TRIADES

• Research type

  Research Study

• Full title

  A 52 week, randomised, double-blind, double dummy, multinational, multicenter, active controlled, 2-arm parallel group study comparing CHF5993 100/6/12.5 µg pMDI (fixed combination of extrafine Beclomethasone Dipropionate plus Formoterol Fumarate plus Glycopyrronium Bromide) to Seretide® Evohaler® 125/25 µg pMDI (fixed combination of Fluticasone Propionate/Salmeterol Xinafoate) in adolescent subjects with uncontrolled asthma on medium doses of inhaled corticosteroids in combination with long-acting β2-agonists.

• IRAS ID

  1012415

• Contact name

  Global Clinical Development Chiesi Farmaceutici

• Contact email

  clinicaltrials_info@chiesi.com

• Sponsor organisation

  Chiesi Farmaceutici s.p.a.

• Eudract number

  2024-514248-95

• Research summary

  A clinical study of 52 weeks conducted on adolescent subjects with uncontrolled asthma done to evaluate how a new pressurized inhalation solution (CHF5993) using novel propellant (HFA-152a), works against a commercial product (Seretide® Evohaler®).

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  25/SC/0364

• Date of REC Opinion

  18 Dec 2025

• REC opinion

  Further Information Favourable Opinion