asthma MedDRA version: 20.0 Level: LLT Classification code 10003555 Term: Asthma bronchial System Organ Class: 100000004855
Conditions
Interventions
16a,17-[(1RS)-butylidenebis(oxy)]-11ß,21-dihydroxypregna-1,4-diene-3,20-dion
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.125-
Trade Name: Nebbu
Sponsors
Aquilon Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged between 18 and 65 years, inclusive. 2. Body mass index = 30 kg/m2. 3. Documented clinical diagnosis of stable, persistent, asthma for at least 3 months, i.e.: • for whom forced expiratory volume in one second (FEV1) = 70% of predicted, and • treated with as-needed reliever medication (short-acting beta2-agonist-containing medication) only. 4. Subjects who are ICS-naïve for minimum 60 days at Screening Visit. 5. Positive methacholine (MCh) challenge test (concentration of MCh provoking an FEV1 fall of 20% [PC20] =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Current smokers or recent ( 10 pack-years. 2. FEV1 470 ms), or any other clinically significant ECG abnormalities as judged by the Investigator based on 12-lead ECG recordings at Screening Visit. 12. Diabetes mellitus. 13. Neuropsychiatric diseases. 14. 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. 15. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the safety of AQ001S 0.125 mg/ml, compare the primary pharmacodynamics, i.e. the bronchoprotection, of AQ001S 0.125 mg/ml with the comparator.;Secondary Objective: To compare 1) the pharmacokinetics and 2) secondary PD/efficacy of AQ001S 0.125 mg/ml with the comparator.;Primary end point(s): Safety: The safety will be evaluated collecting the following information: - Adverse events and serious adverse events, including asthma exacerbations - General tolerability: vital signs, ECG, physical examination - Laboratory parameters: hematology, biochemistry and urinalysis - Local tolerability: o Increased bronchial irritability o Paradoxical bronchospasm o Oropharyngeal examination (e.g. vocal cord myopathy, fungal infection) - Forced expiratory volume at 1 second (FEV1) and forced vital capacity (FVC), measured by spirometry - Assessment of hypothalamic pituitary adrenocortical (HPA) axis function: urinary cortisol/creatinine ratio in first waking urine Pharmacodynamics (PD): Bronchoprotection: Change from baseline in PC20, i.e. the concentration of methacholine provoking an FEV1 fall of 20%, as determined by methacholine challenge test.;Timepoint(s) of evaluation of this end point: Safety: After each treatment period (descriptive comparison with baseline) PD: After each treatment period (change from baseline) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PD/efficacy: The secondary PD/efficacy will be evaluated using the following parameters: - Bronchoprotection and bronchodilation will be investigated by airway volume (av) and lobe volume (lv) measured by functional respiratory imaging (FRI) using computed tomography (CT) scans after Pre-CT scan MCh challenge. - Symptom scores will be recorded using day- and night-time asthma symptom scoring and validated asthma-specific questionnaires (included in trial subject diary). - Use of as-needed reliever medication (as reported in trial subject diary). - Airway inflammation PD biomarkers: fractional concentration of exhaled nitric oxide (FeNO) and blood eosinophil count. - FEV1 and forced inspiratory vital capacity (FIVC), measured by spirometry. Pharmacokinetics (PK): The PK endpoint, i.e. the PK profile of budesonide in plasma, will be evaluated through the following PK parameters, calculated for each treatment period: - Start of treatment period: o single dose 24-hour PK parameters at the time of the first scheduled IMP administration (15 time points): Cmax, tmax, Clast, tlast, AUC0-inf, AUC0-last, AUC0-6h, CL/F, V/F, ?z and t1/2z. - End of treatment period: o single time point PK prior to the penultimate scheduled IMP administration: Cthrough. o abridged PK at the time of the last scheduled IMP administration (7 time points): Cmax, tmax, Clast, tlast, and AUC0-last, AUC0-6h. ;Timepoint(s) of evaluation of this end point: PD/Efficacy: After each treatment period (changes form baseline) PK: as described in PK endpoint | — |
Countries
Belgium
Contacts
Public ContactClinical Operations
Aquilon Pharmaceuticals
Outcome results
None listed