Characterisation of lung function in chronic obstructive pulmonary disease (COPD) and asthma patients using a new lung imaging technique.

Not Applicable

• Conditions: Asthma; Chronic Obstructive Pulmonary Disease; Respiratory - Asthma; Respiratory - Chronic obstructive pulmonary disease

• Registration Number: ACTRN12619000447156
• Lead Sponsor: Woolcock Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-19
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Willing and able to give written informed consent
2. Have a physician-diagnosed COPD or asthma
3. For asthma only:
- no history of smoking or smoking history of less that 10 pack years
4. For COPD only:
- history of current or past smoking, with total exposure of greater than 10
pack years.
- FEV1/FVC ratio of less the 95th percentile of the normal range (according to subject
age, gender and height); AND
- FEV1 less the 95th percentile of the normal range predicted for subject age, gender and
height; or FEV1 within the normal range, in the presence of symptoms consistent with
COPD; AND
- FEV1 greater than or equal to 40% of the predicted value.

Exclusion Criteria

1. Significant cardiac disease (ischemic heart disease or arrhythmia) deemed by the investigators or the subject’s treating cardiologist to make it unsafe for the subject to undertake a supervised near-maximal exercise test.
2. Documented hypersensitivity to, or intolerance of anti-cholinergic therapies.
3. Significant respiratory infection or documented exacerbation of Asthma or COPD within the previous 6 weeks.
4. Intensive Care Unit admission in the last 12 months.
5. Other active or chronic respiratory pathologies (for example, interstitial lung disease, asthma, chest wall pathology causing ventilatory restriction).
6. Past history of lung surgery (including lobectomy or pneumonectomy, but not lung biopsy) or thoracic radiation therapy (excluding isolated mediastinal radiation therapy with no evidence of subsequent pulmonary fibrosis).
7. Any major comorbidities deemed to impact on respiratory physiology or symptoms, including severe on uncontrolled heart failure, morbid obesity (BMI >40), muscular or neurological disorders causing respiratory muscle weakness or dysfunctional swallowing.
8. History of chronic kidney disease (creatine greater than the upper limit of normal).
9. Unable to perform lung function testing.
10. Dependence on domiciliary supplemental oxygen, unable to go without for at least 1 hour.
11. Women who are breast feeding, pregnant, or unwilling to avoid pregnancy during the study period.
12. Unable to provide informed consent
13. Current enrolment in other trials

Study & Design

• Study Type: Interventional
• Study Design: Not specified