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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2, 6 and 12 weeks
Summary
This trial is testing a new inhaled medication called CSJ117 to help people with COPD who still have symptoms despite using standard treatments. The medication aims to reduce lung inflammation and improve breathing.
Eligible Conditions
- Asthma
- Chronic Obstructive Pulmonary Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2, 6 and 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2, 6 and 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in E-RS score
Secondary study objectives
Accumulation ratio (Racc) of CSJ117
Change from baseline in CAT score
Change from baseline in SGRQ-C score
+11 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: CSJ117 8mgExperimental Treatment1 Intervention
Intervention: Drug: CSJ117
Group II: CSJ117 4mgExperimental Treatment1 Intervention
Intervention: Drug: CSJ117
Group III: CSJ117 PlaceboPlacebo Group1 Intervention
Intervention: Drug: Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CSJ117
2021
Completed Phase 2
~70
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,911 Previous Clinical Trials
4,250,638 Total Patients Enrolled
80 Trials studying Asthma
46,022 Patients Enrolled for Asthma
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