Phase
Condition
Asthma
Treatment
BDA MDI
AS 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, 100050
ChinaActive - Recruiting
Research Site
Bengbu, 233060
ChinaActive - Recruiting
Research Site
Chengdu, 610066
ChinaActive - Recruiting
Research Site
Chongqing, 401122
ChinaSite Not Available
Research Site
Hohhot, 10050
ChinaSite Not Available
Research Site
Mianyang, 621000
ChinaActive - Recruiting
Research Site
Shanghai,
ChinaActive - Recruiting
Research Site
Shenyang, 110004
ChinaSite Not Available
Research Site
Shenzhen, 518034
ChinaSite Not Available
Research Site
Suzhou, 215002
ChinaSite Not Available
Research Site
Taizhou, 318000
ChinaSite Not Available
Research Site
Tianjin, 300052
ChinaSite Not Available
Research Site
Wuhan, 430000
ChinaSite Not Available
Research Site
Yanji, 133000
ChinaSite Not Available
Research Site
Yantai, 264000
ChinaActive - Recruiting
Research Site
Zhongshan, 528400
ChinaActive - Recruiting
Research Site
Chihuahua, 31000
MexicoSite Not Available
Research Site
Monterrey, 64465
MexicoSite Not Available
Research Site
Durban, 4001
South AfricaSite Not Available
Research Site
Krugersdorp, 1739
South AfricaSite Not Available
Research Site
Panorama, 7500
South AfricaSite Not Available
Research Site
Somerset West, 7130
South AfricaSite Not Available
Research Site
Anchorage, Alaska 99508
United StatesSite Not Available
Research Site
Gilbert, Arizona 85234
United StatesActive - Recruiting
Research Site
Little Rock, Arkansas 72202
United StatesActive - Recruiting
Research Site
Long Beach, California 90806
United StatesSite Not Available
Research Site
Mission Viejo, California 92691
United StatesActive - Recruiting
Research Site
Orange, California 92868
United StatesSite Not Available
Research Site
Riverside, California 92506
United StatesSite Not Available
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
Denver, Colorado 80206
United StatesSite Not Available
Research Site
Wilmington, Delaware 19803
United StatesSite Not Available
Research Site
Destin, Florida 32541
United StatesActive - Recruiting
Research Site
Jacksonville, Florida 32207
United StatesSite Not Available
Research Site
Miami, Florida 33145
United StatesActive - Recruiting
Research Site
Seminole, Florida 33777
United StatesActive - Recruiting
Research Site
Columbus, Georgia 31904
United StatesActive - Recruiting
Research Site
Fayetteville, Georgia 30214
United StatesActive - Recruiting
Research Site
Normal, Illinois 61761
United StatesSite Not Available
Research Site
River Forest, Illinois 60305
United StatesSite Not Available
Research Site
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Research Site
Louisville, Kentucky 40202
United StatesActive - Recruiting
Research Site
Lafayette, Louisiana 70508
United StatesActive - Recruiting
Research Site
New Orleans, Louisiana 70121
United StatesSite Not Available
Research Site
Silver Spring, Maryland 20902
United StatesSite Not Available
Research Site
White Marsh, Maryland 21162
United StatesActive - Recruiting
Research Site
Detroit, Michigan 48201
United StatesActive - Recruiting
Research Site
Mankato, Minnesota 56001
United StatesActive - Recruiting
Research Site
Kansas City, Missouri 64108
United StatesSite Not Available
Research Site
Missoula, Montana 59804
United StatesActive - Recruiting
Research Site
Lincoln, Nebraska 68510
United StatesActive - Recruiting
Research Site
Omaha, Nebraska 68114
United StatesActive - Recruiting
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
Albuquerque, New Mexico 87106
United StatesActive - Recruiting
Research Site
Albany, New York 12208
United StatesSite Not Available
Research Site
Bronx, New York 10459
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 10032
United StatesSite Not Available
Research Site
Rochester, New York 14607
United StatesActive - Recruiting
Research Site
Vestal, New York 13850
United StatesActive - Recruiting
Research Site
Watertown, New York 13601
United StatesActive - Recruiting
Research Site
Charlotte, North Carolina 28277
United StatesSite Not Available
Research Site
Cincinnati, Ohio 45229
United StatesSite Not Available
Research Site
Dayton, Ohio 45424
United StatesActive - Recruiting
Research Site
Toledo, Ohio 43617
United StatesActive - Recruiting
Research Site
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
Research Site
Yukon, Oklahoma 73099
United StatesActive - Recruiting
Research Site
Pittsburgh, Pennsylvania 15241
United StatesActive - Recruiting
Research Site
Charleston, South Carolina 29425
United StatesSite Not Available
Research Site
Rock Hill, South Carolina 29730
United StatesActive - Recruiting
Research Site
Sioux Falls, South Dakota 57105
United StatesActive - Recruiting
Research Site
Nashville, Tennessee 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
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 77099
United StatesActive - Recruiting
Research Site
Kerrville, Texas 78028
United StatesSite Not Available
Research Site
McKinney, Texas 75069
United StatesSite Not Available
Research Site
San Antonio, Texas 78229
United StatesActive - Recruiting
Research Site
Tyler, Texas 75708
United StatesSite Not Available
Research Site
West Jordan, Utah 84088
United StatesActive - Recruiting
Research Site
Burlington, Vermont 05405
United StatesSite Not Available
Research Site
Burke, Virginia 22015
United StatesActive - Recruiting
Research Site
Bellingham, Washington 98225
United StatesActive - Recruiting
Research Site
Vancouver, Washington 98664
United StatesActive - Recruiting
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