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This is a randomized, cumulative dose, open-label, 2-period crossover, multi-center study to assess the safety, efficacy, PK, and extrapulmonary PD of cumulative doses of AS MDI compared to cumulative doses of Proventil as an active control in subjects with mild to moderate asthma
This is a randomized, cumulative dose, open-label, 2-period crossover, multi-center study to assess the safety, efficacy, PK, and extrapulmonary pharmacodynamics (PD) of cumulative doses of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS MDI) compared to cumulative doses of Proventil® hydrofluoroalkane (HFA; hereafter referred to as Proventil) as an active control in subjects with mild to moderate asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AS MDI | Experimental | AS MDI 1+1+2+4+8 inhalations of 90 μg per inhalation |
|
| Proventil | Active Comparator | Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AS MDI | Drug | AS MDI 1+1+2+4+8 inhalations of 90 μg per inhalation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline-adjusted FEV1 30 Minutes After Each Cumulative Dose | Forced expiratory volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation | At the two study treatment visits, FEV1 (forced expiratory volume in 1 second) will be measured prior to drug administration and 5 times, once at 30 minutes after each of the 5 doses |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline-adjusted FEV1 AUC0-6 After the Last Cumulative Dose | The baseline-adjusted FEV1 AUC0-6 is the area under the curve for change from baseline calculated using the trapezoidal rule and normalized by dividing the AUC by the length of follow up post the last cumulative dose (typically 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose) normalized for length of follow up). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Winter Park | Florida | 32789 | 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 who met all screening and randomization requirements were eligible for rand to Tx Period, comprised of Visits 2 and 3 . Eligible subj were rand via IWRS to receive 2 cumulative-dose Tx's in one of 2 possible Tx sequences: AS MDI, given as 1+1+2+4+8 actuations of AS MDI 90 μg, Proventil, given as 1+1+2+4+8 actuations of Proventil 90 μg
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence A | AS MDI 90 ug then Proventil 90 ug |
| FG001 | Treatment Sequence B | Proventil 90 ug then AS MDI 90 ug |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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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 15, 2018 | Mar 26, 2019 |
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| Proventil |
| Drug |
Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation |
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| Over 6 hours post dose on Day 1 |
| North Dartmouth |
| Massachusetts |
| 02747 |
| United States |
| Research Site | St Louis | Missouri | 63141 | United States |
| Research Site | Raleigh | North Carolina | 27607 | United States |
| Research Site | Medford | Oregon | 97504 | United States |
| Statistical Analysis Plan (SAP) | View source |
| COMPLETED |
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| NOT COMPLETED |
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| Washout |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | mITT Population | The mITT Analysis Set is defined as a subset of the ITT Analysis Set including subjects who received treatment and had post-treatment efficacy data from both Treatment Periods. Data judged to be impacted by major protocol deviations are determined prior to database lock in a blinded fashion and excluded per the statistical protocol deviation plan. Statistical tabulations and analyses are by randomized treatment, but data obtained after subjects received an incorrect treatment are excluded from the affected periods |
| 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 | mITT Population | Least Squares Mean | Standard Deviation | Years |
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| Sex: Female, Male | mITT Population | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | mITT Population | Count of Participants | Participants |
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| Race (NIH/OMB) | mITT Population | Count of Participants | Participants |
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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 | Baseline-adjusted FEV1 30 Minutes After Each Cumulative Dose | Forced expiratory volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation | Posted | Least Squares Mean | 95% Confidence Interval | Liter | At the two study treatment visits, FEV1 (forced expiratory volume in 1 second) will be measured prior to drug administration and 5 times, once at 30 minutes after each of the 5 doses |
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| Secondary | Baseline-adjusted FEV1 AUC0-6 After the Last Cumulative Dose | The baseline-adjusted FEV1 AUC0-6 is the area under the curve for change from baseline calculated using the trapezoidal rule and normalized by dividing the AUC by the length of follow up post the last cumulative dose (typically 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose) normalized for length of follow up). | Posted | Least Squares Mean | 95% Confidence Interval | Liter | Over 6 hours post dose on Day 1 |
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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 until study completion for a maximum of 44 days. This reporting time frame includes the screening period, the two active treatment periods, and the follow up period (i.e. 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 | AS MDI | AS MDI 90 μg 1+1+2+4+8 inhalations of 90 μg per inhalation | 0 | 45 | 0 | 45 | 8 | 45 |
| EG001 | Proventil | Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation | 0 | 46 | 0 | 46 | 10 | 46 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Feeling Jittery | General disorders | MedDRA | Systematic Assessment | MedDRA |
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| Tremor | Nervous system disorders | MedDRA | Systematic Assessment | MedDRA |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment | MedDRA |
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| Blood Potassium decreased | Investigations | MedDRA | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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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 30, 2018 | Jul 1, 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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| 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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| Cumulative Dose - 360 μg |
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| Cumulative Dose - 720 μg |
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| Cumulative Dose - 1440 μg |
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