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To Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg base (Sun Pharmaceuticals Industries Limited) to PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in Subjects With Stable, Mild Asthma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Albuterol Sulfate Inhalation Aerosol, eq 90 mcg |
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| Reference | Active Comparator | PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg |
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| Test Placebo | Placebo Comparator | Placebo for Albuterol Sulfate Inhalation Aerosol |
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| Reference Placebo | Placebo Comparator | Placebo for Albuterol Sulfate Inhalation Aerosol |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zero-dose | Drug | Treatment A |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic Endpoint Post-dose PC20 | The primary pharmacodynamic endpoint is the post-dose PC20, which is the provocative concentration of methacholine challenge agent required to reduce the forced expiry volume in one second (FEV1) by 20%, following the administration of different doses of albuterol (or placebo) by inhalation. Primary analysis group -pharmacodynamic population. | Approximately 15 minutes after last inhalation of study product |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPARC Site 02 | Miami Lakes | Florida | 33014 | United States | ||
| SPARC site 01 |
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Treatments were administered according to a four-treatment, four-period, four-sequence design.
124 eligible subjects were randomized to each one of the four sequences: ABCD
Sequence
Sequence 1 : A B C D Sequence 2: D C B A Sequence 3: C A D B Sequence 4: B D A C
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| ID | Title | Description |
|---|---|---|
| FG000 | Total | Treatment A: Zero-dose : Two different Reference Placebo inhalers and two different Test Placebo inhalers Treatment B: 90 mcg of Reference : One Reference inhaler, one Reference Placebo inhaler, and two different Test Placebo inhalers Treatment C: 180 mcg of Reference Two different Reference inhalers and two different Test Placebo inhalers Treatment D: 90 mcg of Test One Test inhaler, one Test Placebo inhaler, and two different Reference Placebo inhalers |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Sequence 1 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 21, 2018 | Jul 18, 2020 |
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| 90 mcg of PROAIR® HFA | Drug | Treatment B |
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| 180 mcg of 90 mcg of PROAIR® HFA | Drug | Treatment C |
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| 90 mcg of albuterol sulfate inhalation aerosol | Drug | Treatment D |
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| Bethesda |
| Maryland |
| 20814 |
| United States |
| SPARC Site 04 | St Louis | Missouri | 63141 | United States |
| SPARC Site 06 | Gastonia | North Carolina | 28054 | United States |
| SPARC Site 05 | Edmond | Oklahoma | 73034 | United States |
| SPARC Site 07 | Warwick | Rhode Island | 02886 | United States |
| SPARC Site 08 | Boerne | Texas | 78006 | United States |
| SPARC Site 03 | Waco | Texas | 76712 | United States |
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| COMPLETED |
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| NOT COMPLETED |
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| Sequence 2 |
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| Sequence 3 |
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| Sequence 4 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Baseline | Summary of Demographic Data and Baseline Characteristics (Safety Population) |
| 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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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Tobacco Use | Count of Participants | Participants |
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| Number of years patient has suffered from symptoms caused by asthma | Mean | Standard Deviation | years |
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| FEV1 (Pre-saline) | FEV1 is Forced Expiratory Volume (flow rate) in 1 second | Mean | Standard Deviation | Litre |
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| FEV1 (Post-saline) | FEV1 is Forced Expiratory Volume (flow rate) in 1 second | Mean | Standard Deviation | Litre |
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| PC20 FEV1 | PC20 is Provocative concentration (mg/mL) of methacholine required to reduce FEV1 by 20% FEV1 is Forced Expiratory Volume (flow rate) in 1 second | Mean | Standard Deviation | mg/mL |
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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 | Pharmacodynamic Endpoint Post-dose PC20 | The primary pharmacodynamic endpoint is the post-dose PC20, which is the provocative concentration of methacholine challenge agent required to reduce the forced expiry volume in one second (FEV1) by 20%, following the administration of different doses of albuterol (or placebo) by inhalation. Primary analysis group -pharmacodynamic population. | The statistical analysis was performed based on the Dose-Scale approach. This approach was referenced in FDA's draft Guidance on albuterol sulfate metered/inhalation and described in FDA's draft Guidance on Orlistat capsule. The PC20 data from various treatments (such as placebo, 90 mcg Test, 90 mcg Reference and 180 mcg Reference) from different study period was pooled to perform the Dose-Scale model using NONMEM. Therefore, per test arm values were not reported. | Posted | Mean | 90% Confidence Interval | mg/mL | Approximately 15 minutes after last inhalation of study product |
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6 weeks
It is the approximate duration over which adverse event data were collected
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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 A | Zero-dose | 0 | 125 | 0 | 125 | 7 | 125 |
| EG001 | Treatment B | 90 mcg of Reference (PROAIR® HFA) | 0 | 125 | 0 | 125 | 3 | 125 |
| EG002 | Treatment C | 180 mcg of Reference (PROAIR® HFA) | 0 | 123 | 0 | 123 | 9 | 123 |
| EG003 | Treatment D | 90 mcg of Test (Albuterol Sulfate HFA Inhalation Aerosol) | 0 | 126 | 0 | 126 | 5 | 126 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| influenza | Infections and infestations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | Systematic Assessment |
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| nausea | Gastrointestinal disorders | Systematic Assessment |
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| chest discomfort | General disorders | Systematic Assessment |
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| gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
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| Pharyngitis | Infections and infestations | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| FEV1/FVC ratio | Investigations | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| dizziness | Nervous system disorders | Systematic Assessment |
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| headache | Nervous system disorders | Systematic Assessment |
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| tension headache | Nervous system disorders | Systematic Assessment |
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| anxiety | Psychiatric disorders | Systematic Assessment |
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| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| accelerated hypertension | Vascular disorders | Systematic Assessment |
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| flushing | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials | SPIL | 912266455645 | clinical.trials@sparcmail.com |
| SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 17, 2018 | Aug 14, 2020 | Prot_002.pdf |
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| 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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| 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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