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A Study To Validate The Vienna Challenge Chamber, In And Out Of Hayfever Season, And Also A Park Study
This study has been completed.
First Received: November 15, 2006   Last Updated: October 27, 2008   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00400998
  Purpose

The aim of the study is to investigate the trial models, Vienna Challenge Chamber (VCC), in and out of season, and Park Study in season and the clinical efficacy of repeat doses of fluticasone propionate in subjects with seasonal allergic rhinitis. This will be a single-centre, randomised, double-blind, placebo-controlled, 3 phase study in 40 male or female subjects with seasonal allergic rhinitis. The subjects will be randomised to receive either fluticasone propionate aqueous nasal spray or matched placebo. The study consists of three phases with each phase consists of 2 treatment periods. A screening visit will be followed by Phase 1 (Vienna Chamber Challenge out of season), Phase 2 (Park Study, in season) and Phase 3 (Vienna Chamber Challenge in season).

There will be a follow-up visit after Phase 1 and Phase 2 & 3 will be separated by a 10 day wash-out period.

A follow-up visit will be completed 7-14 days after the last received dose. Intranasal fluticasone propionate will be administered daily for 8 days in the VCC and up to 14 days in the Park Study. Primary assessment will consist of major symptoms complex (MSC) during a 5-hour pollen allergen challenge in the Vienna Challenge Chamber (VCC) following final dosing on Day 8 and following final dosing between Day 8 and Day 14 in the Park Study. In addition, nasal flow measured by anterior rhinomanometry, wet tissue weight (as a surrogate of nasal secretion) and categorical scores for ocular symptoms, cough, itchy throat and itchy ears will be measured on day 8 (VCC) or on a day between 8-14 (Park).


Condition Intervention
Allergic Rhinitis
Drug: Fluticasone Propionate

Study Type: Observational
Study Design: Retrospective
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Enrollment: 48
Study Start Date: March 2006
Study Completion Date: November 2006
Detailed Description:

A randomised, double blind, placebo controlled, two-way crossover, three phase, study, to investigate the trial models, Vienna Challenge Chamber, in and out of season, and Park Study in season and the clinical efficacy of repeat doses of fluticasone propionate in subjects with seasonal allergic rhinitis (SAR).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The subject is healthy. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, laboratory studies, and other tests.
  • They have a history of seasonal allergic rhinitis
  • Exhibit a moderate response to 1500 grass pollen grains/m3 after 2 hours in the Vienna Challenge Chamber at screening or within 12 months preceding the screening visit. A moderate response is defined as a total nasal symptom score of at least 6. (Total nasal symptom score is the sum of obstruction, rhinorrhoea, itch and sneeze, each of which has been scored on a scale from 0 to 3).
  • They have a positive skin prick test (wheal ? 4mm) for grass pollen at or within the 12 months preceding the screening visit.
  • They have a positive RAST (? class 2) for grass pollen at or within the 12 months preceding the screening visit.
  • They have demonstrated an ability to use the intranasal spray

    • There are no conditions or factors which would make the subject unlikely to be able to stay in the chamber for 5hours.
  • They are capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form
  • They are available to complete all study measurements

Exclusion Criteria:

  • Pregnant or nursing females.
  • Female subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception [i.e. implants of levonorgestrel, injectable progesterone, an acceptable IUD (any IUD with a failure rate of less than 1% per year), oral contraceptives or any other method with a failure rate of <1% per year] for at least two weeks prior to the first dose of study medication and should continue using the same contraceptive measure until the final pregnancy test has been performed (not less than 72 hours after treatment). Alternatively they may be surgically sterilised (refer to section 6.4) or remain abstinent for 2 weeks before exposure to study drug.
  • On examination the subject is found to have any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent (within 3 weeks) or ongoing upper respiratory tract infection which in the responsible physician's opinion renders the subject unsuitable for participation in the study
  • The subject has any respiratory disease other than mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function.
  • The subject is likely to be unable to abstain from salbutamol use for 8 hours before a challenge
  • The subject has a history of drug or other allergy that, in the opinion of the responsible physician, contraindicates their participation.
  • The subject has participated in a study with a new molecular entity during the previous 3 months or in any clinical study in the previous 2 months
  • The subject is concurrently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device.
  • The subject is currently taking regular (or a course of) medication whether prescribed or not, including steroids, vitamins and herbal remedies (e.g. St. John's Wort). Paracetamol and occasional as needed use of short-acting beta agonists is permitted
  • The subject regularly, or on average, drinks more than 3 units of alcohol per day - where 1 unit = ½ pint of beer (284mL), or 1 glass of wine (125mL), or 1 measure of spirit (25mL).
  • The subject is at risk of non-compliance with the study procedures/restrictions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400998

Locations
Austria
GSK Investigational Site
Vienna, Austria, A-1150
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD, Prof GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: HH3104994
Study First Received: November 15, 2006
Last Updated: October 27, 2008
ClinicalTrials.gov Identifier: NCT00400998     History of Changes
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by GlaxoSmithKline:
Fluticasone Propionate
Validation
Seasonal Allergic Rhinitis
Efficacy
Quality of Life

Study placed in the following topic categories:
Anti-Inflammatory Agents
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis, Allergic, Seasonal
Anti-Asthmatic Agents
Fluticasone
Quality of Life
Rhinitis
Anti-Allergic Agents
Peripheral Nervous System Agents
Bronchodilator Agents

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Otorhinolaryngologic Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Rhinitis
Anti-Allergic Agents
Nose Diseases
Pharmacologic Actions
Respiratory Tract Diseases
Respiratory Tract Infections
Autonomic Agents
Therapeutic Uses
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on September 03, 2009