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| ID | Type | Description | Link |
|---|---|---|---|
| 1U10HL098115 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to find the best asthma treatment to add for Blacks who have asthma that is not well controlled on a low dose of inhaled steroid. This study will also try to find out if Black adults and children differ in how they respond to the medications used in this study.
BARD is a 66 week prospective, randomized, double-blind, crossover trial in Blacks (individuals who self-report Black ancestry) who have inadequately controlled asthma while taking low-dose inhaled corticosteroids (ICS). BARD will examine the efficacy of increasing the dose of ICS with or without the addition of a long-acting beta agonist (LABA) to determine whether individual patients respond better to one treatment than another and, if so, whether the responses are different for children and adults or if they are related to genetic ancestry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crossover sequence 1 | Experimental | Flovent Diskus® 250 mcg,followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 100/50 mcg |
|
| Crossover sequence 2 | Experimental | Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Flovent Diskus® 100 mcg |
|
| Crossover sequence 3 | Experimental | Flovent Diskus® 100 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg |
|
| Crossover sequence 4 | Experimental | Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flovent Diskus® 100 mcg | Drug | Flovent is an ICS |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | This composite outcome uses a hierarchical method to ascertain differences in asthma control. For each participant, treatments are first compared to see if they differ in terms of exacerbations. If one treatment results in fewer exacerbations than another, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by exacerbations, then they are compared by asthma control days (ACDs). If one treatment yields at least 31 annualized ACDs more than another, it is deemed the superior treatment. If treatment superiority still cannot be assigned by ACDs, then they are compared by percent predicted FEV1 at the end of a treatment period. If one treatment yields at least 5% greater FEV1 than another, it is deemed the superior treatment. If treatment superiority cannot be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response. | The last 12 weeks of each 14-week treatment period |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Busse, MD | University of Wisconsin, Madison | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona College of Medicine | Tucson | Arizona | 85724 | United States | ||
| Children's Hospital & Research Center Oakland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31553835 | Derived | Wechsler ME, Szefler SJ, Ortega VE, Pongracic JA, Chinchilli V, Lima JJ, Krishnan JA, Kunselman SJ, Mauger D, Bleecker ER, Bacharier LB, Beigelman A, Benson M, Blake KV, Cabana MD, Cardet JC, Castro M, Chmiel JF, Covar R, Denlinger L, DiMango E, Fitzpatrick AM, Gentile D, Grossman N, Holguin F, Jackson DJ, Kumar H, Kraft M, LaForce CF, Lang J, Lazarus SC, Lemanske RF Jr, Long D, Lugogo N, Martinez F, Meyers DA, Moore WC, Moy J, Naureckas E, Olin JT, Peters SP, Phipatanakul W, Que L, Raissy H, Robison RG, Ross K, Sheehan W, Smith LJ, Solway J, Sorkness CA, Sullivan-Vedder L, Wenzel S, White S, Israel E; NHLBI AsthmaNet. Step-Up Therapy in Black Children and Adults with Poorly Controlled Asthma. N Engl J Med. 2019 Sep 26;381(13):1227-1239. doi: 10.1056/NEJMoa1905560. |
| Label | URL |
|---|---|
| AsthmaNet | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Crossover Sequence 1 | Flovent Diskus® 250 mcg,followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 100/50 mcg Flovent Diskus® 100 mcg: Flovent is an ICS Flovent Diskus® 250 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 | Jul 21, 2017 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Crossover sequence 5 | Experimental | Flovent Diskus® 500 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg |
|
| Crossover sequence 6 | Experimental | Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 500 mcg, followed by Flovent Diskus® 250 mcg |
|
| Crossover sequence 7 | Experimental | Flovent Diskus® 250 mcg, followed by Flovent Diskus® 500 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg |
|
| Crossover sequence 8 | Experimental | Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 500 mcg |
|
| Flovent Diskus® 250 mcg | Drug | Flovent is an ICS |
