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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

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

18 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

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

NCT ID

NCT01230619

First Posted

October 27, 2010

Last Updated

December 3, 2010

Sponsor

Respivert Ltd

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

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

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

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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