Steroid Titration Against Mannitol IN Asthma

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: mannitol (an airway challenge agent)

• Registration Number: NCT01216579
• Lead Sponsor: University of Dundee

Brief Summary

The investigators hypothesise that titration of asthma medication against mannitol challenge results will reduce the number of mild asthma exacerbations, in one year, when compared with titration against BTS guidelines. To test this hypothesis the investigators propose a primary care, parallel treatment, patient blinded study in which matched groups of asthmatic patients will be treated in accordance either with BTS guidelines or with our treatment algorithm dependent on mannitol challenge result.

Purpose of the study is to evaluate the efficacy of a treatment algorithm based on the measurement of airway hyperresponsiveness to mannitol challenge, a surrogate marker of airway inflammation, in the long term treatment of asthma in comparison to BTS guidelines.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Status Verified: 2008-03
• Primary Completion: 2010-02
• Study First Submitted: 2010-10-06
• Study First Submitted QC: 2010-10-06
• Last Update Submitted: 2010-10-06
• Study First Posted: 2010-10-07
• Last Update Posted: 2010-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

• Male or female asthmatics aged >/= 16 years
• Females must be non pregnant and non lactating
• FEV1 >/= 50% predicted
• Mannitol PD10 </= 635 mg at end of step down period
• No recent exacerbations of asthma requiring oral prednisolone in the previous 3 months
• Able to perform all the techniques necessary to carry out the challenge testing and lung function and compliant with taking the study medication
• Good inhaler technique which will be reinforced at each study visit

Exclusion Criteria

• Male or female patients aged 15 or below
• FEV1 </= 50% predicted
• Patients who are currently taking a pulse of oral corticosteroids
• Patients with the following concomitant illnesses:bronchiectasis, allergic bronchopulmonary aspergillosis, COPD, heart failure, pulmonary fibrosis, rhino-sinusitis with polyps
• Immunocompromised patients
• Patients with recurrent LRTI
• Patients with documented aspirin induced asthma on LRTAs
• Pregnancy
• Known or suspected hypersensitivity to ICS or other excipients of the MDIs
• HIV/Hepatitis B or C positive

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference arm	mannitol (an airway challenge agent)	Asthmatic patients managed as per British Thoracic Society guidelines by symptoms and lung function.
Mannitol managed arm	mannitol (an airway challenge agent)	Group of asthmatic patients managed according to their mannitol challenge.