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

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

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

Indications