Phase
Condition
Asthma
Treatment
AS MDI
BDA MDI
Clinical Study ID
Ages 12-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Confirmed clinical diagnosis of asthma at least 12 months.
Receiving one of the following scheduled asthma maintenance therapies for at least 3months with stable dosing for at least the last one month
Low-to-high-dose Inhaled corticosteroid(s) (ICS)
Low-to-high-dose ICS or ICS/long-acting β2-agonist (LABA) with or without oneadditional maintenance therapy from the following: leukotriene receptorantagonist (LTRA), long-acting muscarinic antagonist (LAMA), or theophylline
Receiving inhaled short-acting β2-agonist (SABA) as needed.
A documented history of at least one severe asthma exacerbation within 12 months.
Use of Sponsor-provided albuterol sulfate inhalation aerosol medication.
Demonstrate acceptable MDI administration technique as assessed by the investigator;use of spacers is prohibited.
Able to perform acceptable and reproducible peak expiratory flow (PEF) measurementsas assessed by the investigator.
Participants must adhere to protocol specific contraception methods.
Negative urine pregnancy test for participants of childbearing potential.
Have a BMI < 40 kg/ m^2.
Capable of giving assent (signing the assent form) to participate in the study whichincludes compliance with the requirements and restrictions. The caregiver of thepatient must be capable of giving written informed consent for the patient'sparticipation in the study. Consent and assent forms must be completed prior to anystudy-specific procedures.
Exclusion
Exclusion Criteria:
Life-threatening asthma defined as any history of significant asthma episode(s)requiring intubation associated with hypercapnia, respiratory arrest, hypoxicseizures, or asthma-related syncopal episode(s).
Experienced > 3 severe asthma exacerbations within 12 months before screening.
Completed treatment for lower respiratory infection and severe asthma exacerbationwith SCS within 4 weeks of screening.
Upper respiratory infection involving antibiotic treatment not resolved.
Current smokers, former smokers with > 10 pack-years history, or former smokers whostopped smoking < 6 months (including all forms of tobacco, e-cigarettes [vaping],and marijuana).
Other significant lung disease, including regular or occasional use of oxygen.
Historical or current evidence of a clinically significant disease including, butnot limited to: cardiovascular, hepatic, renal, hematological, neuropsychological,endocrine, or gastrointestinal disorders.
Cancer not in complete remission for at least 5 years.
History or hospitalization for psychiatric disorder or attempted suicide within oneyear.
Significant abuse of alcohol or drugs, in the opinion of the investigator.
Oral corticosteroid(s) (OCS)/SCS use (any dose and any indication) within 4 weeksbefore Visit 1 or chronic use of OCS/SCS (≥ 3 weeks use in 3 months prior to Visit 1).
Use of any oral SABAs within one month.
Having a known or suspected hypersensitivity to albuterol/salbutamol, or budesonideand/or their excipients.
Study Design
Study Description
Connect with a study center
Research Site
Beijing, 100191
ChinaActive - Recruiting
Research Site
Beijing 1816670, 100050
ChinaSite Not Available
Research Site
Bengbu, 233004
ChinaActive - Recruiting
Research Site
Bengbu 1816440, 233004
ChinaSite Not Available
Research Site
Chengdu, 610066
ChinaActive - Recruiting
Research Site
Chengdu 1815286, 610066
ChinaSite Not Available
Research Site
Chongqing, 401122
ChinaActive - Recruiting
Research Site
Chongqing 1814906, 401122
ChinaSite Not Available
Research Site
Hohhot, 10050
ChinaActive - Recruiting
Research Site
Hohhot 2036892, 10050
ChinaSite Not Available
Research Site
Mianyang, 621000
ChinaActive - Recruiting
Research Site
Mianyang 1800627, 621000
ChinaSite Not Available
Research Site
Shanghai, 200433
ChinaActive - Recruiting
Research Site
Shanghai 1796236, 200433
ChinaSite Not Available
Research Site
Shantou, 515041
ChinaActive - Recruiting
