions or factors which would make the subject unlikely to be able to stay in the chamber for 6 hours. 11. The subject is capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form 12. The subject is available to complete all study measurements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. On examination the subject is found to have any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent (within 3 weeks) or ongoing upper respiratory tract infection which in the Responsible Physician’s opinion renders the subject unsuitable for participation in the study 2. The subject has a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. 3. The subject is concurrently participating in another clinical study or has participated in a study with an investigational product (new chemical entity) during the previous 3 months or in any clinical study during the previous month. 4. The subject is currently taking regular (or a course of) medication whether prescribed or not, including steroids, vitamins, macrolides, anti-fungal agents and herbal remedies (e.g. St. John’s Wort). Paracetamol (<=2 g/day) and occasional as-needed use of short-acting beta agonists is permitted. 5. The subject has used oral, injectable or dermal steroids within 5 weeks or intranasal and/or inhaled steroids within 1 week of the screening visit. 6. Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, bronchiectasis or pulmonary fibrosis). 7. The subject regularly drinks more than 21 units of alcohol in a week. One unit of alcohol is defined as a medium (125 mL) glass of wine, half a pint (250 mL) of beer or one measure (25 mL) of spirits. 8. The subject is infected with the Hepatitis B, Hepatitis C, or HIV virus. 9. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). 10. Positive test for drugs or alcohol at screening or prior to dosing that cannot be satisfactorily explained (e.g. recent use of codeine tablets). 11. Previously known allergy to any of the active or inactive ingredients in the study medication (see Table 6). 12. Subject is mentally or legally incapacitated (as deemed by the Investigator). 13. Any other reason that the Investigator considers makes the subject unsuitable to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of repeat intranasal doses of RV568 versus placebo on nasal symptoms of allergic rhinitis provoked by spending 6 hours in the Vienna Challenge Chamber after morning dosing on Day 2.;Secondary Objective: • To explore the effects of repeat doses of RV568 versus placebo on eye and global symptoms, nasal obstruction and secretions in allergic rhinitis provoked by spending 6 hours in the Vienna Challenge Chamber post morning dose on Day 2. • To assess the safety and tolerability of RV568 in mild to moderate allergic rhinitic subjects. ;Primary end point(s): Weighted mean total nasal symptom score (TNSS) (congestion, rhinorrhoea, nasal itching and sneezing) 1 – 6 hours post morning dose period spent in the Vienna Challenge Chamber on Day 2. | — |
Countries
Austria
Outcome results
None listed