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drugset / Trial / NCT04933383

Crossover Trial to Assess Efficacy and Safety of Inhaled AQ001S Compared to a Budesonide Suspension in Mild Asthmatics

NCT04933383 ↗

Phase 1/2 Completed 23 enrolled Aquilon Pharmaceuticals S.A.
RandomizedCrossoverOpen-labelTreatment

Summary

This is a prospective, active-controlled, randomized, open label, single-center, multiple dose, two-period crossover clinical trial to assess the efficacy, safety and pharmacokinetics of AQ001S compared to a budesonide inhalation suspension (comparator) in adults with mild asthma. Both treatments will be administered by nebulization.

Timeline

Start
2021-07-23
Primary completion
2022-12-31
Completion
2023-01-31

Outcome

Met primary endpoint

registry analysis (superiority test); AQ001S 0.125 mg/ml vs Budesonide Inhalation Suspension 0.125 mg/ml; p = 0.000813; difference/ratio of least square means 180.6 NCT04933383 ↗

registry MEAN AQ001S 0.125 mg/ml: 3.7 (0.9 to 6.5) mg/mL MEAN Budesonide Inhalation Suspension 0.125 mg/ml: 1.2 (-0.7 to 3.0) mg/mL NCT04933383 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject AQ001S Unknown 0.125 mg/ml Other

Indications

asthma