A sponsor conducting an international Phase III program of two double- blind, randomised studies comparing triple combination therapy (ICS/LABA/LAMA) with double combination therapy (LABA/LAMA) in patients with severe chronic obstructive pulmonary disease (COPD) consulted ICON’s respiratory experts for assistance in patient enrolment, and study planning and monitoring. For study 2, however, ICON faced the additional challenge of country rejection because of concerns around the study design and how it compared with standard of care as well as clinical supply issues.

For studies 1 and 2, ICON experts pre-screened symptomatic patients on double combination therapy carefully, based on specific lung function criteria – such as FEV1 <50% and FEV1/FVC <0.7 – because of known variations in lung function test results. Moreover, ICON cultivated vendor relationships for spirometry requirements, electronic systems and data capture, as well as clinical supplies management. In study 2, ICON experts enhanced communications between the sponsor and vendors to overcome country rejection and delayed shipment of clinical supplies. Lastly, they implemented strong contingency plans for back-up sites and recruitment initiatives.

Pre-screening patients carefully led to low screen fail and dropout rates in the severe COPD population. Recruitment rates appeared higher in study 1, which offered six months treatment with triple combination therapy, compared to study 2, which offered 12 months treatment with triple or double combination therapy. Moreover, ICON completed enrolment on time for study 1 and close to target for study 2. Finally, by implementing its contingency plans and enhanced communication strategies, ICON recovered two months of time to exceed the targeted date for database cleaning activities for study 2.