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)

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 Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: RV568; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1150
    • Institute for Allergy Research, Vienna Challenge Chamber

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: RV568 treatment group	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
PLACEBO_COMPARATOR: Placebo treatment group	Drug: Placebo; Placebo administered as nasal drops twice daily on Day 1, Placebo administered as nasal drops once daily on Day 2

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Respivert Ltd
• Investigators: Principal Investigator: Prof Dr Friedrich Horak, MD, Institute for Allergy Research - Vienna Challenge Chamber

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): November 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: October 27, 2010
• First Submitted That Met QC Criteria: October 28, 2010
• First Posted (ESTIMATE): October 29, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): December 6, 2010
• Last Update Submitted That Met QC Criteria: December 3, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: RVH002; 2010-022113-25 (EUDRACT_NUMBER)