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Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma

Asthma Clinical Trial

Official title:
A 12-week, Multicenter, Randomized, Double-blind, Parallel-arm, Placebo-controlled Study to Assess the Efficacy and Safety of CSJ117, When Added to Existing Asthma Therapy in Patients ≥ 18 Years of Age With Severe Uncontrolled Asthma.

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of multiple CSJ117 doses (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult patients with uncontrolled asthma with respect to change from baseline in FEV1 at the end of 12 weeks of treatment.

Clinical Trial Description

This was a randomized, multicenter, multi-national, double-blind, placebo-controlled, parallel-arm study evaluating the effect of 5 dose levels of CSJ117 in adult subjects with inadequately controlled asthma despite medium to high dose inhaled corticosteroid (ICS) plus long-acting beta agonist (LABA). Subjects were assigned to one of the following six treatment arms/groups in a ratio of 2:1:1:1:2:2: - Placebo inhaled once daily - CSJ117 0.5 mg inhaled once daily - CSJ117 1.0 mg inhaled once daily - CSJ117 2.0 mg inhaled once daily - CSJ117 4.0 mg inhaled once daily - CSJ117 8.0 mg inhaled once daily The study included: - A screening period of approximately 2 weeks - A single blinded placebo run-in period of 4 weeks (extended to 8 weeks for subjects experiencing an asthma exacerbation or respiratory tract infection during the run-in period) - A double blinded treatment period of 12 weeks - A follow-up period of up to 12 weeks, study drug free, following the last dose of study treatment. Patients who successfully completed 12 weeks of treatment in this study could be offered participation in the Safety Extension Study CCSJ117A12201E1 (NCT04946318). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04410523
Study type Interventional
Source Novartis
Contact
Status Terminated
Phase Phase 2
Start date September 9, 2020
Completion date September 6, 2022
View Details
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