Trial | NCT01230619  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    rv568 ...

  • Study Participants

    75
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.
Study Started
Oct 31
2010
Primary Completion
Nov 30
2010
Study Completion
Dec 31
2010
Last Update
Dec 06
2010
Estimate

Drug RV568

RV568 400 ug administered as nasal drops twice daily on Day 1, RV568 800 ug administered as nasal drops once daily on Day 2

Drug Placebo

Placebo administered as nasal drops twice daily on Day 1, Placebo administered as nasal drops once daily on Day 2

RV568 treatment group Experimental

Placebo treatment group Placebo Comparator

Criteria 

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
No Results Posted