Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients
- Conditions
- COPD
- Registration Number
- JPRN-jRCT2080224866
- Lead Sponsor
- ovartis Pharma. K.K.
- Brief Summary
Efficacy results: Although no dose-response was observed for trough FEV1 at Week 12 (primary endpoint of study), a clear dose-response was observed at Week 24 on trough FEV1, E-RS cough and sputum subscale score, and E-RS total score. The E-RS cough and sputum subscale score also demonstrated a dose-response at Week 12. Safety results: There were no major safety concerns observed in any of the QBW251 arms, and the study drug exhibited a favorable safety and tolerability profile at all doses tested.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 974
Male and female adults aged >=40 years at screening.
- 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.
- Current or ex-smokers who have a smoking history of at least 10 pack years at screening.
- Patients with a history of long-QT syndrome or whose QTcF interval at screening
- Patients who have a clinically significant* ECG abnormality before randomization.
- Clinical laboratory values abnormalities considered as clinically significant in the opinion of the Investigator at screening. Patients who have clinically significant renal, cardiovascular, 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 who develop a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization during screening.
- Patients who have had a respiratory tract infection within 4 weeks prior to screening. If a respiratory tract infection occurs during screening.
- Patients with history of asthma or any other clinically relevant lung diseases..
- Patients with pulmonary lobectomy, lung volume reduction surgery, bronchoscopic lung volume reductions, or lung transplantation.
- Patients with a body mass index (BMI) of more than 40 kg/m2.
- Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy<br>Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12
- Secondary Outcome Measures
Name Time Method