Trials / Completed
CompletedNCT02119234
Pharmacokinetics of CHF 5993 pMDI With and Without Spacer in COPD Patients
Open-label, Randomized, 3-way Cross-over, Placebo Controlled, Single Dose Clinical Pharmacology Study in COPD Patients After Inhalation of CHF 5993 pMDI Using the Standard Actuator With or Without AeroChamber Plus Flow-Vu VHC Spacer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Chiesi Farmaceutici S.p.A. · Industry
- Sex
- All
- Age
- 45 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The study is performed to investigate the effect of the spacing device on the pharmacokinetics of CHF 5993 pMDI active ingredients administered with and without Aerochamber Plus Flow-vu antistatic VHC spacer as a single administration in COPD patients. Moreover, the general safety and tolerability of the treatments will be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Beclometasone/formoterol/glycopyrrolate | |
| DRUG | Placebo |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2015-02-01
- Completion
- 2015-02-01
- First posted
- 2014-04-21
- Last updated
- 2021-10-29
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT02119234. Inclusion in this directory is not an endorsement.