Clinical trial NCT00400998: Investigate Two Trial Models; Vienna Challenge Chamber (in and Out of Season) and Park Study (in Season) Using a Drug for Seasonal Allergic Rhinitis
Official title: A Randomised, Double Blind, Placebo Controlled, 2-way Crossover, 3 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 Rpt Doses of Fluticasone Propionate in Subjects With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Rhinitis, Allergic, Seasonal
Keywords: Seasonal Allergic Rhinitis
Quality of Life
Efficacy
Validation
Fluticasone Propionate
Lead sponsor: Research Consult GmbH
Sponsor class: INDUSTRY
First posted: 2006-11-17
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility 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 per cubic metre 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 size equal to or more than 4mm) for grass pollen at or within the 12 months preceding the screening visit.
* They have a positive RadioAllergoSorbent Test (RAST) (equal to or more than 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 5 hours.
* 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 \[i.e. implants of levonorgestrel, injectable progesterone, an acceptable intra-uterine device (IUD) (any IUD with a failure rate of less than 1% per year), oral contraceptives or any other method with a failure rate of \<1% per year\] 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 (284milliliteres mL), 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.

Primary outcomes:
measure: Weighted mean major symptom complex (MSC) sneeze, nasal itch, rhinorrhoea and itching eyes following 5 hours spent in the Vienna Challenge Chamber (VCC), in and out of season, and 5 hours in the Park Study in season.
timeFrame: 0-5 hour after last dose in either model
Secondary outcomes:
measure: Weighted Mean Total Nasal Symptom Score (TNSS) in both in-Chamber and Park studies
timeFrame: 0-5 hour after last dose in either model
measure: Weighted mean eye symptom score in both in-Chamber and Park studies
timeFrame: 0-5 hour after last dose in either model
measure: Weighted mean global symptom score in both in-Chamber and Park studies
timeFrame: 0-5 hour after last dose in either model
measure: Weighted mean nasal airflow resistance in both in-Chamber and Park studies
timeFrame: 0-5 hour after last dose in either model
measure: Mean nasal secretion weight in both in-Chamber and Park studies
timeFrame: 0-5 hour after last dose in either model
measure: Forced Expiratory Volume in 1 second (FEV1) in both in-Chamber and Park studies
timeFrame: 0-5 hour after last dose in either model
measure: Adverse Events in both in-Chamber and Park studies
timeFrame: 0-5 hour after last dose in either model
measure: Symptoms of local irritancy in both in-Chamber and Park studies
timeFrame: 0-5 hour after last dose in either model
measure: Quality of life in both in-Chamber and Park studies
timeFrame: 0-5 hour after last dose in either model
measure: Time until a 20% reduction is seen in TNSS, mean and global symptom scores, Nasal airflow resistance, Nasal secretion weight and FEV1
timeFrame: 2 hour after last dose in either model
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: