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This is a randomized, double-blind, single-dose, placebo-controlled, 5-period, 5-treatment, crossover, multi-center study to assess the bronchodilatory effect and safety of 2 dose levels of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS MDI), 90 μg and 180 μg, compared with placebo for AS MDI (hereafter referred to as Placebo MDI) and open-label Proventil® hydrofluoroalkane (HFA; hereafter referred to as Proventil) 90 μg and 180 μg in adult and adolescent subjects with mild to moderate asthma. This study design utilizes 10 treatment sequences.
This is a 5-period crossover study. Each Treatment Period is 1 day. Subjects will receive a single dose of randomized study drug at each of the 5 Treatment Visits (Visits 2, 3, 4, 5, and 6), with a 3- to 7-day Washout Period between Treatment Visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| • AS MDI 90 µg | Experimental | (2 actuations of 45 µg/actuation) |
|
| • AS MDI 180 µg | Experimental | (2 actuations of 90 µg/actuation) |
|
| • Placebo MDI | Placebo Comparator | (2 actuations) |
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| • Proventil 90 µg | Active Comparator | (1 actuation of 90 µg/actuation) |
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| • Proventil 180 µg | Active Comparator | (2 actuations of 90 µg/actuation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AS MDI 90 μg | Drug | AS MDI 90 μg (2 actuations of 45 μg/actuation) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FEV1 AUC0-6 | Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-6 (Area under the curve from 0 to 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose) normalized for length of follow up. | Over 6 hours post dose on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FEV1 AUC0-4 | Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-4 (Area under the curve from 0 to 4 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose) normalized for length of follow up. | Over 4 hours post dose on Day 1 |
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Inclusion Criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Rolling Hills Estates | California | 90274 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34089147 | Derived | Cappelletti C, Maes A, Rossman K, Gillen M, LaForce C, Kerwin EM, Reisner C. Dose-Ranging and Cumulative Dose Studies of Albuterol Sulfate MDI in Co-Suspension Delivery Technology (AS MDI; PT007) in Patients with Asthma: the ASPEN and ANTORA Trials. Clin Drug Investig. 2021 Jun;41(6):579-590. doi: 10.1007/s40261-021-01040-7. Epub 2021 Jun 4. |
| Label | URL |
|---|---|
| Protocol | View source |
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Subjects were randomized into one of 10 treatment sequences. Each sequence comprised all 5 treatments included in this study (ie, AS MDI 90 μg, AS MDI 180 μg, Placebo MDI, Proventil 90 μg, and Proventil 180 μg) in a randomized order
This study was conducted at 10 sites in the United States, from December 2017 to March 2018. The study was anticipated to run for at least 23 days but not to exceed 68 days.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects | ITT Analysis set |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jan 12, 2018 | Mar 29, 2019 |
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| AS MDI 180 µg | Drug | AS MDI 180 μg (2 actuations of 90 μg/actuation) |
|
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| Placebo MDI | Other | Placebo MDI (2 actuations) |
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| Proventil 90 μg | Drug | Proventil 90 μg (1 actuation of 90 μg/actuation) |
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| Proventil 180 μg | Drug | Proventil 180 μg (2 actuations of 90 μg/actuation) |
|
|
| Peak Change From Baseline in FEV1 |
Peak Change from baseline in FEV1 (Forced expiratory volume in 1 second) |
| Over 6 hours post dose on Day 1 |
| Stockton |
| California |
| 95207 |
| United States |
| Research Site | Winter Park | Florida | 32789 | United States |
| Research Site | North Dartmouth | Massachusetts | 02747 | United States |
| Research Site | St Louis | Missouri | 63141 | United States |
| Research Site | Raleigh | North Carolina | 27607 | United States |
| Research Site | Cincinnati | Ohio | 45242 | United States |
| Research Site | Medford | Oregon | 97504 | United States |
| Research Site | Spartanburg | South Carolina | 29303 | United States |
| Research Site | El Paso | Texas | 79903 | United States |
| Statistical Analysis Plan (SAP) | View source |
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| Placebo MDI | (2 actuations) |
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| AS MDI 90 µg | (2 actuations of 45 µg/actuation) |
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| AS MDI 180 µg | (2 actuations of 90 µg/actuation) |
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| Proventil 90 µg | (1 actuation of 90 µg/actuation) |
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| Proventil 180 µg | (2 actuations of 90 µg/actuation) |
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| COMPLETED |
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| NOT COMPLETED |
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Overall number of Baseline Participants is from the Safety set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Safety Set |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Safety Set | Mean | Standard Deviation | Years |
| ||||||||||||||||
| Sex: Female, Male | Safety Set | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Safety Set | Count of Participants | Participants |
| |||||||||||||||||
| Race (NIH/OMB) | Safety Set | Count of Participants | Participants |
|
| 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 | Change From Baseline in FEV1 AUC0-6 | Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-6 (Area under the curve from 0 to 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose) normalized for length of follow up. | mITT Population | Posted | Least Squares Mean | 95% Confidence Interval | Liters | Over 6 hours post dose on Day 1 |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in FEV1 AUC0-4 | Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-4 (Area under the curve from 0 to 4 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose) normalized for length of follow up. | mITT Population | Posted | Least Squares Mean | 95% Confidence Interval | Liters | Over 4 hours post dose on Day 1 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Peak Change From Baseline in FEV1 | Peak Change from baseline in FEV1 (Forced expiratory volume in 1 second) | mITT Population | Posted | Least Squares Mean | 95% Confidence Interval | Liters | Over 6 hours post dose on Day 1 |
|
Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug
Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 68 days, which includes screening and follow up (3-7 days after last dose of study drug).
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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 | Placebo MDI | (2 actuations) | 0 | 82 | 0 | 82 | 0 | 82 |
| EG001 | AS MDI 90 µg | (2 actuations of 45 µg/actuation) | 0 | 81 | 0 | 81 | 0 | 81 |
| EG002 | Proventil 180 µg | (2 actuations of 90 µg/actuation) | 0 | 81 | 0 | 81 | 0 | 81 |
| EG003 | Proventil 90 µg | (1 actuation of 90 µg/actuation) | 0 | 82 | 0 | 82 | 0 | 82 |
| EG004 | • Proventil 180 µg | (2 actuations of 90 µg/actuation) | 0 | 79 | 0 | 79 | 0 | 79 |
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Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent it's opinions, or the opinions of the publication committee, if these differ with the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Colin Reisner, MD FCCP, FAAAAI | Pearl Therapeutics, Inc, a Member of the AstraZeneca Group | 9739750321 | Colin.Reisner@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 13, 2018 | Mar 29, 2019 | 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 |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
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| Units | Counts |
|---|
| Participants |
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