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/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
