Australian Mepolizumab Registry (AMR) for Severe Asthma

Not Applicable

Suspended

• Conditions: severe asthma; Respiratory - Asthma

• Registration Number: ACTRN12618001497291
• Lead Sponsor: Hunter New England Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-05
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Able to provide informed written consent
2. Age greater than or equal to 12 years
3. Asthma diagnosis confirmed by doctor or hospital and documented for at least 1 year
4. Confirmed variable airflow obstruction (1 or more of the following):
a. FEV1 reversibility greater than or equal to 12% and greater than or equal to 200mL at baseline within 30 minutes after administration of salbutamol (200-400micrograms), OR
b. Airway hyper-responsiveness (AHR) defined as >20% decline in FEV1 during a direct bronchial provocation test or >15% decline during an indirect test, OR
c. Peak Expiratory Flow (PEF) variability of >15% between the 2 highest and 2 lowest peak expiratory flow rates during 14 days
5. Optimised asthma management skills (formal assessment of and adherence to correct inhaler technique, documented in medical records)
6. FEV1 less than or equal to 80% predicted
7. Eligible to commence mepolizumab via the Pharmaceutical Benefit Scheme (PBS)-subsidised criteria OR outside of the PBS restrictions
8. Optimised asthma therapy (unless contraindicated or not tolerated):
a. greater than or equal to 12 months maximal inhaled therapy with adherence and correct technique documented, including:
i. High dose inhaled corticosteroid (ICS)
ii. Long-acting beta-2 agonist (LABA) therapy
AND
b. Treatment with oral corticosteroids (OCS)
9. Uncontrolled asthma, as defined by:
a. Asthma Control Questionnaire (ACQ-5) score AND
b. One of the following experienced in the previous year:
i. greater than or equal to 1 admission to hospital for a severe asthma exacerbation, OR
ii. greater than or equal to 1 severe asthma exacerbation requiring documented use of systemic corticosteroids (OCS initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.
10. Eosinophilic asthma as determined from peripheral blood eosinophil count (as according to the current PBS criteria).

Exclusion Criteria

1. People highly dependent on medical care
2. Cognitive impairment preventing completion of data collection forms

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in asthma control score <br>(Juniper Asthma Control Questionnaire - ACQ5)[Change in asthma control score is assessed at 4(3-5), 7(6-8), 12, 18 and 24 months post-commencement of treatment. Asthma control is assessed at each time-point for the week preceding.];Number of severe exacerbations<br>Severe asthma exacerbations identified as those requiring use of systemic corticosteroids prescribed or supervised by a physician, hospitalisation or an emergency department visit requiring systemic corticosteroids. Severe exacerbations are captured via clinical staff report/medical record review.[The number of severe exacerbations that have occurred since the previous visit are assessed at 4(3-5), 7(6-8), 12, 18 and 24 months post-commencement of treatment. ]