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To compare the pharmacokinetics of budesonide delivered by BDA MDI to budesonide delivered by Pulmicort Respules in children with Asthma aged 4 to 8 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A/B - Treatment with BDA MDI (PT027) 160/180 μg followed by treatment with Pulmicort Respules 1mg | Experimental | Subjects randomized to receive a single dose of budesonide/albuterol by metered-dose inhaler, BDA MDI, (PT027) 160/180 μg at Visit 2, and a single dose of budesonide by nebulization (Pulmicort Respules) 1mg at Visit 3. |
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| B/A - Treatment with Pulmicort Respules 1 mg followed by treatment with BDA MDI (PT027) 160/180 μg | Experimental | Subjects randomized to receive a single dose of budesonide by nebulization (Pulmicort Respules) 1mg at Visit 2, and a single dose of budesonide/albuterol by metered-dose inhaler, BDA MDI, (PT027) 160/180 μg at Visit 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BDA MDI (PT027) 160/180 μg | Drug | Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/90 μg per puff. Two puffs to administer 160/180 μg dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration | A total of 10 samples were taken per treatment visit at pre-dose and at 10, 20, 40, 60, 120, 240, 360, 480 and 720 minutes after dosing. |
| Cmax | Maximum observed plasma concentration | A total of 10 samples were taken per treatment visit at pre-dose and at 10, 20, 40, 60, 120, 240, 360, 480 and 720 minutes after dosing. |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time to reach maximum observed plasma concentration | A total of 10 samples were taken per treatment visit at pre-dose and at 10, 20, 40, 60, 120, 240, 360, 480 and 720 minutes after dosing. |
| Tlast |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Albers, MD, PhD | Avillion LLP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IPS Research | Oklahoma City | Oklahoma | 73106 | United States | ||
| TTS Research |
No plans to share IPD
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The randomized treatment phase started after a screening period with a maximum duration of 14 days. Subjects who were taking budesonide in any form at Visit 1 were switched to another corticosteroid with a washout of budesonide of 3 to 7 days. In addition to the 12 subjects randomized, 1 subject was screened but did not participate (1 screen failure).
The target population consisted of male or female children aged between 4 and 8 years who had clinician-diagnosed asthma of at least 3 months. Subjects were expected to be stable on treatment with albuterol as needed and/or inhaled corticosteroids and/or leukotriene receptor antagonists for 2 weeks prior to screening. The first subject enrolled on 06 May 2021 and the last subject completed the study on 08 July 2021. Subjects were enrolled at 2 US study centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | A/B - Treatment With BDA MDI (PT027) 160/180 μg Followed by Treatment With Pulmicort Respules 1mg | Subjects randomized to receive a single dose of budesonide/albuterol by metered-dose inhaler, BDA MDI, (PT027) 160/180 μg at Visit 2/Period 1, and a single dose of budesonide by nebulization (Pulmicort Respules) 1mg at Visit 3/Period 2. Visit 2/Period 1 (Day 1) - BDA MDI (PT027) 160/180 μg: Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/90 μg per puff. Two puffs to administer 160/180 μg dose. Visit 3/Period 2 (Day 8 +/- 6 days) - Pulmicort Respules 0.5 mg/mL inhalation suspension: Budesonide 0.5 mg/ml. Each 2 ml Respule contains 1 mg budesonide. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (First Treatment Intervention) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 19, 2021 | Feb 7, 2022 |
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| Pulmicort Respules 0.5 MG/ML Inhalation Suspension | Drug | Budesonide 0.5 mg/ml. Each 2 ml Respule contains 1 mg budesonide. |
|
Time of last quantifiable plasma concentration
| A total of 10 samples were taken per treatment visit at pre-dose and at 10, 20, 40, 60, 120, 240, 360, 480 and 720 minutes after dosing. |
| Clast | Drug concentration at last observed (quantifiable) concentration | A total of 10 samples were taken per treatment visit at pre-dose and at 10, 20, 40, 60, 120, 240, 360, 480 and 720 minutes after dosing. |
| Boerne |
| Texas |
| 78006 |
| United States |
| FG001 | B/A - Treatment With Pulmicort Respules 1 mg Followed by Treatment With BDA MDI (PT027) 160/180 μg | Subjects randomized to receive a single dose of budesonide by nebulization (Pulmicort Respules) 1mg at Visit 2, and a single dose of budesonide/albuterol by metered-dose inhaler, BDA MDI, (PT027) 160/180 μg at Visit 3. Visit 2/Period 1 (Day 1) - Pulmicort Respules 0.5 MG/ML Inhalation Suspension: Budesonide 0.5 mg/ml. Each 2 ml Respule contains 1 mg budesonide. Visit 3/Period 2 (Day 8 +/- 6 days) - BDA MDI (PT027) 160/180 μg: Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/90 μg per puff. Two puffs to administer 160/180 μg dose. |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 (Second Treatment Intervention) |
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| ID | Title | Description |
|---|---|---|
| BG000 | A/B - Treatment With BDA MDI (PT027) 160/180 μg Followed by Treatment With Pulmicort Respules 1mg | Subjects randomized to receive a single dose of budesonide/albuterol by metered-dose inhaler, BDA MDI, (PT027) 160/180 μg at Visit 2/Period 1, and a single dose of budesonide by nebulization (Pulmicort Respules) 1mg at Visit 3/Period 2. Visit 2/Period 1 (Day 1) - BDA MDI (PT027) 160/180 μg: Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/90 μg per puff. Two puffs to administer 160/180 μg dose. Visit 3/Period 2 (Day 8 +/- 6 days) - Pulmicort Respules 0.5 mg/mL inhalation suspension: Budesonide 0.5 mg/ml. Each 2 ml Respule contains 1 mg budesonide. |
