Chronic Obstructive Pulmonary Disease MedDRA version: 21.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 Other protocol-defined inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
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 exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of CSJ117 on disease/symptom burden after 12 weeks of treatment;Secondary Objective: --To assess the effect of CSJ117 on disease/symptom burden --To assess the number and percentage of patients who respond to treatment with CSJ117 with respect to improvement of symptoms --To assess the effect of CSJ117 on lung function --To assess the effect of CSJ117 on use of rescue medication (SABA) --To assess the effect of CSJ117 on COPD exacerbations --To characterize the systemic PK profile of CSJ117 after administration of multiple inhaled doses --To assess the immunogenicity of multiple dose administrations of CSJ117 over 12 weeks --To assess the safety of two doses of CSJ117 once daily, compared with placebo, with respect to (serious) adverse events (AE), electrocardiograms (ECGs), vital signs and laboratory tests ;Primary end point(s): Change from baseline in E-RS score;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): --Change from baseline in CAT --Change from baseline in SGRQ-C --Response in E-RS in total score decrease from baseline --Response in CAT in total score decrease from baseline --Response in SGRQ-C in total score decrease from baseline --Change from baseline in lung function as assessed in spirometry --Puffs of rescue medication per day --Time to COPD exacerbations via EXACT --Rate and severity of COPD exacerbations via EXACT --Time to COPD exacerbations via HCRU --Rate and severity of COPD exacerbations via HCRU --Pre-dose trough concentration (Ctrough) of CSJ117 --Accumulation ratio (Racc) of CSJ117 --Measuring anti-drug antibodies;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Argentina, Australia, Belgium, Canada, Czech Republic, France, Germany, Hungary, India, Israel, Japan, Philippines, Russian Federation, United Kingdom, United States
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed