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Steroid Titration Against Mannitol IN Asthma

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01216579
Enrollment
164
Registered
2010-10-07
Start date
2004-03-31
Completion date
Unknown
Last updated
2010-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

OTHERmannitol (an airway challenge agent)

Sponsors

University of Dundee
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026