A randomized, subjects and investigator blinded, placebo controlled parallel group study to assess the mode of action of QBW251 in patients with Chronic Obstructive Pulmonary Disease (COPD)

ovartis Pharma AG0 sites100 target enrollmentApril 30, 2020

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: ovartis Pharma AG
Enrollment: 100
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 30, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ovartis Pharma AG

Eligibility Criteria

Inclusion Criteria

•Patients who have signed an Informed Consent Form prior to initiation of any study\-related procedure.
•Male and female adults aged \=40 years at screening.
•Patients with stable COPD, stages GOLD 2\-4, according to the current GOLD strategy (GOLD 2019\) at screening.
•Patients with a post\-bronchodilator FEV1/FVC \< 0\.70 at screening
•Patients with airflow limitation indicated by a post\-bronchodilator FEV1 \= 30% and FEV1 \< 80% of the predicted normal at Screening who must have had at least 2 documented moderate or at least 1 documented severe exacerbation(s) in the 12 months prior to study entry.
•Patients with sputum bacterial load (log10\=105 CFU/mL) with at least one strain of potentially pathogenic
•microorganism at screening (H influenzae, H parainfluenzae, P aeruginosa, S pneumoniae, S aureus, Moraxella catarrhalis, Enterobacteriaceae).
•Patients who have been treated with a combination of LABA/LAMA or LABA/ICS or LABA/LAMA/ICS at a stable dose for the last 3 months prior to screening.
•COPD patients are allowed to stay on macrolides as background therapy if they have bronchiectasis as a secondary diagnosis and if they are treated with them at a stable dose 3 months before screening.
•Patients with plasma fibrinogen level \=350 mg/dL at screening.

Exclusion Criteria

•Patients with a history of long\-QT syndrome or whose QTcF interval at screening (Fridericia method) is prolonged (QTcF \>450 ms in males, \>460 ms in females).
•Patients who have a clinically significant ECG abnormality before randomization.
•Clinical laboratory values abnormalities (including Gamma GT, AST, ALT, total bilirubin or creatinine) considered as clinically significant in the opinion of the Investigator at screening.
•Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction), neurological, endocrine, immunological, psychiatric, gastrointestinal, or hematological abnormalities, which could interfere with the assessment of the efficacy and safety of the study treatment, or patients with uncontrolled Type II diabetes.
•Patients with a history or current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or an AST/ALT of more than 1\.5x ULN or abnormal PT/INR at screening.
•Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with a history of cancer and 5 years or more disease free survival time may be included in the study by agreement with Novartis Medical Monitor on a case\-by\-case basis.
•Patients who develop a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization during screening. Re\-screening is permitted after a minimum of 2 weeks after the resolution of the COPD exacerbation (i.e. 2 weeks after the stop of SOC therapy for exacerbation).
•Patients who have had a respiratory tract infection within 4 weeks prior to screening. If a respiratory tract infection occurs during screening, patients can be re\-screened after a minimum of 2 weeks after resolution of the respiratory tract infection.
•Patients with history of asthma or any other clinically relevant lung diseases.
•Patients with suspected active pulmonary tuberculosis or currently being treatment for active pulmonary tuberculosis.