MedTrace Logo

A 6-week Dose Ranging Study of CHF 5259 pMDI in Subjects With Chronic Obstructive Pulmonary Disease

NCT03084796 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 733

Last updated 2021-06-15

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the dose-response of different doses of CHF 5259 pMDI on lung function and other clinical outcomes, to identify the optimal dose(s) in terms of benefit/ risk ratio for further development in the target subject population.

Conditions

Interventions

DRUG

CHF 5259

Dose Response: Test one of four different doses of CHF 5259

DRUG

Placebo

Placebo Control

DRUG

Tiotropium Bromide 18 µg Inhalation Capsule

Active Control

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Edward Kerwin, MD · Crisor LLC c/o Clinical Research Institute of Southern Oregon, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-28
Primary Completion
2018-05-23
Completion
2018-06-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03084796 on ClinicalTrials.gov