A Phase 1 interventional study of VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System and 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer in Wheezing, Reactive Airway Disease and Mild Asthma, sponsored by Vectura Limited. Completed at 3 sites in United States. Open to participants aged 4 Years to 8 Years. Per ClinicalTrials.gov, last updated 2019-10-21.
Sponsored by Vectura Limited · Phase 1, Interventional, and Treatment
Among 68 studies in Respiratory Sounds with a site in United States — 9 open to participants now, 12 under way, 1 of them phase 3. Respiratory Sounds · United States.
Among the 68 studies in Respiratory Sounds with a site in United States, this one is the 35th largest by enrollment of the 39 interventional ones that give a count, is one of 6 that started in 2017, is one of 2 in phase 1, and was the 44th registered.
189 studies on the registry are indexed under Respiratory Sounds; 41 are open to participants now.
Browse Respiratory Sounds studies →9 of the 68 studies in Respiratory Sounds with a site in United States are open now. Recruiting first, the newest first:
Eko Devices, Inc. · Sites in United States
Pfizer · Sites in United States, Argentina, Belgium and 12 more countries
Ages 18–75
Rajesh Kumar · Sites in United States
Ages 2 mo–12 mo · Healthy volunteers
Northwell Health · Sites in United States
Ages 1 days–18 yrs
Oregon Health and Science University · Sites in United States
Ages 6–16
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 31 Respiratory Sounds studies recruiting now, 6 (19%) set no upper age limit and 24 (77%) stop at 75 or younger; 21 take children under 18; 11 take healthy volunteers.
This study: 4 Years to 8 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
68 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 16 · Phase 3 7 · Phase 4 4
First in 2000; this study’s year is marked. 6 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 17 is below the median of 120 across 98 interventional studies indexed under Respiratory Sounds.
Median enrollment 140 across the 39 interventional studies, 150 across the 29 observational. Of the 51 that completed or were terminated, 17 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
26 of 68 have an industry lead sponsor. The 10 most frequent:
Vectura Limited is the lead sponsor of 6 studies on the registry; none are open to participants now.
Vectura Limited has 2 studies filed under Respiratory Sounds — fewer than ten, so there is no comparison to draw.
5 of the studies in Respiratory Sounds with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06691971Aevice Health Pte. Ltd.AeviceMD for Detection of Wheeze in Pediatric and Adult Populations | 2026-12 |
| NCT06977581PfizerA Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma | 2027-03-08 |
| NCT07227376Eko Devices, Inc.Data Collection Using Eko Digital Devices in a Clinical Setting | 2027-04-01 |
| NCT05210361University of Colorado, DenverCritical Windows in the Development of Asthma Endotypes and Phenotypes in High-Risk Toddlers | 2027-07 |
| NCT06106646Oregon Health and Science UniversityVitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term Follow Up | 2027-08 |
Add all 5 to your calendar (.ics) → With an account.
Among the 68 studies in Respiratory Sounds with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary objective of this study is to evaluate budesonide levels in the blood following inhalation of single doses of VR647 Inhalation Suspension in children with wheezing, reactive airway disease or mild asthma using a nebulizer, the VR647 Inhalation System. Secondary objectives include the evaluation of the safety and tolerability of VR647 Inhalation Suspension administered using the VR647 Inhalation System.
The study consists of four visits; a screening visit (Visit 1), two dosing days (Visits 2 and 3) and a follow-up visit (Visit 4). On each dosing day a single dose of treatment will be administered. Treatment allocation at Visits 2 and 3 is determined by a balanced incomplete block design.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System followed by 10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System
Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System
5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System followed by 20 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System
Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System
5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System followed by 1 mg/2 mL Pulmicort Respules delivered by the conventional jet nebulizer nebulized to empty
Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System · Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer
10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System followed by 5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System
Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System
10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System followed by 20 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System
Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System
10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System followed by 1 mg/2 mL Pulmicort Respules delivered by the conventional jet nebulizer nebulized to empty
Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System · Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer
20 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System followed by 5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System
Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System
20 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System followed by 10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System
Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System
20 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System followed by 1 mg/2 mL Pulmicort Respules delivered by the conventional jet nebulizer nebulized to empty
Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System · Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer
1 mg/2 mL Pulmicort Respules delivered by the conventional jet nebulizer nebulized to empty followed by 5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System
Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System · Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer
1 mg/2 mL Pulmicort Respules delivered by the conventional jet nebulizer nebulized to empty followed by 10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System
Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System · Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer
1 mg/2 mL Pulmicort Respules delivered by the conventional jet nebulizer nebulized to empty followed by 20 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System
Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System · Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer
Drug page: Budesonide
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.
