Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
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.
ClinicalTrials.gov Identifier: NCT04410523
Novartis Reference Number: CCSJ117A12201C
Last Update: Jan 08, 2021
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
Study Description
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.
Interventions
Eligibility Criteria
Inclusion Criteria:
Diagnosed asthma
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
Morning pre-BD FEV1 value of ≥ 40% and ≤ 85% of the predicted normal
A positive reversibility test
ACQ-5 score of ≥ 1.5 at screening and end of run-in visits.
History of 1 or 2 asthma exacerbations within the 12 months prior to Screening Visit that required treatment with systemic corticosteroids (tablets, suspension or injection).
Exclusion Criteria:
Patients who have a cigarette smoking history of greater than 10 pack years or current smokers.
Pregnant or nursing (lactating) women
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using specified methods of contraception during dosing of study drug and one week after last study drug treatment
Patients with a history of immunodeficiency disease or hepatitis B or hepatitis C or HIV.
Study Locations
Contacts
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