Pharmacokinetics of CHF 5993 pMDI With and Without Spacer in COPD Patients
NCT ID: NCT02119234
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2014-03-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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CHF5993 pMDI + Spacer
CHF 5993 pMDI (Beclometasone/formoterol/glycopyrrolate 100/6/25 mcg per actuation) x 4 inhalations administered using Aerochamber Plus Flow-vu VHC spacer
Beclometasone/formoterol/glycopyrrolate
CHF5993 pMDI
CHF 5993 pMDI (Beclometasone/formoterol/glycopyrrolate 100/6/25 mcg per actuation) x 4 inhalations administered using standard actuator only
Beclometasone/formoterol/glycopyrrolate
Placebo pMDI
Placebo pMDI x 4 inhalations
Placebo
Interventions
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Beclometasone/formoterol/glycopyrrolate
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* smokers or ex-smokers
* post-bronchodilator FEV1 between 30 and 60% of predicted value
Exclusion Criteria
* Known respiratory disorder other than COPD
* Recent COPD exacerbations or hospitalization for COPD
* Treatment with non-permitted concomitant medication
* clinically relevant concomitant disease
* clinically relevant abnormal laboratory or ECG parameters
45 Years
70 Years
ALL
No
Sponsors
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Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Piotr Kuna, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University Lodz
Locations
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Medical University in Lodz
Lodz, Ul. Kopcińskiego 22, Poland
Countries
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Related Links
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CSR Synopsis available in the Chiesi Clinical Study Register
Other Identifiers
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2013-003770-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CCD-05993AA1-04
Identifier Type: -
Identifier Source: org_study_id