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Clinical Trial Report

Efficacy and Safety of the CFTR Potentiator Icenticaftor (QBW251) in COPD: Results from a Phase 2 Randomized Trial

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Pages 2399-2409 | Published online: 05 Oct 2020

Figures & data

Figure 1 Study design. *Primary efficacy assessments on Day 29–12 hours after the last dose of icenticaftor. **A total of 92 patients were randomized. The first 4 patients in the study received icenticaftor 450 mg b.i.d. or placebo, prior to the protocol amendments reducing the dose to icenticaftor 300 mg b.i.d. #Patients continued on background COPD therapy throughout the study. During the entire study duration, subjects were maintained on stable baseline COPD therapy.

Abbreviations: b.i.d., twice daily; EOS, end of study.
Figure 1 Study design. *Primary efficacy assessments on Day 29–12 hours after the last dose of icenticaftor. **A total of 92 patients were randomized. The first 4 patients in the study received icenticaftor 450 mg b.i.d. or placebo, prior to the protocol amendments reducing the dose to icenticaftor 300 mg b.i.d. #Patients continued on background COPD therapy throughout the study. During the entire study duration, subjects were maintained on stable baseline COPD therapy.

Figure 2 Patient disposition.

Figure 2 Patient disposition.

Table 1 Patient Demographics and Clinical Characteristics at Baseline (Safety Set)

Table 2 Modeled Data on Change from Baseline of LCI and FEV1 Pre- and Post-Bronchodilator (Efficacy Set)

Figure 3 Raw mean change from baseline per treatment arm over time for pre-bronchodilator FEV1, post-bronchodilator FEV1, and lung clearance index (LCI). Numbers at each data point represent number of patients; error bars are indicative of standard error.

Abbreviations: EOS, end of study; FEV1, forced expiratory volume in 1 second; LCI, lung clearance index.
Figure 3 Raw mean change from baseline per treatment arm over time for pre-bronchodilator FEV1, post-bronchodilator FEV1, and lung clearance index (LCI). Numbers at each data point represent number of patients; error bars are indicative of standard error.

Figure 4 Mean change from baseline for sweat chloride (A) and fibrinogen (B) over time. Numbers at each data point represent number of patients; error bars are indicative of standard error.

Figure 4 Mean change from baseline for sweat chloride (A) and fibrinogen (B) over time. Numbers at each data point represent number of patients; error bars are indicative of standard error.