Bronchodilator Effect of CHF1535 pMDI Versus Free Combination of Beclometasone Plus Formoterol pMDI in Asthmatic Children

PHASE2CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

February 28, 2013

Study Completion Date

February 28, 2013

Conditions
Asthma
Interventions
DRUG

beclomethasone+formoterol 50/6 (1 inhalation)

CHF 1535 50/6 (fixed combination of extrafine beclomethasone dipropionate 50 µg + formoterol fumarate 6 µg/metered dose) administered via a pMDI with spacer

DRUG

CHF 1535 50/6 (2 inhalations)

CHF 1535 50/6 (fixed combination of extrafine beclomethasone dipropionate 50 µg + formoterol fumarate 6 µg/metered dose) administered via a pMDI with spacer

DRUG

CHF 1535 50/6 (4 inhalations)

CHF 1535 50/6 (fixed combination of extrafine beclomethasone dipropionate 50 µg + formoterol fumarate 6 µg/metered dose) administered via a pMDI with spacer

DRUG

Formoterol + Beclomethasone dipropionate

"* Formoterol HFA pMDI 6 µg / actuation~* Extrafine BDP HFA pMDI 50 µg/actuation"

DRUG

Placebo (6 inhalations)

Matched placebo via pMDI

Trial Locations (2)

69063

Zaporizhzhia State Medical University, Zaporizhzhia

39 -200

Poradnia Alergologiczna, Dębica

All Listed Sponsors
lead

Chiesi Farmaceutici S.p.A.

INDUSTRY

NCT01584492 - Bronchodilator Effect of CHF1535 pMDI Versus Free Combination of Beclometasone Plus Formoterol pMDI in Asthmatic Children | Biotech Hunter | Biotech Hunter