A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary DiseaseThe purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
40 to 90
Participation Criteria
Inclusion Criteria:
* Completion of the 52-week treatment period in either parent GB43311 or GB44332
Exclusion Criteria:
* Withdrawal of consent and/or premature discontinuation from parent study
* Any permanent discontinuation of study drug in parent study
* Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment
* Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study
* Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study
* Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study
Study Location
Synergy Respiratory & Cardiac Care - Synergy Wellness Centre Location
Synergy Respiratory & Cardiac Care - Synergy Wellness Centre LocationSherwood Park, Alberta
Canada
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Dr. Syed Anees Medicine Profession Corporation
Dr. Syed Anees Medicine Profession CorporationWindsor, Ontario
Canada
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Bluewater Clinical Research Group
Bluewater Clinical Research GroupSarnia, Ontario
Canada
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Dynamic Drug Advancement Ltd.
Dynamic Drug Advancement Ltd.Ajax, Ontario
Canada
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Burlington Lung Clinic
Burlington Lung ClinicBurlington, Ontario
Canada
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Dr Anil Dhar Professional Medicine Corporation
Dr Anil Dhar Professional Medicine CorporationWindsor, Ontario
Canada
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Clinique de pneumologie et du sommeil de Lanaudiere
Clinique de pneumologie et du sommeil de LanaudiereSaint-charles-borromee, Quebec
Canada
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Edmonton Respiratory Consultants
Edmonton Respiratory ConsultantsEdmonton, Alberta
Canada
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- Study Sponsored By
- Hoffmann-La Roche
- Participants Required
- More Information
- Study ID:
NCT05878769