Where you'll go
1788 West Fairbanks Avenue, Winter Park, FL, USA 32789
11021 Shadow Creek Parkway, Pearland, TX, USA 77584
2300 Maitland Center Parkway, Maitland, FL, USA 32751
7309 West Flagler Street, Miami, FL, USA 33144
470 Toll Gate Road, Warwick, RI, USA 02886
Los Angeles, CA, USA 90017
100 College Avenue Southeast, Gainesville, GA, USA 30501
Daytona Beach, FL, USA 32117
17742 Beach Boulevard, Huntington Beach, CA, USA 92647
6327 Southeast Milwaukie Avenue, Portland, OR, USA 97202
2300 Centerville Road, Tallahassee, FL, USA 32308
5776 Ruffin Road, San Diego, CA, USA 92123
8585 West Forest Home Avenue, Greenfield, WI, USA 53228
14120 Beach Boulevard, Westminster, CA, USA 92683
627 South Edwin C Moses Boulevard, Dayton, OH, USA 45417
Charlotte, NC, USA 28207
Festus, MO, USA 63028
1085 North Harbor Boulevard, Anaheim, CA, USA 92801
4421 South Carolina 81, Anderson, SC, USA 29621
2600 Redondo Avenue, Long Beach, CA, USA 90806
Glendale, AZ, USA 85306
2709 North Tejon Street, Colorado Springs, CO, USA 80907
East Providence, RI, USA 02941
Little Rock, AR, USA 72209
Crowley, LA, USA 70526
Grove City, OH, USA 43123
Escondido, CA, USA 92025
Loxahatchee Groves, FL, USA 33470
8444 Winton Road, Cincinnati, OH, USA 45231
10401 Old Georgetown Road, Bethesda, MD, USA 20814
Plantation, FL, USA 33322
4901 Lang Avenue Northeast, Albuquerque, NM, USA 87109
1950 Sawtelle Boulevard, Los Angeles, CA, USA 90025
301 West Bastanchury Road, Fullerton, CA, USA 92835
Rock Hill, SC, USA 29732
800 South Wells Street, Chicago, IL, USA 60607
Bronx, NY, USA 10455
Baltimore, MD, USA 21236
3000 North Halsted Street, Chicago, IL, USA 60657
Saint George, UT, USA 84790
Orlando, FL, USA 32801
400 Gresham Drive, Norfolk, VA, USA 23507
Pompano Beach, FL, USA 33060
Las Vegas, NV, USA 89102
Tempe, AZ, USA 85238
825 Nicollet Mall, Minneapolis, MN, USA 55402
Surprise, AZ, USA 85374
8045 Providence Road, Charlotte, NC, USA 28277
Gastonia, NC, USA 28054
Miami, FL, USA 33157
1447 Ebenezer Road, Rock Hill, SC, USA 29732
509 E 10th St # Ll, Rolla, MO, USA 65401
Columbia, MO, USA 65203
407 East Russell Avenue, Warrensburg, MO, USA 64093
Spring Hill, TN, USA 37174
Dayton, OH, USA 45409
Smyrna, TN, USA 37167
2492 Walnut Avenue, Tustin, CA, USA 92780
3750 Auburn Boulevard, Sacramento, CA, USA 95821
Ann Arbor, MI, USA 48106
125 Rampart Way, Denver, CO, USA 80230
3400 Southwest 107th Avenue, Miami, FL, USA 33165
3860 Crater Lake Avenue, Medford, OR, USA 97504
Marietta, GA, USA 30060
826 Harrison Avenue, New Orleans, LA, USA 70124
1125 West 6th Street, Los Angeles, CA, USA 90017
201 Richard Street, Easley, SC, USA 29640
Jacksonville, FL, USA 32204
Greenwood, CO, USA 80112
21150 Biscayne Boulevard, Aventura, FL, USA 33180
Miami, FL, USA 33173
4343 West Newberry Road, Gainesville, FL, USA 32607
Beaumont, TX, USA 77702
373 New Boston Road, Fall River, MA, USA 02720
30 Pointe Circle, Greenville, SC, USA 29615
3625 Braselton Highway, Dacula, GA, USA 30019
Montgomery, AL, USA 36106
