Respiratory
Conditions
Interventions
Placebo Comparator
Sponsors
Hoffmann La Roche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Documented COPD diagnosis for = 12 months *History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to screening *Post-bronchodilator FEV1 = 20% and < 80% of predicted at screening *Post-bronchodilator FEV1/FVC < 0.70 at screening *Modified Medical Research Council (dyspnea scale) (mMRC) score = 2 *Current tobacco smoker or former smoker with a history of smoking = 10 pack-years *On optimized COPD maintenance therapy as defined below for = 12 months prior to screening, and stable on current therapy for at least 4 weeks prior to screening: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA *Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or chest X-ray during the screening period that confirms the absence of clinically significant lung disease besides COPD
Exclusion criteria
Exclusion criteria: *Current documented diagnosis of asthma *History of clinically significant pulmonary disease other than COPD *Diagnosis of 1-antitrypsin deficiency *History of long-term treatment with oxygen at > 4.0 liters/minute *Lung volume reduction surgery or procedure within 12 months prior to screening *Individuals participating in, or scheduled for, an intensive COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible) *History of lung transplant *Any infection that resulted in hospital admission for = 24 hours and/or treatment with oral, IV, or IM antibiotics within 4 weeks prior to or during screening *Upper or lower respiratory tract infection within 4 weeks prior to or during screening *Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug *Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months prior to screening *Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first moderate or severe COPD exacerbation during the 52-week treatment period;Absolute change from baseline in health-related quality of life (HRQoL) at Week 52 as assessed through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) total score;Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Week 52;Absolute change from baseline in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) total score at Week 52;Proportion of participants with improvement in HRQoL at Week 52;Annualized rate of severe COPD exacerbations over the 52-week treatment period | — |
Countries
Kenya
Contacts
Public ContactVidelis Ndube
Principal Investigator
Outcome results
None listed