Network Management Core (NEMO) for the Pulmonary Trials Cooperative (PTC) ? RETHINC Study
Grant
Overview
abstract
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RETHINC is a Phase III, double-blind, placebo-controlled, parallel-design multi-site study comparing indacaterol/glycopyrrolate 27.5/15.6 mcg inhaled twice daily vs placebo in subjects with =20 pack-years smoking history with post-bronchodilator FEV1/FVC =0.70 and CAT = 10. Treatment duration is 12 weeks with 290 patients in each arm. SGRQ, CAT, BDI/TDI and spirometry will be performed at baseline and 12 weeks. A phone call at 4 weeks will assess for adverse events.
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