The Topic Trial - Study to Determine the Safety and Efficacy of Ivacaftor

Summary

The study is a Phase 2 Study to establish the safety and efficacy of a drug called Ivacaftor (VX-770) in patients with chronic obstructive pulmonary disease (COPD), chronic bronchitis, and acquired CFTR dysfunction as detected by sweat chloride analysis. The design is a pilot, randomized (3:1, active:placebo), double-blind, placebo-controlled study. Approximately 40 subjects with COPD will be randomized.

Timeline

Start

2017-03-16

Primary completion

2022-09-30

Completion

2022-09-30

Publications

• Vijaykumar K, Solomon GM, Guimbellot J, Acosta EP, Bhambhavni PG, White S, Kim H, Raju SV, Rasmussen LW, Harris N, Liu B, Hathorne H, Rowe SM, Dransfield MT. Ivacaftor for Chronic Obstructive Pulmonary Disease: Results from a Phase 2, Randomized Controlled Trial. Am J Respir Crit Care Med. 2025 May;211(5):823-831. doi: 10.1164/rccm.202407-1302OC.

Drugs

Indications