Treatment Withdrawal Criteria Sample Clauses

Treatment Withdrawal Criteria. For subjects who exhibit worsening COPD disease status while on study treatment, the investigator is encouraged to maximise non-study treatments (e.g., theophylline, short-acting anticholinergic, short-acting β-agonist). The investigator should be concerned if the subject experiences significant numbers of exacerbations requiring oral corticosteroids or hospitalisations during a short period of time. As a guideline, ≥3 exacerbations requiring oral corticosteroids or ≥2 exacerbations requiring hospitalisation during a 6-month period might be considered excessive. If the subject's condition worsens to such an extent that in the opinion of the investigator they can no longer continue in the study, they should be withdrawn. Such patients must be followed-up for a period of three years from randomisation and the primary end point (survival status), number of moderate and severe exacerbations at 12 weekly intervals and the COPD concomitant medications recorded. Reason for withdrawal should be recorded in the case record form. Subjects who have had lung-volume reduction surgery and/or a lung transplant during the study must be withdrawn from study medication.‌