Study of Fluticasone/Formoterol/Glycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR)
1252 patients around the world
Available in Brazil
This is a phase 3 non-inferiority, randomized, open-label study with active control to
compare the efficacy and safety of a fixed-dose triple combination to another triple
combination with already established efficacy in subjects with symptomatic chronic
obstructive pulmonary disease (COPD).
This study will be conducted in two stages. Study Step 1 The primary assessment of
non-inferiority will be performed after 12 weeks of treatment by assessing FEV1 (Forced
expiratory volume in the first second) in relation to baseline.
Study Step 2 In a second step, it will be assessed whether the benefits of the new triple
combination on respiratory symptoms and health-related quality of life are sustained in
the long term and to determine the annual rate of flares in 52 weeks of treatment.
The study will comprise a screening phase, consisting of a screening and run-in visit
lasting up to 14 days, and a treatment phase in which, after collecting baseline data
(which includes assessment of FEV1 (Forced expiratory volume in the first second) and
quality of life through a questionnaire), participants will be randomized and begin their
respective treatments.
Visits during Step 1 of treatment will be performed at weeks 4 and 12. The week 12 visit
will be the primary endpoint visit.
After 12 weeks, Step 2 of the study will begin with all participants who completed Step 1
and who agreed to remain in the study to receive Eurofarma's experimental drug for up to
52 weeks. Visits during this step will be performed at weeks 24, 36 and 52 to assess
safety, quality of life, lung function and flare rate (exploratory endpoints).
Eurofarma Laboratorios S.A.
1Research sites
1252Patients around the world
This study is for people with
Chronic obstructive pulmonary disease
Copd
Requirements for the patient
From 40 Years
All Gender
Medical requirements
Participants of both sexes who meet all of the following criteria will be included in the study:.
Signed Informed Consent Form (ICF).
Male or female aged 40 or over.
Medical diagnosis of chronic obstructive pulmonary disease (COPD) documented by post-bronchodilator FEV1/FVC (Forced Expiratory Volume in the 1st second/ Forced Vital Capacity) ratio < 0.7 (Previous examination report or examination performed at the screening visit).
Participants who meet any of the following criteria will be excluded from the study:.
Pregnant or lactating women.
Current diagnosis of asthma without current diagnosis of chronic obstructive pulmonary disease (COPD). Observation: Subjects with a prior history of asthma are eligible if they have a current diagnosis of chronic obstructive pulmonary disease (COPD).
Other respiratory disorders other than chronic obstructive pulmonary disease (COPD) (for example, but not restricted to: active tuberculosis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension).