A PHASE II, MONOCENTRE, OPEN, RANDOMIZED, 6-WAY CROSS-OVER CLINICAL PHARMACOLOGY STUDY TO EVALUATE THE LUNG BIOAVAILABILITY OF BDP/B17MP AND FORMOTEROL AND THE TOTAL SYSTEMIC EXPOSURE ACROSS TWO DIFFERENT DOSE STRENGTHS OF CHF 1535 NEXThaler® DPI (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE 100/6 µg and 200/6 µg) ADMINISTERED WITH AND WITHOUT ACTIVATED CHARCOAL IN ADULT ASTHMATIC PATIENTS
Phase of Trial: Phase II
Latest Information Update: 22 Jul 2017
At a glance
- Drugs Beclometasone/formoterol (Primary) ; Charcoal; Fluticasone propionate
- Indications Asthma; Respiratory tract disorders
- Focus Pharmacodynamics; Pharmacokinetics
- Sponsors Chiesi Farmaceutici SpA
- 31 Aug 2018 Biomarkers information updated
- 01 Jan 2013 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
- 29 Nov 2012 Planned End Date changed from 11 Jun 2013 to 1 Nov 2013 as reported by ClinicalTrials.gov.