Not Yet RecruitingPhase 2Phase 3ACTRN12625000663459

PRE-TREAT: A clinical trial exploring if a combination inhaler prevents early lung changes from developing into full chronic obstructive pulmonary disease (COPD).

Does inhaled triple therapy in individuals with pre-COPD arrest progression to full-blown COPD? A double-blind randomised placebo-controlled trial (PRE-TREAT)


Sponsor

The University of Melbourne

Enrollment

500 participants

Start Date

Jul 1, 2026

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 60 Yearss

Inclusion Criteria1

  • 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 Criteria1

  • 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)

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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 b

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.


Locations(1)

TAS,VIC, Australia

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ACTRN12625000663459