Steroid Titration Against Mannitol IN Asthma

University of Dundee

Status: Completed

Conditions: Asthma

Treatments: Other: mannitol (an airway challenge agent)

Study type: Interventional

Funder types: Other

Identifiers

NCT01216579

FARD002

Details and patient eligibility

About

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.

Enrollment: 164 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

164 participants in 2 patient groups, including a placebo group

Reference arm

Placebo Comparator group

Description:

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

Treatment:

Other: mannitol (an airway challenge agent)

Mannitol managed arm

Active Comparator group

Description:

Group of asthmatic patients managed according to their mannitol challenge.

Treatment:

Other: mannitol (an airway challenge agent)