MedTrace Logo

Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD

NCT04882124 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-11-28

No results posted yet for this study

Summary

This is a Phase 2 study in patients with chronic obstructive pulmonary disease (COPD) to assess the efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and safety of two dose levels of CSJ117 in comparison to placebo. For this, the impact of CSJ117 on disease symptom burden and lung function will be explored.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

CSJ117

CSJ117 (4 mg and 8 mg) inhaled once daily for 12 weeks. Delivered via Concept1 device.

DRUG

Placebo

Placebo inhaled once daily for 12 weeks. Delivered via Concept1 device

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-24
Primary Completion
2022-09-15
Completion
2022-09-15
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Hungary
  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT04882124 on ClinicalTrials.gov