Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
28/11/2022

Titles & IDs
Public title
Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD
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)
Secondary ID [1] 0 0
CCSJ117B12201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in E-RS score
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Baseline, 12 weeks
Secondary outcome [1] 0 0
Change from baseline in CAT score
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Baseline, 12 weeks
Secondary outcome [2] 0 0
Change from baseline in SGRQ-C score
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Baseline, 12 weeks
Secondary outcome [3] 0 0
Response in E-RS in total score decrease from baseline
Assessment method [3] 0 0
To assess the number of patients who responded to treatment
Timepoint [3] 0 0
Baseline, 12 weeks
Secondary outcome [4] 0 0
Response in CAT in total score decrease from baseline
Assessment method [4] 0 0
To assess the number of patients who responded to treatment
Timepoint [4] 0 0
Baseline, 12 weeks
Secondary outcome [5] 0 0
Response in SGRQ-C in total score decrease from baseline
Assessment method [5] 0 0
To assess the number of patients who responded to treatment
Timepoint [5] 0 0
Baseline, 12 weeks
Secondary outcome [6] 0 0
Change from baseline in trough FEV1 after 2, 6, and 12 weeks of treatment
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Baseline, 2, 6 and 12 weeks
Secondary outcome [7] 0 0
Puffs of rescue medication per day
Assessment method [7] 0 0
To assess use of rescue medication
Timepoint [7] 0 0
12 weeks
Secondary outcome [8] 0 0
Time to COPD exacerbations via EXACT
Assessment method [8] 0 0
Time to COPD exacerbations based on EXACT.
Timepoint [8] 0 0
12 weeks
Secondary outcome [9] 0 0
Rate and severity of COPD exacerbations via EXACT
Assessment method [9] 0 0
Rate and severity of COPD exacerbations based on the Exacerbations of chronic obstructive pulmonary disease tool (EXACT).
Timepoint [9] 0 0
12 weeks
Secondary outcome [10] 0 0
Time to COPD exacerbations via HCRU
Assessment method [10] 0 0
Time to COPD exacerbations based on HCRU
Timepoint [10] 0 0
12 weeks
Secondary outcome [11] 0 0
Rate and severity of COPD exacerbations via HCRU
Assessment method [11] 0 0
Rate and severity of COPD exacerbations based on the Health Care Resource Utilization (HCRU).
Timepoint [11] 0 0
12 weeks
Secondary outcome [12] 0 0
Pre-dose trough concentration (Ctrough) of CSJ117
Assessment method [12] 0 0
To assess pharmacokinetic (PK) parameters of CSJ117 based on total serum concentrations.
Timepoint [12] 0 0
12 weeks
Secondary outcome [13] 0 0
Accumulation ratio (Racc) of CSJ117
Assessment method [13] 0 0
To assess PK parameters of CSJ117 based on total serum concentrations.
Timepoint [13] 0 0
12 weeks
Secondary outcome [14] 0 0
Measuring anti-drug antibodies
Assessment method [14] 0 0
To assess the immunogenicity of CSJ117
Timepoint [14] 0 0
12 weeks

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
Minimum age
40 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/09/2022
Sample size
Target
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Novartis Investigative Site - South Brisbane
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Louisiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Czechia
State/province [6] 0 0
Czech Republic
Country [7] 0 0
Hungary
State/province [7] 0 0
Balassagyarmat
Country [8] 0 0
Hungary
State/province [8] 0 0
Godollo
Country [9] 0 0
Hungary
State/province [9] 0 0
Szeged
Country [10] 0 0
Japan
State/province [10] 0 0
Aichi
Country [11] 0 0
Japan
State/province [11] 0 0
Ibaraki

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


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