Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD) (TRIVERSYTI)
Summary
Primary Objective • To demonstrate the superiority of CHF 5993 pressurised metered dose inhaler (pMDI) over Symbicort® Turbuhaler® in terms of pulmonary function (change from baseline in pre-dose morning forced expiratory volume in the first second of a forced vital capacity manoeuvre \[FEV1\] and 2-hour post-dose morning FEV1 at Week 24). Secondary Objectives Key secondary objective: • To demonstrate the superiority of CHF 5993 pMDI over Symbicort® Turbuhaler® in terms of pulmonary function (change from baseline in pre-dose morning FEV1 and 2-hour post-dose morning FEV1 at Week 24) in the subgroup of Chinese population. Other secondary objectives: * To evaluate the effect of CHF 5993 pMDI on other lung function parameters, patient's health status and clinical outcome measures; * To collect data in order to assess the impact of study treatments on health economic outcomes; * To assess the safety and the tolerability of the study treatments.
Timeline
- Start
- 2016-12-14
- Primary completion
- 2020-05-26
- Completion
- 2020-05-26
Outcome
Met primary endpoint
registry analysis (superiority test); CHF 5993 100/6/12.5 µg - ITT Population vs Symbicort Turbuhaler 160/4.5 µg - ITT Population; p < 0.001; adjusted mean difference 0.062 (95% CI 0.038 to 0.085) NCT03197818 ↗
registry analysis (superiority test); CHF 5993 100/6/12.5 µg - ITT Population vs Symbicort Turbuhaler 160/4.5 µg - ITT Population; p < 0.001; adjusted mean difference 0.113 (95% CI 0.087 to 0.140) NCT03197818 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Budesonide | Small molecule | 160 ug | Inhaled |
| Comparator | Formoterol | Other / unclassified | 4.5 ug | Inhaled |
| Comparator | Formoterol | Other / unclassified | 6 ug | Inhaled |
| Subject | Glycopyrronium | Unknown | 12.5 ug | Inhaled |
| Subject | beclomethasone dipropionate | Other / unclassified | 100 ug | Inhaled |