MedTrace Logo

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

NCT04933383 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-09-03

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

AQ001S 0.125 mg/ml

administered by nebulization once daily

DRUG

Budesonide 0.125 mg/ml inhalation suspension

administered by nebulization once daily

Sponsors & Collaborators

  • Aquilon Pharmaceuticals S.A.

    lead INDUSTRY

Principal Investigators

  • Jean-Benoît Martinot · Pneumocare SPRL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04933383 on ClinicalTrials.gov