Efficacy & safety of CHF6001 DPI vs double-dummy added to COPD therapy

• Research type

  Research Study

• Full title

  A 52-week, randomized, double-blind, double-dummy, placebo- and active controlled (Roflumilast, Daliresp® 500μg), 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

  294048

• Contact name

  Dinesh Saralaya

• Contact email

  dinesh.saralaya@bthft.nhs.uk

• Sponsor organisation

  Chiesi Farmaceutici S.p.A.

• Eudract number

  2020-003648-97

• Clinicaltrials.gov Identifier

  NCT04636814

• Duration of Study in the UK

  3 years, 3 months, 3 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 3980 participants in about 310 study sites in 19 countries. There will be 4 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: Roflumilast* 500* micrograms
  (μg)/day (*250 micrograms (μg)/day for the first 4
  weeks of treatment, as recommended in the
  patient leaflet, then 500 micrograms (μg)/day)orally
  - Treatment D: Placebo (it is similar to CHF6001/Roflumilast but does not contain active substance)
  Whichever treatment participants are assigned to, they will have to take:
  - 2 inhalations in the morning of CH6001 or matching placebo
  - 2 inhalations in the evening of CH6001 or matching placebo
  - 1 tablet once daily of Roflumilast or matching placebo

  At the first visit (Visit 0), the Study Doctor will fully explain the study procedures, discuss medications which you are not able to take during the study and give you 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. 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 will be 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 the medical condition is appropriate for the study, participant will receive
  one of the four 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
  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. There are some fasting conditions for blood sampling, see Main PIS/ICF. 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/0055

• Date of REC Opinion

  1 Apr 2021

• REC opinion

  Further Information Favourable Opinion