None listed
Conditions
Brief summary
This projects aims to study the effects of different inhaled bronchodilator medications used in the management of COPD. Clinical trials have demonstrated their effects on the large airways of the lungs, however their effects on the small airways are not yet known. This project will use sensitive tests of small airway function to identify the effects of bronchodilator therapy on the small airways in COPD. Specifically, we aim to determine if two different classes of bronchodilators have a greater effect when given in combination than when given alone. We hope to use this information to enhance our knowledge of how these medications work, which may help us improve the treatment of patients with COPD.
Interventions
At each of the four study visits, participants will have baseline lung function and complex lung mechanics (forced oscillation technique [FOT] and multiple breath nitrogen washout [MBNW]) measured. They will then be administered a single dose of either indacaterol 150 microg, glycopyrronium 50 microg, glycopyrronium/indacaterol 50/110 microg combination, or salmeterol 50 microg, via oral inhalation route. The lung function and complex lung mechanics will then be repeated at pre-specified time in
At each of the four study visits, participants will have baseline lung function and complex lung mechanics (forced oscillation technique [FOT] and multiple breath nitrogen washout [MBNW]) measured. They will then be administered a single dose of either indacaterol 150 microg, glycopyrronium 50 microg, glycopyrronium/indacaterol 50/110 microg combination, or salmeterol 50 microg, via oral inhalation route. The lung function and complex lung mechanics will then be repeated at pre-specified time intervals up to 2 hours post-administration. Each study visit will be separated by a period of at least 48 hours to ensure washout of the previous medication.
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Adults with physician-diagnosed mild-moderate chronic obstructive pulmonary disease, with a history of current or past smoking (total exposure > 10 pack years)
Exclusion criteria
* Use of glycopyrronium, indacaterol, salmeterol or any other LAMA or LABA within the previous 4 weeks (unless able to undergo a 2 week washout period) * Documented hypersensitivity to, or intolerance of, beta-agonists or 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 severe renal or 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