| Primary | AUClast of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | AUClast is the area under the plasma concentration-time curve, from time 0 to the time of the last measurable concentration (Clast). | Pharmacokinetic set included 13 (76%) subjects. | Posted | | Mean | Standard Deviation | pg*hr/mL | | Pre-dose, and at 20 minutes, 40 minutes, 1.5, 3, 4, 6 and 8 hours after start of nebulization on Day 1 (Visit 2) and Day 8 (Visit 3). | | | | ID | Title | Description |
|---|
| OG000 | A - 5 Breaths VR647 | 5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG001 | B - 10 Breaths VR647 | 10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG002 | C - 20 Breaths VR647 | 20 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG003 | D - Pulmicort | 1 mg/2 mL Pulmicort Respules delivered by the conventional jet nebulizer nebulized to empty 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer: Commercial Pulmicort Respules (budesonide inhalation suspension 1 mg/2 mL) delivered by a conventional jet nebulizer operated to sputtering. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000120.7± 20.498
- OG001327.5± 119.49
- OG002759.5± 311.79
- OG003
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | | | | | Geometric mean ratio (%) | 8.69 | | | 2-Sided | | | | | | | | Other | | The intra-subject coefficient of variation was 25.33%. | | | |
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| Primary | AUCinf of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | AUCinf is the area under the plasma concentration-time curve, from time 0 extrapolated to infinity. AUCinf is calculated as the sum of AUClast plus the ratio of the last measurable plasma concentration (Clast) to the elimination rate constant (λz). | Pharmacokinetic set included 13 (76%) subjects. | Posted | | Mean | Standard Deviation | pg*hr/mL | | Pre-dose, and at 20 minutes, 40 minutes, 1.5, 3, 4, 6 and 8 hours after start of nebulization on Day 1 (Visit 2) and Day 8 (Visit 3). | | | | ID | Title | Description |
|---|
| OG000 | A - 5 Breaths VR647 | 5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG001 | B - 10 Breaths VR647 | 10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. |
|
| Primary | Cmax of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | Cmax is the maximum observed concentration. | Pharmacokinetic set included 13 (76%) subjects. | Posted | | Mean | Standard Deviation | pg/mL | | Pre-dose, and at 20 minutes, 40 minutes, 1.5, 3, 4, 6 and 8 hours after start of nebulization on Day 1 (Visit 2) and Day 8 (Visit 3). | | | | ID | Title | Description |
|---|
| OG000 | A - 5 Breaths VR647 | 5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG001 | B - 10 Breaths VR647 | 10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG002 | C - 20 Breaths VR647 |
|
| Primary | Tmax of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | Tmax is the time to reach Cmax. | Pharmacokinetic set included 13 (76%) subjects. | Posted | | Median | Full Range | hours | | Pre-dose, and at 20 minutes, 40 minutes, 1.5, 3, 4, 6 and 8 hours after start of nebulization on Day 1 (Visit 2) and Day 8 (Visit 3). | | | | ID | Title | Description |
|---|
| OG000 | A - 5 Breaths VR647 | 5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG001 | B - 10 Breaths VR647 | 10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG002 | C - 20 Breaths VR647 |
|
| Primary | Tlast of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | Tlast is the time of the last measurable concentration (Clast). | Pharmacokinetic set included 13 (76%) subjects. | Posted | | Mean | Standard Deviation | hours | | Pre-dose, and at 20 minutes, 40 minutes, 1.5, 3, 4, 6 and 8 hours after start of nebulization on Day 1 (Visit 2) and Day 8 (Visit 3). | | | | ID | Title | Description |
|---|
| OG000 | A - 5 Breaths VR647 | 5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG001 | B - 10 Breaths VR647 | 10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG002 | C - 20 Breaths VR647 |
|
| Primary | T1/2 of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | T1/2 is the apparent first-order terminal elimination half-life. | Pharmacokinetic set included 13 (76%) subjects. | Posted | | Mean | Standard Deviation | hours | | Pre-dose, and at 20 minutes, 40 minutes, 1.5, 3, 4, 6 and 8 hours after start of nebulization on Day 1 (Visit 2) and Day 8 (Visit 3). | | | | ID | Title | Description |
|---|
| OG000 | A - 5 Breaths VR647 | 5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG001 | B - 10 Breaths VR647 | 10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG002 | C - 20 Breaths VR647 |
|
| Secondary | Mean Modified Patient Satisfaction and Preference Questionnaire (PASAPQ) Total Score (Q1 to Q8). | The PASAPQ is a validated multi-item measure of satisfaction and preference with inhaler devices. The modified PASAPQ consists of 10 questions. The first 8 questions generate the total score domain. Data from this questionnaire were listed by subject and summarized by treatment. The results from Questions 1 through 8 were added for each subject to generate the Total Score (n = Q1+Q2+Q3+Q4+Q5+Q6+Q7+Q8) and expressed as percentage of maximum total score (i.e., (n/56)*100). Questions 1 to 8 were answered using scores from 1 (i.e., very dissatisfied) to 7 (i.e., very satisfied). | Safety set included 15 (88%) subjects who received at least one dose of study treatment. | Posted | | Mean | Standard Deviation | percentage of maximum total score | | Following dosing on Day 1 (Visit 2) and Day 8 (Visit 3). | | | | ID | Title | Description |
|---|
| OG000 | A - 5 Breaths VR647 | 5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG001 | B - 10 Breaths VR647 | 10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. |
|
