Last updated: 11/04/2018 10:23:20
A Study To Investigate If MRI Scanning Is Effective At Seeing What Hayfever Drugs Do In Nasal Passage.
GSK study ID
RES101509
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: An investigation to evaluate the technique of MRI as an assessment of the effect of anti-allergy drug treatment on internal nasal and sinus mucosal anatomy following intranasal allergen challenge in subjects with seasonal allergic rhinitis.
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Cross-sectional airspace area (and thus also airspace volume) of the nasal passages
Timeframe: at 1hr post-dose and 30-60mins post-allergen challenge.
Secondary outcomes:
Volume of fluid identified adjacent to the airspace. Mucosal surface area. Nasal cavity volume. Nasal tissue volume derived from the nasal cavity volume less airspace and fluid volumes.
Timeframe: At 1hr post-dose and 30-60mins post-allergen challenge
Interventions:
Drug: pseudoephedrine hydrochloride
Drug: cetirizine hydrochloride
Enrollment:
21
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Seasonal Allergic Rhinitis, Sinusitis
Product
Not applicable
Collaborators
Not applicable
Study date(s)
March 2007 to May 2007
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 60 years
Accepts healthy volunteers
No
- A medically diagnosed hay fever patient who is otherwise healthy.
- Aged 18 to 60 years.
- Pregnant or nursing females.
- Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception.
Inclusion and exclusion criteria
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.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2007-29-05
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website