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The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration, FDA) in the African American population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symbicort | Experimental | Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID) |
|
| Budesonide | Experimental | Budesonide HFA pMDI 160 ug x 2 actuations BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/formoterol (SYMBICORT) pMDI | Drug | Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Asthma Exacerbations | An exacerbation was defined as symptomatic worsening requiring oral/systemic glucocorticoid therapy and/or emergency room visit and/or urgent care center visit and/or hospitalization. | 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Exacerbations | Number of participants with at least 1 exacerbation | 52 Weeks |
| QT Interval Corrected Using the Fridericia Formula Measured Via Electrocardiogram (ECG) | QT interval corrected using the Fridericia formula [QTc (Frid)] - Change from baseline to end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christer Hultquist, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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The study included a run-in period of 2 weeks when all patients were prescribed budesonide HFA pMDI 160 μg times 2 actuations BID at individual daily doses and rescue medication, as needed. To be randomized to treatment the patients needed to show pre-dose FEV1 of ≥50%. One patient in the budesonide group did not receive any dose.
First patient enrolled on 8 February 2007, the last patient completed the study on 30 November 2009. The study randomized participants only in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Symbicort | Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID |
| FG001 | Budesonide | Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Budesonide HFA pMDI | Drug | Budesonide HFA pMDI 160 ug x 2 actuations BID |
|
| Baseline and 52 weeks |
| Number of Patients With Shift From Normal to High Rate of Total Ectopic Ventricular Beats as Measured by 24-hour Holter Monitor Assessment | Total ectopic ventricular (VE) beats - number of participants with shift from normal (<50) to high (≥50) from baseline to visit 4. | Baseline and 2 weeks (visit 4) |
| Number of Patients With Shift From Normal to High Rate of Total Ectopic Supraventricular Beats as Measured by 24-hour Holter Monitor Assessment | Total ectopic supraventricular (VE) beats - number of participants with shift normal (<50) to high (≥50) from baseline to visit 4. | Baseline and 2 weeks (visit 4) |
| Total Number of Ventricular Runs as Measured by 24-hour Holter Monitor Assessment | Total ventricular runs - number of participants with shift normal (<1) to high (≥1) from baseline to week 2. | Baseline and 2 weeks (visit 4) |
| Diary Assessments - Rescue-free Day | Calculated as the number of rescue-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % rescue-free days in the baseline period and the active treatment period. A rescue-free day was one in which the patient answered "no" to having used rescue medication that day | baseline and 52 weeks |
| Diary Assessments - Symptom-free Day | Calculated as the number of symptom-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % symptom-free days in the baseline period and the active treatment period. A symptom-free day was one in which the patient answered "no" to having symptoms that day | baseline and 52 weeks |
| Diary Assessments - Asthma-control Day | Calculated as the number of asthma control days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % asthma control days in the baseline period and the active treatment period. An asthma control day was one in which the patient answered "no" to having symptoms and "0" to the use of rescue medication that day | baseline and 52 weeks |
| Onset of Effect Questionnaire (OEQ) | Number of participants with positive response to Item 2 in questionnaire "During the past week,you could feel your study medication begin to work right away. A positive response was defined as a response of "strongly agree" or "somewhat agree" | 1 week |
| Onset of Effect Questionnaire (OEQ) | Number of participants with positive response to Item 5 in questionnaire "During the past week, you were satisfied with how quickly you felt your study medication begin to work." The scale was scored on a 5-point Likert scale from strongly agree to strongly disagree. A positive response was defined as a response of "strongly agree" or "somewhat agree" | 1 week |
| Peak Expiratory Flow (PEF) in Morning | Change in AM PEF from baseline (mean over the 2 weeks run-in) to the average of the randomized treatment period. | baseline and 52 weeks |
| Forced Expiratory Volume in One Second (FEV1) | Change in pre-dose FEV1 from baseline (end of run-in, visit 3) to the average of the randomized treatment period | baseline and 52 weeks |
| Asthma Treatment Satisfaction Measure (ATSM) | Overall score - change from baseline to end of treatment. For 11 individual attributes, expectations were subtracted from the outcomes. This difference and the importance rating were combined in a weighted average which was then multiplied by the raw satisfaction measure. The final derived satisfaction measure was transformed to a 0 to 100 scale, with higher scores representing greater satisfaction. | Baseline and 52 weeks |
| Mobile |
| Alabama |
| United States |
| Research Site | Montgomery | Alabama | United States |
| Research Site | Muscle Shoals | Alabama | United States |
| Research Site | Phoenix | Arizona | United States |
| Research Site | Little Rock | Arkansas | United States |
| Research Site | Buena Park | California | United States |
| Research Site | Foothill Ranch | California | United States |
| Research Site | Long Beach | California | United States |
| Research Site | Los Angeles | California | United States |
| Research Site | Riverside | California | United States |
| Research Site | Rolling Hills Estates | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | Stockton | California | United States |
| Research Site | Torrance | California | United States |
| Research Site | Winnetka | California | United States |
| Research Site | Colorado Springs | Colorado | United States |
| Research Site | Denver | Colorado | United States |
| Research Site | Newark | Delaware | United States |
| Research Site | Washington D.C. | District of Columbia | United States |
| Research Site | Altamonte Springs | Florida | United States |
| Research Site | Clearwater | Florida | United States |
| Research Site | Destin | Florida | United States |
| Research Site | Gainesville | Florida | United States |
| Research Site | Hollywood | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Opa-locka | Florida | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Pensacola | Florida | United States |
| Research Site | Port Charlotte | Florida | United States |
| Research Site | South Miami | Florida | United States |
| Research Site | Tampa | Florida | United States |
| Research Site | West Palm Beach | Florida | United States |
| Research Site | Albany | Georgia | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Augusta | Georgia | United States |
| Research Site | Columbus | Georgia | United States |
| Research Site | Gainesville | Georgia | United States |
| Research Site | Savannah | Georgia | United States |
| Research Site | Stone Mountain | Georgia | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Peoria | Illinois | United States |
| Research Site | River Forest | Illinois | United States |
| Research Site | Indianapolis | Indiana | United States |
| Research Site | Merrillville | Indiana | United States |
| Research Site | South Bend | Indiana | United States |
| Research Site | Topeka | Kansas | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | Owensboro | Kentucky | United States |
| Research Site | Baton Rouge | Louisiana | United States |
| Research Site | Bogalusa | Louisiana | United States |
| Research Site | Marrero | Louisiana | United States |
| Research Site | Metairie | Louisiana | United States |
| Research Site | Monroe | Louisiana | United States |
| Research Site | New Orleans | Louisiana | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Sunset | Louisiana | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Bethesda | Maryland | United States |
| Research Site | Mitchellville | Maryland | United States |
| Research Site | Montgomery Village | Maryland | United States |
| Research Site | Wheaton | Maryland | United States |
| Research Site | Russells Mills | Massachusetts | United States |
| Research Site | Bay City | Michigan | United States |
| Research Site | Paw Paw | Michigan | United States |
| Research Site | Saginaw | Michigan | United States |
| Research Site | Southfield | Michigan | United States |
| Research Site | Minneapolis | Minnesota | United States |
| Research Site | Prentiss | Mississippi | United States |
| Research Site | Vicksburg | Mississippi | United States |
| Research Site | Omaha | Nebraska | United States |
| Research Site | Blackwood | New Jersey | United States |
| Research Site | Cherry Hill | New Jersey | United States |
| Research Site | Teaneck | New Jersey | United States |
| Research Site | Verona | New Jersey | United States |
| Research Site | Brooklyn | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Newburgh | New York | United States |
| Research Site | North Syracuse | New York | United States |
| Research Site | Rochester | New York | United States |
| Research Site | The Bronx | New York | United States |
| Research Site | Tonawanda | New York | United States |
| Research Site | Asheville | North Carolina | United States |
| Research Site | Charlotte | North Carolina | United States |
| Research Site | Greensboro | North Carolina | United States |
| Research Site | Hickory | North Carolina | United States |
| Research Site | Highpoint | North Carolina | United States |
| Research Site | Mooresville | North Carolina | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Cleveland | Ohio | United States |
| Research Site | Lyndhurst | Ohio | United States |
| Research Site | Parma | Ohio | United States |
| Research Site | Toledo | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Beaver | Pennsylvania | United States |
| Research Site | Collegeville | Pennsylvania | United States |
| Research Site | Harrisburg | Pennsylvania | United States |
| Research Site | Havertown | Pennsylvania | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Upland | Pennsylvania | United States |
| Research Site | Yardley | Pennsylvania | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Site | Columbia | South Carolina | United States |
| Research Site | Gaffney | South Carolina | United States |
| Research Site | Greenville | South Carolina | United States |
| Research Site | Simpsonville | South Carolina | United States |
| Research Site | Spartanburg | South Carolina | United States |
| Research Site | Union | South Carolina | United States |
| Research Site | Chattanooga | Tennessee | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Killeen | Texas | United States |
| Research Site | Missouri City | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Sugar Land | Texas | United States |
| Research Site | Sugarland | Texas | United States |
| Research Site | Waco | Texas | United States |
| Research Site | Hampton | Virginia | United States |
| Research Site | Norfolk | Virginia | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Springfield | Virginia | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Symbicort | Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID |
| BG001 | Budesonide | Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID |
| BG002 | 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 |
|
| 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 | Total Number of Asthma Exacerbations | An exacerbation was defined as symptomatic worsening requiring oral/systemic glucocorticoid therapy and/or emergency room visit and/or urgent care center visit and/or hospitalization. | The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization. | Posted | Number | Exacerbations | 52 Weeks |
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| |||||||||||||||||||||||||||||
| Secondary | Asthma Exacerbations | Number of participants with at least 1 exacerbation | The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization. | Posted | Number | Participants | 52 Weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | QT Interval Corrected Using the Fridericia Formula Measured Via Electrocardiogram (ECG) | QT interval corrected using the Fridericia formula [QTc (Frid)] - Change from baseline to end of treatment | The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization. | Posted | Least Squares Mean | 95% Confidence Interval | msec | Baseline and 52 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Patients With Shift From Normal to High Rate of Total Ectopic Ventricular Beats as Measured by 24-hour Holter Monitor Assessment | Total ectopic ventricular (VE) beats - number of participants with shift from normal (<50) to high (≥50) from baseline to visit 4. | Data were available for a subset of patients. | Posted | Number | Participants | Baseline and 2 weeks (visit 4) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Shift From Normal to High Rate of Total Ectopic Supraventricular Beats as Measured by 24-hour Holter Monitor Assessment | Total ectopic supraventricular (VE) beats - number of participants with shift normal (<50) to high (≥50) from baseline to visit 4. | Data were available for a subset of patients | Posted | Number | Participants | Baseline and 2 weeks (visit 4) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Total Number of Ventricular Runs as Measured by 24-hour Holter Monitor Assessment | Total ventricular runs - number of participants with shift normal (<1) to high (≥1) from baseline to week 2. | Data were available for a subset of patients. | Posted | Number | Participants | Baseline and 2 weeks (visit 4) |
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| Secondary | Diary Assessments - Rescue-free Day | Calculated as the number of rescue-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % rescue-free days in the baseline period and the active treatment period. A rescue-free day was one in which the patient answered "no" to having used rescue medication that day | The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of Rescue Free Day | baseline and 52 weeks |
|
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| Secondary | Diary Assessments - Symptom-free Day | Calculated as the number of symptom-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % symptom-free days in the baseline period and the active treatment period. A symptom-free day was one in which the patient answered "no" to having symptoms that day | The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of Symptom-free day | baseline and 52 weeks |
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| Secondary | Diary Assessments - Asthma-control Day | Calculated as the number of asthma control days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % asthma control days in the baseline period and the active treatment period. An asthma control day was one in which the patient answered "no" to having symptoms and "0" to the use of rescue medication that day | The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of Asthma-control day | baseline and 52 weeks |
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| Secondary | Onset of Effect Questionnaire (OEQ) | Number of participants with positive response to Item 2 in questionnaire "During the past week,you could feel your study medication begin to work right away. A positive response was defined as a response of "strongly agree" or "somewhat agree" | The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization. | Posted | Number | Participants | 1 week |
|
| ||||||||||||||||||||||||||||||
| Secondary | Onset of Effect Questionnaire (OEQ) | Number of participants with positive response to Item 5 in questionnaire "During the past week, you were satisfied with how quickly you felt your study medication begin to work." The scale was scored on a 5-point Likert scale from strongly agree to strongly disagree. A positive response was defined as a response of "strongly agree" or "somewhat agree" | The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization. | Posted | Number | Participants | 1 week |
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| Secondary | Peak Expiratory Flow (PEF) in Morning | Change in AM PEF from baseline (mean over the 2 weeks run-in) to the average of the randomized treatment period. | The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization. | Posted | Least Squares Mean | 95% Confidence Interval | Liters/minute | baseline and 52 weeks |
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| Secondary | Forced Expiratory Volume in One Second (FEV1) | Change in pre-dose FEV1 from baseline (end of run-in, visit 3) to the average of the randomized treatment period | The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization. | Posted | Least Squares Mean | 95% Confidence Interval | Litres | baseline and 52 weeks |
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| Secondary | Asthma Treatment Satisfaction Measure (ATSM) | Overall score - change from baseline to end of treatment. For 11 individual attributes, expectations were subtracted from the outcomes. This difference and the importance rating were combined in a weighted average which was then multiplied by the raw satisfaction measure. The final derived satisfaction measure was transformed to a 0 to 100 scale, with higher scores representing greater satisfaction. | The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline and 52 weeks |
|
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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 | Symbicort | Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID | 12 | 377 | 98 | 377 | ||
| EG001 | Budesonide | Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID | 15 | 365 | 84 | 365 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oesophageal Fistula | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Pneumonia Bacterial | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Subcutaneous Abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Foreign Body Trauma | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Gun Shot Wound | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Hip Fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Calculus Urinary | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
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| Haemorrhagic Ovarian Cyst | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
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| Ovarian Mass | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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The PI may use the Multi-Center Study Results and the Site Data for the limited purpose of his or her own research and academic analysis until the earlier of the publication of the first Multi-Center Study at all participating sites
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| 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 |
|---|---|
| D019819 | Budesonide |
| D000068759 | Formoterol Fumarate |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
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