709 5th Avenue West, Hendersonville, NC, USA 28739
Detroit, MI, USA 48340
21216 Northwest Freeway, Cypress, TX, USA 77429
18320 Franjo Road, Palmetto Bay, FL, USA 33157
North Dartmouth, MA, USA 02747
6655 Alvarado Road, San Diego, CA, USA 92120
Doral, FL, USA 33166
170 Medical Park Road, Mooresville, NC, USA 28117
2441 Ridgecrest Drive Southeast, Albuquerque, NM, USA 87108
3555 Northwest 58th Street, Oklahoma City, OK, USA 73112
Savannah, GA, USA 31405
Saint Louis, MO, USA 63141
602 South Sutherland Avenue, Monroe, NC, USA 28112
2683 Palmer Street, Missoula, MT, USA 59808
2130 Northeast Interstate 410 Loop, San Antonio, TX, USA 78217
Fall River, MA, USA 02721
9395 Kenwood Road, Cincinnati, OH, USA 45242
Chattanooga, TN, USA 37419
6914 Office Park Creek, Knoxville, TN, USA 37909
Brooklyn, NY, USA 11201
New York, NY, USA 10022
1501 Superior Avenue, Newport Beach, CA, USA 92663
South Dartmouth, MA, USA 02747
3840 Watt Avenue, Sacramento, CA, USA 95821
Brooklyn, NY, USA 11229
530 1st Avenue, New York, NY, USA 10016
120 North Bryant Avenue, Edmond, OK, USA 73034
Saint Cloud, FL, USA 34769
1121 North Central Avenue, Kissimmee, FL, USA 34741
4700 State Road 7, Lauderdale Lakes, FL, USA 33319
550 Deep Valley Drive, Rolling Hills Estates, CA, USA 90274
500 University Drive, Hershey, PA, USA 17033
5499 Glen Lakes Drive, Dallas, TX, USA 75231
Phoenix, AZ, USA 85014
1907 Tradd Court, Wilmington, NC, USA 28401
Skillman, NJ, USA 08558
North Hollywood, CA, USA 91606
10040 Regency Circle, Omaha, NE, USA 68114
5701 West Charleston Boulevard, Las Vegas, NV, USA 89146
The Woodlands, TX, USA 77380
Dallas, TX, USA 75224
1653 W Congress Pkwy, Chicago, IL, USA 60612
141 Harold Fleming Court, Spartanburg, SC, USA 29303
450 Veterans Memorial Parkway, East Providence, RI, USA 02914
Sarasota, FL, USA 34239
Sherman, TX, USA 75092
Hialeah, FL, USA 33016
2928 Maplewood Avenue, Winston-Salem, NC, USA 27103
Los Angeles, CA, USA 90048
802 North Belcher Road, Clearwater, FL, USA 33765
1625 Medical Center Point, Colorado Springs, CO, USA 80907
Munroe Falls, OH, USA 44262
3401 North Broad Street, Philadelphia, PA, USA 19140
53 Timber Lane, South Burlington, VT, USA 05403
5700 Monroe Street, Sylvania, OH, USA 43560
1005 Thompson Boulevard, Union, SC, USA 29379
Tampa, FL, USA 33613
750 Highland Avenue, Madison, WI, USA 53726
3500 Duluth Park Lane Northwest, Duluth, GA, USA 30096
201 South B Street, Easley, SC, USA 29640
Gaffney, SC, USA 29340
Gastonia, NC, USA 28054
1447 Ebenezer Road, Rock Hill, SC, USA 29732
317 North El Camino Real, Encinitas, CA, USA 92024
Saint Louis, MO, USA 63110
2121 Wyoming Avenue, El Paso, TX, USA 79903
4251 Kipling Street, Wheat Ridge, CO, USA 80033
12728 19th Avenue Southeast, Everett, WA, USA 98208
6035 Shallowford Road, Chattanooga, TN, USA 37421
Details for the study
Treatments and/or Procedures
- Male or female subjects aged ≥18 and ≤75 years who have signed an Informed Consent form prior to initiation of any study-related procedure.
