NCT lookup

Inclusion criteria:

-Adults and adolescent participants with a physician diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2014 Guidelines and the following criteria:

a) Existing treatment with medium to high dose ICS (≥250 mcg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, long-acting beta agonist, leukotriene receptor antagonist) for at least 3 months with a stable dose ≥1 month prior to Visit 1.

i) Note for Japan: for participants aged 18 years and older, ICS must be on ≥200 mcg of fluticasone propionate twice daily or equivalent; for participants aged 12 to 17 years, ICS must be ≥100 mcg of fluticasone propionate twice daily or equivalent).

ii) Participants requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose ≥1 month prior to Visit 1.

Exclusion criteria:

* Participants \<12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (For those countries where local regulations permit enrollment of adults only, participant recruitment will be restricted to those who are ≥18 years of age).
* Weight is less than 30 kilograms.
* Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, etc) which may impair lung function.
* A participant who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to the Screening Visit up to and including the Baseline Visit).
* Evidence of lung disease(s) other than asthma, either clinical evidence or imaging (Chest X-ray, CT, MRI) within 12 months of Visit 1 or at the screening visit, as per local standard of care.
* Note for Japan: According to the request from the health authority, chest X-ray should be performed at screening visit if there is no chest imaging (Chest X-ray, computed tomography \[CT\], magnetic resonance imaging \[MRI\]) available within 3 months prior to screening to exclude participants with suspected active or untreated latent tuberculosis.
* Current smoker or cessation of smoking within 6 months prior to Visit 1.
* Previous smoker with a smoking history \>10 pack-years.
* Comorbid disease that might interfere with the evaluation of Investigational Medicinal Product.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

• Birmingham, Alabama, United States
• Flagstaff, Arizona, United States
• Gilbert, Arizona, United States
• Scottsdale, Arizona, United States
• Little Rock, Arkansas, United States
• Bakersfield, California, United States
• Costa Mesa, California, United States
• Fresno, California, United States
• Long Beach, California, United States
• Los Angeles, California, United States
• Los Angeles, California, United States
• Los Angeles, California, United States
• Mission Viejo, California, United States
• Newport Beach, California, United States
• North Hollywood, California, United States
• Redwood City, California, United States
• Rolling Hills Estates, California, United States
• Roseville, California, United States
• San Jose, California, United States
• Centennial, Colorado, United States
• Colorado Springs, Colorado, United States
• Denver, Colorado, United States
• Denver, Colorado, United States
• New Haven, Connecticut, United States
• Aventura, Florida, United States
• Boynton Beach, Florida, United States
• Brandon, Florida, United States
• Clearwater, Florida, United States
• Hialeah, Florida, United States
• Loxahatchee Groves, Florida, United States
• + 359 more on CT.gov