Chronic obstructive pulmonary disease MedDRA version: 21.1 Level: LLT Classification code 10029972 Term: Obstructive airways disease (chronic) System Organ Class: 100000004855
Conditions
Interventions
Product Code: QBW251
Pharmaceutical Form: Capsule
INN or Proposed INN: Not yet available
Current Sponsor code: QBW251
Other descriptive name: QBW251
Concentration unit: mg milligram(s)
Concentration
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
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. • A COPD Assessment Test (CAT) score of at least 10 at Run-In 1 visit. • Patients with a post-bronchodilator FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range 478
Exclusion criteria
Exclusion criteria: • Patients who have a history of long-QT syndrome, a clinically significant ECG abnormality at baseline, or whose QTc measured at baseline is prolonged. • 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, with a clinically significant laboratory abnormality at baseline, or patients with Type I diabetes or uncontrolled Type II diabetes. • 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 between screening and randomization. • Patients with any documented history of asthma, or with an onset of chronic respiratory symptoms, including a COPD diagnosis, prior to age 40 years. • Patients with a body mass index (BMI) of more than 40 kg/m2. • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Characterize the dose-response relationship of QBW251 administered orally over 12 weeks on lung function, compared to placebo when added to inhaled triple combination therapy (long-acting ß2- agonist/long-acting muscarinic receptor antagonist/inhaled corticosteroid; LABA/LAMA/ICS).;Secondary Objective: - Evaluate symptoms (overall COPD symptoms, cough and sputum) across various dose levels of QBW251 administered orally over 24 weeks, compared to placebo at Weeks 12 and 24. - Evaluate health-related quality of life across various dose levels of QBW251 administered orally over 24 weeks, compared to placebo, at Weeks 12 and 24. - Evaluate lung function across various dose levels of QBW251 administered orally over 24 weeks, compared to placebo, over 4, 8, 16, 20 and 24 weeks. - Evaluate safety and tolerability across various dose levels of QBW251, administered orally over 24 weeks, compared to placebo. - Assess the pharmacokinetics of QBW251 in COPD patients. Additionally this information may be used to understand the relation between drug exposure and efficacy and/or safety.;Primary end point(s): Trough FEV1 change from baseline after 12 weeks of treatment;Timepoint(s) of evaluation of this end point: 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline in the Evaluating Respiratory Symptoms in COPD (E-RS) weekly mean scores (total and subscale scores). Change from baseline in Patient Global Impression of Severity (PGI-S) score. Change from baseline in the Cough and Sputum Assessment Questionnaire (CASA-Q) domain scores - cough symptoms, cough impact, sputum symptoms, and sputum Impact. - Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total and domain scores at weeks 12 and 24 - Trough FEV1 change from baseline after 4, 8, 16, 20 and 24 weeks of treatment, respectively - Assessment of drug exposure (trough concentration; Cmin) on all visits and around Cmax on Days 1, 15 and 169. AUC and Cmax on Days 1 and 15 in a subset of patients;Timepoint(s) of evaluation of this end point: Specified in the endpoints descriptions | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, Colombia, Czechia, Czech Republic, Denmark, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Italy, Japan, Korea, Republic of, Netherlands, Philippines, Poland, Slovakia, Spain, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactDRA information desk
Novartis Slovakia s.r.o.
Outcome results
None listed