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| ID | Type | Description | Link |
|---|---|---|---|
| 5U10HL064313 | U.S. NIH Grant/Contract | View source | |
| 5U10HL064288 | U.S. NIH Grant/Contract | View source | |
| 5U10HL064305 | U.S. NIH Grant/Contract | View source | |
| 5U10HL064295 | U.S. NIH Grant/Contract | View source | |
| 5U10HL064287 | U.S. NIH Grant/Contract | View source | |
| 5U10HL064307 | 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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Asthma is a common, serious illness among children in the United States. It can be effectively controlled through the use of preventative medications and "rescue" medications, which are used to control symptoms. This study will evaluate the impact and severity of asthma exacerbations that occur in children with mild persistent asthma who are receiving various combinations of medications for daily and rescue use.
Almost 9 million children in the United States have asthma, and it is a leading cause of hospitalizations and school absenteeism. Common asthma symptoms include wheezing, shortness of breath, chest tightness, and coughing. While there is no cure for asthma, most children who receive proper treatment are able to control symptoms and lead a normal life. Asthma is commonly treated with two types of medications: long-term control medication, such as inhaled corticosteroids (ICS), which is taken on a regular schedule to prevent symptoms and keep asthma under control, and quick-relief, or "rescue" medication, such as albuterol, which is used on an as-needed-basis with the onset of symptoms or an asthma attack. The purpose of this study is to assess the impact and severity of asthma exacerbations that occur in children with mild persistent asthma who are receiving ICS on a daily basis plus ICS and albuterol as rescue medications.
This study will begin with a 4-week screening period during which participants will be monitored while they use an inhaler with a low dose of ICS medication. Study visits will occur at study entry and Week 4. Participants will undergo a physical examination, lung function and airway pressure testing, and blood collection. At the Week 4 study visit, participants will be randomly assigned to one of the following four groups for 44 weeks of treatment:
Each participant will receive three inhalers with their assigned medication. One inhaler will be used twice daily throughout the study. The other two inhalers will be used consecutively on an as-needed-basis as rescue medication. Study visits will occur at Weeks 8, 16, 24, 32, 40, and 48. A physical examination, blood collection, and lung function and airway pressure testing will occur at selected visits. Questionnaires to assess quality of life and asthma control will also be completed. A methacholine challenge test will be completed at some study visits. This test artificially triggers an asthma attack to determine the severity of an individual's asthma. Throughout the study, participants will record asthma symptoms and rescue medication usage in a daily diary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily ICS + Rescue ICS | Experimental | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed |
|
| Daily ICS | Active Comparator | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed |
|
| Rescue ICS | Experimental | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed |
|
| Placebo | Placebo Comparator | Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beclomethasone dipropionate | Drug | Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants Experiencing an Asthma Exacerbation That Requires Systemic Corticosteroid Therapy | Measured during the 44-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Change Between Week 44 and Week 0 in the Asthma Control Days | An asthma control day was determined daily during each of the 44-week treatment periods. The primary analysis constructed the change between week 14 and week 0. | |
| Change Between Week 44 and Week 0 in Rescue Albuterol Puffs Per Day |
Not provided
Inclusion Criteria:
Able to perform reproducible spirometry according to American Thoracic Society (ATS) criteria
History of asthma symptoms that are adequately controlled in the 4 weeks prior to study entry, and meets at least one of the following criteria:
Forced expiratory volume in one second (FEV1) reversibility of greater than or equal to 12% following bronchodilator administration (4 puffs); individuals who do not meet this requirement may qualify for enrollment if their methacholine provocative concentration at 20% (PC20) is less than or equal to 12.5 milligrams per milliliter (mg/ml)
History of clinical varicella or varicella vaccine; individuals needing the vaccine may receive it from their primary care physician prior to study entry
Ability of parent to provide informed consent; verbal assent must be obtained from children less than 7 years of age and written assent must be obtained from children between 7 and 18 years of age
If female, willing to use an effective form of contraception
Participants will be eligible for the 44 weeks of treatment if, after the 4-week screening period, their asthma remains controlled, and they demonstrate at least 80% predicted pre-bronchodilator FEV1. Participants must meet ALL of the criteria stated below during the 8-week screening period to continue in the study:
Meets the definition of acceptable asthma control, which is NOT having one or more of the following during ANY 2-week period:
On average, on more than 2 days per week, experiences one or more of the following:
More than 1 night-time awakening due to asthma
Demonstrates adherence with taking study medications (at least 75% of scheduled doses), rescue medications (using both rescue inhalers for at least 75% of rescue doses), and completing patient diaries (at least 75% of days)
Pre-bronchodilator FEV1 greater than or equal to 80% predicted at study visits 2 and 3
Agrees to not use a spacer with beclomethasone/placebo study and rescue medications
NOTE: In January 2008, the Data and Safety Monitoring Board (DSMB) approved changes in the TREXA eligibility criteria, by which neither FEV1 reversibility ≥ 12% nor a participant's methacholine PC20 ≤ 12.5 mg/ml were required for randomization.
