NCT01216579

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for not_applicable asthma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2010

Completed
Last Updated

October 7, 2010

Status Verified

March 1, 2008

Enrollment Period

5.9 years

First QC Date

October 6, 2010

Last Update Submit

October 6, 2010

Conditions

Asthma

Study Arms (2)

Reference arm

PLACEBO COMPARATOR

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

Other: mannitol (an airway challenge agent)

Mannitol managed arm

ACTIVE COMPARATOR

Group of asthmatic patients managed according to their mannitol challenge.

Other: mannitol (an airway challenge agent)

Interventions

mannitol (an airway challenge agent)OTHER
Mannitol managed armReference arm

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 28065396DERIVED

  • 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.

    PMID: 22438232DERIVED

  • 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.

    PMID: 21998259DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Brian J Lipworth, MD

    University of Dundee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2010

First Posted

October 7, 2010

Study Start

March 1, 2004

Primary Completion

February 1, 2010

Last Updated

October 7, 2010

Record last verified: 2008-03