Asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Sponsors
Verus Pharmaceuticals Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age 4 to 8 years, inclusive, at the Screening Visit. 2.History of asthma for greater than 6 months prior to the Screening Visit as confirmed with clinical signs and symptoms. For the purposes of this study, “asthma” is defined by the Global Initiative for Asthma in the GSAMP[7]. 3.For steroid-requiring subjects, the dose of inhaled steroid medication received prior to the Screening Visit must be equal to or less than 1000 mcg/day budesonide or beclomethasone dipropionate or 500 mcg/day fluticasone proprionate. 4.Must otherwise be healthy as judged by general physical examination, medical history and routine clinical laboratory screening. 5.For subjects on inhaled budesonide medication, they must be willing to discontinue or replace treatment with their budesonide-containing medications with alternative medication for at least 5 days prior to the Treatment Visit. 6.Provide written informed consent (parent or legal guardian) and, as appropriate, subject assent. 7.Willing and able to attend scheduled visits and complete the entire study. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.History of life-threatening asthma. This category includes those paediatric subjects with a history of systemic corticosteroid treatment within 3 months of study entry, or near-fatal asthma requiring intubation or a hospitalisation or an Urgent Care Facility visit for asthma in the past year. 2.Current evidence or history of any clinically significant disease or abnormality. “Clinically significant” is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study. 3.History of concomitant lung disease. 4.An upper or lower respiratory tract infection within 4 weeks prior to the Screening Visit. 5.Current evidence of oral candidiasis. 6.Current evidence or history of hypersensitivity or idiosyncratic reaction to inhaled budesonide or any medication. 7.Receipt of an investigational drug within 30 days of the Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the systemic bioavailability of budesonide after single dose treatment with CBIS delivered via eFlow® to conventional budesonide inhalation suspension (Pulmicort Respules?) delivered via a general purpose nebuliser (LC Plus, PARI, Munich, Germany) using standard pharmacokinetic (PK) parameters;Secondary Objective: ? To determine the safety and tolerability of Captisol-Enabled? Budesonide Inhalation Solution (CBIS) delivered via an electronic nebuliser (eFlow?, PARI, Munich, Germany) in asthmatic children 4 to 8 years of age using clinical endpoints (heart rate, blood pressure, pulse oximetry), serum chemistry, physical examination including chest auscultation and adverse events after single dose exposure;Primary end point(s): Safety: vital signs, pulse oximetry, serum chemistry and haematology and the incidence of treatment-emergent AEs Pharmacokinetics: Cmax, tmax, t1/2, AUC0-t, and AUC0-inf. | — |
Countries
United Kingdom
Outcome results
None listed