Research Site
Shenyang, 110004
ChinaActive - Recruiting
Research Site
Shenyang 2034937, 110004
ChinaSite Not Available
Research Site
Shenzhen, 518026
ChinaActive - Recruiting
Research Site
Shenzhen 1795565, 518026
ChinaSite Not Available
Research Site
Suzhou, 215002
ChinaActive - Recruiting
Research Site
Suzhou 1886760, 215002
ChinaSite Not Available
Research Site
Taizhou, 318000
ChinaActive - Recruiting
Research Site
Taizhou 1793505, 318000
ChinaSite Not Available
Research Site
Tianjin, 300211
ChinaActive - Recruiting
Research Site
Tianjin 1792947, 300050
ChinaSite Not Available
Research Site
Wuhan, 430000
ChinaActive - Recruiting
Research Site
Wuhan 1791247, 430000
ChinaSite Not Available
Research Site
Yanji, 133000
ChinaActive - Recruiting
Research Site
Yanji 2033467, 133000
ChinaSite Not Available
Research Site
Yantai, 264000
ChinaActive - Recruiting
Research Site
Yantai 1787093, 264000
ChinaSite Not Available
Research Site
Zhongshan, 528400
ChinaActive - Recruiting
Research Site
Zhongshan 6986104, 528400
ChinaSite Not Available
Research Site
Chihuahua, 31238
MexicoSite Not Available
Research Site
Chihuahua City, 31000
MexicoActive - Recruiting
Research Site
Chihuahua City 4014338, 31000
MexicoSite Not Available
Research Site
Guadalajara, 44500
MexicoActive - Recruiting
Research Site
Guadalajara 4005539, 44100
MexicoSite Not Available
Research Site
Monterrey, 64465
MexicoActive - Recruiting
Research Site
Monterrey 3995465, 64465
MexicoSite Not Available
Research Site
Durban, 4092
South AfricaActive - Recruiting
Research Site
Durban 1007311, 3630
South AfricaSite Not Available
Research Site
Krugersdorp, 1739
South AfricaActive - Recruiting
Research Site
Krugersdorp 986822, 1739
South AfricaSite Not Available
Research Site
Middelburg, 1055
South AfricaActive - Recruiting
Research Site
Middelburg 976361, 1055
South AfricaSite Not Available
Research Site
Panorama, 7500
South AfricaActive - Recruiting
Research Site
Panorama 966305, 7500
South AfricaSite Not Available
Research Site
Somerset West, 7130
South AfricaSite Not Available
Research Site
Somerset West 6951112, 7130
South AfricaSite Not Available
Research Site
Welkom, 9460
South AfricaActive - Recruiting
Research Site
Welkom 940909, 9460
South AfricaSite Not Available
Research Site
Anchorage, Alaska 99508
United StatesActive - Recruiting
Research Site
Anchorage 5879400, Alaska 5879092 99508
United StatesSite Not Available
Research Site
Gilbert, Arizona 85234
United StatesActive - Recruiting
Research Site
Phoenix, Arizona 85016
United StatesSite Not Available
Research Site
Gilbert 5295903, Arizona 5551752 85234
United StatesSite Not Available
Research Site
Phoenix 5308655, Arizona 5551752 85016
United StatesSite Not Available
Research Site
Little Rock, Arkansas 72202
United StatesActive - Recruiting
Research Site
Little Rock 4119403, Arkansas 4099753 72202
United StatesSite Not Available
Research Site
Long Beach, California 90815
United StatesActive - Recruiting
Research Site
Madera, California 93636
United StatesSite Not Available
Research Site
Mission Viejo, California 92691
United StatesActive - Recruiting
Research Site
Moreno Valley, California 92553
United StatesActive - Recruiting
Research Site
Orange, California 92868
United StatesActive - Recruiting
Research Site
Riverside, California 92506
United StatesActive - Recruiting
Research Site
San Diego, California 92123
United StatesActive - Recruiting
Research Site
San Francisco, California 94143
United StatesSite Not Available
Research Site
Westminster, California 92683
United StatesActive - Recruiting
Research Site
Long Beach 5367929, California 5332921 90815
United StatesSite Not Available
Research Site
Madera 5369568, California 5332921 93636
United StatesSite Not Available
Research Site
Mission Viejo 5373763, California 5332921 92691
United StatesSite Not Available
Research Site
Moreno Valley 5374732, California 5332921 92553
United StatesSite Not Available
Research Site
Orange 5379513, California 5332921 92868