Exclusion Criteria:
Corticosteroid treatment for any condition prior to study entry within the following defined timepoints:
Current or prior use of medications known to significantly interact with corticosteroid disposition (within a 2-week period of study visit 1), including but not limited to carbamazepine, erythromycin or other macrolide antibiotics, phenobarbital, phenytoin, rifampin, or ketoconazole
Pre-bronchodilator FEV1 less than 60% predicted at study visit 1
Any hospitalization for asthma in the year prior to study entry
Presence of chronic or active lung disease other than asthma
Significant medical illness other than asthma, including thyroid disease, diabetes mellitus, Cushing's disease, Addison's disease, hepatic disease, or concurrent medical problems that could require oral corticosteroids during the study
History of cataracts, glaucoma, or any other medical disorder associated with an adverse effect to corticosteroids
Any asthma exacerbation in the past 3 months or more than 2 in the past year.
History of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure
History of adverse reactions to ICS preparations or any of its ingredients
Receiving hyposensitization therapy other than an established maintenance regimen (continuous regimen for at least 3 months)
Pregnant or breastfeeding
Cigarette smoking or smokeless tobacco use in the year prior to study entry
Refusal to consent to a genotype evaluation
Current participation or participation within 1 month of study entry in another investigational drug trial
Evidence that the family may be unreliable or nonadherent, or may move from the clinical center area before study completion
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| Name | Affiliation | Role |
|---|---|---|
| David T. Mauger, PhD | Penn State College of Medicine | Principal Investigator |
| Stanley J. Szefler, MD, PhD | National Jewish Health | Principal Investigator |
| Robert F. Lemanske, Jr., MD | University of Wisconsin, Madison | Principal Investigator |
| Robert S. Zeiger, MD, PhD | Kaiser Permanente Medical Center | Principal Investigator |
| Robert C. Strunk, MD | Washington University School of Medicine | Principal Investigator |
| Fernando D. Martinez, MD | University of Arizona College of Medicine | Principal Investigator |
| Lynn M. Taussig, MD | University of Denver | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona College of Medicine | Tucson | Arizona | 85724 | United States | ||
| Los Angeles, Kaiser Permanente Allergy Department |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21324520 | Result | Martinez FD, Chinchilli VM, Morgan WJ, Boehmer SJ, Lemanske RF Jr, Mauger DT, Strunk RC, Szefler SJ, Zeiger RS, Bacharier LB, Bade E, Covar RA, Friedman NJ, Guilbert TW, Heidarian-Raissy H, Kelly HW, Malka-Rais J, Mellon MH, Sorkness CA, Taussig L. Use of beclomethasone dipropionate as rescue treatment for children with mild persistent asthma (TREXA): a randomised, double-blind, placebo-controlled trial. Lancet. 2011 Feb 19;377(9766):650-7. doi: 10.1016/S0140-6736(10)62145-9. Epub 2011 Feb 14. | |
| 36161875 |
| Label | URL |
|---|---|
| Click here for the Childhood Asthma Research and Education (CARE) Network web site | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | A: Daily ICS + Rescue ICS | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate : Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Beclomethasone dipropionate | Drug | Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed |
|
|
| Albuterol sulfate | Drug | Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed |
|
|
| Rescue albuterol puffs were measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. |
| Change Between Week 44 and Week 0 in the Pre-bronchodilator Forced Expiratory Volume in One Second (FEV!) | Pre-bronchodilator FEV1 was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. |
| Change Between Week 44 and Week 0 in the Morning Peak Expiratory Flow Rate (PEFR) | Morning PEFR was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. |
| Change Between Week 44 and Week 0 in the Evening Peak Expiratory Flow Rate Variability (PEFR) | Evening PEFR was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. |
| Change Between Week 44 and Week 0 Peak Expiratory Flow Rate (PEFR) Variability | PEFR variability represents the relative change between the evening and morning PEFR measurements, so it could be a positive or negative number. It was measured daily during the 44-week treatment period. Specifically, the PEFR variability on a specific day is defined as 100% x (evening PEFR - morning PEFR)/{0.5*(evening PEFR + morning PEFR)} | PEFR variability was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. |
