Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis

Launched by RESPIVERT LTD · Oct 28, 2010

Keywords

ClinConnect Summary

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Gender

MALE

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