IMPACT Study: Triple dose therapy in COPD patients
Research type
Research Study
Full title
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 fluticasone furoate/umeclidinium/vilanterol, with the fixed dose dual combinations of fluticasone furoate/vilanterol and umeclidinium/vilanterol, all administered once-daily in the morning via a dry powder inhaler in subjects with chronic obstructive pulmonary disease
IRAS ID
160814
Contact name
Anthony De Soyza
Contact email
Sponsor organisation
GSK
Eudract number
2013-003075-35
Research summary
Chronic Obstructive Pulmonary Disease (COPD) is characterised by symptoms such as cough and shortness of breath. Sudden worsening of these symptoms can occur which are called exacerbations (flare-ups).
The most common medicines used for the treatment of COPD are called inhaled bronchodilators that help open up and relax muscles in the airways, used either alone or in combination with medicines called inhaled corticosteroids that help reduce inflammation (swelling and irritation) in the lungs.
The study funded by GlaxoSmithKline will test how well an investigational study medicine Fluticasone furoate (FF) /Umeclidinium (UMEC)/Vilanterol (VI) works at preventing COPD exacerbations. In addition, the safety will be tested. FF is an inhaled corticosteroid and both UMEC and VI are inhaled bronchodilators.
FF/UMEC/VI will be compared with FF/VI and UMEC/VI, which are already used for the treatment of COPD. Participants will get one of these three study medicines and will have a 2 in 5 chance of being placed in either FF/UMEC/VI group or FF/VI group, and a 1 in 5 chance of being placed in the UMEC/VI group. All three study medicines will be given as a powder that will be breathed in through the mouth using an inhaler.
Worldwide, approximately 10,000 participants will be enrolled into the study. Each participant will be in the study for about 55 weeks and will need to take their study medicine once a day each morning for 52 weeks. There are 7 visits to attend during which various blood tests, questionnaires, ECG (heart monitoring) and lung tests will be carried out. A daily diary will need to be completed to help monitor COPD exacerbations. Any participants developing an exacerbation will be asked to return to clinic and may need to have a chest x-ray. Seven days after study medicine stops participants will receive a follow-up phone call from the study team.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
14/NE/1102
Date of REC Opinion
16 Oct 2014
REC opinion
Further Information Favourable Opinion