Clinical Pharmacology of CHF 1535 50/6 ug Next DPI in Children 5-11 Years Old

PHASE2CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

August 31, 2012

Study Completion Date

August 31, 2012

Conditions
Asthma in Children
Interventions
DRUG

free comb. beclomethasone DPI and formoterol DPI

free combination of beclomethasone dipropionate 100 ug/unit DPI (two inhalations, total dose 200 ug), and formoterol fumarate 6 ug/unit DPI (four inhalations, total dose 24 ug).

DRUG

CHF 1535 50/6 NEXT DPI

four inhalations of CHF 1535 50/6 NEXT DPI, a fixed combination of beclomethasone dipropionate 50 ug plus formoterol fumarate 6 ug (TOTAL DOSE:BDP/FF 200/24 ug)

Trial Locations (1)

2100

BørneAstmaKlinikken, Hans Knudsens Plads 1A,, Copenhagen

All Listed Sponsors
lead

Chiesi Farmaceutici S.p.A.

INDUSTRY

NCT01468272 - Clinical Pharmacology of CHF 1535 50/6 ug Next DPI in Children 5-11 Years Old | Biotech Hunter | Biotech Hunter