|
| Flovent Diskus® 500 mcg | Drug | Flovent is an ICS |
|
| Advair Diskus® 100/50 mcg | Drug | Advair is an ICS/LABA combination |
|
| Advair Diskus® 250/50 mcg | Drug | Advair is an ICS/LABA combination |
|
| Oakland |
| California |
| 94609 |
| United States |
| UCSF Benioff Children's Hospital | San Francisco | California | 94143 | United States |
| University of California - San Francisco | San Francisco | California | 94143 | United States |
| National Jewish Health | Denver | Colorado | 80206 | United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| Nemours Children's Clinic | Orlando | Florida | 32827 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| Ann and Robert H. Lurie Children's Hospital | Chicago | Illinois | 60614 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Duke University School of Medicine | Durham | North Carolina | 27110 | United States |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Rainbow Babies and Children's Hospital, Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| University of Wisconsin-Madison | Madison | Wisconsin | 53792 | United States |
| Center for Urban Population Health | Milwaukee | Wisconsin | 53223 | United States |
| FG001 |
| Crossover Sequence 2 |
Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Flovent Diskus® 100 mcg Flovent Diskus® 100 mcg: Flovent is an ICS Flovent Diskus® 250 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination |
| FG002 | Crossover Sequence 3 | Flovent Diskus® 100 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg Flovent Diskus® 100 mcg: Flovent is an ICS Flovent Diskus® 250 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination |
| FG003 | Crossover Sequence 4 | Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg Flovent Diskus® 100 mcg: Flovent is an ICS Flovent Diskus® 250 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination |
| FG004 | Crossover Sequence 5 | Flovent Diskus® 500 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg Flovent Diskus® 250 mcg: Flovent is an ICS Flovent Diskus® 500 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination |
| FG005 | Crossover Sequence 6 | Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 500 mcg, followed by Flovent Diskus® 250 mcg Flovent Diskus® 250 mcg: Flovent is an ICS Flovent Diskus® 500 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination |
| FG006 | Crossover Sequence 7 | Flovent Diskus® 250 mcg, followed by Flovent Diskus® 500 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg Flovent Diskus® 250 mcg: Flovent is an ICS Flovent Diskus® 500 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination |
| FG007 | Crossover Sequence 8 | Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 500 mcg Flovent Diskus® 250 mcg: Flovent is an ICS Flovent Diskus® 500 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination |
| Completed 1st Period |
|
| Completed 2nd Period |
|
| Completed 3rd Period |
|
| Completed 4th Period |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Crossover Sequence 1 | Flovent Diskus® 250 mcg,followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 100/50 mcg Flovent Diskus® 100 mcg: Flovent is an ICS Flovent Diskus® 250 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination |
| BG001 | Crossover Sequence 2 | Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Flovent Diskus® 100 mcg Flovent Diskus® 100 mcg: Flovent is an ICS Flovent Diskus® 250 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination |
| BG002 | Crossover Sequence 3 | Flovent Diskus® 100 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg Flovent Diskus® 100 mcg: Flovent is an ICS Flovent Diskus® 250 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination |
| BG003 | Crossover Sequence 4 | Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg Flovent Diskus® 100 mcg: Flovent is an ICS Flovent Diskus® 250 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination |
| BG004 | Crossover Sequence 5 | Flovent Diskus® 500 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg Flovent Diskus® 250 mcg: Flovent is an ICS Flovent Diskus® 500 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination |
| BG005 | Crossover Sequence 6 | Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 500 mcg, followed by Flovent Diskus® 250 mcg Flovent Diskus® 250 mcg: Flovent is an ICS Flovent Diskus® 500 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination |
| BG006 | Crossover Sequence 7 | Flovent Diskus® 250 mcg, followed by Flovent Diskus® 500 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg Flovent Diskus® 250 mcg: Flovent is an ICS Flovent Diskus® 500 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination |
| BG007 | Crossover Sequence 8 | Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 500 mcg Flovent Diskus® 250 mcg: Flovent is an ICS Flovent Diskus® 500 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||
| Forced expiratory volume at one second (FEV1) Percent of Predicted | FEV1, expressed as percent of predicted FEV1 based on age, sex, race, and height. | Mean | Standard Deviation | percent |
| |||||||||
| Asthma Control Test | Asthma Control Test: The score is calculated as the sum total of a 5-item questionnaire. Each item ranges from 1 (poor control) to 5 (good control) so that the range of the total score is 5 to 25. Scores below 20 indicate that asthma is not well controlled. | Asthma Control Test is not validated for use in children | Mean | Standard Deviation | units on a scale |
| ||||||||
| Childhood Asthma Control Test | Childhood Asthma Control Test is for children 4-11 years of age: The score is calculated as the sum total of a 7-item questionnaire. Four items ranges from 0 (poor control) to 3 (good control) and three items ranges from 0 (poor control) to 5 (good control) so so that the range of the total score is 0 to 27. Scores below 20 indicate that asthma is not well controlled. | Childhood Asthma Control Test is not validated for use in adults | Mean | Standard Deviation | units on a scale |
|
| 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 | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | This composite outcome uses a hierarchical method to ascertain differences in asthma control. For each participant, treatments are first compared to see if they differ in terms of exacerbations. If one treatment results in fewer exacerbations than another, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by exacerbations, then they are compared by asthma control days (ACDs). If one treatment yields at least 31 annualized ACDs more than another, it is deemed the superior treatment. If treatment superiority still cannot be assigned by ACDs, then they are compared by percent predicted FEV1 at the end of a treatment period. If one treatment yields at least 5% greater FEV1 than another, it is deemed the superior treatment. If treatment superiority cannot be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response. | Not all treatments were used in all participants. Flovent 500 was not used in children and Flovent 100 was not used in adolescents and adults | Posted | Number | probability | The last 12 weeks of each 14-week treatment period |
|
|
|
|
Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flovent 250 in Pediatric Group | Flovent 250 in participants under 12 years | 0 | 280 | 8 | 280 | 64 | 280 |
| EG001 | Advair 250/50 in Pediatric Group | Advair 250/50 in participants under 12 years | 0 | 280 | 1 | 280 | 52 | 280 |
| EG002 | Flovent 100 in Pediatric Group | Flovent 100 in participants under 12 years | 0 | 280 | 2 | 280 | 43 | 280 |
| EG003 | Advair 100/50 in Pediatric Group | Advair 100/50 in participants under 12 years | 0 | 280 | 4 | 280 | 27 | 280 |
| EG004 | Flovent 500 in Adolescent/Adult Group | Flovent 500 in participants 12 years and older | 0 | 294 | 10 | 294 | 53 | 294 |
| EG005 | Advair 250/50 in Adolescent/Adult Group | Advair 250/50 in participants 12 years and older | 0 | 294 | 7 | 294 | 47 | 294 |
| EG006 | Flovent 250 in Adolescent/Adult Group | Flovent 250 in participants 12 years and older | 0 | 294 | 7 | 294 | 35 | 294 |
| EG007 | Advair 100/50 in Adolescent/Adult Group | Advair 100/50 in participants 12 years and older | 0 | 294 | 8 | 294 | 34 | 294 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | ICD-9 | Non-systematic Assessment |
| |
| Acute Pericarditis | Cardiac disorders | ICD-9 | Non-systematic Assessment |
| |
| Acute Gastritis | Gastrointestinal disorders | ICD-9 | Non-systematic Assessment |
| |
| Acute Peptic Ulcer | Gastrointestinal disorders | ICD-9 | Non-systematic Assessment |
| |
| Acute Kidney Failure | Renal and urinary disorders | ICD-9 | Non-systematic Assessment |
| |
| Lumbar Spinal Cord Compression | Musculoskeletal and connective tissue disorders | ICD-9 | Non-systematic Assessment |
| |
| Acute Post-Op Pain | Nervous system disorders | ICD-9 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | ICD-9 | Non-systematic Assessment |
| |
| Asthma Exacerbation | Respiratory, thoracic and mediastinal disorders | ICD-9 | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | ICD-9 | Non-systematic Assessment |
| |
| Flu | Respiratory, thoracic and mediastinal disorders | ICD-9 | Non-systematic Assessment |
| |
| Adverse Food Reaction | Injury, poisoning and procedural complications | ICD-9 | Non-systematic Assessment |
| |
| Anaphylactic Shock | Injury, poisoning and procedural complications | ICD-9 | Non-systematic Assessment |
| |
| Closed Fracture | Injury, poisoning and procedural complications | ICD-9 | Non-systematic Assessment |
| |
| Major Depression | Psychiatric disorders | ICD-9 | Non-systematic Assessment |
| |
| Drug Withdrawal | Psychiatric disorders | ICD-9 | Non-systematic Assessment |
| |
| Intermittent Explosive Disorder | Psychiatric disorders | ICD-9 | Non-systematic Assessment |
| |
| Malignant Neoplasm Brain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ICD-9 | Non-systematic Assessment |
| |
| Malignant Neoplasm Thyroid | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ICD-9 | Non-systematic Assessment |
| |
| Altered Mental Status | Psychiatric disorders | ICD-9 | Non-systematic Assessment |
| |
| Chest Pain Not Elsewhere Classified | Gastrointestinal disorders | ICD-9 | Non-systematic Assessment |
| |
| Convulsions Not Elsewhere Classified | General disorders | ICD-9 | Non-systematic Assessment |
| |
| Syncope and Collapse | General disorders | ICD-9 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | ICD-9 | Non-systematic Assessment |
| |
| Acute Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | ICD-9 | Non-systematic Assessment |
| |
| Asthma Exacerbation | Respiratory, thoracic and mediastinal disorders | ICD-9 | Non-systematic Assessment |
| |
| Cough | General disorders | ICD-9 | Non-systematic Assessment |
| |
| Fever | General disorders | ICD-9 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Mauger | Penn State University | 717-531-7178 | dmauger@psu.edu |
| Aug 31, 2018 |
| Prot_SAP_000.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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
|
|
|
|
| Other |
|
|
|
|
|
|
| Advair 100/50 inferior to Flovent 250 |
|
|
| Advair 100/50 superior to Flovent 500 |
|
|
| Advair 100/50 inferior to Flovent 500 |
|
|
| Advair 100/50 superior to Advair 250/50 |
|
|
| Advair 100/50 inferior to Advair 250/50 |
|
|
| Advair 100/50 superior to Flovent 100 |
|
|
| Advair 100/50 inferior to Flovent 100 |
|
|
| Advair 250/50 superior to Flovent 250 |
|
|
| Advair 250/50 inferior to Flovent 250 |
|
|
| Advair 250/50 superior to Flovent 500 |
|
|
| Advair 250/50 inferior to Flovent 500 |
|
|
| Flovent 500 superior to Flovent 250 |
|
|
| Flovent 500 inferior to Flovent 250 |
|
|
| Flovent 250 superior to Flovent 100 |
|
|
| Flovent 250 inferior to Flovent 100 |
|
|
| Mixed Models Analysis |
| 0.9 |
| Superiority |
| Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 500 is equal to the inferiority of Advair 100/50 compared to Fluticasone 500 | Mixed Models Analysis | <0.001 | Superiority |
| Test of the null hypothesis that the superiority of Advair 100/50 compared to Advair 250/50 is equal to the inferiority of Advair 100/50 compared to Advair 250/50 | Mixed Models Analysis | 0.42 | Superiority |
| Test of the null hypothesis that the superiority of Advair 100/50 compared to Advair 250/50 is equal to the inferiority of Advair 100/50 compared to Advair 250/50 | Mixed Models Analysis | 0.84 | Superiority |
| Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 500 is equal to the inferiority of Advair 250/50 compared to Fluticasone 500 | Mixed Models Analysis | 0.015 | Superiority |
| Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 250 is equal to the inferiority of Advair 250/50 compared to Fluticasone 250 | Mixed Models Analysis | 0.085 | Superiority |
| Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 250 is equal to the inferiority of Advair 250/50 compared to Fluticasone 250 | Mixed Models Analysis | 0.62 | Superiority |
| Test of the null hypothesis that the superiority of Fluticasone 500 compared to Fluticasone 250 is equal to the inferiority of Fluticasone 500 compared to Fluticasone 250 | Mixed Models Analysis | 0.48 | Superiority |
| Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 100 is equal to the inferiority of Advair 100/50 compared to Fluticasone 100 | Mixed Models Analysis | 0.14 | Superiority |
| Test of the null hypothesis that the superiority of Fluticasone 250 compared to Fluticasone 100 is equal to the inferiority of Fluticasone 250 compared to Fluticasone 100 | Mixed Models Analysis | 0.096 | Superiority |