Study of effect of CSJ117 on symptoms, pharmacodynamics and safety in patients with COPD
- Conditions
- Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
- Registration Number
- CTRI/2022/03/040746
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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 < 0.7 and post-bronchodilator FEV1� 25 and � 80% of predicted at Run-In 1
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 � 80%) OR least 1 moderate or severe COPD exacerbation (for FEV1� 25 and � 50%) within 12 months prior to screening
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
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 �±-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method