United StatesSite Not Available
Research Site
Riverside 5387877, California 5332921 92506
United StatesSite Not Available
Research Site
San Diego 5391811, California 5332921 92123
United StatesSite Not Available
Research Site
San Francisco 5391959, California 5332921 94143
United StatesSite Not Available
Research Site
Westminster 5408406, California 5332921 92683
United StatesSite Not Available
Research Site
Denver, Colorado 80206
United StatesActive - Recruiting
Research Site
Denver 5419384, Colorado 5417618 80206
United StatesSite Not Available
Research Site
Wilmington, Delaware 19803
United StatesActive - Recruiting
Research Site
Wilmington 4145381, Delaware 4142224 19803
United StatesSite Not Available
Research Site
Destin, Florida 32541
United StatesActive - Recruiting
Research Site
Jacksonville, Florida 32207
United StatesActive - Recruiting
Research Site
Largo, Florida 33777
United StatesActive - Recruiting
Research Site
Miami, Florida 33145
United StatesActive - Recruiting
Research Site
Pembroke Pines, Florida 33026
United StatesSite Not Available
Research Site
Seminole, Florida 33777
United StatesSite Not Available
Research Site
Tampa, Florida 33613
United StatesSite Not Available
Research Site
Destin 4153188, Florida 4155751 32541
United StatesSite Not Available
Research Site
Jacksonville 4160021, Florida 4155751 32207
United StatesSite Not Available
Research Site
Largo 4161580, Florida 4155751 33777
United StatesSite Not Available
Research Site
Miami 4164138, Florida 4155751 33145
United StatesSite Not Available
Research Site
Pembroke Pines 4168139, Florida 4155751 33026
United StatesSite Not Available
Research Site
Tampa 4174757, Florida 4155751 33613
United StatesSite Not Available
Research Site
Atlanta, Georgia 30329
United StatesActive - Recruiting
Research Site
Columbus, Georgia 31904
United StatesActive - Recruiting
Research Site
Fayetteville, Georgia 30214
United StatesActive - Recruiting
Research Site
Atlanta 4180439, Georgia 4197000 30329
United StatesSite Not Available
Research Site
Columbus 4188985, Georgia 4197000 31904
United StatesSite Not Available
Research Site
Fayetteville 4194474, Georgia 4197000 30214
United StatesSite Not Available
Research Site
Meridian, Idaho 83646
United StatesSite Not Available
Research Site
Meridian 5600685, Idaho 5596512 83646
United StatesSite Not Available
Research Site
Normal, Illinois 61761
United StatesActive - Recruiting
Research Site
River Forest, Illinois 60305
United StatesSite Not Available
Research Site
Normal 4903780, Illinois 4896861 61761
United StatesSite Not Available
Research Site
River Forest 4907637, Illinois 4896861 60305
United StatesSite Not Available
Research Site
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Research Site
Indianapolis 4259418, Indiana 4921868 46202
United StatesSite Not Available
Research Site
Kansas City 4273837, Kansas 4273857 66160
United StatesSite Not Available
Research Site
Louisville, Kentucky 40202
United StatesActive - Recruiting
Research Site
Louisville 4299276, Kentucky 6254925 40202
United StatesSite Not Available
Research Site
Lafayette, Louisiana 70508
United StatesActive - Recruiting
Research Site
New Orleans, Louisiana 70121
United StatesActive - Recruiting
Research Site
Lafayette 4330145, Louisiana 4331987 70508
United StatesSite Not Available
Research Site
New Orleans 4335045, Louisiana 4331987 70121
United StatesSite Not Available
Research Site
Ellicott City, Maryland 21043
United StatesActive - Recruiting
Research Site
Silver Spring, Maryland 20902
United StatesActive - Recruiting
Research Site
White Marsh, Maryland 21162
United StatesActive - Recruiting
Research Site
Ellicott City 4354265, Maryland 4361885 21043
United StatesSite Not Available
Research Site
Silver Spring 4369596, Maryland 4361885 20902
United StatesSite Not Available
Research Site
White Marsh 4373426, Maryland 4361885 21162
United StatesSite Not Available
Research Site
Boston, Massachusetts 02114
United StatesSite Not Available
Research Site
