Phase 2
Completed N=23
Crossover Trial to Assess Efficacy and Safety of Inhaled AQ001S Compared to a Budesonide Suspension in Mild Asthmatics
Source: ClinicalTrials.gov NCT04933383 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Change From Baseline in PC20 After Each Treatment Period Assessed by Methacholine (MCh) Challenge Test — 3.7; 1.2 mg/mL — p=0.000813
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in PC20 After Each Treatment Period Assessed by Methacholine (MCh) Challenge Test |
3.7; 1.2 | 0.000813 sig |
| PRIMARY Incidence of Treatment-Emergent Adverse Events |
0; 0; 0; 0; 3; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Body mass index between 18.5 and 29 kg/m2.
- Documented clinical diagnosis of stable, persistent, asthma for at least 3 months
- Subjects who are ICS-naïve for minimum 60 days at Screening Visit.
- Positive methacholine (MCh) challenge test (concentration of MCh provoking an FEV1 fall of 20% [PC20] 10 pack-years.
- Pregnant or breastfeeding female subjects.
- Inability to carry out pulmonary function testing.
- FEV1 470 ms), or any other clinically significant ECG abnormalities as judged by the Investigator based on 12-lead ECG recordings at Screening Visit.
- Diabetes mellitus.
- Neuropsychiatric diseases.
- Clinically relevant laboratory abnormalities at Screening Visit.
- Blood or plasma donation within 30 days prior to Screening Visit.
- History or presence of malignancy of any system organ class (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years prior to Screening Visit, regardless of whether there is evidence of local recurrence or metastases.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the clinical trial.
- History or presence of any other clinically relevant disease of any major system organ class (e.g. cardiovascular, pulmonary, renal, hepatic, gastrointestinal, reproductive, endocrinological, neurological, psychiatric or orthopedic disease) as judged by the Investigator.
- Human immunodeficiency virus (HIV) and severe acute respiratory syndrome (SARS)-CoV-2 infections.
- Subjects who participated in an investigational trial within the 12 weeks prior to the start of the trial.
Data sourced from ClinicalTrials.gov (NCT04933383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.