Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients

Phase 3 Completed 542 enrolled Chiesi Farmaceutici S.p.A.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Primary objective To show the superiority of CHF 1535 (BDP/FF) pMDI (800/24 μg per day) over BDP HFA pMDI (800 μg per day) in terms of change from baseline to the entire treatment period in average pre-dose morning peak expiratory flow (PEF) in adult asthmatic patients not adequately controlled on high doses of ICS or on medium doses of ICS plus LABA. Secondary objective To evaluate the effect of CHF 1535 pMDI on clinical outcome measures and other lung function parameters and to evaluate the safety and tolerability profile.

Timeline

Start: 2012-04-20
Primary completion: 2012-11-29
Completion: 2012-11-29

Outcome

Met primary endpoint

registry analysis (superiority test); CHF 1535 200/6µg - ITT vs BDP 100µg - ITT; p <0.001; Adjusted Mean Difference 18.53 (95% CI 10.33 to 26.73) NCT01577082 ↗

paper The primary endpoint [change from baseline over the entire treatment period in average pre-dose morning peak expiratory flow (PEF)] demonstrated the superiority of BDP/FF over BDP monotherapy PMID 27938358 ↗

Publications

Results Paggiaro P, Corradi M, Latorre M, Raptis H, Muraro A, Gessner C, Siergiejko Z, Scuri M, Petruzzelli S. High strength extrafine pMDI beclometasone/formoterol (200/6 mug) is effective in asthma patients not adequately controlled on medium-high dose of inhaled corticosteroids. BMC Pulm Med. 2016 Dec 9;16(1):180. doi: 10.1186/s12890-016-0335-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Formoterol	Other / unclassified	6 ug	Inhaled
Comparator	beclomethasone dipropionate	Other / unclassified	100 ug	Inhaled
Comparator	beclomethasone dipropionate	Other / unclassified	200 ug	Inhaled