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This purpose of the study is to investigate if budesonide pMDI 160 �g twice a day during 6 weeks is effective and safe in treating asthmatic children aged 6 to <12 years
Phase 2, double-blind, randomized, parallel-group, placebo-controlled, multicenter study, comparing budesonide pMDI 160 �g bid with placebo: a 6-week efficacy and safety study in children aged 6 to <12 years with asthma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Budesonide pMDI 160 ug bid (80 ug x 2 inhalations bid) |
|
| 2 | Placebo Comparator | Placebo pMDI 2 inhalations bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| budesonide | Drug | pMDI, inhalation, bid, 6 weeks |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average | The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period. | Baseline to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average | FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Göran Eckerwall, MD | AZ R&D Mölndal | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Scottsdale | Arizona | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26460293 | Derived | Meltzer EO, Pearlman DS, Eckerwall G, Uryniak T, DePietro M, Lampl K. Efficacy and safety of budesonide administered by pressurized metered-dose inhaler in children with asthma. Ann Allergy Asthma Immunol. 2015 Dec;115(6):516-22. doi: 10.1016/j.anai.2015.09.007. Epub 2015 Oct 13. |
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The study consisted of a screening visit (Visit 1), an enrollment visit (Visit 2), a 7- to 21-day run-in/qualification period, a randomization visit (Visit 3), and 6 further weekly visits during a treatment period of 6 weeks. A telephone follow-up was conducted approximately 2 weeks after the final study visit.
This multicenter study was conducted in Bulgaria, Hungary, Latvia, Poland, Slovakia, South Africa, and the United States between 07 August 2011 and 05 April 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo pMDI bid |
| FG001 | Budesonide | Budesonide pMDI 160 mcg bid |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
pMDI, inhalation, bid, 6 weeks |
|
| Baseline to 6 weeks |
| Change in Evening PEF From Baseline to the Treatment Period Average | The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period. | Baseline to 6 weeks |
| Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average | FVC is the total volume of air expired after a full inspiration. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period. | Baseline to 6 weeks |
| Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average | FEF25-75 is the average rate of airflow during the midportion of the forced vital capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period. | Baseline to 6 weeks |
| Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average | Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep. | Baseline to 6 weeks |
| Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average | Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep. | Baseline to 6 weeks |
| Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average | Patients, with the help of their caregiver, were asked to respond to a standard question each morning as they completed their eDiary. The question to be answered was, "Did your asthma cause you to wake-up last night?" If yes, patients were asked, "Did you need to use your reliever medication (albuterol/salbutamol inhaler) before you went back to sleep?" Baseline is defined as the percentage of days where patient experienced nighttime awakenings out of all available days where data was collected during the last 7 days of the run-in period. | Baseline to 6 weeks |
| Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average | The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, "How many albuterol/salbutamol inhalations since last diary entry?" | Baseline to 6 weeks |
| Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average | The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, "How many albuterol/salbutamol inhalations since last diary entry?" | Baseline to 6 weeks |
| Number of Withdrawals Due to Pre-defined Asthma Events | Patients were considered to have experienced a "pre-defined asthma event" if any of the following conditions were met during the study: 1. At each visit or follow-up visit, a decrease in morning pre-dose FEV1 >=20% from the Visit 3 (randomization visit) morning pre-dose FEV1 or a decrease to <65% of predicted normal value; 2. The use of >=8 actuations of albuterol/salbutamol per day on 3 or more days within any period of 7 consecutive days following randomization; 3. A decrease in morning PEF >=20% from baseline on 3 or more days within any period of 7 consecutive days after randomization; 4. Two or more nights with an awakening due to asthma, which required the use of reliever medication within any period of 7 consecutive days after randomization; 5. A clinical exacerbation requiring emergency treatment, hospitalization, or use of an asthma medication not allowed by the study protocol. | Baseline to 6 weeks |
| Fresno |
| California |
| United States |
| Research Site | Granada Hills | California | United States |
| Research Site | Huntington Beach | California | United States |
| Research Site | Mission Viejo | California | United States |
| Research Site | Orange | California | United States |
| Research Site | Palmdal | California | United States |
| Research Site | Rolling Hills Estate | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | Stockton | California | United States |
| Research Site | Centennial | Colorado | United States |
| Research Site | Colorado Springs | Colorado | United States |
| Research Site | Denver | Colorado | United States |
| Research Site | Coral Gables | Florida | United States |
| Research Site | Orange City | Florida | United States |
| Research Site | Sarasota | Florida | United States |
| Research Site | Albany | Georgia | United States |
| Research Site | Gainesville | Georgia | United States |
| Research Site | Normal | Illinois | United States |
| Research Site | Overland Park | Kansas | United States |
| Research Site | Bethesda | Maryland | United States |
| Research Site | North Dartmouth | Massachusetts | United States |
| Research Site | Ypsilanti | Michigan | United States |
| Research Site | Plymouth | Minnesota | United States |
| Research Site | Columbia | Missouri | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Bozeman | Montana | United States |
| Research Site | Bellevue | Nebraska | United States |
| Research Site | Omaha | Nebraska | United States |
| Research Site | Ocean City | New Jersey | United States |
| Research Site | Skillman | New Jersey | United States |
| Research Site | Teaneck | New Jersey | United States |
| Research Site | Rockville Centre | New York | United States |
| Research Site | High Point | North Carolina | United States |
| Research Site | Canton | Ohio | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Cleveland | Ohio | United States |
| Research Site | Sylvania | Ohio | United States |
| Research Site | Toledo | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Gresham | Oregon | United States |
| Research Site | Lake Oswego | Oregon | United States |
| Research Site | Medford | Oregon | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Altoona | Pennsylvania | United States |
| Research Site | Pittsburgh | Pennsylvania | United States |
