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Steroid Titration Against Mannitol IN Asthma

NCT ID: NCT01216579

Last Updated: 2010-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Reference arm

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

Group Type PLACEBO_COMPARATOR

mannitol (an airway challenge agent)

Intervention Type OTHER

Mannitol managed arm

Group of asthmatic patients managed according to their mannitol challenge.

Group Type ACTIVE_COMPARATOR

mannitol (an airway challenge agent)

Intervention Type OTHER

Interventions

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mannitol (an airway challenge agent)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Dundee

OTHER

Sponsor Role lead

Responsible Party

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University of Dundee

Principal Investigators

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Brian J Lipworth, MD

Role: PRINCIPAL_INVESTIGATOR

University of Dundee

References

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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.

Reference Type DERIVED
PMID: 28065396 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22438232 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21998259 (View on PubMed)

Other Identifiers

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FARD002

Identifier Type: -

Identifier Source: org_study_id