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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

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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: RV568 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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)
Study Start Date : October 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arm Intervention/treatment
Experimental: RV568 treatment group 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 Comparator: Placebo treatment group Drug: Placebo
Placebo administered as nasal drops twice daily on Day 1, Placebo administered as nasal drops once daily on Day 2




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230619


Locations
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Austria
Institute for Allergy Research, Vienna Challenge Chamber
Vienna, Austria, 1150
Sponsors and Collaborators
Respivert Ltd
Investigators
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Principal Investigator: Prof Dr Friedrich Horak, MD Institute for Allergy Research - Vienna Challenge Chamber
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Responsible Party: Dr Garth Rapeport, Respivert Ltd
ClinicalTrials.gov Identifier: NCT01230619    
Other Study ID Numbers: RVH002
2010-022113-25 ( EudraCT Number )
First Posted: October 29, 2010    Key Record Dates
Last Update Posted: December 6, 2010
Last Verified: December 2010
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases