Phase
Condition
Asthma
Treatment
AS MDI
BDA MDI
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be ≥12 years of age, at the time of signing the electronic informedconsent form (eICF). For participants from 12 years of age to age of majority, theirparents/legal guardian must provide signed consent, as appropriate, and participantswill sign an assent form.
Diagnosis of asthma by a prescribing healthcare professional. Protocol-specifieddocumentation of asthma diagnosis is required to confirm diagnosis of asthma.
Participants actively using SABA alone or SABA on a background of either low-doseICS or LTRA.
Self-reported use of a SABA on ≥2 occasions, in response to symptoms (ie, not forexercise prophylaxis only), in the previous 2 weeks prior to enrollment.
An Asthma Impairment and Risk Questionnaire (AIRQ) score of ≥2 at Screening (Visit1/re-screen) and Randomisation (Randomization (Visit2) where applicable. Note,where screening Visit1/re-screen and randomization occur on the same day, AIRQ willonly be completed once.
Females of child-bearing potential must have a negative pregnancy test prior torandomization and agree to use an acceptable method of contraception throughout thestudy.
Male participants who are in heterosexual relationships must be surgically sterileor agree to use an effective method of contraception (condom) if the female partnerdoes not use contraception from the date the eICF is signed until 2 weeks aftertheir last dose.
Exclusion
Exclusion Criteria:
Any evidence of significant lung disease other than asthma, such as chronicobstructive pulmonary disease, emphysema, idiopathic pulmonary fibrosis, sarcoidosisetc or any other significant disease (like malignancies or severe chronic diseases)that by Investigator judgment would interfere with the participant being able tocomply with study procedures or complete the study.
Hospitalization due to asthma in the 3 months prior to enrollment or self-reportedadmission to the Intensive Care Unit with life-threatening asthma at any time in thepast
Self-reported use of inhaled Long-Acting Beta-Agonists (LABA), theophylline, inhaledanticholinergic agent, cromone or medium/high dose ICS daily, as regular maintenanceasthma therapy in the 3 months prior to enrollment
Self-reported use of systemic corticosteroids (SCS) for the treatment of asthma andany other condition in the 6 weeks prior to enrollment
Participants with a home supply of oral corticosteroids (OCS) to be used in the caseof an asthma exacerbation or any other condition that could require a course of OCS,who are not willing to commit to the treating physician to stop using thismedication for the duration of the study.
Receipt of any marketed (eg, omalizumab, mepolizumab, reslizumab, benralizumab,dupilumab, tezepelumab) or investigational biologic for the treatment of asthma atany time in the past
Receipt of bronchothermoplasty
Use of a SABA prophylactically primarily to prevent exercise induced bronchospasm (EIB) and not to treat symptoms
Currently receiving systemic treatment with potent cytochrome P3A4 inhibitors (eg,ketoconazole, itraconazole, and ritonavir)
Judgment by the Investigator that the participant should not participate in thestudy if the participant is unlikely to comply with study procedures, restrictions,and requirements.
Previous screening, enrollment or randomization in the present study.
For females only - currently pregnant (confirmed with positive pregnancy test) orbreastfeeding.
Participants without access to a smartphone or the internet.
Study Design
Study Description
Connect with a study center
Pulmonary Associates of Mobile PC
Mobile, Alabama 36608
United StatesSite Not Available
One of a Kind Clinical Research Center
Paradise Valley, Arizona 85253
United StatesSite Not Available
Fiel Family and Sports Medicine/CCT Research
Tempe, Arizona 85283
United StatesSite Not Available
Kern Research Inc.
Bakersfield, California 93301
United StatesSite Not Available
Science 37
Culver City, California 90230
United StatesSite Not Available
Antelope Valley Clinical Trials
Lancaster, California 93534
United StatesSite Not Available
Allergy & Asthma Medical Group and Research (AAMGRC) - Allergy, Asthma and Immunology
San Diego, California 92123
United StatesSite Not Available
Clinical Research of California
Walnut Creek, California 94598
United StatesSite Not Available
Asthma and Allergy Associates
Colorado Springs, Colorado 80907
United StatesSite Not Available
Velocity Clinical Research, Denver
Denver, Colorado 80209
United StatesSite Not Available
Helix Biomedics
Boynton Beach, Florida 33435
United StatesSite Not Available
Allergy and Asthma Diagnostic Treatment Center
Tallahassee, Florida 32308
United StatesSite Not Available
Centricity Research
Columbus, Georgia 31907
United StatesSite Not Available
Lifeline Primary Care
Lilburn, Georgia 30047
United StatesSite Not Available
Javara Inc./Privia Medical Group Georgia, LLC
Savannah, Georgia 31406
United StatesSite Not Available
Velocity Clinical Research - Boise
Meridian, Idaho 83642
United StatesSite Not Available
Velocity Clinical Research - Valparaiso
Valparaiso, Indiana 46383
United StatesSite Not Available
Velocity Clinical Research
Lafayette, Louisiana 70508
United StatesSite Not Available
Javara Inc.
Annapolis, Maryland 21401
United StatesSite Not Available
Baltimore Early Phase Clinical Unit (EPCU)
Baltimore, Maryland 21225
United StatesSite Not Available
Chesapeake Clinical Research
White Marsh, Maryland 21162
United StatesSite Not Available
Genesis Clinical Research and Consulting, LLC
Fall River, Massachusetts 02723
United StatesSite Not Available
Infinity Medical Research
North Dartmouth, Massachusetts 02747
United StatesSite Not Available
Mankato Clinic
Mankato, Minnesota 56001
United StatesSite Not Available
Spectrum Clinical Research
Kansas City, Missouri 64118
United StatesSite Not Available
Meridian Clinical Research, LLC
Lincoln, Nebraska 68510
United StatesSite Not Available
Midwest Regional Health Services, LLC/CCT Research
Omaha, Nebraska 68144
United StatesSite Not Available
Meridian Clinical Research
Endwell, New York 13760
United StatesSite Not Available
Modern Migraine MD/CTNX
New York, New York 10001
United StatesSite Not Available
Javara Inc.
Charlotte, North Carolina 28277
United StatesSite Not Available
Javara Inc/Wake Forest Health Network, LLC
Clemmons, North Carolina 27012
United StatesSite Not Available
Monroe Biomedical Research
Monroe, North Carolina 28112
United StatesSite Not Available
North Carolina Clinical Research
Raleigh, North Carolina 27607
United StatesSite Not Available
Wilmington Health (Innovo Research)
Wilmington, North Carolina 28401
United StatesSite Not Available
Buckeye Health and Research
Columbus, Ohio 43207
United StatesSite Not Available
Velocity Clinical Resarch - Medford
Medford, Oregon 97504
United StatesSite Not Available
Northwest Research Center
Portland, Oregon 97202
United StatesSite Not Available
Hatboro Medical Associates
Hatboro, Pennsylvania 19040
United StatesSite Not Available
Velocity Clinical Research - Providence
East Greenwich, Rhode Island 02818
United StatesSite Not Available
AAPRI Clinical Research Institute
Warwick, Rhode Island 02886
United StatesSite Not Available
CVS Health
Woonsocket, Rhode Island 02897
United StatesSite Not Available
Velocity Clinical Research - Anderson
Anderson, South Carolina 29621
United StatesSite Not Available
Velocity Clinical Research, Greenville
Greenville, South Carolina 29615
United StatesSite Not Available
Velocity Clinical Research, Austin
Cedar Park, Texas 78759
United StatesSite Not Available
Privia Medical Group Gulf Coast
Cypress, Texas 77433
United StatesSite Not Available
CardioVoyage LLC
Denison, Texas 75020
United StatesSite Not Available
Texas Health Care, PLLC d/b/a Privia Medical Group- North Texas
Fort Worth, Texas 76133
United StatesSite Not Available
Allure Health at Mt Olympus Medical Research
Friendswood, Texas 77546
United StatesSite Not Available
Mt. Olympus Medical Research
Friendswood, Texas 77546
United StatesSite Not Available
LinQ Research, LLC
Pearland, Texas 77584
United StatesSite Not Available
Mt. Olympus Medical Research
Sugar Land, Texas 77479
United StatesSite Not Available
South Ogden Family Medicine clinic
Ogden, Utah 84405
United StatesSite Not Available
Velocity Clinical Research -Salt Lake City
West Jordan, Utah 84088
United StatesSite Not Available
Meridian Clinical Research
Portsmouth, Virginia 23703
United StatesSite Not Available
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