Commercial Pulmicort Respules (budesonide inhalation suspension 1 mg/2 mL) delivered by a conventional jet nebulizer operated to sputtering.
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).
Time frame: 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 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).
Time frame: 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 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.
Time frame: 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 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.
Time frame: 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 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).
Time frame: 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 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.
Time frame: 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).
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).
Time frame: Following dosing on Day 1 (Visit 2) and Day 8 (Visit 3).
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).
Time frame: Following dosing on Day 1 (Visit 2) and Day 8 (Visit 3).
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).
Time frame: Following dosing on Day 1 (Visit 2) and Day 8 (Visit 3).
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).
Time frame: Following dosing on Day 1 (Visit 2) and Day 8 (Visit 3).
Changes in Vital Signs (Blood Pressure)
Mean values for blood pressure from pre-dose to 0.5 hours post-dose.
Time frame: Baseline to Day 1 0.5 hours post-dose
Changes in Vital Signs (Heart Rate)
Mean values for heart rate from pre-dose to 0.5 hours post-dose.
Time frame: Baseline to Day 1 0.5 hours post-dose
Changes in Vital Signs (Respiration Rate)
Mean values for respiratory rate from pre-dose to 0.5 hours post-dose.
Time frame: Baseline to Day 1 0.5 hours post-dose
Changes in Vital Signs (Temperature)
Mean values for temperature from pre-dose to 0.5 hours post-dose.
Time frame: Baseline to Day 1 0.5 hours post-dose
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.
Time frame: Visit 1, and Day 8 of Visit 3.
Use of Concomitant Medications
Number of subjects using concomitant medications.
Time frame: Visit 1
| Milestone | AB - VR647 5 Breaths, Then VR647 10 Breaths | AC - VR647 5 Breaths, Then VR647 20 Breaths | AD - VR647 5 Breaths, Then Pulmicort | BA - VR647 10 Breaths, Then VR647 5 Breaths | BC - VR647 10 Breaths, Then VR647 20 Breaths | BD - VR647 10 Breaths, Then Pulmicort | CA - VR647 20 Breaths, Then VR647 5 Breaths | CB - VR647 20 Breaths, Then VR647 10 Breaths | CD - VR647 20 Breaths, Then Pulmicort | DA - Pulmicort, Then VR647 5 Breaths | DB - Pulmicort, Then VR647 10 Breaths | DC - Pulmicort, Then VR647 20 Breaths |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 1 | 3 | 1 | 1 | 3 | 1 | 1 | 1 | 1 | 2 | 1 | 1 |
| Completed | 1 | 1 | 1 | 1 | 3 | 1 | 1 | 1 | 1 | 2 | 1 | 1 |
| Not completed | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject or legal guardian | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | AB - VR647 5 Breaths, Then VR647 10 Breaths | AC - VR647 5 Breaths, Then VR647 20 Breaths | AD - VR647 5 Breaths, Then Pulmicort | BA - VR647 10 Breaths, Then VR647 5 Breaths | BC - VR647 10 Breaths, Then VR647 20 Breaths | BD - VR647 10 Breaths, Then Pulmicort | CA - VR647 20 Breaths, Then VR647 5 Breaths | CB - VR647 20 Breaths, Then VR647 10 Breaths | CD - VR647 20 Breaths, Then Pulmicort | DA - Pulmicort, Then VR647 5 Breaths | DB - Pulmicort, Then VR647 10 Breaths | DC - Pulmicort, Then VR647 20 Breaths |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 1 | 1 | 1 | 1 | 3 | 1 | 1 | 1 | 1 | 2 | 1 | 1 |
| Completed | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 1 |
| Not completed | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject or legal guardian | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | AB - VR647 5 Breaths, Then VR647 10 Breaths | AC - VR647 5 Breaths, Then VR647 20 Breaths | AD - VR647 5 Breaths, Then Pulmicort | BA - VR647 10 Breaths, Then VR647 5 Breaths | BC - VR647 10 Breaths, Then VR647 20 Breaths | BD - VR647 10 Breaths, Then Pulmicort | CA - VR647 20 Breaths, Then VR647 5 Breaths | CB - VR647 20 Breaths, Then VR647 10 Breaths | CD - VR647 20 Breaths, Then Pulmicort | DA - Pulmicort, Then VR647 5 Breaths | DB - Pulmicort, Then VR647 10 Breaths | DC - Pulmicort, Then VR647 20 Breaths |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 1 |
| Completed | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 1 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
AUClast is the area under the plasma concentration-time curve, from time 0 to the time of the last measurable concentration (Clast).
| pg*hr/mL | A - 5 Breaths VR647 | B - 10 Breaths VR647 | C - 20 Breaths VR647 | D - Pulmicort |
|---|---|---|---|---|
| AUClast of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | 120.7 ± 20.498 | 327.5 ± 119.49 | 759.5 ± 311.79 | 1357 ± 564.06 |
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).
| pg*hr/mL | A - 5 Breaths VR647 | B - 10 Breaths VR647 | C - 20 Breaths VR647 | D - Pulmicort |
|---|---|---|---|---|
| AUCinf of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | 138.3 ± 25.189 | 326.2 ± 116.09 | 737.1 ± 313.27 | 1492 ± 707.99 |
Cmax is the maximum observed concentration.
| pg/mL | A - 5 Breaths VR647 | B - 10 Breaths VR647 | C - 20 Breaths VR647 | D - Pulmicort |
|---|---|---|---|---|
| Cmax of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | 71.25 ± 9.5776 | 179.7 ± 79.442 | 390.3 ± 178.07 | 601.8 ± 405.32 |
Tmax is the time to reach Cmax.
| hours | A - 5 Breaths VR647 | B - 10 Breaths VR647 | C - 20 Breaths VR647 | D - Pulmicort |
|---|---|---|---|---|
| Tmax of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | 0.3330 (0.317 to 0.367) | 0.3330 (0.317 to 0.350) | 0.3500 (0.300 to 0.700) | 0.3330 (0.333 to 0.367) |
Tlast is the time of the last measurable concentration (Clast).
| hours | A - 5 Breaths VR647 | B - 10 Breaths VR647 | C - 20 Breaths VR647 | D - Pulmicort |
|---|---|---|---|---|
| Tlast of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | 5.325 ± 1.6331 | 7.386 ± 0.9539 | 7.620 ± 0.7962 | 7.937 ± 0.0447 |
T1/2 is the apparent first-order terminal elimination half-life.
| hours | A - 5 Breaths VR647 | B - 10 Breaths VR647 | C - 20 Breaths VR647 | D - Pulmicort |
|---|---|---|---|---|
| T1/2 of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer). | 1.703 ± 0.7005 | 1.991 ± 0.3587 | 2.059 ± 0.5895 | 2.200 ± 0.3300 |
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).
| percentage of maximum total score | A - 5 Breaths VR647 | B - 10 Breaths VR647 | C - 20 Breaths VR647 | D - Pulmicort |
|---|---|---|---|---|
| Mean Modified Patient Satisfaction and Preference Questionnaire (PASAPQ) Total Score (Q1 to Q8). | 97.7 ± 3.95 | 95.8 ± 7.23 | 97.5 ± 3.56 | 88.6 ± 8.28 |
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).
| scores on a scale | A - 5 Breaths VR647 | B - 10 Breaths VR647 | C - 20 Breaths VR647 | D - Pulmicort |
|---|---|---|---|---|
| Question 1 | 6.9 ± 0.38 | 6.6 ± 0.52 | 6.3 ± 0.82 | 6.4 ± 0.53 |
| Question 2 | 6.9 ± 0.38 | 6.5 ± 0.76 | 7.0 ± 0.00 | 6.0 ± 1.15 |
| Question 6 | 6.7 ± 0.49 | 6.6 ± 0.52 | 6.8 ± 0.41 | 6.1 ± 1.07 |
| Question 7 | 7.0 ± 0.00 | 6.8 ± 0.71 | 7.0 ± 0.00 | 5.3 ± 1.60 |
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).
| scores on a scale | A - 5 Breaths VR647 | B - 10 Breaths VR647 | C - 20 Breaths VR647 | D - Pulmicort |
|---|---|---|---|---|
| Mean Modified PASAPQ Satisfaction Score (Q9). | 6.9 ± 0.38 | 6.6 ± 0.74 | 6.8 ± 0.41 | 5.7 ± 0.95 |
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).
| scores on a scale | A - 5 Breaths VR647 | B - 10 Breaths VR647 | C - 20 Breaths VR647 | D - Pulmicort |
|---|---|---|---|---|
| Mean Modified PASAPQ Score Indicating Willingness to Continue With the Device (Q10). | 98.6 ± 3.78 | 93.5 ± 11.75 | 98.3 ± 4.08 | 77.3 ± 22.10 |
Mean values for blood pressure from pre-dose to 0.5 hours post-dose.
| mm Hg | A - 5 Breaths VR647 | B - 10 Breaths VR647 | C - 20 Breaths VR647 | D - Pulmicort |
|---|---|---|---|---|
| Change in systolic blood pressure | -8.4 ± 8.40 | 9.0 ± 5.35 | 0.8 ± 4.67 | 4.4 ± 5.19 |
| Change in diastolic blood pressure | -7.4 ± 13.60 | 2.1 ± 7.30 | -6.3 ± 12.93 | 1.9 ± 9.51 |
Mean values for heart rate from pre-dose to 0.5 hours post-dose.
| change in beats per minute | A - 5 Breaths VR647 | B - 10 Breaths VR647 | C - 20 Breaths VR647 | D - Pulmicort |
|---|---|---|---|---|
| Changes in Vital Signs (Heart Rate) | 6.6 ± 9.86 | 2.6 ± 13.18 | 4.0 ± 11.30 | -2.6 ± 17.09 |
Mean values for respiratory rate from pre-dose to 0.5 hours post-dose.
| Change in breaths per minute | A - 5 Breaths VR647 | B - 10 Breaths VR647 | C - 20 Breaths VR647 | D - Pulmicort |
|---|---|---|---|---|
| Changes in Vital Signs (Respiration Rate) | 0.0 ± 1.15 | 0.3 ± 0.71 | 0.3 ± 1.51 | 0.3 ± 0.76 |
Mean values for temperature from pre-dose to 0.5 hours post-dose.
| Change in degrees Celsius | A - 5 Breaths VR647 | B - 10 Breaths VR647 | C - 20 Breaths VR647 | D - Pulmicort |
|---|---|---|---|---|
| Changes in Vital Signs (Temperature) | 0.27 ± 0.373 | 0.04 ± 0.320 | 0.05 ± 0.207 | 0.14 ± 0.351 |
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.
| Participants | A - 5 Breaths VR647 | B - 10 Breaths VR647 | C - 20 Breaths VR647 | D - Pulmicort |
|---|---|---|---|---|
| Changes in Physical Examination | 0 | 0 | 0 | 0 |
Number of subjects using concomitant medications.
| Participants | A - 5 Breaths VR647 | B - 10 Breaths VR647 | C - 20 Breaths VR647 | D - Pulmicort |
|---|---|---|---|---|
| Use of Concomitant Medications | 7 | 8 | 6 | 7 |
Collected over Adverse events (AEs) and adverse device effects were monitored throughout the trial, until resolution. The total duration of participation for each subject was approximately 47 days, which included a 30-day screening period, two dosing visits with a washout period of 4 to 10 days between each dose, and a follow-up assessment approximately 7 days after last nebulization.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A - 5 Breaths VR647 | 0/7 (0%) | 0/7 (0%) | 1/7 (14.3%) |
| B - 10 Breaths VR647 | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| C - 20 Breaths VR647 | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| D - Pulmicort | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Overall Treatment | 0/15 (0%) | 0/15 (0%) | 2/15 (13.3%) |
| Event | A - 5 Breaths VR647 | B - 10 Breaths VR647 | C - 20 Breaths VR647 | D - Pulmicort | Overall Treatment |
|---|---|---|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 0/7 | 1/8 | 1/6 | 0/7 | 1/15 |
| NauseaGastrointestinal disorders | 1/7 | 0/8 | 0/6 | 0/7 | 1/15 |
| VomitingGastrointestinal disorders | 1/7 | 0/8 | 0/6 | 0/7 | 1/15 |
A total of 17 subjects were enrolled. However, 2 subjects withdrew from the study prior to treatment with the first intervention. As baseline characteristics were not reported for these two subjects, the overall number of baseline participants was 15 subjects.
| Age, Continuous(months) | Overall Treatment |
|---|---|
| Mean | 82.6 ± 14.05 |
| Sex: Female, Male(Participants) | Overall Treatment |
|---|---|
| Female | 8 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | Overall Treatment |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 15 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Overall Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 9 |
| White | 6 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Mar 2018, 3 months.
Results were first posted in Oct 2019, 1 year 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Budesonide
Vectura Limited