None listed
Conditions
Brief summary
Chronic Obstructive Pulmonary Disease and Severe Asthma are chronic obstructive airway diseases associated with a high disease burden. They are complex diseases that can be complicated by significant comorbidity. A new and emerging approach to these conditions is to focus on the identification and treatment of the processes that underlie individual disease. These components are termed ‘treatable traits’. An important aspect of the treatable traits approach is objective monitoring to select and continue therapy. Most current monitoring approaches are assessed using nonobjective measures, that do not capture improvements after treatment. Functional lung ventilation imaging with quantification using Technegas may address this clinical need. Tomographic pulmonary scintigraphy (ventilation/perfusion single photon emission computed tomography: V/P SPECT) is a nuclear medicine investigation that gives a 3dimensional functional map of the ventilation and perfusion of the lungs and shows how these are affected by disease. We believe that this new imaging approach may be a useful objective measure of disease and treatment response in severe asthma and COPD. In the current study, we aim to quantify: 1. Whether functional lung ventilation technology can objectively quantify ventilation heterogeneity in patients with severe obstructive airway disease (asthma or COPD). 2. Determine whether functional lung ventilation imaging can be used to quantify response to therapies.
Interventions
Functional lung ventilation imaging with quantification using Technegas will be used. Tomographic pulmonary scintigraphy (ventilation/perfusion single photon emission computed tomography: V/P SPECT) is a nuclear medicine investigation that gives a 3dimensional functional map of the ventilation and perfusion of the lungs and shows how these are affected by disease. The participant will breathe in a very small amount of nanoparticle suspension for ventilation images and be given an injection of ra
Functional lung ventilation imaging with quantification using Technegas will be used. Tomographic pulmonary scintigraphy (ventilation/perfusion single photon emission computed tomography: V/P SPECT) is a nuclear medicine investigation that gives a 3dimensional functional map of the ventilation and perfusion of the lungs and shows how these are affected by disease. The participant will breathe in a very small amount of nanoparticle suspension for ventilation images and be given an injection of radioactive material, called Technetium99mTc, for the perfusion images. The VQ scan takes less than an hour. A low radiation CT scan will also be performed as part of the imaging. All 100 participants will undergo the baseline imaging. A subgroup of 30 participants will receive a second imaging session after 12 weeks of add-on therapy. This treatment will be part of their current clinical practice at the John Hunter Hospital Respiratory Clinic, under the supervision of the patient’s treating physician. Participants in the sub-group will receive either Mepolizumab, Omalizumab or Macrolide antibiotics. Mepolizumab is administered by subcutaneous injection of 150mg every 4 weeks. Omalizumab will also be administered by subcutaneous injections every 2 weeks or 4 weeks with the patient's pre-treatment serum total IgE level (IU/mL) and body weight (lb or kg) being used to determine doses (mg) and dosing frequency. The dosing table can be found at: https://www.xolair.com/allergic-asthma/hcp/determining-the-dose.html.. Macrolide antibiotics will be administered as oral azithromycin as either 250mg daily or 500mg, 3 times per week depending on the patient's preference and perceived adherence. The overall time-frame of each add-on therapy may vary between participants, however the second imaging scan will happen after they have undergone 12 weeks of their treatment. Medication adherence will be routinely assessed by respiratory nurses and clinicians at each clinic review by open ended questions. Adherence will also be checked by the clinical research assistant at the 12-week follow-up study visit.
Sponsors
Vanessa McDonald
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed