Case Study: a global pharmaceutical company secures COPD drug approval with Clario respiratory and safety solutions

Global pharmaceutical company secures new drug approval with Clario after proving bronchodilator efficacy

A global pharmaceutical company needed to prove the superiority of its new bronchodilator treatment for COPD patients over an existing therapy. Their challenge was to demonstrate efficacy through key respiratory parameters like FEV1, capture accurate patient-reported outcomes, and reduce the reliance on rescue medication. They partnered with Clario to utilize its integrated clinical trial solutions, including respiratory and eCOA services.

Clario implemented its MasterScope™ spirometer integrated with the EXPERT® platform for centralized spirometry and its AM3™ device for home monitoring and electronic patient-reported outcomes (ePRO) collection. This solution successfully established patient baselines, detected exacerbations with alerts, and provided a robust assessment of treatment effects. As a result, Clario's integrated technology and expertise supported the global pharmaceutical company in securing new drug approval from U.S. and European regulatory authorities.

Global Pharmaceutical Company