Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis
Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis
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.
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