A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of Atuliflapon Given Orally Once Daily for Twelve Weeks in Adults with Moderate to Severe Uncontrolled Asthma

Conditions

Moderate-to-Severe Uncontrolled Asthma

Brief summary

Time to first CompEx Asthma event

Detailed description

Clinical efficacy endpoints: Change from baseline in: 1 pre-BD FEV1: Week 4, and Week 12 2 SGRQ: Week 4, and Week 12, Clinical efficacy endpoints: Change from Baseline in: 1 ACQ-6: Week 4, 8, 12, and average over the 12-weeks 2 average morning and average evening PEF: Week 4, 8, 12, and average over 12-weeks 3 daily asthma symptom score (total, daytime, and night-time): Week 4, 8, 12, and average over the 12-weeks, Clinical efficacy endpoints: 1 time to first severe asthma exacerbation 2 event status (CompEx Asthma event yes/no), To evaluate the PK of Atuliflapon: 1 Atuliflapon plasma concentrations and PK parameters 2 Atuliflapon plasma concentrations: pre-dose samples at Baseline, Week 4, and Week 12, Safety Endpoints: Safety and tolerability evaluations using AEs, vital sign measures, clinical laboratory assessments, ECG and C-SSRS. For full information please refer to the protocol

Related papers

No related papers found yet.

Interventions

DRUGAtuliflapon

DRUGSALBUTAMOL

DRUGPlacebo to Atuliflapon

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to first CompEx Asthma event	—

Secondary

Measure	Time frame
Clinical efficacy endpoints: Change from baseline in: 1 pre-BD FEV1: Week 4, and Week 12 2 SGRQ: Week 4, and Week 12, Clinical efficacy endpoints: Change from Baseline in: 1 ACQ-6: Week 4, 8, 12, and average over the 12-weeks 2 average morning and average evening PEF: Week 4, 8, 12, and average over 12-weeks 3 daily asthma symptom score (total, daytime, and night-time): Week 4, 8, 12, and average over the 12-weeks, Clinical efficacy endpoints: 1 time to first severe asthma exacerbation 2 event status (CompEx Asthma event yes/no), To evaluate the PK of Atuliflapon: 1 Atuliflapon plasma concentrations and PK parameters 2 Atuliflapon plasma concentrations: pre-dose samples at Baseline, Week 4, and Week 12, Safety Endpoints: Safety and tolerability evaluations using AEs, vital sign measures, clinical laboratory assessments, ECG and C-SSRS. For full information please refer to the protocol	—

Measure

Time frame

Clinical efficacy endpoints: Change from baseline in: 1 pre-BD FEV1: Week 4, and Week 12 2 SGRQ: Week 4, and Week 12, Clinical efficacy endpoints: Change from Baseline in: 1 ACQ-6: Week 4, 8, 12, and average over the 12-weeks 2 average morning and average evening PEF: Week 4, 8, 12, and average over 12-weeks 3 daily asthma symptom score (total, daytime, and night-time): Week 4, 8, 12, and average over the 12-weeks, Clinical efficacy endpoints: 1 time to first severe asthma exacerbation 2 event status (CompEx Asthma event yes/no), To evaluate the PK of Atuliflapon: 1 Atuliflapon plasma concentrations and PK parameters 2 Atuliflapon plasma concentrations: pre-dose samples at Baseline, Week 4, and Week 12, Safety Endpoints: Safety and tolerability evaluations using AEs, vital sign measures, clinical laboratory assessments, ECG and C-SSRS. For full information please refer to the protocol

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Countries

Bulgaria, Croatia, Germany, Hungary, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain

Outcome results

None listed