Mannitol and nasal mucociliary clearance

Phase 3

Completed

• Conditions: Chronic Rhinosinusitis; Allergic Rhinitis; Respiratory - Other respiratory disorders / diseases; Inflammatory and Immune System - Allergies

• Registration Number: ACTRN12605000473662
• Lead Sponsor: Woolcock Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mucociliary clearance rate will be measured using the radiolabeled aerosol tracer method which is a previously established method for measurement of mucociliary clearance rates. The same nasal cavity side will be used for each assessment.[Measurements will made immediately prior to the inhalation of the first dose of mannitol or placebo (single baseline reading) and then 1 hour after the first dose of mannitol /placebo and 12 hours after the last dose of mannitol/placebo, after a weeks' treatment. All of these readings will be taken in the morning.]