None listed
Conditions
Brief summary
Chronic Obstructive Pulmonary Disease (COPD) is a severe condition causing millions of deaths annually, with late diagnosis and progressive lung damage making current treatments only symptomatic. The trial focuses on the pre-COPD phase, a critical period when lung function begins to decline but before permanent damage occurs, offering an opportunity for intervention. Inhaled Triple Therapy (fluticasone furoate, umeclidinium, and vilanterol) may slow lung function decline and prevent progression to COPD. This double-blind, randomized, placebo-controlled trial will involve 500 participants from the Tasmanian Longitudinal Health Study (TAHS) to evaluate the therapy's effectiveness and cost efficiency. If successful, this groundbreaking study could shift COPD management to prevention, reduce its global burden, and lay the foundation for future research and drug development.
Interventions
A triple therapy inhaler that includes three medicines, i.e., inhaled corticosteroid (ICS, e.g., fluticasone furoate), + long-acting muscarinic antagonist (LAMA, e.g., umeclidinium), and long-acting beta-agonist (LABA, e.g., vilanterol). Each inhalation will include fluticasone furoate 100 mcg, umeclidinium 62.5 mcg and vilanterol 25 mcg. Dose is one puff once a day for 12 months. Adherence will be monitored through regular check-ups via phone calls/emails/dairies, as well as return of empty inh
A triple therapy inhaler that includes three medicines, i.e., inhaled corticosteroid (ICS, e.g., fluticasone furoate), + long-acting muscarinic antagonist (LAMA, e.g., umeclidinium), and long-acting beta-agonist (LABA, e.g., vilanterol). Each inhalation will include fluticasone furoate 100 mcg, umeclidinium 62.5 mcg and vilanterol 25 mcg. Dose is one puff once a day for 12 months. Adherence will be monitored through regular check-ups via phone calls/emails/dairies, as well as return of empty inhalers.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Tasmania Longitudinal Health Study (TAHS) participants who belong to a pre-COPD lung function trajectory (a higher rate of lung function decline plus a high risk of COPD), were defined using longitudinal modelling of FEV1 or FEV1/FVC.
Exclusion criteria
Systemic steroid use <28 days before enrolment, current use of any of the generic triple therapy (TT) components, COPD (FEV1/FVC ratio less than the lower limit of normal)
Outcome results
None listed