COPD
Conditions
Interventions
The study has a duration of approximately 12 weeks. After screening is
completed, eligible participants will be randomized in a 1:1 ratio to receive
selnoflast or placebo and commence a 2-week, blin
Sponsors
F.Hoffmann-La Roche Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Between 35 and 75 years of age (inclusive) - Patients with a >= 12-month diagnosis of COPD - Radiologic evidence of air trapping at screening based on chest HRCT conducted per imaging acquisition protocol and reviewed by the imaging central reader - Extent of emphysema on HRCT at screening is = 30% and == 2 or >= 1 leading to hospitalization within the last 12 months - COPD assessment test (CAT) score >=10 and with a clinical diagnosis of chronic bronchitis, characterized by cough and sputum production on most days for a minimum of 3 months during the last year - Participant must have a body mass index (BMI) between 18 and 35 kg/m^2 - Abnormal laboratory values: high sensitivity CRP (hs-CRP) >= 3 mg/L at screening AND absolute neutrophil count >= 6.0 x 10 high 9 /L in whole blood at screening - Vital signs (body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate) will be assessed in the sitting position after the subject has rested for at least 3 minute - Unchanged standard regimen of care for >= 4 weeks prior to screening - Ex-smokers with at least a 10-pack year smoking history or current smokers with at least a 10 pack-year smoking history who smoke =
Exclusion criteria
Exclusion criteria: - Any condition or disease detected during the medical interview/physical examination that would render the patient unsuitable for the study, place the patient at undue risk, or interfere with the ability of the patient to complete the study - Known active or uncontrolled bacterial, viral, fungal, mycobacterial, or other infection, excluding fungal infection of nail beds, including participants exhibiting symptoms consistent with SARS-CoV-2 within 2 weeks prior to screening - Positive polymerase chain reaction (PCR) test for SARS-CoV-2 within 6 weeks prior to Day 1 - Diagnosis of severe bronchiectasis in chart or history - Patients with another concomitant pulmonary disease, including but not exclusive of, interstitial pulmonary fibrosis, sarcoidosis, or other granulomatous or infectious process - Patients treated for active asthma within 2 years prior to the screening visit - Any COPD exacerbation or upper or lower respiratory tract infection requiring antibiotics, oral steroids, or hospitalization within 2 weeks prior to screening, during the screening period, or during the run-in period - Patients requiring long-term oxygen therapy for daytime hypoxemia - Patients with a diagnosis of alpha-1 antitrypsin deficiency - History of lung transplant or malignancy of any organ system (other than localized basal cell carcinoma of the skin) within the past 5 years - Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study - History of clinically significant ECG abnormalities, or ECG abnormalities at screening or baseline - Known family history or known presence of long QT syndrome - Patients with a history of acute coronary syndrome in 3 months prior to the screening visit - Patients with a history of coronary artery bypass surgery or other major vascular surgery within 6 months prior to the screening visit - Evidence of urinary obstruction or difficulty in voiding - History of any clinically significant hepatic disease or cirrhosis - Significant illness not resolved within 2 weeks prior to screening - Use of systemic steroids, ICS, theophylline, and phosphodiesterase 4 (PDE4) inhibitors within 4 weeks of screening - Vaccines within 4 weeks prior to the first dose - Current treatment with medications that are well known to prolong the QT interval - Donation or loss of 450 mL or more of blood within 8 weeks prior to initial dosing, or longer if required by local regulation - Plasma donation > 150 mL within 7 days prior to first dosing - Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations - History of hypersensitivity to the study drugs or to drugs of similar chemical classes or excipients - QTcF > 450 ms in male participants and > 470 ms in female participants demonstrated by at least two ECGs > 30 minutes apart - Liver function test abnormalities at screening. Re-testing during the screening period is possible once. This laboratory assessment may be repeated once during the screening period, if necessary - Anemia (hemoglobin levels > 10.0 g/dL at screening). This laboratory assess
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Incidence, severity, and causal relationship ofadverse events (AEs), incidence of serious AEs (SAEs) and AEs leading to treatment discontinuation - Incidence of abnormal laboratory findings - Incidence of abnormal vital signs and electrocardiogram (ECG) parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in: o Pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) o Post-bronchodilator (post-BD) FEV1 o Pre-BD FEV1 percentage of predicted o Post-BD FEV1 percentage of predicted o Pre-BD total lung capacity (TLC) o Pre-BD residual volume (RV) o Pre-BD functional residual capacity (FRC) o RV/TLC ratio o Pre-BD forced expiratory flow over the middle o one half of the FVC (FEF25-75) o Post-BD FEF25-75 Pharmacokinetic parameters of RO7486967 in blood by PK population analysis. | — |
Countries
Netherlands
Outcome results
None listed