The purpose of this study is to establish whether MRI scanning is a sensitive measure of the
effects of existing drug treatments on nasal dimensions following challenge with intranasal
allergen in subjects with hayfever. If successful this technique could be applied to
increase confidence for internal decision making and ultimately may be used to assess how
effective a new drug treatment is.
Inclusion Criteria:
- A medically diagnosed hay fever patient who is otherwise healthy.
- Aged 18 to 60 years.
- Body mass index less than 30 kg/m² with weight range of 50kg (females 45kg) to 100kg.
- A positive skin prick test (wheal = 3mm) for grass pollen at or within 12 months of
starting the study and/or a positive RAST (= class 2) for grass pollen at or within
12 months of starting the study.
- Baseline FEV1 = 80% predicted and a baseline FEV1/FVC = 70% predicted (using standard
predicted guidelines).
- Capable of giving informed consent which includes compliance with the requirements
and restrictions listed in the consent form.
- Available to complete all study measurements.
Exclusion Criteria:
- Pregnant or nursing females.
- Women of childbearing potential who are unwilling or unable to use an appropriate
method of contraception.
- On examination the subject is found to have any nasal abnormalities or nasal
polyposis, a history of frequent nosebleeds, or nasopharyngeal surgery.
- Recent (within 3 weeks) or ongoing chest infection which in the physician responsible
opinion renders the subject unsuitable for participation in the study.
- The subject has a history or current evidence of perennial rhinitis, sinusitis, or
any other condition potentially or directly involving the nasal cavity, sinuses or
nasopharynx.
- A history of any medical condition that would not allow the use of pseudoephedrine
(e. g. hypertension, diabetes mellitus, ischaemic heart disease, raised intraocular
pressure, hyperthyroidism, benign prostatic hyperplasia) or cetirizine (eg.
antihistamine hypersensitivity).
- 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
physician responsible, contraindicates their participation.
- The subject has participated in another study during the previous 3 months.
- The subject is currently taking regular (or a course of) medication whether
prescribed or not, including steroids, vitamins, oral contraceptives and herbal
remedies.
- The subject regularly, or on average, drinks more than 4 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 smokes more than 5 cigarettes per day.
- The subject has a history of porphyria.
