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Steroid Titration Against Mannitol IN Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mannitol (an airway challenge agent)
Sponsored by
University of Dundee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Asthma

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Reference arm

    Mannitol managed arm

    Arm Description

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

    Group of asthmatic patients managed according to their mannitol challenge.

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 6, 2010
    Last Updated
    October 6, 2010
    Sponsor
    University of Dundee
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01216579
    Brief Title
    Steroid Titration Against Mannitol IN Asthma
    Official Title
    Titrating Inhaled Steroid Dose Against Mannitol Hyper-responsiveness or BTS Outcomes: Comparative Effects on Asthma Exacerbations Over 1 Year
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2004 (undefined)
    Primary Completion Date
    February 2010 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Dundee

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    164 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Reference arm
    Arm Type
    Placebo Comparator
    Arm Description
    Asthmatic patients managed as per British Thoracic Society guidelines by symptoms and lung function.
    Arm Title
    Mannitol managed arm
    Arm Type
    Active Comparator
    Arm Description
    Group of asthmatic patients managed according to their mannitol challenge.
    Intervention Type
    Other
    Intervention Name(s)
    mannitol (an airway challenge agent)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brian J Lipworth, MD
    Organizational Affiliation
    University of Dundee
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28065396
    Citation
    Anderson WJ, Short PM, Jabbal S, Lipworth BJ. Inhaled corticosteroid dose response in asthma: Should we measure inflammation? Ann Allergy Asthma Immunol. 2017 Feb;118(2):179-185. doi: 10.1016/j.anai.2016.11.018. Epub 2017 Jan 3.
    Results Reference
    derived
    PubMed Identifier
    22438232
    Citation
    Anderson WJ, McFarlane LC, Lipworth BJ. Prospective follow-up of novel markers of bone turnover in persistent asthmatics exposed to low and high doses of inhaled ciclesonide over 12 months. J Clin Endocrinol Metab. 2012 Jun;97(6):1929-36. doi: 10.1210/jc.2011-3410. Epub 2012 Mar 21.
    Results Reference
    derived
    PubMed Identifier
    21998259
    Citation
    Lipworth BJ, Short PM, Williamson PA, Clearie KL, Fardon TC, Jackson CM. A randomized primary care trial of steroid titration against mannitol in persistent asthma: STAMINA trial. Chest. 2012 Mar;141(3):607-615. doi: 10.1378/chest.11-1748. Epub 2011 Oct 13.
    Results Reference
    derived

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    Steroid Titration Against Mannitol IN Asthma

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