CTT116855 Twelve month study to compare three investigational medications in patients with chronic obstructive pulmonary disease who have a history of COPD exacerbation

CTT116855 A phase III, 52 week, randomized, double-blind, 3-arm parallel group study, comparing the efficacy, safety and tolerability of the fixed dose triple combination FF/UMEC/VI with the fixed dose dual combinations of FF/VI and UMEC/VI, all administered once-daily in the morning via a dry powder inhaler in subjects with chronic obstructive pulmonary disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-4sxpff

Enrollment

Unknown

Registered

2016-07-05

Start date

2014-06-30

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease

Interventions

Arm 1: 4000 subjects receives fluticasone furoate/umeclidinium bromide/vilanterol 100 mcg/62.5 mcg/25 mcg once daily, in the morning, during 52 weeks Arm 2: 4000 subjects receives fluticasone furoate

Drug

N02.421.668.438

Eligibility

Age

40 Years to No maximum

Inclusion criteria

Inclusion criteria: Subjects with at least 40 years old with history of cronic obstructive pulmonary disease and also smoking history; that is currently receiving cronic treatment for cronic obstructive pulmonary disease and have history of exacerbations

Exclusion criteria

Exclusion criteria: Pregnancy or lactating women; subjects with asthma diagnostics or other respiratory disorders; hepatic unstable disease or cardiopaty unstrable; others

Design outcomes

Primary

Measure	Time frame
Decrease of annual rate of on-treatment moderate and severe exacerbations comparing fluticasone furoate/umeclidinium bromide/vilanterol with umeclidinium bromide/vilanterol and comparing fluticasone furoate/umeclidinium bromide/vilanterol with fluticasone furoate/vilanterol	—

Secondary

Measure	Time frame
Changes in the outcome of pulmonary function test, the register exacerbations and also in the questionnaire about respiratory disease	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Israel, Japan, Netherlands, New Zealand, Norway, Peru, Poland, Puerto Rico, Republic of Korea, Romania, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Kingdom, United States, Viet Nam

Contacts

Public ContactPesquisador;Serviço de Atendimento ao Cliente Responsável - Contato Público;SAC

GlaxoSmithKline Brasil;GlaxoSmithKline Brasil

sac.brasil@gsk.com;sac.brasil@gsk.com+55 21 21416000;+55 21 21416000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)