Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00975754 | Lung Deposition Via Different Inhalation Devices | PHASE1 | COMPLETED | 16 | — | — | Sep 1, 2009 | Nov 1, 2009 | Dec 11, 2009 | 1 | Sweden |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Pulmicort pMDI |
| 2 | EXPERIMENTAL | Budesonide pMDI |
| 3 | EXPERIMENTAL | Budesonide pMDI + Aerochamber Zero-stat spacer |
| 4 | EXPERIMENTAL | Pulmicort repulses via Spira Nebuliser |
| 5 | EXPERIMENTAL | Pulmicort Turbohaler |
| Name | Type | Description |
|---|---|---|
| Pulmicort pMDI HFA | DRUG | Inhalation aerosol, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations |
| Budesonide pMDI HFA | DRUG | Inhalation aerosol, 160 μg/ metered dose. Each subject receive a single dose from 4 inhalations |
| Pulmicort Repulses | DRUG | Suspension for nebulisation, 0.5 mg/mL. Each subject receive a single dose from 100 inhalations |
| Pulmicort Turbohaler | DRUG | Inhaled powder, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations |
Inclusion Criteria: * Provision of informed consent prior to any study specific procedures * BMI between 18 and 30 kg/m2 * Non-smokers/non-snuffers Exclusion Criteria: * Pregnant and/or lactating women * Use of oral contraceptives or hormonal implants * Known or suspected hypersensitivity to gluc...