Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis

Seasonal Allergic Rhinitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01230619
• Other study ID #: RVH002
• Secondary ID: 2010-022113-25
• Status: Completed
• Phase: Phase 2
• First received: October 27, 2010
• Last updated: December 3, 2010
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: Respivert Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

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

Locations

Country	Name	City	State
Austria	Institute for Allergy Research, Vienna Challenge Chamber	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Respivert Ltd

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 day treatment period	No
Secondary	Eye symptom score	Watery eyes, itchy eyes, red eyes will be scored on a categorical scale of 0 to 3	2 day treatment period	No
Secondary	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	2 day treatment period	No
Secondary	Nasal airflow resistance		2 day treatment period	No
Secondary	Safety parameters	Spirometry, 12-lead ECG, laboratory assessments and adverse event assessment	3 weeks	No