| Secondary | Mean Modified PASAPQ Performance Score | The PASAPQ is a validated multi-item measure of satisfaction and preference with inhaler devices; it was originally a 15-item questionnaire, with performance assessed over 7 items. The modified PASAPQ (mPASAPQ) has 10 questions, including only 4 from the performance domain; the 3 questions not included were dropped from the mPASAPQ as they were not applicable to patient population and device under study. Questions 1, 2, 6, and 7 were assessed, covering satisfaction with nebulizer reliability, ease of inhalation, use and treatment time. Although specified in the protocol, the mPASAPQ performance score was not summarized in the efficacy analysis. The results for each question are presented below, however it was not considered appropriate to analyze the performance domain, as it is not possible to verify the validity of the questionnaire utilising only 4 of the original 7 questions. Questions were answered using scores from 1 (i.e., very dissatisfied) to 7 (i.e., very satisfied). | Although specified in the protocol, mPASAPQ performance score wasn't summarized in the efficacy analysis as 3 questions were dropped from the PASAPQ that were not applicable. This change from the protocol-planned analysis was described in the SAP, finalized before DB lock. Individual scores for the 4 remaining performance questions are presented. | Posted | | Mean | Standard Deviation | scores on a scale | | Following dosing on Day 1 (Visit 2) and Day 8 (Visit 3). | | | | ID | Title | Description |
|---|
| OG000 | A - 5 Breaths VR647 | 5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. |
|
| Secondary | Mean Modified PASAPQ Satisfaction Score (Q9). | The PASAPQ is a validated multi-item measure of satisfaction and preference with inhaler devices. The modified PASAPQ consists of 10 questions. Question 9 asks for overall satisfaction with the device(s) used in the trial. Question 9 was answered using scores from 1 (i.e., very dissatisfied) to 7 (i.e., very satisfied). | Safety set included 15 (88%) subjects who received at least one dose of study treatment. | Posted | | Mean | Standard Deviation | scores on a scale | | Following dosing on Day 1 (Visit 2) and Day 8 (Visit 3). | | | | ID | Title | Description |
|---|
| OG000 | A - 5 Breaths VR647 | 5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG001 | B - 10 Breaths VR647 | 10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. |
|
| Secondary | Mean Modified PASAPQ Score Indicating Willingness to Continue With the Device (Q10). | The PASAPQ is a validated multi-item measure of satisfaction and preference with inhaler devices. The modified PASAPQ consists of 10 questions. Question 10 asks about willingness to continue with the device(s) used in the trial. Parents/legal guardians were asked to indicate how willing they would be for their child to use the nebulizer used during the study, providing a number between 0 (unwilling) and 100 (willing). | Safety set included 15 (88%) subjects who received at least one dose of study treatment. | Posted | | Mean | Standard Deviation | scores on a scale | | Following dosing on Day 1 (Visit 2) and Day 8 (Visit 3). | | | | ID | Title | Description |
|---|
| OG000 | A - 5 Breaths VR647 | 5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG001 | B - 10 Breaths VR647 | 10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. |
|
| Secondary | Changes in Vital Signs (Blood Pressure) | Mean values for blood pressure from pre-dose to 0.5 hours post-dose. | | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Day 1 0.5 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | A - 5 Breaths VR647 | 5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG001 | B - 10 Breaths VR647 | 10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG002 | C - 20 Breaths VR647 | 20 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. |
|
| Secondary | Changes in Vital Signs (Heart Rate) | Mean values for heart rate from pre-dose to 0.5 hours post-dose. | | Posted | | Mean | Standard Deviation | change in beats per minute | | Baseline to Day 1 0.5 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | A - 5 Breaths VR647 | 5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG001 | B - 10 Breaths VR647 | 10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG002 | C - 20 Breaths VR647 | 20 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. |
|
| Secondary | Changes in Vital Signs (Respiration Rate) | Mean values for respiratory rate from pre-dose to 0.5 hours post-dose. | | Posted | | Mean | Standard Deviation | Change in breaths per minute | | Baseline to Day 1 0.5 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | A - 5 Breaths VR647 | 5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG001 | B - 10 Breaths VR647 | 10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG002 | C - 20 Breaths VR647 | 20 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. |
|
| Secondary | Changes in Vital Signs (Temperature) | Mean values for temperature from pre-dose to 0.5 hours post-dose. | | Posted | | Mean | Standard Deviation | Change in degrees Celsius | | Baseline to Day 1 0.5 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | A - 5 Breaths VR647 | 5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG001 | B - 10 Breaths VR647 | 10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG002 | C - 20 Breaths VR647 | 20 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. |
|
| Secondary | Changes in Physical Examination | Physical examination data were listed. The number of participants with a change in physical examination status (i.e. from normal to abnormal, or from abnormal to normal) is presented below. | | Posted | | Count of Participants | | Participants | | Visit 1, and Day 8 of Visit 3. | | | | ID | Title | Description |
|---|
| OG000 | A - 5 Breaths VR647 | 5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG001 | B - 10 Breaths VR647 | 10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG002 | C - 20 Breaths VR647 | 20 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. |
|
| Secondary | Use of Concomitant Medications | Number of subjects using concomitant medications. | | Posted | | Count of Participants | | Participants | | Visit 1 | | | | ID | Title | Description |
|---|
| OG000 | A - 5 Breaths VR647 | 5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG001 | B - 10 Breaths VR647 | 10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. | | OG002 | C - 20 Breaths VR647 | 20 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial. |
|