Phase
Condition
Asthma
Treatment
Placebo
Budesonide/formoterol
Short-Acting Beta Agonists (SABA)
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Physician-diagnosed mild-to-moderate asthma for more than 12 months based on GINAguidelines.
At least 1 asthma exacerbation in the year prior to Screening (Visit 1).
Pre-BD FEV1 of equal or more than 40% of predicted normal (by Global Lung FunctionInitiative [GLI] standards) at Screening (Visit 1).
Exclusion
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Other severe lung diseases (eg, chronic obstructive pulmonary disease [COPD].bronchiectasis, idiopathic pulmonary fibrosis, etc) which may impair lung function.
Participants who experience a deterioration of asthma that results in emergencytreatment or hospitalization, or treatment with systemic steroids within 1 monthprior to the Screening (Visit 1) (counting from the date of completion of treatmentfor asthma exacerbation).
Participants who have experienced an upper or lower respiratory tract infectionwithin the 4 weeks prior to Screening (Visit 1).
Known history of, or suspected, significant current immunosuppression, includinghistory of invasive opportunistic or helminthic infections despite infectionresolution or otherwise recurrent infections of abnormal frequency or prolongedduration.
Evidence of any infection requiring systemic anti-infective treatment within 2 weeksbefore Screening (Visit 1) or during the screening period. Significant viralinfections within 2 weeks before Screening (Visit 1) or during the screening periodeven if the participant has not received systemic antiviral treatment (eg, influenzareceiving only symptomatic treatment).
Participants with active tuberculosis (TB), latent TB, a history of incompletelytreated TB, suspected extrapulmonary TB infection, or who are at high risk ofcontracting TB (such as close contact with individuals with active TB), or receivedBacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1).
Severe concomitant illness that would in the Investigator's opinion inhibit theparticipant's participation in the study, including for example, but not limited to,hypertension, renal disease, neurological conditions, heart failure, and pulmonarydisease.
NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical study.
Study Design
Connect with a study center
Investigational Site Number : 0320001
Buenos Aires, 1425
ArgentinaActive - Recruiting
Investigational Site Number : 0320002
Buenos Aires, 1414
ArgentinaActive - Recruiting
Investigational Site Number : 0320004
Buenos Aires, 1425
ArgentinaActive - Recruiting
Investigational Site Number : 0320014
Mendoza, 5500
ArgentinaActive - Recruiting
Investigational Site Number : 0320003
San Miguel de Tucumán, 4000
ArgentinaActive - Recruiting
Investigational Site Number : 1240011
Kelowna, British Columbia V1Y 4N7
CanadaActive - Recruiting
Investigational Site Number : 1240012
North Vancouver, British Columbia V7M 1R9
CanadaActive - Recruiting
Investigational Site Number : 1240003
Guelph, Ontario N1H 6J2
CanadaActive - Recruiting
Investigational Site Number : 1240002
Sherbrooke, Quebec J1H 5N4
CanadaActive - Recruiting
Investigational Site Number : 1520008
Concepción, Biobío 4070094
ChileActive - Recruiting
Investigational Site Number : 1520002
Talca, Maule 3465584
ChileActive - Recruiting
Investigational Site Number : 1520001
Santiago, Reg Metropolitana De Santiago 7500692
ChileActive - Recruiting
Investigational Site Number : 1520003
Santiago, Reg Metropolitana De Santiago 7500698
ChileActive - Recruiting
Investigational Site Number : 1520009
Santiago, Reg Metropolitana De Santiago 7691236
ChileActive - Recruiting
Investigational Site Number : 1520005
Quillota, Valparaíso 2260877
ChileActive - Recruiting
Investigational Site Number : 1520007
Viña Del Mar, Valparaíso 2540364
ChileActive - Recruiting
Investigational Site Number : 1560027
Beijing, 100029
ChinaActive - Recruiting
Investigational Site Number : 1560005
Changchun, 130021
ChinaActive - Recruiting
Investigational Site Number : 1560021
Chengde, 067400
ChinaActive - Recruiting
Investigational Site Number : 1560039
Chengdu, 611130
ChinaActive - Recruiting
Investigational Site Number : 1560010
Guangzhou, 510000
ChinaActive - Recruiting
Investigational Site Number : 1560033
Guangzhou, 510180
ChinaActive - Recruiting
Investigational Site Number : 1560042
Hangzhou, 310005
ChinaActive - Recruiting
Investigational Site Number : 1560029
Huizhou, 516001
ChinaActive - Recruiting
Investigational Site Number : 1560034
Jinan, 250001
ChinaActive - Recruiting
Investigational Site Number : 1560014
