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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04882124
Registration number
NCT04882124
Ethics application status
Date submitted
28/04/2021
Date registered
11/05/2021
Titles & IDs
Public title
Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD
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Scientific 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)
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Secondary ID [1]
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CCSJ117B12201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CSJ117
Treatment: Drugs - Placebo
Experimental: CSJ117 8mg - Intervention: Drug: CSJ117
Experimental: CSJ117 4mg - Intervention: Drug: CSJ117
Placebo comparator: CSJ117 Placebo - Intervention: Drug: Placebo
Treatment: Drugs: CSJ117
CSJ117 (4 mg and 8 mg) inhaled once daily for 12 weeks. Delivered via Concept1 device.
Treatment: Drugs: Placebo
Placebo inhaled once daily for 12 weeks. Delivered via Concept1 device
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline in E-RS score
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Assessment method [1]
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The Evaluating Respiratory Symptoms (E-RS) scale is based on the 11 respiratory symptom items included in the EXACT Tool (a validated 14-item electronic questionnaire). These 11 items generate a total score of 0-40, with higher scores indicating more severe respiratory symptoms.
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Timepoint [1]
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Baseline, 12 weeks
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Secondary outcome [1]
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Change from baseline in CAT score
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Assessment method [1]
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The COPD assessment test (CAT) is a short instrument used to quantify the symptom burden of COPD and will be used to assess the health status of participants. The assessment consists of 8 items, each presented as a semantic 6-point differential scale, providing a total score out of 40. A higher score indicates a worse health status.
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Timepoint [1]
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Baseline, 12 weeks
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Secondary outcome [2]
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Change from baseline in SGRQ-C score
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Assessment method [2]
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The St. George Respiratory Questionnaire for COPD patients Specific Version (SGRQ-C) contains 40 items divided into two parts covering three aspects of health related to COPD: symptoms, activity and impacts. Total score ranges between 0 and 100, with higher scores indicating greater impairment of health status.
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Timepoint [2]
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Baseline, 12 weeks
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Secondary outcome [3]
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Response in E-RS in total score decrease from baseline
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Assessment method [3]
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To assess the number of patients who responded to treatment
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Timepoint [3]
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Baseline, 12 weeks
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Secondary outcome [4]
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Response in CAT in total score decrease from baseline
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Assessment method [4]
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To assess the number of patients who responded to treatment
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Timepoint [4]
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Baseline, 12 weeks
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Secondary outcome [5]
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Response in SGRQ-C in total score decrease from baseline
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Assessment method [5]
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To assess the number of patients who responded to treatment
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Timepoint [5]
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Baseline, 12 weeks
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Secondary outcome [6]
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Change from baseline in trough FEV1 after 2, 6, and 12 weeks of treatment
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Assessment method [6]
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Forced expiratory volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
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Timepoint [6]
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Baseline, 2, 6 and 12 weeks
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Secondary outcome [7]
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Puffs of rescue medication per day
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Assessment method [7]
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To assess use of rescue medication
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Timepoint [7]
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12 weeks
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Secondary outcome [8]
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Time to COPD exacerbations via EXACT
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Assessment method [8]
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Time to COPD exacerbations based on EXACT.
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Timepoint [8]
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12 weeks
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Secondary outcome [9]
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Rate and severity of COPD exacerbations via EXACT
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Assessment method [9]
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Rate and severity of COPD exacerbations based on the Exacerbations of chronic obstructive pulmonary disease tool (EXACT).
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Timepoint [9]
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12 weeks
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Secondary outcome [10]
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Time to COPD exacerbations via HCRU
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Assessment method [10]
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Time to COPD exacerbations based on HCRU
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Timepoint [10]
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12 weeks
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Secondary outcome [11]
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Rate and severity of COPD exacerbations via HCRU
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Assessment method [11]
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Rate and severity of COPD exacerbations based on the Health Care Resource Utilization (HCRU).
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Timepoint [11]
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12 weeks
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Secondary outcome [12]
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Pre-dose trough concentration (Ctrough) of CSJ117
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Assessment method [12]
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To assess pharmacokinetic (PK) parameters of CSJ117 based on total serum concentrations.
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Timepoint [12]
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12 weeks
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Secondary outcome [13]
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Accumulation ratio (Racc) of CSJ117
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Assessment method [13]
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To assess PK parameters of CSJ117 based on total serum concentrations.
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Timepoint [13]
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12 weeks
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Secondary outcome [14]
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Measuring anti-drug antibodies
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Assessment method [14]
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To assess the immunogenicity of CSJ117
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Timepoint [14]
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12 weeks
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Eligibility
Key inclusion criteria
* Male and female COPD patients aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
* Current or ex-smokers who have a smoking history of at least 10 pack years
* Patients who have been treated with a triple combination of LABA/LAMA/ICS for the last 3 months prior to screening
* Patients with a documented diagnosis of COPD for at least 1 year prior to screening visit
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Minimum age
40
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patients with a past or current medical history of asthma
* Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization, or a respiratory tract infection in the 4 weeks prior to screening, or hospitalization between screening and prior to treatment.
* Use of other investigational drugs (approved or unapproved) within 30 days or 5 half-lives prior to screening, or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or longer if required by local regulations
* Pregnant or nursing (lactating) women, and women of childbearing potential not willing to use acceptable effective methods of contraception during study participation
* Patients with a body mass index (BMI) of more than 40 kg/m2 Other protocol-defined inclusion/exclusion criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/09/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/09/2022
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Sample size
Target
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Accrual to date
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Final
38
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Novartis Investigative Site - South Brisbane
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Recruitment postcode(s) [1]
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4101 - South Brisbane
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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Louisiana
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Country [3]
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United States of America
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State/province [3]
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Missouri
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Country [4]
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United States of America
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State/province [4]
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North Carolina
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Country [5]
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Canada
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State/province [5]
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Quebec
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Country [6]
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Czechia
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State/province [6]
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Czech Republic
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Country [7]
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Hungary
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State/province [7]
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Balassagyarmat
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Country [8]
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Hungary
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State/province [8]
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Godollo
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Country [9]
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Hungary
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State/province [9]
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Szeged
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Country [10]
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Japan
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State/province [10]
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Aichi
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Country [11]
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Japan
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State/province [11]
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Ibaraki
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 2 study in patients with chronic obstructive pulmonary disease (COPD) to assess the efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and safety of two dose levels of CSJ117 in comparison to placebo. For this, the impact of CSJ117 on disease symptom burden and lung function will be explored.
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Trial website
https://clinicaltrials.gov/study/NCT04882124
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04882124