Investigate Two Trial Models; Vienna Challenge Chamber (in and Out of Season) and Park Study (in Season) Using a Drug for Seasonal Allergic Rhinitis
Investigate Two Trial Models; Vienna Challenge Chamber (in and Out of Season) and Park Study (in Season) Using a Drug for Seasonal Allergic Rhinitis
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.
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).
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.