Steroid Titration Against Mannitol IN Asthma

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mannitol (an airway challenge agent)

Other

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Registry information

Official study title

Titrating Inhaled Steroid Dose Against Mannitol Hyper-responsiveness or BTS Outcomes: Comparative Effects on Asthma Exacerbations Over 1 Year

Important dates

Study start: 2004
Primary completion: 2010
First posted: Oct 7, 2010
Registry last updated: Oct 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed