Trial · NCT03421730
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | AUClast of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | 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). | Pharmacokinetic set included 13 (76%) subjects. | pg*hr/mL | MEAN |
| PRIMARY | AUCinf of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | 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). | Pharmacokinetic set included 13 (76%) subjects. | pg*hr/mL | MEAN |
| PRIMARY | Cmax of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | 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). | Pharmacokinetic set included 13 (76%) subjects. | pg/mL | MEAN |
| PRIMARY | Tmax of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | 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). | Pharmacokinetic set included 13 (76%) subjects. | hours | MEDIAN |
| PRIMARY | Tlast of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | 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). | Pharmacokinetic set included 13 (76%) subjects. | hours | MEAN |
| PRIMARY | T1/2 of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | 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). | Pharmacokinetic set included 13 (76%) subjects. | hours | MEAN |
| SECONDARY | Mean Modified Patient Satisfaction and Preference Questionnaire (PASAPQ) Total Score (Q1 to Q8). | Following dosing on Day 1 (Visit 2) and Day 8 (Visit 3). | Safety set included 15 (88%) subjects who received at least one dose of study treatment. | percentage of maximum total score | MEAN |
| SECONDARY | Mean Modified PASAPQ Performance Score | Following dosing on Day 1 (Visit 2) and Day 8 (Visit 3). | 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. | scores on a scale | MEAN |
| SECONDARY | Mean Modified PASAPQ Satisfaction Score (Q9). | Following dosing on Day 1 (Visit 2) and Day 8 (Visit 3). | Safety set included 15 (88%) subjects who received at least one dose of study treatment. | scores on a scale | MEAN |
| SECONDARY | Mean Modified PASAPQ Score Indicating Willingness to Continue With the Device (Q10). | Following dosing on Day 1 (Visit 2) and Day 8 (Visit 3). | Safety set included 15 (88%) subjects who received at least one dose of study treatment. | scores on a scale | MEAN |
| SECONDARY | Changes in Vital Signs (Blood Pressure) | Baseline to Day 1 0.5 hours post-dose | mm Hg | MEAN | |
| SECONDARY | Changes in Vital Signs (Heart Rate) | Baseline to Day 1 0.5 hours post-dose | change in beats per minute | MEAN | |
| SECONDARY | Changes in Vital Signs (Respiration Rate) | Baseline to Day 1 0.5 hours post-dose | Change in breaths per minute | MEAN | |
| SECONDARY | Changes in Vital Signs (Temperature) | Baseline to Day 1 0.5 hours post-dose | Change in degrees Celsius | MEAN | |
| SECONDARY | Changes in Physical Examination | Visit 1, and Day 8 of Visit 3. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Use of Concomitant Medications | Visit 1 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03421730/outcomes