Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis
Primary Purpose
Seasonal Allergic Rhinitis
Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
RV568
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis
Eligibility 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
Sites / Locations
- Institute for Allergy Research, Vienna Challenge Chamber
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
RV568 treatment group
Placebo treatment group
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Eye symptom score
Watery eyes, itchy eyes, red eyes will be scored on a categorical scale of 0 to 3
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
Nasal airflow resistance
Safety parameters
Spirometry, 12-lead ECG, laboratory assessments and adverse event assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01230619
Brief Title
Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Respivert Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RV568 treatment group
Arm Type
Experimental
Arm Title
Placebo treatment group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
RV568
Intervention Description
RV568 400 ug administered as nasal drops twice daily on Day 1, RV568 800 ug administered as nasal drops once daily on Day 2
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered as nasal drops twice daily on Day 1, Placebo administered as nasal drops once daily on Day 2
Primary Outcome Measure Information:
Title
Total nasal symptom score (TNSS)
Description
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
Time Frame
2 day treatment period
Secondary Outcome Measure Information:
Title
Eye symptom score
Description
Watery eyes, itchy eyes, red eyes will be scored on a categorical scale of 0 to 3
Time Frame
2 day treatment period
Title
Global symptom score
Description
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
Time Frame
2 day treatment period
Title
Nasal airflow resistance
Time Frame
2 day treatment period
Title
Safety parameters
Description
Spirometry, 12-lead ECG, laboratory assessments and adverse event assessment
Time Frame
3 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof Dr Friedrich Horak, MD
Organizational Affiliation
Institute for Allergy Research - Vienna Challenge Chamber
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Allergy Research, Vienna Challenge Chamber
City
Vienna
ZIP/Postal Code
1150
Country
Austria
12. IPD Sharing Statement
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Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis
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