Skip to main content
OpenTrials
Completed

NCT Number: NCT01230619

Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Institute for Allergy Research, Vienna Challenge Chamber

Vienna, 1150, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RV568

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

Drug

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

Primary outcomes

  1. Total nasal symptom score (TNSS)

    Time frame: 2 day treatment period

    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

Secondary outcomes

  1. Eye symptom score

    Time frame: 2 day treatment period

    Watery eyes, itchy eyes, red eyes will be scored on a categorical scale of 0 to 3

  2. Global symptom score

    Time frame: 2 day treatment period

    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

  3. Nasal airflow resistance

    Time frame: 2 day treatment period

  4. Safety parameters

    Time frame: 3 weeks

    Spirometry, 12-lead ECG, laboratory assessments and adverse event assessment

Sponsors and collaborators

Lead sponsor

Respivert Ltd

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 29, 2010
Registry last updated
Dec 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.