* COPD POC study CSJ117 vs placebo
Research type
Research Study
Full title
A 12-week, randomized, participant-and investigator-blinded, placebo-controlled, parallel group study to explore the efficacy, pharmacodynamics, safety, and pharmacokinetics of two doses of inhaled CSJ117 in adults with Chronic Obstructive Pulmonary Disease (COPD)
IRAS ID
234910
Contact name
Sarah Brunner
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2021-000692-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 14 days
Research summary
Summary of Research
The purpose of this study is to see if the inhaled study medication CSJ117 works better than placebo in improving symptoms of patients with chromic obstructive pulmonary disorder (COPD), as well as if there are side effects of CSJ117, how serious they are, and how many times they happen compared with placebo. It will also assess how patients’ bodies respond to CSJ117 by assessing how the body absorbs, distributes, and gets rid of CSJ117 (this is called pharmacokinetics).CSJ117 has already been examined in two clinical studies in healthy volunteers and in one clinical study with people with mild asthma and it has been shown to be a safe drug in these studies. A fourth clinical study with people with severe asthma is currently ongoing. The safety and effectiveness of CSJ117 has not been established in people with COPD.
In this study, patients will be randomly assigned to receive CSJ117 or placebo for 12 weeks. There are two doses of CSJ117 being tested, so patients will have a 2/3 chance of receiving CSJ117 and 1/3 chance of receiving placebo. The study treatment will be inhaled once daily.
In addition to CSJ117 or placebo, patients will also receive a background COPD medication i.e. a combination inhaled medication that combines three medicines in one inhaler. This medicine is called Trelegy Ellipta®. Trelegy Ellipta® will be taken once every day. This will allow for an assessment of the clinical benefit of CSJ117 in patients who also take this background medication.
Patients will also be allowed to use a COPD rescue medication (salbutamol 100 µg or albuterol 90 µg) whenever they need it.
Approximately 300 people with COPD aged ≥ 40 years are being invited to join this study in approximately 14 countries. The pharmaceutical company named Novartis sponsors this study.
Summary of Results
Participant disposition: A total of 112 participants entered the pre-randomization period and 75 (67%) participants did not complete pre-randomization period. The main reasons for not completing the pre-randomization period were screen failure of 50 (44.5%) participants and study terminated by sponsor for 23 (20.5%) participants.
In study treatment epoch, 37 participants were treated (16 participants in CSJ117 4mg arm, 11 participants in CSJ117 8mg arm and 10 participants in placebo arm) and 27 (73.0%) participants discontinued. The main reason for discontinuation was study terminated by sponsor [24 (64.9%) participants]).REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0143
Date of REC Opinion
30 Sep 2021
REC opinion
Further Information Favourable Opinion