Condition: Pulmonary Disease, Chronic Obstructive · Sponsor: Novartis Pharmaceuticals
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.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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.
| Novartis Investigative Site | Andalusia, Alabama, United States | — |
| Novartis Investigative Site | Crowley, Louisiana, United States | — |
| Novartis Investigative Site | New Orleans, Louisiana, United States | — |
| Novartis Investigative Site | Saint Charles, Missouri, United States | — |
| Novartis Investigative Site | St Louis, Missouri, United States | — |
| Novartis Investigative Site | Huntersville, North Carolina, United States | — |
| Novartis Investigative Site | Shelby, North Carolina, United States | — |
| Novartis Investigative Site | South Brisbane, Queensland, Australia | — |
| Novartis Investigative Site | Sainte-Foy, Quebec, Canada | — |
| Novartis Investigative Site | Ostrava Poruba, Czech Republic, Czechia | — |
| Novartis Investigative Site | Balassagyarmat, Hungary | — |
| Novartis Investigative Site | Gödöllő, Hungary | — |
+ 3 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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