Indacaterol: The First Once-daily Long-acting Beta2 Agonist for COPD (Milestones in Drug Therapy)

Chronic obstructive pulmonary disease (COPD) is a multi-component condition that results in increasingly limited airflow, usually associated with an abnormal inflammatory response of the lung. It constitutes a major public health burden worldwide, while only very few effective therapies are available. This book provides a comprehensive overview of the development of Onbrez Breezhaler, a newly approved once-daily inhaled β2 agonist for the treatment of COPD. It reviews the current pharmacotherapy for COPD and discusses topics such as the chemical design and the pre-clinical pharmacology of the molecule, the early clinical development, the INHANCE study (which provides a successful example of the use of an adaptive design in the confirmatory setting) and the Phase III clinical efficacy study, as well as the history and performance of the Breezhaler device. Finally, a list of emerging targets is included that could well offer future treatment options for COPD. Chronic obstructive pulmonary disease (COPD) is a multi-component condition that results in increasingly limited airflow, usually associated with an abnormal inflammatory response of the lung -- Font no determinada It constitutes a major public health burden worldwide, while only very few effective therapies are available -- Font no determinada This book provides a comprehensive overview of the development of Onbrez Breezhaler, a newly approved once-daily inhaled [beta]2 agonist for the treatment of COPD -- Font no determinada It reviews the current pharmacotherapy for COPD and discusses topics such as the chemical design and the pre-clinical pharmacology of the molecule, the early clinical development, the INHANCE study (which provides a successful example of the use of an adaptive design in the confirmatory setting) and the Phase III clinical efficacy study, as well as the history and performance of the Breezhaler device -- Font no determinada Finally, a list of emerging targets is included that could well offer future treatment options for COPD -- Font no determinada Chronic obstructive pulmonary disease (COPD) is a multi-component condition that results in increasingly limited airflow, usually associated with an abnormal inflammatory response of the lung. It constitutes a major public health burden worldwide, while only very few effective therapies are available. This book provides a comprehensive overview of the development of Onbrez Breezhaler, a newly approved once-daily inhaled {esc}(Sb{esc}(B2 agonist for the treatment of COPD. It reviews the current pharmacotherapy for COPD and discusses topics such as the chemical design and the pre-clinical pharmacology of the molecule, the early clinical development, the INHANCE study (which provides a successful example of the use of an adaptive design in the confirmatory setting) and the Phase III clinical efficacy study, as well as the history and performance of the Breezhaler device. Finally, a list of emerging targets is included that could well offer future treatment options for COPD Front Matter....Pages i-vii Current Pharmacotherapy for COPD....Pages 1-23 The Preclinical Pharmacology of Indacaterol....Pages 25-37 The Design of the Indacaterol Molecule....Pages 39-65 The Early Clinical Development of Indacaterol....Pages 67-76 INHANCE: An Adaptive Confirmatory Study with Dose Selection at Interim....Pages 77-92 Phase 3 Clinical Efficacy Studies: Lung Function....Pages 93-106 Phase III Clinical Efficacy of Indacaterol: Patient-Centered Outcomes....Pages 107-115 The History and Performance of the Breezhaler Device....Pages 117-128 What Does the Future Hold for the Therapy of COPD?....Pages 129-146 Here is a comprehensive overview of the development of Onbrez Breezhaler, a newly approved once-daily inhaled beta2 agonist for treating COPD. Covers design and pre-clinical pharmacology of the molecule, early clinical development, efficacy studies and more.