Can Functional Lung Ventilation Imaging in Asthma and Chronic obstructive pulmonary disease identify response to treatment.

Not Applicable

Completed

• Conditions: Severe asthma; Respiratory - Asthma; Chronic obstructive pulmonary disease; Respiratory - Chronic obstructive pulmonary disease

• Registration Number: ACTRN12617001275358
• Lead Sponsor: Vanessa McDonald

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-05
• Study Completion: 2019-07-31
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Adults (greater than or equal to 18 years) with severe treatment refractory asthma defined according to ATS/ERS criteria:
-Asthma which requires treatment with guidelines-suggested medications for GINA steps 4-5 (high dose ICS and LABA or leukotriene modifier/theophylline) for the previous year or systemic corticosteroids for greater than or equal to 50% of the previous year to prevent it from becoming uncontrolled” or which remains uncontrolled” despite this therapy
-Uncontrolled asthma defined as at least one of the following:
*Poor symptom control: ACQ consistently > 1.5, ACT < 20
*Frequent severe exacerbations: 2 or more bursts of systemic corticosteroids (greater than 3 days each) in the previous year
*Serious exacerbations: at least one hospitalisation, ICU stay or mechanical ventilation in the previous year
*Airflow limitation: after appropriate bronchodilator withhold FEV1 < 80% predicted (in the face of reduced FEV1/FVC defined as less than the lower limit of normal)
OR
Adults (greater than or equal to 18 years) with obstructive airways disease (either asthma or COPD) who are to be treated with add on therapies (macrolides, monoclonal antibody therapies or itraconazole). This includes moderate or severe asthma or COPD, with persistent symptoms, and/or frequent exacerbations. Exacerbations will be defined as indicated below.

Exclusion Criteria

•Inability to attend study visits.
•Current lung cancer or other blood, lymphatic or solid organ malignancy
•Diagnosis with primary respiratory disease other than asthma or COPD (e.g. active tuberculosis, pulmonary fibrosis)
•Expected prognosis poor <3 months survival
•Pregnancy or breast-feeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ventilation heterogeneity among patients with severe obstructive airways diseases as assessed using technegas functional lung ventilation and perfusion with imaging and quantification[0 weeks (all participants) ];Technegas functional lung ventilation and perfusion imaging quantification responsiveness to change following intervention in patients with severe obstructive airways diseases.<br><br>[12 weeks (30 participants)]

Secondary Outcome Measures

Name	Time	Method
ACQ score[0 weeks (all participants) and 12 weeks (30 participants)]