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Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis

NCT ID: NCT01230619

Last Updated: 2010-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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RV568 treatment group

Group Type EXPERIMENTAL

RV568

Intervention Type DRUG

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 treatment group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Respivert Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Respivert Ltd

Principal Investigators

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Prof Dr Friedrich Horak, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Allergy Research - Vienna Challenge Chamber

Locations

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Institute for Allergy Research, Vienna Challenge Chamber

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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2010-022113-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RVH002

Identifier Type: -

Identifier Source: org_study_id