| Change Between Week 44 and Week 0 in the Exhaled Nitric Oxide (eNO) Measured in Parts Per Billion | eNO was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. |
| Change Between Week 44 and Week 0 in the Asthma-specific Quality of Life Assessment | The asthma-specific quality of life scale ranged from 1 (worst) to 7 (best) | The asthma-specific quality of life assessment was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. |
| Change Between Week 44 and Week 0 in the Asthma Control Test (ACT) | The ACT consisted of five questions, each ranging from 1 (worst) to 5 (best). The five questions were summed to yield an overall score that ranged from 5 (worst) to 25 (best). | The ACT was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. |
| Los Angeles |
| California |
| 90027 |
| United States |
| Kaiser Permanente Medical Center | San Diego | California | 92111 | United States |
| National Jewish Medical and Research Center | Denver | Colorado | 80206 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| University of Wisconsin - Madison | Madison | Wisconsin | 53792-3244 | United States |
| Kew KM, Flemyng E, Quon BS, Leung C. Increased versus stable doses of inhaled corticosteroids for exacerbations of chronic asthma in adults and children. Cochrane Database Syst Rev. 2022 Sep 26;9(9):CD007524. doi: 10.1002/14651858.CD007524.pub5. |
| FG001 | B: Daily ICS | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed |
| FG002 | C: Rescue ICS | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed |
| FG003 | D: Placebo | Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | A: Daily ICS + Rescue ICS | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed |
| BG001 | B: Daily ICS | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed |
| BG002 | C: Rescue ICS | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed |
| BG003 | D: Placebo | Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed |
| BG004 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Participants Experiencing an Asthma Exacerbation That Requires Systemic Corticosteroid Therapy | All randomized participants were included in the time-to-event analysis | Posted | Number | 95% Confidence Interval | participants | Measured during the 44-week treatment period |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change Between Week 44 and Week 0 in the Asthma Control Days | All randomized participants were included in the linear mixed-effects model analysis | Posted | Least Squares Mean | Standard Error | proportion of asthma control days | An asthma control day was determined daily during each of the 44-week treatment periods. The primary analysis constructed the change between week 14 and week 0. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change Between Week 44 and Week 0 in Rescue Albuterol Puffs Per Day | All randomized participants were included in the linear mixed-effects model analysis | Posted | Least Squares Mean | Standard Error | count of the number of puffs per day | Rescue albuterol puffs were measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change Between Week 44 and Week 0 in the Pre-bronchodilator Forced Expiratory Volume in One Second (FEV!) | All randomized participants were included in the linear mixed-effects model analysis | Posted | Least Squares Mean | Standard Error | liters | Pre-bronchodilator FEV1 was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change Between Week 44 and Week 0 in the Morning Peak Expiratory Flow Rate (PEFR) | All randomized participants were included in the linear mixed-effects model analysis | Posted | Least Squares Mean | Standard Error | liters per minute | Morning PEFR was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change Between Week 44 and Week 0 in the Evening Peak Expiratory Flow Rate Variability (PEFR) | All randomized participants were included in the linear mixed-effects model analysis | Posted | Least Squares Mean | Standard Error | liters per minute | Evening PEFR was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change Between Week 44 and Week 0 Peak Expiratory Flow Rate (PEFR) Variability | PEFR variability represents the relative change between the evening and morning PEFR measurements, so it could be a positive or negative number. It was measured daily during the 44-week treatment period. Specifically, the PEFR variability on a specific day is defined as 100% x (evening PEFR - morning