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The purpose of the present pilot study is to test the hypothesis that in patients with group 1 pulmonary arterial hypertension (PAH) who are on regular oral pulmonary vasodilator therapy, inhaled albuterol causes transient pulmonary vasodilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albuterol followed by placebo | Experimental | Participants in this group will receive albuterol first followed by Placebo on the next visit |
|
| Placebo followed by albuterol | Experimental | Participants in this group will receive placebo first followed by albuterol on the next visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albuterol | Drug | inhalation of 270μg albuterol through a spacer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Pulmonary Artery Pressure (MPAP) | Change in MPAP will be measured using echocardiogram | Baseline, up to 30 minutes after inhalation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pulmonary Vascular Resistance (PVR) | Change in PVR will be measured using echocardiogram | Baseline, up to 30 minutes after inhalation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Wanner, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Albuterol Followed by Placebo | Participants in this group will receive albuterol first followed by Placebo on the next visit Albuterol: inhalation of 270μg albuterol through a spacer Placebo: inhalation of placebo through a spacer |
| FG001 | Placebo Followed by Albuterol | Participants in this group will receive placebo first followed by albuterol on the next visit Albuterol: inhalation of 270μg albuterol through a spacer Placebo: inhalation of placebo through a spacer |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Albuterol Followed by Placebo | Participants in this group will receive albuterol first followed by Placebo on the next visit Albuterol: inhalation of 270μg albuterol through a spacer Placebo: inhalation of placebo through a spacer |
| BG001 | Placebo Followed by Albuterol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 in Mean Pulmonary Artery Pressure (MPAP) | Change in MPAP will be measured using echocardiogram | This is a cross-over study design. All enrolled participants received both the albuterol and placebo intervention. | Posted | Mean | Standard Error | mmHg | Baseline, up to 30 minutes after inhalation |
|
1 day
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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 | Albuterol Group | This is a cross-over study. All participants received albuterol. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adam Wanner | University of Miami | 3053010563 | awanner@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 4, 2021 | Aug 4, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo | Drug | inhalation of placebo through a spacer |
|
Participants in this group will receive placebo first followed by albuterol on the next visit Albuterol: inhalation of 270μg albuterol through a spacer Placebo: inhalation of placebo through a spacer |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change in Pulmonary Vascular Resistance (PVR) | Change in PVR will be measured using echocardiogram | This is a cross-over study design. All enrolled participants received both the albuterol and placebo intervention. | Posted | Mean | Standard Error | dyn.s.cm-5 | Baseline, up to 30 minutes after inhalation |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Placebo Group | This is a cross-over study. All participants received placebo. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D002318 |
| Cardiovascular Diseases |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |