Management of severe asthma using a combination of exhaled and blood markers of inflammatio

Phase 4

Completed

• Conditions: asthma; Respiratory - Asthma

• Registration Number: ACTRN12616001015437
• Lead Sponsor: Hunter New England Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-02
• Study Completion: 2019-05-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

* Diagnosed severe treatment-resistant asthma (GINA step 4 or higher) with documented evidence of variable airflow limitation or Respiratory consultant diagnosis of asthma)
* Never or ex-smoker
* Prescribed greater than 1000 micrograms of inhaled beclomethasone (CFC) metered dose inhaler (or equivalent) and inhaled long acting beta-2 agonist (LABA) for at least 6 months
* Remain uncontrolled with an asthma control questionnaire (ACQ) score greater than or equal to 1.5 OR Have had a hospital admission for asthma in the last 12 months OR Have experienced at least 2 asthma exacerbations in the past 12 months requiring a course of OCS (at least 3 days).

Exclusion Criteria

* Current smoker or smoking cessation within the last 6 months
* Severe exacerbation or alteration to asthma therapy within 4 weeks prior to Visit 1
* Eligible for commencing Omalizumab (according to current Pharmaceutical Benefits Scheme criteria), or currently within the first 6 months of commencing Omalizumab.
* Other medical comorbidity or research study requiring chronic systemic corticosteroid (for example rheumatologic conditions, adrenal insufficiency, etc.)
* Eligible for commencing Mepolizumab or currently within the first 6 weeks of commencing Mepolizumab

Study & Design

• Study Type: Interventional
• Study Design: Not specified