Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
NCT ID: NCT03215758
Last Updated: 2026-01-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
675 participants
INTERVENTIONAL
2017-11-01
2019-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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QAW039
QAW039 once daily
QAW039
QAW039 once daily
Placebo
Placebo once daily
Placebo
Placebo once daily
Interventions
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QAW039
QAW039 once daily
Placebo
Placebo once daily
Eligibility Criteria
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Inclusion Criteria
* Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1 and the doses have been stable for at least 4 weeks prior to Visit 1.
* FEV1 of ≤85% for patients aged ≥18 years. FEV1 of ≤90% for patients aged 12 to \<18 years.
* Daytime asthma symptom score (0 to 6 scale) of ≥1 per day during 4 of the last 7 days of the placebo run- in period.
* Total daily SABA use ≥1 puff per day during 4 of the last 7 days of the placebo run-in period.
* Demonstrated reversible airway obstruction.
* Asthma control questionnaire (ACQ) score ≥ 1.5.
Exclusion Criteria
* A resting QTcF (Fridericia) ≥450 msec (male) or
≥460 msec (female).
* Pregnant or nursing (lactating) women.
* Serious co-morbidities.
* Patients on \>20 mg of simvastatin, \> 40 mg of atorvastatin, \>40 mg of pravastatin, or \>2 mg of pitavastatin.
12 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Flagstaff, Arizona, United States
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Huntington Beach, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Mission Viejo, California, United States
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Mountain View, California, United States
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Orange, California, United States
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Roseville, California, United States
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Walnut Creek, California, United States
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Denver, Colorado, United States
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Tamarac, Florida, United States
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Winter Park, Florida, United States
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Albany, Georgia, United States
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Dacula, Georgia, United States
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Honolulu, Hawaii, United States
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Lihue, Hawaii, United States
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Overland Park, Kansas, United States
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Louisville, Kentucky, United States
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Columbia, Missouri, United States
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Rolla, Missouri, United States
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Missoula, Montana, United States
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Bellevue, Nebraska, United States
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La Vista, Nebraska, United States
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Skillman, New Jersey, United States
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Asheville, North Carolina, United States
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Gastonia, North Carolina, United States
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High Point, North Carolina, United States
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Cincinnati, Ohio, United States
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Edmond, Oklahoma, United States
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Eugene, Oregon, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Rapid City, South Dakota, United States
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Boerne, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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McKinney, Texas, United States
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Seattle, Washington, United States
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Greenfield, Wisconsin, United States
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Berazategui, Buenos Aires, Argentina
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CABA, Buenos Aires, Argentina
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CABA, Buenos Aires, Argentina
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CABA, Buenos Aires, Argentina
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CABA, Buenos Aires, Argentina
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Lanús, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Santa Rosa, La Pampa Province, Argentina
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Buenos Aires, Nueve De Julio, Argentina
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Santa Fe, Rosario, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Córdoba, , Argentina
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Mendoza, , Argentina
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Mendoza, , Argentina
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Salta, , Argentina
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Peine, Lower Saxony, Germany
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Cottbus, Saxony, Germany
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Aschaffenburg, , Germany
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Bamberg, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Fürstenwalde, , Germany
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Gauting, , Germany
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Leipzig, , Germany
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Lübeck, , Germany
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Prien A Chiemsee, , Germany
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Rudersdorf, , Germany
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Schleswig, , Germany
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Schwerin, , Germany
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Witten, , Germany
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Budaörs, HUN, Hungary
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Ajka, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Gödöllő, , Hungary
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Szeged, , Hungary
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Culiacán, Sinaloa, Mexico
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Río de Janeiro, , Mexico
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Lipa City, Batangas, Philippines
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Quezon City, Manila, Philippines
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Iloilo City, , Philippines
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Manila, , Philippines
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Riyadh, SAU, Saudi Arabia
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Jeddah, , Saudi Arabia
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Bardejov, Slovak Republic, Slovakia
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Kežmarok, , Slovakia
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Michalovce, , Slovakia
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Poprad, , Slovakia
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Prešov, , Slovakia
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Spišská Nová Ves, , Slovakia
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Žilina, , Slovakia
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Tygerberg, Cape Town, South Africa
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Cape Town, , South Africa
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Chatsworth, , South Africa
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Durban, , South Africa
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Pretoria, , South Africa
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Istanbul, TUR, Turkey (Türkiye)
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Mersin, , Turkey (Türkiye)
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Talas / Kayseri, , Turkey (Türkiye)
Novartis Investigative Site
Yenisehir/Izmir, , Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on novartisclinicaltrials.com
A Pediatric Plain Language Trial Summary is available on www.novctrd.com
Other Identifiers
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2017-001273-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CQAW039A2316
Identifier Type: -
Identifier Source: org_study_id
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