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Study identifier: NCT04882124 Synced from ClinicalTrials.gov · August 10, 2026
● Study status: Completed

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

Condition: Pulmonary Disease, Chronic Obstructive  ·  Sponsor: Novartis Pharmaceuticals

PhasePhase 2
Planned participants38
Who can joinAll sexes, 40 Years to 90 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where15 locations · 6 countries
For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.Open the site landscape →

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: * Male and female COPD patients aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure * Current or ex-smokers who have a smoking history of at least 10 pack years * Patients who have been treated with a triple combination of LABA/LAMA/ICS for the last 3 months prior to screening * Patients with a documented diagnosis of COPD for at least 1 year prior to screening visit Exclusion Criteria: * Patients with a past or current medical history of asthma * Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization, or a respiratory tract infection in the 4 weeks prior to screening, or hospitalization between screening and prior to treatment. * Use of other investigational drugs (approved or unapproved) within 30 days or 5 half-lives prior to screening, or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or longer if required by local regulations * Pregnant or nursing (lactating) women, and women of childbearing potential not willing to use acceptable effective methods of contraception during study participation * Patients with a body mass index (BMI) of more than 40 kg/m2 Other protocol-defined inclusion/exclusion criteria may apply

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (15)

Novartis Investigative SiteAndalusia, Alabama, United States
Novartis Investigative SiteCrowley, Louisiana, United States
Novartis Investigative SiteNew Orleans, Louisiana, United States
Novartis Investigative SiteSaint Charles, Missouri, United States
Novartis Investigative SiteSt Louis, Missouri, United States
Novartis Investigative SiteHuntersville, North Carolina, United States
Novartis Investigative SiteShelby, North Carolina, United States
Novartis Investigative SiteSouth Brisbane, Queensland, Australia
Novartis Investigative SiteSainte-Foy, Quebec, Canada
Novartis Investigative SiteOstrava Poruba, Czech Republic, Czechia
Novartis Investigative SiteBalassagyarmat, Hungary
Novartis Investigative SiteGödöllő, Hungary

+ 3 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

AndalusiaCrowleyNew OrleansSaint Charles

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