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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


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
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