Clinical trial NCT01216579: 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
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2010-10-07
Enrollment: 164
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Dundee
name: Brian J Lipworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.