Ningbo, 315010
ChinaActive - Recruiting
Investigational Site Number : 1560001
Shanghai, 200080
ChinaActive - Recruiting
Investigational Site Number : 1560016
Shenyang, 110004
ChinaActive - Recruiting
Investigational Site Number : 1560008
Suzhou, 215006
ChinaActive - Recruiting
Investigational Site Number : 1560017
Taiyuan, 030001
ChinaActive - Recruiting
Investigational Site Number : 1560012
Xuzhou, 221006
ChinaActive - Recruiting
Investigational Site Number : 3760006
Haifa, 3436212
IsraelActive - Recruiting
Investigational Site Number : 3760002
Jerusalem, 9112001
IsraelActive - Recruiting
Investigational Site Number : 3760005
Petah Tikva, 4941492
IsraelActive - Recruiting
Investigational Site Number : 3760001
Rehovot, 7610001
IsraelActive - Recruiting
Investigational Site Number : 3760004
Tel Aviv, 6423906
IsraelActive - Recruiting
Investigational Site Number : 7920001
Akdeniz, 33070
TurkeyActive - Recruiting
Investigational Site Number : 7920003
Kayseri, 38039
TurkeyActive - Recruiting
Investigational Site Number : 8260007
Corby, Northamptonshire NN17 2UN
United KingdomActive - Recruiting
Investigational Site Number : 8260005
Barnsley, S75 2EP
United KingdomActive - Recruiting
Investigational Site Number : 8260001
London, W1T 6AH
United KingdomActive - Recruiting
Investigational Site Number : 8260006
Nottingham, NG7 2UH
United KingdomActive - Recruiting
Epic Medical Research - Surprise- Site Number : 8400052
Surprise, Arizona 85378
United StatesActive - Recruiting
Epic Medical Research- Site Number : 8400052
Surprise, Arizona 85378
United StatesActive - Recruiting
Modena Allergy + Asthma- Site Number : 8400021
La Jolla, California 92037
United StatesActive - Recruiting
Velocity Clinical Research - San Diego- Site Number : 8400024
La Mesa, California 91942
United StatesActive - Recruiting
Carbon Health - North Hollywood - NoHo West- Site Number : 8400061
North Hollywood, California 91606
United StatesActive - Recruiting
Carbon Health - San Mateo CA Urgent Care & Primary Care- Site Number : 8400062
San Mateo, California 94403
United StatesActive - Recruiting
Helix Biomedics, LLC Site Number : 8400005
Boynton Beach, Florida 33435
United StatesActive - Recruiting
Helix Biomedics- Site Number : 8400005
Boynton Beach, Florida 33435
United StatesActive - Recruiting
Beautiful Minds Clinical Research Center- Site Number : 8400019
Cutler Bay, Florida 33157
United StatesActive - Recruiting
Alfa Medical Research- Site Number : 8400071
Davie, Florida 33024
United StatesActive - Recruiting
Innovations Biotech Site Number : 8400044
Miami, Florida 33186
United StatesActive - Recruiting
Innovations Biotech- Site Number : 8400044
Miami, Florida 33186
United StatesActive - Recruiting
Research Institute of South Florida- Site Number : 8400023
Miami, Florida 33173
United StatesActive - Recruiting
Avanza Medical Research Center- Site Number : 8400056
Pensacola, Florida 32503
United StatesActive - Recruiting
Private Practice - Dr. Frank Hull - Plantation- Site Number : 8400079
Plantation, Florida 33324
United StatesActive - Recruiting
Christie Clinic on University- Site Number : 8400003
Champaign, Illinois 61820
United StatesActive - Recruiting
Velocity Clinical Research, Rockville- Site Number : 8400036
Rockville, Maryland 20854
United StatesActive - Recruiting
Javara Inc/Privia Medical Group, PLLC- Site Number : 8400042
Silver Spring, Maryland 20901
United StatesActive - Recruiting
Javara - Mankato Clinic- Site Number : 8400001
Mankato, Minnesota 56001
United StatesActive - Recruiting
Asthma & Allergy Center - Toledo- Site Number : 8400020
Toledo, Ohio 43617
United StatesActive - Recruiting
OK Clinical Research- Site Number : 8400060
Edmond, Oklahoma 73034
United StatesActive - Recruiting
Clinical Research Associates of Central PA - Dubois- Site Number : 8400013
DuBois, Pennsylvania 15801
United StatesActive - Recruiting
Clinical Research Associates of Central PA- Site Number : 8400013
DuBois, Pennsylvania 15801
United StatesActive - Recruiting
Epic Medical Research- Site Number : 8400051
DeSoto, Texas 75115
United StatesActive - Recruiting
Metroplex Pulmonary and Sleep Center- Site Number : 8400012
McKinney, Texas 75069
United StatesActive - Recruiting
Bandera Family Health Care - San Antonio- Site Number : 8400049
San Antonio, Texas 78249
United StatesActive - Recruiting
STAAMP Research LLC- Site Number : 8400059
San Antonio, Texas 78229
United StatesActive - Recruiting
Javara Inc/Privia Medical Group North Texas, PLLC- Site Number : 8400038
Stephenville, Texas 76401
United StatesActive - Recruiting
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