Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: DB CSJ117 4mg: 4mg capsule for use with Concept 1 inhalation device once a day for 12 weeks via oral inhalation.
Intervention2: CSJ117 8 mg: 8mg capsule for use with Concept 1 inhalatio
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Able to provide written informed consent 2. Male and female adult patients aged >= 40 years at screening visit 3. Able to perform acceptable and reproducible spirometry with post-bronchodilator FEV1/FVC = 25 and 4. CAT >=15 points prior to randomization 5. Patients with a documented physician-diagnosed history of COPD for at least 1 year prior to screening 6. Documented history of at least 2 moderate or 1 severe COPD exacerbations (for FEV1>= 50 and = 25 and 7. Availability of HRCT (current or historic) before randomization 8. Current or ex-smokers who have a smoking history of at least 10 pack-years
Exclusion criteria
Exclusion criteria: 1. Patients with a past or current documented medical history of asthma 2. Patients with a current or past medical history of conditions other than COPD or allergic rhinitis that could result in elevated circulating eosinophils levels (e.g.,asthma, hypereosinophilic syndrome, Churg-Strauss Syndrome). Patients with known parasitic infestation within 6 months prior to screening are also excluded. 3. Patients with a clinical diagnosis of α-1 anti-trypsin deficiency (heterozygous genotype may be enrolled) 4. Patients with history of concomitant chronic or severe pulmonary disease (e.g., clinically significant bronchiectasis, lung fibrosis, sarcoidosis, interstitial lung disease, cystic fibrosis, pulmonary hypertension, neuromuscular pulmonary restrictive diseases, tuberculosis). Exception: Patients with concomitant mild or moderate pulmonary hypertension or bronchiectasis are permitted to participate 5. Patients on protocol prohibited concomitant medications 6. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of CSJ117 on disease/symptom burden after 12 weeks of treatmentTimepoint: Change in Evaluating Respiratory Symptoms Score (E-RS) (part of EXACT tool) from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of CSJ117 on disease/symptom burden over the treatment periodTimepoint: Change from baseline in CAT, SGRQ-C Change from baseline in domains/items of respective PROs ;To assess the number and percentage of patients who respond to treatment with CSJ117 with respect to improvement of symptoms over the treatment periodTimepoint: Response in E-RS, total score â?¥ 1.5 points decrease from baseline Response in CAT, total score â?¥2 points decrease from baseline Response in SGRQ-C, total score â?¥4 points decrease from baseline ;To assess the effect of CSJ117 on lung function over the treatment periodTimepoint: 1.Change from baseline in lung function as assessed in spirometry 2. % of patients achieving â?¥ 100 mL of increase in change from baseline in pre- and post bronchodilator FEV1 ;To assess the effect of CSJ117 on use of rescue medication (SABA) over the treatment periodTimepoint: Puffs of rescue med per day as captured by electronic diary;To assess the effect of CSJ117 on COPD exacerbations over the treatment periodTimepoint: Rate of, time to, and severity of exacerbation (using the EXACT instrument and healthcare resource utilization (HCRU) defined exacerbations);To characterize the systemic PK profile of CSJ117 after administration of multiple inhaled doses.Timepoint: Measurement of total CSJ117 serum concentration and calculation of PK parameters(e.g., Ctrough, Racc). Other PK parameters may be derived based on the PK data obtained;To assess the immunogenicity of multiple dose administrations of CSJ117 over 12 weeksTimepoint: Measurement of anti-CSJ117 antibodies (anti-drug antibodies; ADA) | — |
Countries
Argentina, Australia, Belgium, Canada, France, Germany, Hungary, India, Israel, Japan, Philippines, Russian Federation, United Kingdom, United States of America
Contacts
Public ContactMurugananthan K
Novartis Healthcare PVT LTD
Outcome results
None listed