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Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01230619
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : December 6, 2010
Sponsor:
Information provided by:
Respivert Ltd

Tracking Information
First Submitted Date  ICMJE October 27, 2010
First Posted Date  ICMJE October 29, 2010
Last Update Posted Date December 6, 2010
Study Start Date  ICMJE October 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2010)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2010)
  • 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
  • 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
  • Nasal airflow resistance [ Time Frame: 2 day treatment period ]
  • Safety parameters [ Time Frame: 3 weeks ]
    Spirometry, 12-lead ECG, laboratory assessments and adverse event assessment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis
Official Title  ICMJE 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)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Seasonal Allergic Rhinitis
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Placebo administered as nasal drops twice daily on Day 1, Placebo administered as nasal drops once daily on Day 2
Study Arms  ICMJE
  • Experimental: RV568 treatment group
    Intervention: Drug: RV568
  • Placebo Comparator: Placebo treatment group
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2010)
75
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2010)
90
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01230619
Other Study ID Numbers  ICMJE RVH002
2010-022113-25 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Garth Rapeport, Respivert Ltd
Study Sponsor  ICMJE Respivert Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Prof Dr Friedrich Horak, MD Institute for Allergy Research - Vienna Challenge Chamber
PRS Account Respivert Ltd
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP