Efficacy & safety of CHF6001 DPI vs placebo added to COPD therapy
Research type
Research Study
Full title
A 52-week, randomized, double-blind, placebo-controlled, parallel-group, study to evaluate the efficacy and safety of two doses of CHF6001 DPI add-on to maintenance triple therapy in subjects with Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis.
IRAS ID
294045
Contact name
Dinesh Saralaya
Contact email
Sponsor organisation
Chiesi Farmaceutici S.p.A
Eudract number
2020-003666-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 9 months, 9 days
Research summary
The purpose of this study is to obtain information on the efficacy (effectiveness) and the safety of two doses of CHF6001, a product developed by Chiesi Farmaceutici S.p.A. for the treatment of Chronic Obstructive Pulmonary Disease (COPD). The study will last 56 weeks, with approx 2985 participants in about 270 study sites in 19 countries. There will also be a subgroup for pharmacokinetic evaluation and biobanking, however these are both optional.
There will be three study treatments. patients will be randomised to one of these.
- Treatment A: CHF6001, 1600 micrograms (μg)/day by inhalation
- Treatment B: CHF6001, 3200 micrograms (μg)/day by inhalation
- Treatment C: Placebo (it is similar to CHF6001 but does not contain any active substance)
Whichever treatment participants are assigned to, they will have to take:
- 2 inhalations in the morning of CHF6001 or matching placebo
- 2 inhalations in the evening of CHF6001 or matching placebo
This study will be carried out without either the participant or Study Doctor knowing which treatment is being administered (double blind).
At the first visit (Visit 0), the Study Doctor will fully explain the study procedures and give participant the opportunity to ask any questions to clarify anything that may not be clear or that they don’t understand. If they agree to participate in this study, they will need to sign the Informed Consent. Form. Participants will be instructed on the procedures to follow such as medication restrictions and fasting conditions before the next visit. Some demographic data as age, sex, race and ethnic origins will be collected. A card will be given with the study centre/hospital address, telephone number of the Study Doctor to contact in case of emergency and participants should always carry this card with them while they are involved in the study. At the second visit (Visit 1, also called Screening), the Study Doctor will check if they are suitable for participating in the study. Participants may be asked to stop some medications, the Study Doctor will provide further details. As usual, they will continue to take their maintenance triple therapy for COPD during the 2 following weeks. During this period, participants will have to complete questionnaires on a daily basis in the electronic device that they are provided with. It is possible, under specific conditions, Visit 0 and Visit 1 could be combined. At the third visit (Visit 2 also called Randomisation), if medical condition is appropriate for the study, participant will receive one of the three study treatments which they will continue on for treatment period v2-v7.
ECGS will be performed at Visits, 1, 2, 3, 5 & 7.
Lung functions tests will be completed for visits 1-7
Blood samples will be performed at visits 1, 2, 5 &
7 – for those participating in the optional PK additional blood samples will be taken at visits 2, 4, 5 & 6. There are some fasting conditions for blood sampling, see Main PIS/ICF.
There may be additional testing for COVID-19 throughout the study if participants develop symptoms. The results would be shared and if positive all efforts will be made to keep participant on the study. Participants will be provided an electronic diary (smartphone type) which will be used for recording symptoms by answering the EXACT questionnaire daily, along with recording study/rescue medications and maintenance triple therapy intake whilst at home. There will also be questionnaires to complete at site regarding participant health status. At end of study visit or early treatment discontinuation there will be a Safety Follow-up Call to check the occurrence of COPD exacerbation (if any), and to monitor any unresolved or new adverse events (and any other medications taken for COPD or AE. Once the study is complete there will be no provision for study drug to be continued to be provided. A final report will be written at the end of the study. The study doctors will be able to share the results of the study with the participants once the report is available, should you request this.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
21/NE/0054
Date of REC Opinion
1 Apr 2021
REC opinion
Further Information Favourable Opinion