- A diagnosis of asthma as defined in the GINA Report, 2016, documented for at least 1 year prior to screening.
- Subjects with poorly controlled or uncontrolled asthma evidenced by a score at the Asthma Control Questionnaire 7 © (ACQ-7) ≥1.5 (this criterion must be met at screening and at randomization visits).
- Subjects with a pre-bronchodilator FEV1 ≥50% and <85% of their predicted normal value, after appropriate washout from bronchodilators, at the screening and randomization visits.
- Subjects with a positive response to a reversibility test at screening (pre - post BD), within 1 year prior to or at screening defined as ΔFEV1≥12% and ≥200mL over baseline within 30 minutes after inhaling 4 puffs of albuterol HFA 90µg/actuation.
- Use of inhaled corticosteroids (low/medium dose according to GINA Report 2016) with or without a LABD for 3 months (stable dose in the last 4 weeks) before screening visit
- A cooperative attitude and ability to demonstrate correct use of the diary, peak flow meter, and pMDI inhalers.
- A basal morning (7-10 am) serum cortisol level between 7-28 µg/dL at screening (V1).
- A Body Mass Index: 18.5 ≤ BMI <35 kg/m2.
- Pregnant (as evident by a positive urine hCG or serum β-hCG test) or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS they are willing to use a highly effective birth control method
- Subjects who suffer from COPD as defined by the GOLD Report 2017, or are suspected of having Asthma COPD Overlap Syndrome (ACOS) as defined in GINA Report, 2016.
- Inability to carry out pulmonary lung function testing, to comply with study procedures or with study drug intake.
- Current smokers or ex-smokers (tobacco, vapor cigarettes, marijuana) with a smoking history of >10 pack-years or having stopped smoking one year or less prior to screening visit.
- History of life-threatening asthma, clinically significant uncontrolled disease or respiratory infection.
- An asthma exacerbation requiring oral corticosteroids within 3 months or hospitalization within 6 months prior to screening.
- Subjects with unresolved bacterial or viral respiratory tract, sinus or middle ear infection affecting asthma status within 2 weeks prior to screening.
- Subjects who received a vaccination within 2 weeks prior to screening or during the run-in.
- Subjects with oral candidiasis at screening or at randomization.
- Subjects with any clinically significant, uncontrolled condition
- Subjects who have clinically significant cardiovascular condition
- Subjects who have a clinically significant abnormal 12-lead ECG that results in active medical problem which may impact the safety of the subject according to Investigator's judgement.
- Subjects whose 12-lead ECG shows Fridericia corrected QT interval (QTcF) >450ms for males or QTcF >470ms for females at screening and randomization visits.
- Subjects with known intolerance/hypersensitivity or contra-indication to treatment with ß2-adrenergic receptor agonists, inhaled corticosteroids or propellant gases/excipients.
- Subjects with concomitant immunosuppressive therapy, use of oral or injected corticosteroids, anti-IgE, anti-IL5 or other monoclonal or polycolonal antibodies within 12 weeks prior to screening.
- Use of potent cytochrome P450 3A4 inhibitors and inducers within 4 weeks prior to screening.
- History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening.
- Subjects who have received an investigational drug within 1 month or 5 half-lives (whichever is greater) prior to screening visit, or have been previously randomized in this trial, or are currently participating in another clinical trial.
- Subjects who are mentally or legally incapacitated, or subjects accommodated in an establishment as a result of an official or judicial order.
- Subjects who have undergone major surgery in the 3 months prior to screening visit or have a planned surgery during the trial.