| BG001 | B/A - Treatment With Pulmicort Respules 1 mg Followed by Treatment With BDA MDI (PT027) 160/180 μg | Subjects randomized to receive a single dose of budesonide by nebulization (Pulmicort Respules) 1mg at Visit 2, and a single dose of budesonide/albuterol by metered-dose inhaler, BDA MDI, (PT027) 160/180 μg at Visit 3. Visit 2/Period 1 (Day 1) - Pulmicort Respules 0.5 MG/ML Inhalation Suspension: Budesonide 0.5 mg/ml. Each 2 ml Respule contains 1 mg budesonide. Visit 3/Period 2 (Day 8 +/- 6 days) - BDA MDI (PT027) 160/180 μg: Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/90 μg per puff. Two puffs to administer 160/180 μg dose. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height | Mean | Standard Deviation | Centimeters (cm) |
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| Weight | Mean | Standard Deviation | Kilograms (kg) |
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| Body Mass Index | Mean | Standard Deviation | Kilograms per meter squared |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUC0-t | Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration | Budesonide PK samples were available from 12 children. There were 2 instances, one for each treatment intervention, where the pre-dose budesonide concentration was considered too high (16% and 46% of Cmax), potentially having an impact on the post-dose concentrations. There was also 1 instance in the Pulmicort Respules 1mg treatment intervention where post-dose samples were not collected due to difficulty with the catheter. PK parameters were not calculated in these three instances. | Posted | Mean | Standard Deviation | h*pg/mL | A total of 10 samples were taken per treatment visit at pre-dose and at 10, 20, 40, 60, 120, 240, 360, 480 and 720 minutes after dosing. |
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| Primary | Cmax | Maximum observed plasma concentration | Budesonide PK samples were available from 12 children. There were 2 instances, one for each treatment intervention, where the pre-dose budesonide concentration was considered too high (16% and 46% of Cmax), potentially having an impact on the post-dose concentrations. There was also 1 instance in the Pulmicort Respules 1mg treatment intervention where post-dose samples were not collected due to difficulty with the catheter. PK parameters were not calculated in these three instances. | Posted | Mean | Standard Deviation | pg/mL | A total of 10 samples were taken per treatment visit at pre-dose and at 10, 20, 40, 60, 120, 240, 360, 480 and 720 minutes after dosing. |
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| Secondary | Tmax | Time to reach maximum observed plasma concentration | Budesonide PK samples were available from 12 children. There were 2 instances, one for each treatment intervention, where the pre-dose budesonide concentration was considered too high (16% and 46% of Cmax), potentially having an impact on the post-dose concentrations. There was also 1 instance in the Pulmicort Respules 1mg treatment intervention where post-dose samples were not collected due to difficulty with the catheter. PK parameters were not calculated in these three instances. | Posted | Median | Full Range | hours | A total of 10 samples were taken per treatment visit at pre-dose and at 10, 20, 40, 60, 120, 240, 360, 480 and 720 minutes after dosing. |
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| Secondary | Tlast | Time of last quantifiable plasma concentration | Budesonide PK samples were available from 12 children. There were 2 instances, one for each treatment intervention, where the pre-dose budesonide concentration was considered too high (16% and 46% of Cmax), potentially having an impact on the post-dose concentrations. There was also 1 instance in the Pulmicort Respules 1mg treatment intervention where post-dose samples were not collected due to difficulty with the catheter. PK parameters were not calculated in these three instances. | Posted | Median | Full Range | hours | A total of 10 samples were taken per treatment visit at pre-dose and at 10, 20, 40, 60, 120, 240, 360, 480 and 720 minutes after dosing. |
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| Secondary | Clast | Drug concentration at last observed (quantifiable) concentration | Budesonide PK samples were available from 12 children. There were 2 instances, one for each treatment intervention, where the pre-dose budesonide concentration was considered too high (16% and 46% of Cmax), potentially having an impact on the post-dose concentrations. There was also 1 instance in the Pulmicort Respules 1mg treatment intervention where post-dose samples were not collected due to difficulty with the catheter. PK parameters were not calculated in these three instances. | Posted | Mean | Standard Deviation | pg/mL | A total of 10 samples were taken per treatment visit at pre-dose and at 10, 20, 40, 60, 120, 240, 360, 480 and 720 minutes after dosing. |
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Approximately one week for each treatment intervention.
Safety population included all subjects who received at least one treatment intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Intervention - BDA MDI (PT027) 160/180 μg - All Subjects | Safety analysis of subjects receiving Treatment A - BDA MDI (PT027) 160/180 μg | 0 | 12 | 0 | 12 | 0 | 12 |
| EG001 | Treatment Intervention B - Pulmicort Respules 1 mg | Safety analysis of subjects receiving Treatment B - Pulmicort Respules 1mg | 0 | 12 | 0 | 12 | 1 | 12 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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data or results obtained from this study must not be published without prior approval from the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Avillion LLP | +44 (0)203 764 9530 | avillion@avillionllp.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 18, 2021 | Feb 7, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| >= 6 to <9 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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| Participants |
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