PEFR)/{0.5*(evening PEFR + morning PEFR)} | All randomized participants were included in the linear mixed-effects model analysis | Posted | Least Squares Mean | Standard Error | relative change (AM and PM peak flow) | PEFR variability was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change Between Week 44 and Week 0 in the Exhaled Nitric Oxide (eNO) Measured in Parts Per Billion | All randomized participants were included in the linear mixed-effects model analysis | Posted | Least Squares Mean | Standard Error | parts per billion | eNO was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change Between Week 44 and Week 0 in the Asthma-specific Quality of Life Assessment | The asthma-specific quality of life scale ranged from 1 (worst) to 7 (best) | All randomized participants were included in the linear mixed-effects model analysis | Posted | Least Squares Mean | Standard Error | units on a scale | The asthma-specific quality of life assessment was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change Between Week 44 and Week 0 in the Asthma Control Test (ACT) | The ACT consisted of five questions, each ranging from 1 (worst) to 5 (best). The five questions were summed to yield an overall score that ranged from 5 (worst) to 25 (best). | All randomized participants were included in the linear mixed-effects model analysis | Posted | Least Squares Mean | Standard Error | units on a scale | The ACT was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. |
|
1 year
does not differ from the clinicaltrials.gov definitions
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 | A: Daily ICS + Rescue ICS | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed | 4 | 71 | 0 | 71 | ||
| EG001 | B: Daily ICS | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed | 2 | 72 | 0 | 72 | ||
| EG002 | C: Rescue ICS | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed | 6 | 71 | 0 | 71 | ||
| EG003 | D: Placebo | Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed | 17 | 74 | 0 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Treatment Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Treatment failure was defined as the requirement for a second dose of prednisone within any 6-month period. |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vernon M. Chinchilli, PhD | Penn State College of Medicine | 717-531-4262 | vchinchi@psu.edu |
| 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 |
|---|---|
| D001507 | Beclomethasone |
| D000420 | Albuterol |
| D017265 | Procaterol |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D006912 | Hydroxyquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| OG002 | C: Rescue ICS | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed |
| OG003 | D: Placebo | Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed |
|
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| OG002 | C: Rescue ICS | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed |
| OG003 | D: Placebo | Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed |
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| OG002 | C: Rescue ICS | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed |
| OG003 | D: Placebo | Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed |
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| OG002 | C: Rescue ICS | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed |
| OG003 | D: Placebo | Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed |
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| OG002 | C: Rescue ICS | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed |
| OG003 | D: Placebo | Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed |
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| OG002 | C: Rescue ICS | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed |
| OG003 | D: Placebo | Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed |
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| OG002 | Rescue ICS | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed |
| OG003 | Placebo | Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed |
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| OG002 | C: Rescue ICS | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed |
| OG003 | D: Placebo | Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed |
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| OG002 | C: Rescue ICS | Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed |
| OG003 | D: Placebo | Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed |
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