Trial · NCT03421730
A Study of the Pharmacokinetics, Safety and Tolerability of Single Doses of VR647 Inhalation Suspension Administered Using the VR647 Inhalation System in Children With Wheezing, Reactive Airway Disease or Mild Asthma
NCT03421730, Phase 1, Completed, Vectura Limited; results first posted 2019-10-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Pharmacokinetics, Safety and Tolerability of Single Doses of VR647 Inhalation Suspension Administered Using the VR647 Inhalation System in Children With Wheezing, Reactive Airway Disease or Mild Asthma. Trials, record NCT03421730. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03421730
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of the Pharmacokinetics, Safety and Tolerability of Single Doses of VR647 Inhalation Suspension Administered Using the VR647 Inhalation System in Children With Wheezing, Reactive Airway Disease or Mild Asthma
- NCT number
- NCT03421730
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 17 participants, actual
- Lead sponsor
- Vectura Limited
- Conditions
- Wheezing, Reactive Airway Disease, Mild Asthma
- Interventions
- VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System, 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer
- First posted
- 2018-02-05
- Last updated
- 2019-10-21
- Results first posted
- 2019-10-21
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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). | AUClast is the area under the plasma concentration-time curve, from time 0 to the time of the last measurable concentration (Clast). |
| 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). | 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). |
| 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). | Cmax is the maximum observed concentration. |
| 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). | Tmax is the time to reach Cmax. |
| 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). | Tlast is the time of the last measurable concentration (Clast). |
| 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). | T1/2 is the apparent first-order terminal elimination half-life. |
| 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). | 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). |
| Secondary | Mean Modified PASAPQ Performance Score | Following dosing on Day 1 (Visit 2) and Day 8 (Visit 3). | 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). |
| Secondary | Mean Modified PASAPQ Satisfaction Score (Q9). | Following dosing on Day 1 (Visit 2) and Day 8 (Visit 3). | 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). |
| 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). | 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). |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| AUClast of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | A - 5 Breaths VR647 | 120.7 | Standard Deviation 20.498 | pg*hr/mL | |
| AUClast of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | B - 10 Breaths VR647 | 327.5 | Standard Deviation 119.49 | pg*hr/mL | |
| AUClast of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | C - 20 Breaths VR647 | 759.5 | Standard Deviation 311.79 | pg*hr/mL | |
| AUClast of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | D - Pulmicort | 1357 | Standard Deviation 564.06 | pg*hr/mL | |
| AUCinf of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | A - 5 Breaths VR647 | 138.3 | Standard Deviation 25.189 | pg*hr/mL | |
| AUCinf of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | B - 10 Breaths VR647 | 326.2 | Standard Deviation 116.09 | pg*hr/mL | |
| AUCinf of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | C - 20 Breaths VR647 | 737.1 | Standard Deviation 313.27 | pg*hr/mL | |
| AUCinf of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | D - Pulmicort | 1492 | Standard Deviation 707.99 | pg*hr/mL | |
| Cmax of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | A - 5 Breaths VR647 | 71.25 | Standard Deviation 9.5776 | pg/mL | |
| Cmax of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | B - 10 Breaths VR647 | 179.7 | Standard Deviation 79.442 | pg/mL |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow108
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (Day 1, Visit 2) | STARTED | AB - VR647 5 Breaths, Then VR647 10 Breaths | 1 | |
| First Intervention (Day 1, Visit 2) | STARTED | AC - VR647 5 Breaths, Then VR647 20 Breaths | 3 | |
| First Intervention (Day 1, Visit 2) | STARTED | AD - VR647 5 Breaths, Then Pulmicort | 1 | |
| First Intervention (Day 1, Visit 2) | STARTED | BA - VR647 10 Breaths, Then VR647 5 Breaths | 1 | |
| First Intervention (Day 1, Visit 2) | STARTED | BC - VR647 10 Breaths, Then VR647 20 Breaths | 3 | |
| First Intervention (Day 1, Visit 2) | STARTED | BD - VR647 10 Breaths, Then Pulmicort | 1 | |
| First Intervention (Day 1, Visit 2) | STARTED | CA - VR647 20 Breaths, Then VR647 5 Breaths | 1 | |
| First Intervention (Day 1, Visit 2) | STARTED | CB - VR647 20 Breaths, Then VR647 10 Breaths | 1 | |
| First Intervention (Day 1, Visit 2) | STARTED | CD - VR647 20 Breaths, Then Pulmicort | 1 | |
| First Intervention (Day 1, Visit 2) | STARTED | DA - Pulmicort, Then VR647 5 Breaths | 2 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 participant flowAdverse events15
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | A - 5 Breaths VR647 | 1 | 7 | 1 |
| other | Nausea | Gastrointestinal disorders | B - 10 Breaths VR647 | 0 | 8 | 0 |
| other | Nausea | Gastrointestinal disorders | C - 20 Breaths VR647 | 0 | 6 | 0 |
| other | Nausea | Gastrointestinal disorders | D - Pulmicort | 0 | 7 | 0 |
| other | Nausea | Gastrointestinal disorders | Overall Treatment | 1 | 15 | 1 |
| other | Vomiting | Gastrointestinal disorders | A - 5 Breaths VR647 | 1 | 7 | 1 |
| other | Vomiting | Gastrointestinal disorders | B - 10 Breaths VR647 | 0 | 8 | 0 |
| other | Vomiting | Gastrointestinal disorders | C - 20 Breaths VR647 | 0 | 6 | 0 |
| other | Vomiting | Gastrointestinal disorders | D - Pulmicort | 0 | 7 | 0 |
| other | Vomiting | Gastrointestinal disorders | Overall Treatment | 1 | 15 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A - 5 Breaths VR647 | 0 | 7 |
| Total, all-cause mortality | B - 10 Breaths VR647 | 0 | 8 |
| Total, all-cause mortality | C - 20 Breaths VR647 | 0 | 6 |
| Total, all-cause mortality | D - Pulmicort | 0 | 7 |
| Total, all-cause mortality | Overall Treatment | 0 | 15 |
| Total, other adverse events | A - 5 Breaths VR647 | 1 | 7 |
| Total, other adverse events | B - 10 Breaths VR647 | 1 | 8 |
| Total, other adverse events | C - 20 Breaths VR647 | 1 | 6 |
| Total, other adverse events | D - Pulmicort | 0 | 7 |
| Total, other adverse events | Overall Treatment | 2 | 15 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
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Read this trial from software.
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