Asthma MedDRA version: 8.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Sponsors
Verus Pharmaceuticals Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age 16 to 60 years, inclusive, at the Screening Visit. 2.Male or female (neither pregnant nor lactating). All female subjects must have a negative urine pregnancy test immediately prior to entry into the study and must be using an acceptable means of birth control. 3.History of asthma for greater than or equivalent to 6 months prior to the Screening Visit as confirmed with clinical signs and symptoms. 4.For steroid-requiring subjects, the dose of inhaled steroid medication received prior to the Screening Visit must be less than or equal to 1000 mcg/day beclomethasone dipropionate or equivalent. 5.History of FEV1 of > 60% of predicted normal values following appropriate withholding of inhaled beta-agonist and corticosteroid medication. Predicted FEV1 will be obtained by using the normal prediction equations of ERS 6.Airway responsiveness to methacholine demonstrated by a provocation concentration causing 10% decrease in FEV1 (PC10) =65 years) 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 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. If more than 12 puffs of salbutamol, per day, are used. 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 determine the safety and tolerability of Captisol-Enabled Budesonide Inhalation Solution (CBIS) delivered via an electronic nebuliser (eFlow, PARI, Munich, Germany) in asthmatic adults 16-60 years of age using clinical endpoints (heart rate, blood pressure), 12-hour overnight urinary cortisol, and adverse events after 2 weeks exposure. ;Secondary Objective: To compare the efficacy of CBIS delivered via eFlow to conventional budesonide inhalation suspension (Pulmicort Respules) delivered via a general purpose nebuliser (LC Plus, PARI, Munich, Germany) using methacholine (MCH) challenge test, fractional exhaled nitric oxide (FeNO), clinical asthma symptoms and pulmonary function tests after twice daily treatments for 2 weeks.;Primary end point(s): Safety: The primary safety outcome is change in overnight urinary cortisol from baseline. The other safety variables will include the changes in vital signs, physical examination findings, and the incidence of treatment-emergent AEs during the Treatment Period. Efficacy: The primary efficacy outcome is change in PC10 from baseline (pooled value of post-Run-in and post-Washout Period values), following methacholine challenge. The other efficacy variables will include the changes in asthma symptom scores, pulmonary function tests, and airway and alveolar nitric oxide (FeNO). | — |
Countries
United Kingdom
Outcome results
None listed