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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and female patients aged ≥18 and ≤75 years
Patients who have been treated with medium or high dose ICS plus LABA with up to 2 additional controllers
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and week 12: pre-dose, 2 and 4 hours post-dose; weeks 2, 4 and 8: pre-dose and 4 hours post-dose; weeks 14, 16, 20 and 24: pre-dose
Awards & highlights
Study Summary
This trial is testing how well different doses of an inhaled medication work to improve asthma symptoms in adults who are not well controlled on current asthma treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 and week 12: pre-dose, 2 and 4 hours post-dose; weeks 2, 4 and 8: pre-dose and 4 hours post-dose; weeks 14, 16, 20 and 24: pre-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and week 12: pre-dose, 2 and 4 hours post-dose; weeks 2, 4 and 8: pre-dose and 4 hours post-dose; weeks 14, 16, 20 and 24: pre-dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average Change From Baseline in Pre-dose FEV1 at Week 8 and Week 12
Secondary outcome measures
Average Change From Baseline in ACQ-5 Score at Week 8 and Week 12
Average Change From Baseline in AQLQ+12 Score at Week 8 and Week 12
Average Change From Baseline in FeNO at Week 8 and Week 12
+8 moreTrial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: CSJ117 8mgExperimental Treatment2 Interventions
CSJ117 8 mg inhaled once daily
Group II: CSJ117 4mgExperimental Treatment2 Interventions
CSJ117 4 mg inhaled once daily
Group III: CSJ117 2mgExperimental Treatment2 Interventions
CSJ117 2 mg inhaled once daily
Group IV: CSJ117 1mgExperimental Treatment2 Interventions
CSJ117 1 mg inhaled once daily
Group V: CSJ117 0.5mgExperimental Treatment2 Interventions
CSJ117 0.5 mg inhaled once daily
Group VI: PlaceboPlacebo Group2 Interventions
Placebo inhaled once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
CSJ117
2021
Completed Phase 2
~70
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,851 Previous Clinical Trials
4,197,254 Total Patients Enrolled
79 Trials studying Asthma
45,687 Patients Enrolled for Asthma
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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