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
Research Site
Detroit, Michigan 48201
United StatesActive - Recruiting
Research Site
Detroit 4990729, Michigan 5001836 48201
United StatesSite Not Available
Research Site
Mankato, Minnesota 56001
United StatesActive - Recruiting
Research Site
Mankato 5036420, Minnesota 5037779 56001
United StatesSite Not Available
Research Site
Kansas City, Missouri 64108
United StatesSite Not Available
Research Site
Kansas City 4393217, Missouri 4398678 64108
United StatesSite Not Available
Research Site
Missoula, Montana 59804
United StatesActive - Recruiting
Research Site
Missoula 5666639, Montana 5667009 59804
United StatesSite Not Available
Research Site
Lincoln, Nebraska 68510
United StatesActive - Recruiting
Research Site
Omaha, Nebraska 68114
United StatesActive - Recruiting
Research Site
Lincoln 5072006, Nebraska 5073708 68510
United StatesSite Not Available
Research Site
Omaha 5074472, Nebraska 5073708 68114
United StatesSite Not Available
Research Site
Newark, New Jersey 07103
United StatesActive - Recruiting
Research Site
Northfield, New Jersey 08225
United StatesActive - Recruiting
Research Site
Ocean City, New Jersey 07712
United StatesActive - Recruiting
Research Site
Paramus, New Jersey 07652
United StatesActive - Recruiting
Research Site
Newark 5101798, New Jersey 5101760 07103
United StatesSite Not Available
Research Site
Northfield 4503316, New Jersey 5101760 08225
United StatesSite Not Available
Research Site
Ocean City 4503351, New Jersey 5101760 07712
United StatesSite Not Available
Research Site
Paramus 5102387, New Jersey 5101760 07652
United StatesSite Not Available
Research Site
Albuquerque, New Mexico 87106
United StatesActive - Recruiting
Research Site
Albuquerque 5454711, New Mexico 5481136 87106
United StatesSite Not Available
Research Site
Albany, New York 12208
United StatesActive - Recruiting
Research Site
Bronx, New York 10461
United StatesSite Not Available
Research Site
Cortland, New York 13045
United StatesActive - Recruiting
Research Site
Hawthorne, New York 10532
United StatesActive - Recruiting
Research Site
Hollis, New York 11423
United StatesSite Not Available
Research Site
New York, New York 10019
United StatesSite Not Available
Research Site
Rochester, New York 14607
United StatesActive - Recruiting
Research Site
The Bronx, New York 10459
United StatesActive - Recruiting
Research Site
Vestal, New York 13850
United StatesSite Not Available
Research Site
Watertown, New York 13601
United StatesActive - Recruiting
Research Site
Albany 5106834, New York 5128638 12208
United StatesSite Not Available
Research Site
Cortland 5113790, New York 5128638 13045
United StatesSite Not Available
Research Site
Hawthorne 5120284, New York 5128638 10532
United StatesSite Not Available
Research Site
Hollis 5121026, New York 5128638 11423
United StatesSite Not Available
Research Site
New York 5128581, New York 5128638 10032
United StatesSite Not Available
Research Site
Rochester 5134086, New York 5128638 14607
United StatesSite Not Available
Research Site
The Bronx 5110266, New York 5128638 10459
United StatesSite Not Available
Research Site
Vestal 5142296, New York 5128638 13850
United StatesSite Not Available
Research Site
Watertown 5143396, New York 5128638 13601
United StatesSite Not Available
Research Site
Charlotte, North Carolina 28277
United StatesSite Not Available
Research Site
Charlotte 4460243, North Carolina 4482348 28277
United StatesSite Not Available
Research Site
Cincinnati, Ohio 45229
United StatesSite Not Available
Research Site
Dayton, Ohio 45424
United StatesActive - Recruiting
Research Site
Findlay, Ohio 45840
United StatesActive - Recruiting
Research Site
Toledo, Ohio 43617
United StatesActive - Recruiting
Research Site
Cincinnati 4508722, Ohio 5165418 45229
United StatesSite Not Available
Research Site
Columbus 4509177, Ohio 5165418 43205
United StatesSite Not Available
Research Site
Dayton 4509884, Ohio 5165418 45424
United StatesSite Not Available
