A study to investigate the real-life use of the Vannair SMART regime in adult asthma (the SMART study).

Phase 4

Completed

• Conditions: Asthma; Respiratory - Asthma

• Registration Number: ACTRN12610000515099
• Lead Sponsor: Medical Research Institute of New Zealand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. A doctor's diagnosis of asthma; 2. A current prescription for inhaled corticosteroid (ICS) medications; 3. No change in the dose of ICS in the last month; 4. An asthma exacerbation in the previous year where the patient presented to a General Practitioner or Emergency Department and was prescribed a course of oral steroids and/or received a spacer/nebuliser-delivered bronchodilator and patients who self-administered prednisone for asthma for at least 3 days.

Exclusion Criteria

1. Onset of respiratory symptoms after the age of 40 years in current or ex-smokers with a greater than or equal to 10 pack years smoking history; 2. use of an at-home nebuliser (unless patients agree to withhold nebuliser use for the study duration); 3. treatment with oral prednisone in the previous 4 weeks; 4. diagnosis of Chronic Obstructive Pulmonary Disease (COPD), interstitial lung disease or bronchiectasis; 5. unsuitable cardiovascular or other medical history, or any other safety concern at the investigator's discretion; 6. unable or unwillling to give consent to participate, to follow the study requirements and/or to change from current asthma treatment regime.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of high beta-agonist use episodes in the SMART group compared with the Standard Group as defined by the proportion of patients in the SMART group who at any point within the 24 week study period used greater than 8 actuations of Vannair as a reliever per 24 hour period compared to the proportion of patients in the Standard group who used greater than 16 actuations of Ventolin in a 24 hour period, as recorded by the electronic monitoring devices.[As assessed after the 24 week study period on the data from the electronic monitoring devices.]