Clinical Study to Assess the Mode of Action of QBW251 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic obstructive pulmonary diseaseMedDRA version: 21.1Level: LLTClassification code 10029972Term: Obstructive airways disease (chronic)System Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2019-000325-49-DE
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
•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 2-3, 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) between January 2019 to study screening.
• Patients with sputum positive (>0 CFU) for at least one
strain of potentially pathogenic microorganism at screening (H
influenzae, H parainfluenzae, P aeruginosa, S pneumoniae, S aureus, Moraxella catarrhalis, Enterobacteriaceae, Stenotrophomonas
maltophilia, Burkholderia species, and Achromobacter species or any
potential pathogenic bacteria measured by dilution/outgrowth. Any
organism that is to be included and that is not included in the list of the
protocol defined pathogens will be discussed case by case). Sputum
samples may be re-collected and re-tested once during the screening
period.
•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 =320 mg/dL at screening.
Fibrinogen may be re-tested once during the screening period.
•A COPD Assessment Test (CAT) score of at least 10 at screening.
•Current or ex-smokers who have a smoking history of at least 10 pack
years at screening. (e.g. 10 pack years = 1 pack/day x 10 years, or 0.5
pack/day x 20 years) at screening.
•Patients featuring chronic bronchitis, defined as productive cough that
occurs on most days (defined as >50% of days) during at least 3
consecutive months in the year prior to screening, as assessed by
documentation of patient recollection(anamnesis) or documented in
patients' records.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
•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 hepatitis, cirrhosis or hepatic failure.
-Patients with stable chronic hepatitis may be included in the study by
agreement with Novartis Medical Expert on a case-by-case basis.
-A history of resolved Hepatitis A is not exclusionary.
-Patients with prothrombin time international normalized ratio
(PT/INR) of more than 1.5xULN at screening. Patients excluded for the
PT/INR of more
than 1.5xULN can be re-screened when the values have returned to
normal.
•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 Expert 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.
Note: Patients with a history of pulmonary tuberculosis can be enrolled if
they meet the following requirements: history of appropriate drug
treatment followed by negative imaging results within 12 months prior
to screening suggesting low probability of recurrent active tuberculosis.
•Patients with pulmonary lobectomy, lung volume reduction surgery,
bronchoscopic lung volume reductions, or lung transplantation.
•Patients participating in or planning to participate in the active phase of
a supervised pulmonary rehabilitation program during the trial.
Participation in a maintenance program is permitted. Note: the
supervised pulmonary rehabilitation program as a maintenance program
has to be ongoing for at least 3 months at the time of enrollment.
•Patients with a body mass index (BMI) of more than 40 kg/m2.
•Pregnant or nursing (lactating) women where pregnancy was defined
as the
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method