| Research Site | Upland | Pennsylvania | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | El Paso | Texas | United States |
| Research Site | Fort Worth | Texas | United States |
| Research Site | Georgetown | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Waco | Texas | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Greenfield | Wisconsin | United States |
| Research Site | West Allis | Wisconsin | United States |
| Research Site | Plovdiv | Bulgaria |
| Research Site | Rousse | Bulgaria |
| Research Site | Sofia | Bulgaria |
| Research Site | Budapest | Hungary |
| Research Site | Debrecen | Hungary |
| Research Site | Győr | Hungary |
| Research Site | Kiskunhalas | Hungary |
| Research Site | Marcali | Hungary |
| Research Site | Miskolc | Hungary |
| Research Site | Nyíregyháza | Hungary |
| Research Site | Sopron | Hungary |
| Research Site | Szeged | Hungary |
| Research Site | Szigetvár | Hungary |
| Research Site | Törökbálint | Hungary |
| Research Site | Zalaegerszeg | Hungary |
| Research Site | Ogre | Latvia |
| Research Site | Rēzekne | Latvia |
| Research Site | Riga | Latvia |
| Research Site | Bialystok | Poland |
| Research Site | Częstochowa | Poland |
| Research Site | Karpacz | Poland |
| Research Site | Lodz | Poland |
| Research Site | Pabianice | Poland |
| Research Site | Bratislava | Slovakia |
| Research Site | Lučenec | Slovakia |
| Research Site | Krugersdorp | Gauteng | South Africa |
| Research Site | Durban | KwaZulu-Natal | South Africa |
| Research Site | Pietermariztburg | KwaZulu-Natal | South Africa |
| Research Site | Claremont | W Cape | South Africa |
| Research Site | Panorama | W Cape | South Africa |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo pMDI bid |
| BG001 | Budesonide | Budesonide pMDI 160 mcg 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 |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Forced expiratory volume in 1 second (FEV1) | Mean | Standard Deviation | liters |
|
| 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 Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average | The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period. | The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint. | Posted | Least Squares Mean | Standard Error | liters/minute | Baseline to 6 weeks |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average | FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period. | The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint. | Posted | Least Squares Mean | Standard Error | liters | Baseline to 6 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Evening PEF From Baseline to the Treatment Period Average | The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period. | The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint. | Posted | Least Squares Mean | Standard Error | liters/minute | Baseline to 6 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average | FVC is the total volume of air expired after a full inspiration. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period. | The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint. | Posted | Least Squares Mean | Standard Error | liters | Baseline to 6 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average | FEF25-75 is the average rate of airflow during the midportion of the forced vital capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period. | The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint. | Posted | Least Squares Mean | Standard Error | liters/second | Baseline to 6 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average | Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep. | The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 6 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average | Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep. | The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 6 weeks |
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| Secondary | Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average | Patients, with the help of their caregiver, were asked to respond to a standard question each morning as they completed their eDiary. The question to be answered was, "Did your asthma cause you to wake-up last night?" If yes, patients were asked, "Did you need to use your reliever medication (albuterol/salbutamol inhaler) before you went back to sleep?" Baseline is defined as the percentage of days where patient experienced nighttime awakenings out of all available days where data was collected during the last 7 days of the run-in period. | The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint. | Posted | Least Squares Mean | Standard Error | percentage of days with awakenings | Baseline to 6 weeks |
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| Secondary | Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average | The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, "How many albuterol/salbutamol inhalations since last diary entry?" | The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint. | Posted | Least Squares Mean | Standard Error | inhalations per day | Baseline to 6 weeks |
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| Secondary | Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average | The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, "How many albuterol/salbutamol inhalations since last diary entry?" | The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint. | Posted | Least Squares Mean | Standard Error | inhalations per day | Baseline to 6 weeks |
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| Secondary | Number of Withdrawals Due to Pre-defined Asthma Events | Patients were considered to have experienced a "pre-defined asthma event" if any of the following conditions were met during the study: 1. At each visit or follow-up visit, a decrease in morning pre-dose FEV1 >=20% from the Visit 3 (randomization visit) morning pre-dose FEV1 or a decrease to <65% of predicted normal value; 2. The use of >=8 actuations of albuterol/salbutamol per day on 3 or more days within any period of 7 consecutive days following randomization; 3. A decrease in morning PEF >=20% from baseline on 3 or more days within any period of 7 consecutive days after randomization; 4. Two or more nights with an awakening due to asthma, which required the use of reliever medication within any period of 7 consecutive days after randomization; 5. A clinical exacerbation requiring emergency treatment, hospitalization, or use of an asthma medication not allowed by the study protocol. | The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint. | Posted | Number | participants | Baseline to 6 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 | Budesonide pMDI 160mcg b.i.d. | 0 | 152 | 27 | 152 | |||
| EG001 | Placebo pMDI b.i.d. | 0 | 152 | 40 | 152 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INFLUENZA | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Geoff Gilmartin | AstraZeneca | ClinicalTrialTransparency@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 |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
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| 8 to- <12 years |
|
| Male |
|
| Native Hawaiian/Pacific Islander |
|
| African American |
|
| Asian (other than Chinese and Japanese) |
|
| Not Applicable |
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| Other |
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| Units | Counts |
|---|---|
| Participants |
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