Phase
Condition
Asthma
Treatment
Intervention: AS MDI
Intervention: Ventolin Evohaler
Intervention: Placebo matching AS MDI
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age
Participant must be aged 18 to 65 years (inclusive), at the time of signing theinformed consent. Type of Participant and Disease Characteristics
Participants should have a documented history of physician-diagnosed asthma ≥ 6months prior to Visit 1.
Must be receiving one of the following required inhaled asthma therapies listedbelow for at least the last 30 days:
Only SABA, which is used as needed for rescue.
Low to medium doses of ICS (alone or in combination with LABA), used regularlyas maintenance asthma therapy.
Pre-BD FEV1 of ≥ 40% of the PN value at Visit 1, after withholding SABA for ≥ 6hours (and Visit 1a and/or Visit 1b, if applicable).
Confirmed FEV1 reversibility to 4 actuations of Ventolin HFA, defined as apost-Ventolin HFA increase in FEV1 at 30 minutes of ≥ 12% and ≥ 200 mL at eitherVisit 1, Visit 1a, or Visit 1b; only 2 reversibility testing attempts are allowed.
Demonstrate acceptable spirometry performance (ie, meet ATS/ERSacceptability/repeatability criteria).
Willing and, in the opinion of the investigator, able to adjust current asthmatherapy, as required by the protocol.
Demonstrate acceptable MDI administration technique. Note: Use of a spacer deviceduring the screening and randomized treatment periods is not permitted. Weight
Body mass index < 40 kg/m2. Sex and Contraceptive/Barrier Requirements
Contraceptive use by females should be consistent with local regulations regardingthe methods of contraception for those participating in clinical studies.
Female participants: A participant of childbearing potential, must have a negativeurine pregnancy test at Visit 1 (to be read locally). Participants not of childbearing potential are defined as those who arephysiologically incapable of becoming pregnant, including any participant who is 2years postmenopausal, or surgically sterile (defined as having a bilateraloophorectomy, hysterectomy, tubal ligation, or other permanent birth controlmeasures). Participants aged ≥ 50 years will be considered postmenopausal if they have beenamenorrheic for 12 consecutive months or more following cessation of all exogenoushormonal treatment. Participants aged < 50 years will be considered postmenopausal if they have beenamenorrheic for 12 consecutive months or more following cessation of exogenoushormonal treatment and in the absence of any alternative medical cause, as judged bythe investigator.
Participants of childbearing potential must use a highly effective form ofcontraception from signing of the ICF to 14 days after the last study intervention.Highly effective birth control methods are listed below: Total sexual abstinence is an acceptable method provided it is the usual lifestyleof the participant (defined as refraining from heterosexual intercourse during theentire period of risk associated with the study treatments). Combined (estrogen and progestogen containing) hormonal contraception associatedwith inhibition of ovulation):
Oral
Intravaginal (eg, NuvaRing®)
Transdermal (eg, Evra Patch™, Xulane™) Progestogen-only hormonal contraception associated with inhibition of ovulation:
Oral
Injectable (eg, Depo-Provera™)
Implantable (eg, Implanon®) Intrauterine device or intrauterinehormone-releasing system Bilateral tubal occlusion Male partnersterilization/vasectomy with documentation of azoospermia prior to the femaleparticipant's entry into the study, and this male is the sole partner for thatparticipant. The documentation on male sterility can come from the sitepersonnel's review of participant's medical records, medical examination and/orsemen analysis, or medical history interview provided by her or her partner. Note: Periodic abstinence (calendar, ovulation, symptothermal, post-ovulationmethods), withdrawal (coitus interruptus), declaration of abstinence for theduration of exposure to study intervention, spermicides only, and lactationalamenorrhea method are not acceptable methods of contraception. Informed Consent
Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the ICF and in this protocol. Other Inclusion Criteria
Compliance: must be willing to remain at the study site as required per protocol tocomplete all visit assessments.
Exclusion
Exclusion Criteria:
5.2 Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions and History
Any evidence of chronic obstructive pulmonary disease or other significant lungdisease (eg, chronic bronchitis, emphysema, bronchiectasis with the need oftreatment, cystic fibrosis, or bronchopulmonary dysplasia). Significant is definedas any disease that, in the opinion of the investigator, would put the safety of theparticipant at risk through participation, or that could affect the efficacy orsafety analysis.
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) within the last 5 years.
Upper respiratory infection not resolved within 7 days of Visit 1 and throughout thescreening period.
Hospitalizations for asthma exacerbation within the last 3 months prior to Visit 1.
Historical or current evidence of a clinically significant disease including, butnot limited to: cardiovascular (eg, congestive heart failure, known aortic aneurysm,clinically significant cardiac arrhythmia, participants with known QTcF ≥ 480 ms,coronary heart disease), hepatic, renal, hematological, neuropsychological,endocrine (eg, uncontrolled diabetes mellitus, uncontrolled thyroid disorder,Addison's disease, Cushing's syndrome), or gastrointestinal (eg, poorly controlledpeptic ulcer, gastroesophageal reflux disease). Significant is defined as anydisease that, in the opinion of the investigator, would put the safety of theparticipant at risk through study participation, or that could affect the efficacyor safety analysis if the disease/condition exacerbated during the study.
Cancer not in complete remission for at least 5 years prior to Visit 1. Note:Participants with squamous cell carcinoma of the skin or basal cell carcinoma of theskin or cervical carcinoma in situ are eligible, if in the opinion of theinvestigator, the condition has been adequately worked up and clinically controlled,and the participant's participation in the study would not represent a safetyconcern.
Hospitalized for psychiatric disorder or attempted suicide within one year prior toVisit 1.
History of psychiatric disease, intellectual deficiency, poor motivation, or otherconditions limiting informed consent validity.
Received a live attenuated vaccination within 7 days of Visit 1. Prior/ConcomitantTherapy
Oral/systemic corticosteroid use (any dose) within 6 weeks of Visit 1.
Chronic use of oral corticosteroids (≥ 3 weeks use in the 3 months prior to Visit 1).
Received any marketed (eg, omalizumab, mepolizumab, reslizumab) or investigationalbiologic within 3 months or 5 half-lives, whichever is longer, or any othermedication specifically prohibited by the protocol within the indicated exclusionarytime periods.
Received tiotropium within 2 weeks of Visit 1.
Received treatment for lower respiratory infection or asthma exacerbation within 6weeks of Visit 1.
Unable to abstain from protocol-defined prohibited medications during screening andthe study.
Using any herbal products by inhalation or nebulizer within 2 weeks of Visit 1 anddoes not agree to stop during the study duration. Prior/Concurrent Clinical Study Experience
Treatment with investigational study intervention (or device) in another clinicalstudy within the last 30 days or 5 half-lives, whichever is longer, prior to Visit
Hypersensitivity to β2-agonists or any component of the investigational MDI or anycomponent of Ventolin Evohaler or HFA (or Pulmicort Flexhaler, if applicable). Other Exclusions
Significant abuse of alcohol or drugs in the opinion of the investigator.
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).
Study investigators, sub-investigators, coordinators, and their employees orimmediate family members, or employees of the sponsor.
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.
For female participants only: currently pregnant (confirmed with positive pregnancytest) or breastfeeding.
Study Design
Study Description
Connect with a study center
Research Site
Encinitas, California 92024
United StatesSite Not Available
Research Site
Los Angeles, California 90025
United StatesSite Not Available
Research Site
Newport Beach, California 92663
United StatesSite Not Available
Research Site
San Diego, California 92123
United StatesSite Not Available
Research Site
San Jose, California 95117
United StatesSite Not Available
Research Site
Stockton, California 95207
United StatesSite Not Available
Research Site
Clearwater, Florida 33765
United StatesSite Not Available
Research Site
Miami, Florida 33175
United StatesActive - Recruiting
Research Site
Tallahassee, Florida 32308
United StatesSite Not Available
Research Site
Tampa, Florida 33607
United StatesSite Not Available
Research Site
White Marsh, Maryland 21162
United StatesActive - Recruiting
Research Site
Columbia, Missouri 65203
United StatesSite Not Available
Research Site
Saint Charles, Missouri 63301
United StatesSite Not Available
Research Site
Saint Louis, Missouri 63141
United StatesSite Not Available
Research Site
Raleigh, North Carolina 27607
United StatesActive - Recruiting
Research Site
Medford, Oregon 97504
United StatesSite Not Available
Research Site
Portland, Oregon 97202
United StatesSite Not Available
Research Site
Gaffney, South Carolina 29340
United StatesSite Not Available
Research Site
North Charleston, South Carolina 29420
United StatesSite Not Available
Research Site
Austin, Texas 78759
United StatesSite Not Available
Research Site
El Paso, Texas 79903
United StatesSite Not Available
Research Site
San Antonio, Texas 78229
United StatesSite Not Available
Research Site
Victoria, Texas 77901
United StatesSite Not Available
Research Site
Milwaukee, Wisconsin 53228
United StatesSite Not Available
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