None listed
Conditions
Brief summary
Inhaled “bronchodilator” medications (found in puffers/inhalers) are used for the treatment of COPD at all stages of the disease. Large clinical trials have proven the benefits of these medications in patients with COPD. However, we still do not fully understand the effects of these medications on lung function. Our research team has access to advanced methods of measuring lung function, and by using these techniques we hope to understand more about the lungs respond to bronchodilator treatment. By improving our understanding of the effects of these medications on lung function, we may be able to improve future treatments for patients with COPD.
Interventions
Participants will self-administer 18 micrograms tiotropium bromide via oral inhalation route once-daily for 28 +/- 2 days (the precise finish date determined by the availability of the PET scanner). Adherence to therapy will be monitored by drug return and counting
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Adults with physician-diagnosed mild-moderate chronic obstructive pulmonary disease, with history of current or past smoking (total exposure > 10 pack years)
Exclusion criteria
* Use of tiotropium or any other LAMA or LABA within the previous 4 weeks * Musculoskeletal (for example, severe arthritis) or other conditions which limit the ability to walk at near-maximal pace * Significant cardiac disease (ischaemic 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 * Documented hypersensitivity to, or intolerance of, anti-cholinergic therapies * Significant respiratory infection or documented exacerbation of COPD within the previous 6 weeks * Other active or chronic respiratory pathologies (for example, interstitial lung disease, asthma, chest wall pathology causing ventilatory restriction) * 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) * Any major comorbidities deemed to impact on respiratory physiology or symptoms, including severe on uncontrolled heart failure, morbid obesity, muscular or neurological disorders causing respiratory muscle weakness or dysfunctional swallowing * History of chronic kidney disease (moderate to severe, eGFR less than or equal to 45 mL/min/1.73m2) or severe hepatic impairment * Unable to perform lung function testing at the enrollment visit * Dependence on domiciliary supplemental oxygen, unable to go without for at least 1 hour * Women who are breast feeding, pregnant, or unwilling to avoid pregnancy during the study period * Unable to provide informed consent * Current enrolment in other trials
Outcome results
None listed