Research Site
Findlay 5153924, Ohio 5165418 45840
United StatesSite Not Available
Research Site
Toledo 5174035, Ohio 5165418 43617
United StatesSite Not Available
Research Site
Oklahoma City, Oklahoma 73120
United StatesActive - Recruiting
Research Site
Yukon, Oklahoma 73099
United StatesActive - Recruiting
Research Site
Oklahoma City 4544349, Oklahoma 4544379 73104
United StatesSite Not Available
Research Site
Yukon 4556165, Oklahoma 4544379 73099
United StatesSite Not Available
Research Site
Pittsburgh, Pennsylvania 15241
United StatesActive - Recruiting
Research Site
Pittsburgh 5206379, Pennsylvania 6254927 15241
United StatesSite Not Available
Research Site
Charleston, South Carolina 29425
United StatesActive - Recruiting
Research Site
Rock Hill, South Carolina 29730
United StatesActive - Recruiting
Research Site
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
Research Site
Rock Hill 4593142, South Carolina 4597040 29730
United StatesSite Not Available
Research Site
Sioux Falls, South Dakota 57105
United StatesActive - Recruiting
Research Site
Sioux Falls 5231851, South Dakota 5769223 57105
United StatesSite Not Available
Research Site
Nashville, Tennessee 37232
United StatesActive - Recruiting
Research Site
Nashville 4644585, Tennessee 4662168 37232
United StatesSite Not Available
Research Site
Austin, Texas 78759
United StatesActive - Recruiting
Research Site
Baytown, Texas 77521
United StatesActive - Recruiting
Research Site
Beaumont, Texas 77701
United StatesActive - Recruiting
Research Site
Bellaire, Texas 77401
United StatesActive - Recruiting
Research Site
Corsicana, Texas 75110
United StatesActive - Recruiting
Research Site
Dallas, Texas 75231
United StatesActive - Recruiting
Research Site
Frisco, Texas 75034
United StatesSite Not Available
Research Site
Houston, Texas 77065
United StatesActive - Recruiting
Research Site
Kerrville, Texas 78028
United StatesSite Not Available
Research Site
McKinney, Texas 75069
United StatesActive - Recruiting
Research Site
San Antonio, Texas 78229
United StatesActive - Recruiting
Research Site
Tyler, Texas 75708
United StatesActive - Recruiting
Research Site
Austin 4671654, Texas 4736286 78759
United StatesSite Not Available
Research Site
Baytown 4672731, Texas 4736286 77521
United StatesSite Not Available
Research Site
Beaumont 4672989, Texas 4736286 77701
United StatesSite Not Available
Research Site
Bellaire 4673353, Texas 4736286 77401
United StatesSite Not Available
Research Site
Corsicana 4683462, Texas 4736286 75110
United StatesSite Not Available
Research Site
Dallas 4684888, Texas 4736286 75231
United StatesSite Not Available
Research Site
Frisco 4692559, Texas 4736286 75034
United StatesSite Not Available
Research Site
Houston 4699066, Texas 4736286 77065
United StatesSite Not Available
Research Site
Kerrville 4703078, Texas 4736286 78028
United StatesSite Not Available
Research Site
McKinney 4710178, Texas 4736286 75069
United StatesSite Not Available
Research Site
San Antonio 4726206, Texas 4736286 78215
United StatesSite Not Available
Research Site
Tyler 4738214, Texas 4736286 75708
United StatesSite Not Available
Research Site
West Jordan, Utah 84088
United StatesActive - Recruiting
Research Site
West Jordan 5784549, Utah 5549030 84088
United StatesSite Not Available
Research Site
Burlington, Vermont 05405
United StatesActive - Recruiting
Research Site
Burlington 5234372, Vermont 5242283 05405
United StatesSite Not Available
Research Site
Burke, Virginia 22015
United StatesSite Not Available
Research Site
Burke 4749950, Virginia 6254928 22015
United StatesSite Not Available
Research Site
Bellingham, Washington 98225
United StatesActive - Recruiting
Research Site
Vancouver, Washington 98664
United StatesActive - Recruiting
Research Site
Bellingham 5786899, Washington 5815135 98225
United StatesSite Not Available
Research Site
Vancouver 5814616, Washington 5815135 98664
United StatesSite Not Available

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