CCD-05993AA-08_Chiesi_COPD_TRIBUTE
Research type
Research Study
Full title
A 52-week, double blind, double dummy, randomized, multinational, multicentre, 2-arm parallel group, active controlled clinical trial of fixed combination of Beclomethasone dipriprionate plus Formoterol fumarate plus Glycopyrronium bromide administered via pMDI (CHF 5993) versus Indacaterol/Glycopyrronium (Ultibro) via DPI in patients with chronic obstructive pulmonary disease
IRAS ID
171359
Contact name
Dinesh Saralaya
Contact email
Sponsor organisation
Chiesi
Eudract number
2014-001704-22
Duration of Study in the UK
2 years, 3 months, 16 days
Research summary
The purpose of this study is principally to assess the effectiveness of a combined treatment option called CHF 5993 pMDI compared to a currently available option, in the treatment of individuals with severe to very severe chronic obstructive pulmonary disease (COPD). This combination therapy is hoped to provide greater flexibility to the physicians and patients with regards to the treatment of COPD. The effect of the CHF 5993 pMDI will be measured and assessed in a variety of ways including blood tests, ECGs, spirometer tests (blowing tests) and patient questionnaires.
COPD is a major public health problem and a significant cause of global morbidity and mortality, with an accompanied substantial economic impact as the disease provides the patient with life changing disabilities which in turn burdens local health care systems. It is a disease characterised by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with abnormal inflammatory response of the lungs. Besides preventing disease progression, therapeutic options are required that look into relieving symptoms, improve health status and prevent disease exacerbations (characterised as a sustained worsening of the subject's condition from the stable state).
To be eligible for participation in the study, participants can be male or female and must be 40 or older at the start of the study. They must have a diagnosis of COPD at least 12 months prior to the screening visit and meet a variety of clinical criteria. Participants should also be of sound mind and able to consent and complete questionnaires and an eDiary at home.
The study will last for 56 weeks in total and will include 7 visits to the hospital to see the study team. It is expected that approximately 1534 patients (male and female) will be included in the study at about 200 sites.REC name
South West - Central Bristol Research Ethics Committee
REC reference
15/SW/0233
Date of REC Opinion
23 Oct 2015
REC opinion
Further Information Favourable Opinion