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
Overview
- Phase
- Phase 1
- Intervention
- AQ001S 0.125 mg/ml
- Conditions
- Asthma
- Sponsor
- Aquilon Pharmaceuticals S.A.
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Change From Baseline in PC20 After Each Treatment Period Assessed by Methacholine (MCh) Challenge Test
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body mass index between 18.5 and 29 kg/m
- •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% \[PC20\] \< 8 mg/ml or dose of MCh provoking an FEV1 fall of 20% \[PD20\] \< 0.2 mg) in the last year.
- •Post-bronchodilator FEV1 at least 80% of the predicted, documented in the last year.
- •Clinical laboratory test results, 12-lead electrocardiogram (ECG), blood pressure and heart rate (supine) within normal reference range or judged to be not clinically significant by the Investigator.
- •Female subjects of childbearing potential should have a negative pregnancy test at Screening Visit and use a highly effective method of contraception.
- •Reliable subjects who are willing to be available for the duration of the clinical trial and willing to comply with clinical trial procedures.
- •Subjects who have the ability to understand the requirements of the clinical trial.
- •Subjects who have given written informed consent.
Exclusion Criteria
- •Current smokers or recent (\< 8 weeks) ex-smokers or ex-smokers if \> 10 pack-years.
- •Pregnant or breastfeeding female subjects.
- •Inability to carry out pulmonary function testing.
- •FEV1 \< 70%.
- •History of near-fatal asthma and/or intensive care unit admission for asthma symptoms.
- •Exacerbations of asthma requiring oral steroids, hospitalization or change in asthma treatment in the previous three months.
- •Evidence of symptomatic chronic or acute respiratory infection in the previous 8 weeks.
- •Diagnosis of chronic obstructive pulmonary disease (COPD) or bronchiectasis.
- •Pulmonary malformations, tuberculosis, cystic fibrosis.
- •History of hypersensitivity or existing contraindication to budesonide or any other Investigational Medicinal Product (IMP) ingredients.
Arms & Interventions
budesonide inhalation suspension 0.125 mg/ml
Budesonide 0.125 mg/ml is a budesonide inhalation suspension administered by nebulization once daily.
Intervention: AQ001S 0.125 mg/ml
AQ001S 0.125 mg/ml
AQ001S 0.125 mg/ml is a budesonide inhalation solution administered by nebulization once daily.
Intervention: AQ001S 0.125 mg/ml
AQ001S 0.125 mg/ml
AQ001S 0.125 mg/ml is a budesonide inhalation solution administered by nebulization once daily.
Intervention: Budesonide 0.125 mg/ml inhalation suspension
budesonide inhalation suspension 0.125 mg/ml
Budesonide 0.125 mg/ml is a budesonide inhalation suspension administered by nebulization once daily.
Intervention: Budesonide 0.125 mg/ml inhalation suspension
Outcomes
Primary Outcomes
Change From Baseline in PC20 After Each Treatment Period Assessed by Methacholine (MCh) Challenge Test
Time Frame: visit 1 (baseline) - visit 2 (at the end of Treatment Period 1) and visit 4 (end of Treatment Period 2)
At Visit 1 (baseline), Visit 2 (29-day treatment period 1) and Visit 4 (29-day treatment period 2), a MCh challenge test will be performed, i.e. up to the administration of a concentration of MCh provoking an FEV1 fall of 20% (PC20). FEV1 is measured by spirometry. The change in PC20 from baseline to the end of each period (two periods) was assessed.
Incidence of Treatment-Emergent Adverse Events
Time Frame: Over the treatment period, from the informed consent signature up to the end of second 29-day treatment period
Incidence of Treatment-Emergent Adverse Events as assessed by collection of (Serious) Adverse Events