None listed
Conditions
Interventions
A double-blind cross-over placebo controlled system will be used. Computer generated randomisation will be conducted internally by a non-study related third party. Patients will be randomly assigned to receive either mannitol first and then placebo, or placebo first and then mannitol. There will be a one-week washout period between treatments. At the same time each morning and evening (approx. 12 h apart) for one week, subjects will be required to intranasally apply one actuation (40 mg) of eith
A double-blind cross-over placebo controlled system will be used. Computer generated randomisation will be conducted internally by a non-study related third party. Patients will be randomly assigned to receive either mannitol first and then placebo, or placebo first and then mannitol. There will be a one-week washout period between treatments. At the same time each morning and evening (approx. 12 h apart) for one week, subjects will be required to intranasally apply one actuation (40 mg) of either mannitol (contained within a gelatin capsule) or placebo (gelatin capsule containing 40mg lactose) to each nostril using a dry powder inhaler device (Teijen spray applicator). All capsules will be weighed prior to and after each inhalation to check compliance and to determine the actual amount of mannitol delivered.
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All subjects must: be able to give written, informed consent; be willing, able and likely to complete the study including compliance with study procedures and restrictions; be able to read, comprehend and record information in English; be between 18 and 70 years of age at first visit; be non-smokers. Only females >55 years of age who have not had a menstrual period in the last 12 months or females <55 years of age who have not had a menstrual period in the past 12 months and who have had their post-menopausal condition confirmed by laboratory blood test, will be eligible to participate. In addition, all subjects must withhold the following medications prior to and for the duration of the study: intranasal steroids, 2 weeks; oral or intranasal antihistamines, 48 h; intranasal decongestants, 24 h.Healthy subjects: Must have no upper or lower respiratory diseases or disorders; no current symptoms of allergic rhinitis or chronic sinusitis; no history of allergic rhinitis or chronic sinusitis; no severe physical obstruction of the nose (i.e. deviated septum or nasal polyps).Persistent allergic rhinitis subjects: Must have a positive skin prick test response to a perennially-occurring allergen (animal dander, house dust mite, cockroach, mould) within the last 12 months; have nasal symptoms that are present for more than 4 days a week and for more than 4 weeks per year (current definition of persistent allergic rhinitis)[15].Chronic rhinosinusitis: Must have had symptoms continuously present for >12 weeks; must present with 2 or more major factors or 1 major and at least 2 minor factors from the following lists; Major: facial pain/pressure nasal blockage, nasal discharge/purulence/ discoloured postnasal drainage, hyposmia/anosmia; purulence in nasal cavity on examination. Minor: headache, fever, halitosis, fatigue, dental pain, cough, ear pain/pressure/fullness[16]. An abnormal CT scan will be required to confirm the diagnosis. Previous surgery does not exclude the subject so long as the latest CT scan is abnormal.
Exclusion criteria
Current asthmatics will be excluded from the study and all subjects will have a baseline FEV1 which is >70% predicted.
Outcome results
None listed