Clincosm LogoSign in Get a demo

Steroid Titration Against Mannitol IN Asthma

Sponsor
University of Dundee (Other)
Overall Status
Completed
CT.gov ID
NCT01216579
Collaborator
(none)
164
Enrollment
2
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: mannitol (an airway challenge agent)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
164 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Titrating Inhaled Steroid Dose Against Mannitol Hyper-responsiveness or BTS Outcomes: Comparative Effects on Asthma Exacerbations Over 1 Year
Study Start Date :
Mar 1, 2004
Actual Primary Completion Date :
Feb 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Reference arm

Asthmatic patients managed as per British Thoracic Society guidelines by symptoms and lung function.

Other: mannitol (an airway challenge agent)
Active Comparator: Mannitol managed arm

Group of asthmatic patients managed according to their mannitol challenge.

Other: mannitol (an airway challenge agent)

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Dundee

    Investigators

    • Principal Investigator: Brian J Lipworth, MD, University of Dundee

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01216579
    Other Study ID Numbers:
    • FARD002
    First Posted:
    Oct 7, 2010
    Last Update Posted:
    Oct 7, 2010
    Last Verified:
    Mar 1, 2008
    Additional relevant MeSH terms:
    Asthma
    Mannitol

    Study Results

    No Results Posted as of Oct 7, 2010