MiSTIC

• Research type

  Research Study

• Full title

  A 26 week, randomized, double blind, multinational, multicentre, active controlled, 2-arm parallel group trial comparing CHF 5993 100/6/12.5 μg pMDI (fixed combination of extra fine formulation of beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) to CHF 1535 200/6 μg pMDI (fixed combination of extra fine formulation of beclometasone dipropionate plus formoterol fumarate) in subjects with asthma uncontrolled on medium doses of inhaled corticosteroids in combination with long-acting ß2-agonists.

• IRAS ID

  1004813

• Contact name

  Isabelle Viaud

• Contact email

  i.viaud@chiesi.com

• Sponsor organisation

  Chiesi Farmaceutici S.p.A.

• Eudract number

  2021-002391-39

• ISRCTN Number

  ISRCTN46960773

• Clinicaltrials.gov Identifier

  NCT05018598

• Research summary

  The purpose of this study is to assess the efficacy (effectiveness) and safety of Trimbow® medium dose, compared with Foster® high dose, in participants with asthma. Participation will help the sponsor to further understand which treatment works better in achieving specific goals in the management of participants disease, including control of symptoms, quality of life, and prevention of disease worsening and side effects of the study drugs. Participants are invited to take part because their asthma is not well controlled with their current asthma treatment
  It is expected that approx 1400 participants will be included in the study in about 200 sites in approx 16 countries. It will last 30 weeks with 7 visits in total. At the first visit (Visit 0), the Study Doctor will explain the study procedures and give participants a contact card. The 2nd visit (v1 - screening) is where study Dr will check they are suitable for the study. Participants will be given CHF 1535 medication (100/6 micrograms) to be used for the first 2 weeks of the study (run-in period) at the dose of 2 puffs twice a day (2 inhalations in the morning and 2 inhalations in the evening). The 3rd visit (v1 - tandomisation) is where participants will be assigned to either Treatment A: CHF 5993 100/6/12.5 micrograms (i.e. 100 micrograms of beclometasone dipropionate plus 6 micrograms of formoterol fumarate plus 12.5 micrograms of glycopyrronium bromide) or Treatment B: CHF 1535 200/6 micrograms (i.e. 200 micrograms of beclometasone dipropionate plus 6 micrograms of formoterol fumarate) to be taken for 26 weeks (v2-v6).Dosing will be 2 puffs twice a day (2 inhalations in the morning and 2 in the evening). Neither participant or study Dr will know which treatment is assigned until study end. Study procedures include: physical exam, ECG, tests relating to your lungs (Oscillometry/lung function) /airway (FeNO test), blood & urine samples, covid testing, questionnaires, e-diary questions

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  22/NW/0077

• Date of REC Opinion

  25 May 2022

• REC opinion

  Further Information Favourable Opinion