NCT02000609

A Phase II, 5-way Cross-over Study to Evaluate the Pharmacodynamics of "Nexthaler" Dry Powder Inhaler in COPD Patients

Phase II, Partial Blind, Randomized, Placebo Controlled, 5-way Cross-over Study to Evaluate the Pharmacodynamics of BDP(Beclomethasone Diproprionate)/B17MP (Beclomethasone-17-Monoproprionate) and FORMOTEROL FUMARATE (FF) Across Two Different Dose Levels of CHF 1535 NEXThaler DPI (Dry Powder Inhaler) and CHF 1535 pMDI (Pressurized Metered-dose Inhaler)in Adult COPD (Chronic Obstructive Pumonary Disease) Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study aim is to compare the pharmacodynamic effects (cardiovascular effects- primary variable: Heart rate over 4 hours post dosing- ) after administration of BDP and formoterol administered as CHF 1535 100/6 NEXThaler DPI or CHF1535 pMDI at two different dose levels.

Detailed description

The effects of both formulations on serum potassium and serum glucose and the general safety and tolerability of study treatments will be also evaluated

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	CHF 1535 NEXThaler 800/48
DRUG	CHF 1535 NEXThaler 200/12
DRUG	CHF 1535 NEXThaler PLACEBO
DRUG	CHF 1535 pMDI 200/12
DRUG	CHF1535 pMDI 800/48

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2013-12-04
• Last updated: 2021-10-29

Locations

1 site across 1 country: United Kingdom