Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis

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Status and phase

Completed

Phase 2

Conditions

Seasonal Allergic Rhinitis

Treatments

Drug: RV568

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01230619

2010-022113-25 (EudraCT Number)

RVH002

Details and patient eligibility

About

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.

Enrollment

75 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

No 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