An Open Label Placebo Study To Assess The Inhalation Profile Obtained By Acoustic Monitoring In COPD Patients Using The NEXThaler DPI
NCT02018549 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2021-10-29
Summary
Phase IIa, single center, open-label, single-arm study, to evaluate the inspiration profile through the NEXThaler device in adult COPD patients with varying degrees of airflow limitation
Conditions
Interventions
- DEVICE
-
Inhalation through Chiesi NEXThaler DPI
Inhalatory manoeuvre through Chiesi NEXThaler DPI repeated at least twice in order to have two evaluable data set
Sponsors & Collaborators
-
Chiesi Farmaceutici S.p.A.
lead INDUSTRY
Principal Investigators
-
Mario Scuri, MD · Chiesi Farmaceutici S.p.A.
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-12-31
- Primary Completion
- 2014-06-30
- Completion
- 2014-06-30
Countries
- Italy
Study Locations
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