Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Brief summary
Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.
Detailed description
Annualized rate of moderate to severe COPD exacerbations in former or current smokers, Change from baseline in SGRQ total score in former smokers, Change from baseline in SGRQ total score in former or current smokers, Annualized rate of severe COPD exacerbations in former smokers, Annualized rate of severe COPD exacerbations in former or current smokers, Change from baseline in E-RS:COPD total score in former smokers, Change from baseline in E-RS:COPD total score in former or current smokers, Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former smokers, Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former or current smokers, Time to first moderate to severe COPD exacerbation, Time to first severe COPD exacerbation, Change from baseline in CAT total score, Proportion of participants achieving MCID in CAT score, Proportion of participants achieving MCID in SGRQ total score, Proportion of participants achieving MCID in E-RS:COPD total score, Annualized rate of healthcare resource utilization, Change from baseline in rescue medication, Trough serum concentrations of tozorakimab, Presence of anti-drug antibodies, Time to death, Safety and tolerability, Change from baseline in post-bronchodilator FEV1 (mL) in former smokers, Change from baseline in post-bronchodilator FEV1 (mL) in former or current smokers, Annualised rate of COPD exacerbations requiring hospitalisations and/or Emergency Room /Emergency Department visits in former smokers, Annualised rate of COPD exacerbations requiring hospitalisations and/or Emergency Room /Emergency Department visits in former or current smokers
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers. | — |
Secondary
| Measure | Time frame |
|---|---|
| Annualized rate of moderate to severe COPD exacerbations in former or current smokers, Change from baseline in SGRQ total score in former smokers, Change from baseline in SGRQ total score in former or current smokers, Annualized rate of severe COPD exacerbations in former smokers, Annualized rate of severe COPD exacerbations in former or current smokers, Change from baseline in E-RS:COPD total score in former smokers, Change from baseline in E-RS:COPD total score in former or current smokers, Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former smokers, Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former or current smokers, Time to first moderate to severe COPD exacerbation, Time to first severe COPD exacerbation, Change from baseline in CAT total score, Proportion of participants achieving MCID in CAT score, Proportion of participants achieving MCID in SGRQ total score, Proportion of participants achieving MCID in E-RS:COPD total | — |
Countries
Belgium, Bulgaria, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Spain