NCT04933383

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

A Prospective, Active-controlled, Randomized, Open Label, Single-center, Multiple Dose, Crossover Clinical Trial to Assess the Efficacy, Safety and PK of AQ001S Compared to a Budesonide Inhalation Suspension in Adults With Mild Asthma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Aquilon Pharmaceuticals S.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Adults patients with mild asthma (18 to 65 years old), who are 'inhaled corticosteroid (ICS)'-naïve for minimum 60 days at Screening Visit will be enrolled in the study. The patients will be treated for 28 days. The primary endpoint will be assessed by a provocative concentration of methacholine that results in a 20% drop (PC20) in the first second forced expiratory volume (FEV1) as determined by methacholine challenge test. The pharmacokinetics (PK) endpoint, i.e. PK profile of budesonide in plasma, and pharmacodynamics (PD) endpoints, i.e. recording of symptom scores, use of reliever drugs as needed, biomarkers of airway inflammation and pulmonary function tests will be assessed during the study.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	AQ001S 0.125 mg/ml	administered by nebulization once daily
DRUG	Budesonide 0.125 mg/ml inhalation suspension	administered by nebulization once daily

Timeline

• Start date: 2021-07-23
• Primary completion: 2022-12-31
• Completion: 2023-01-31
• First posted: 2021-06-21
• Last updated: 2024-09-03
• Results posted: 2024-09-03

Locations

1 site across 1 country: Belgium