Steroid Titration Against Mannitol IN Asthma

Asthma Clinical Trial

Official title:

Titrating Inhaled Steroid Dose Against Mannitol Hyper-responsiveness or BTS Outcomes: Comparative Effects on Asthma Exacerbations Over 1 Year

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216579
• Other study ID #: FARD002
• Status: Completed
• Phase: N/A
• First received: October 6, 2010
• Last updated: October 6, 2010
• Start date: March 2004

Study information

• Verified date: March 2008
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• mannitol (an airway challenge agent)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Dundee