Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis

Study Overview
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Brief Summary
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RV568 is being developed for the treatment of diseases such as asthma, COPD and allergic rhinitis (e.g. hayfever). The main aim of this study is to investigate whether RV568 ameliorates the nasal symptoms to low doses of grass pollen in healthy subjects with seasonal allergic rhinitis.

Official Title
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A Two Day, Randomised, Single Blind, Parallel Group Trial of Repeat Doses of Intranasal RV568 in the Vienna Challenge Chamber in Subjects With Seasonal Allergic Rhinitis (SAR)

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: RV568
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is healthy History of seasonal allergic rhinitis Male aged between 18 and 55 years Body weight >/= 50 kg with BMI in range 19 - 29 kg/m2 (inclusive) Exhibits a moderate response to 4 hour exposure to grass pollen in the challenge chamber with a total nasal symptom score (TNSS) of >/= 6 Positive skin prick test (wheal >/= 4 mm) for grass pollen Positive total IgE result (RAST class >/= 2) for grass pollen Current non-smoker who has not used tobacco in the past 6 months with a pack history of </= 10 pack years Baseline FEV1 >/= 80% and FEV1/FVC >/= 70% of predicted values No conditions or factors that may preclude subjects ability to remain in the challenge chamber for a period of 6 hours capable of giving informed consent and is compliant with protocol requirements available to complete all study measurements Exclusion Criteria: structural nasal abnormalities or nasal polyps, history of frequent nosebleeds, recent nasal surgery or recent (within 3 weeks) or ongoing upper respiratory tract infection history of drug allergy participation in another clinical trial or has participated in a study using an NCE within the previous 3 months, or any clinical study within 1 month taking regular (or a course of) medication whether prescribed or not, including steroids, vitamins, macrolides, anti-fungal agents and herbal remedies. Paracetamol (</= 2g / day) and occasional short acting beta agonists are permitted use of oral, injectable or dermal steroids within 5 weeks or intranasal and/or inhaled steroids within 1 week of the screening visit past or present disease, which as judged by the investigator, may affect the outcome of the study regular consumption of > 21 units alcohol per week infected with Hepatitis B, Hepatitis C, or HIV virus current or chronic history of liver disease, or known hepatic or biliary abnormalities positive test for drugs of abuse or alcohol at screening previously known allergy to any of the active or inactive ingredients in the study medication mentally or legally incapacitated any other reason that the investigator considers makes the subject unsuitable to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RV568 treatment group<br> | Drug: RV568<br>* RV568 400 ug administered as nasal drops twice daily on Day 1, RV568 800 ug administered as nasal drops once daily on Day 2<br>|
| Placebo Comparator: Placebo treatment group<br> | Drug: Placebo<br>* Placebo administered as nasal drops twice daily on Day 1, Placebo administered as nasal drops once daily on Day 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total nasal symptom score (TNSS) | Nasal congestion, rhinorrhoea, nasal itching and sneezing will be scored on a categorical scale from 0 to 3. Individual scores will be summed to produce the TNSS | 2 day treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye symptom score | Watery eyes, itchy eyes, red eyes will be scored on a categorical scale of 0 to 3 | 2 day treatment period | 
| Global symptom score | Sum of symptom scores; TNSS, Eye symptom score, Other symptom score,(comprising congestion, rhinorrhoea, nasal itching, sneezing, watery eyes, itchy eyes, red eyes, cough, itchy throat and itchy ears) will be scored categorically from 0 to 3 | 2 day treatment period | 
| Nasal airflow resistance |  | 2 day treatment period | 
| Safety parameters | Spirometry, 12-lead ECG, laboratory assessments and adverse event assessment | 3 weeks |