Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma

NCT03226392 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CQAW039A23172017-001272-40
• Study Type: interventional
• Target: 704
• Locations: 18 countries
• Sites: 142

Brief Summary

A randomized, multicenter, double-blind, placebo- controlled parallel-group study to determine the efficacy and safety of QAW039, compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1 second (FEV1) at the end of 12 weeks of treatment.

Conditions

Asthma

Keywords

QAW039, uncontrolled asthma

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Pre-dose FEV1

  Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.

  Baseline and Week 12

Secondary Outcomes (3)

• Change From Baseline in Daytime Asthma Symptom Score

  Baseline and Week 12

• Change From Baseline in Number of Puffs of SABA Taken Per Day

  Baseline (daily mean for up to three weeks prior to baseline visit) and Week 12 (daily mean post baseline up to Week 12)

• Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Score

  Baseline and Week 12

Study Arms (2)

QAW039

ACTIVE COMPARATOR

QAW039 once daily

Drug: QAW039

Placebo

PLACEBO COMPARATOR

Placebo once daily

Drug: Placebo

Interventions

QAW039 DRUG

QAW039 once daily

QAW039

Placebo DRUG

Placebo once daily

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.
• 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.

You may not qualify if:

• Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (142)

Novartis Investigative Site

Andalusia, Alabama, 36420, United States

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Birmingham, Alabama, 35209, United States

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Tucson, Arizona, 85745, United States

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Los Angeles, California, 90048, United States

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Newport Beach, California, 92663, United States

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Rolling Hills Estates, California, 90274, United States

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San Diego, California, 92117, United States

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San Diego, California, 92120, United States

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Novartis Investigative Site

San Jose, California, 95117, United States

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Stockton, California, 95207, United States

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Colorado Springs, Colorado, 80907, United States

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Denver, Colorado, 80230, United States

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Lafayette, Colorado, 80026, United States

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Miami, Florida, 33176, United States

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Miami Gardens, Florida, 33169, United States

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Tallahassee, Florida, 32308, United States

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Winter Park, Florida, 32789, United States

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Paducah, Kentucky, 42001, United States

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Columbia, Maryland, 21044, United States

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White Marsh, Maryland, 21162, United States

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North Dartmouth, Massachusetts, 02747-3322, United States

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Ann Arbor, Michigan, 48106, United States

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Minneapolis, Minnesota, 55402, United States

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Rochester, Minnesota, 55905, United States

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Saint Charles, Missouri, 63301, United States

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St Louis, Missouri, 63110, United States

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St Louis, Missouri, 63141, United States

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Warrensburg, Missouri, 64093, United States

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Omaha, Nebraska, 68134, United States

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Brooklyn, New York, 11235, United States

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Raleigh, North Carolina, 27607, United States

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Cincinnati, Ohio, 45245, United States

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Columbus, Ohio, 43215, United States

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Marion, Ohio, 43302, United States

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Mayfield Heights, Ohio, 44124, United States

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Tulsa, Oklahoma, 74136, United States

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Altoona, Pennsylvania, 16602, United States

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Pittsburgh, Pennsylvania, 15241, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Dallas, Texas, 75231, United States

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New Braunfels, Texas, 78130, United States

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San Antonio, Texas, 78205, United States

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Murray, Utah, 84107, United States

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Newport News, Virginia, 23606, United States

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Spokane, Washington, 99204, United States

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Goiânia, Goiás, 74110-030, Brazil

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Porto Alegre, Porto Alegre RS, 90610 000, Brazil

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Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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Blumenau, Santa Catarina, 89030101, Brazil

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São Bernardo do Campo, São Paulo, 09715 090, Brazil

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São Paulo, São Paulo, 05437 010, Brazil

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Sorocaba, São Paulo, Brazil

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Pleven, 5800, Bulgaria

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Rousse, 7002, Bulgaria

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Sofia, 1000, Bulgaria

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Stara Zagora, 6000, Bulgaria

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Kingston, Ontario, K7L 2V7, Canada

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Toronto, Ontario, M6H 3M2, Canada

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Toronto, Ontario, M9V 4B4, Canada

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Windsor, Ontario, N8X 5A6, Canada

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Ibagué, Tolima Department, 730006, Colombia

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Bogota DC, 110221, Colombia

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Bogotá, 110111, Colombia

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Bucaramanga, Colombia

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Berlin, 10367, Germany

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Erlangen, 91052, Germany

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Frankfurt, 60389, Germany

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Halle, 06108, Germany

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Hamburg, 20354, Germany

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Hanover, 30167, Germany

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Leipzig, 04357, Germany

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Lübeck, 23552, Germany

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Hajdúnánás, HUN, 4080, Hungary

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Kapuvár, HUN, 9330, Hungary

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Püspökladány, HUN, 4150, Hungary

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Budapest, 1106, Hungary

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Pécs, 7635, Hungary

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Siófok, 8600, Hungary

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Szigetszentmiklós, H-2310, Hungary

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Ahmedabad, Gujarat, 380 060, India

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Vadodara, Gujarat, 390022, India

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Nashik, Maharashtra, 422007, India

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Bikaner, Rajasthan, 334 001, India

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Coimbatore, Tamil Nadu, 641 045, India

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Dehradun, Uttarakhand, 248001, India

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Ashkelon, 78278, Israel

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Haifa, 3436212, Israel

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Jerusalem, Israel

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Rehovot, 76100, Israel

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Brescia, BS, 25123, Italy

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Florence, FI, 50134, Italy

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Rozzano, MI, 20089, Italy

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Pisa, PI, 56124, Italy

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Milan, 20157, Italy

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Lima Cercado, Lima region, 01, Peru

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San Isidro, Lima region, 27, Peru

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San Martín de Porres, Lima region, 31, Peru

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Cusco, 84, Peru

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Lima, 1, Peru

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Piura, 2000, Peru

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San Juan, 00909, Puerto Rico

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Barnaul, 656024, Russia

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Chelyabinsk, 454021, Russia

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Moscow, 109544, Russia

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Moscow, 115478, Russia

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N.Novgorod, 603126, Russia

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Penza, 440067, Russia

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Perm, 614068, Russia

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Ryazan, 390039, Russia

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Saint Petersburg, 191186, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 197022, Russia

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Stavropol, 355000, Russia

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Yaroslavl, 150054, Russia

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Yekaterinburg, 620109, Russia

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Wŏnju, Gangwon-do, 26427, South Korea

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Bucheon-si, Gyeonggi-do, 14584, South Korea

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Hwaseong-si, Gyeonggi-do, 18450, South Korea

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Suwon, Gyeonggi-do, 16499, South Korea

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Seoul, Korea, 03312, South Korea

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Seoul, Seocho Gu, 06591, South Korea

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Daegu, 705703, South Korea

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Novartis Investigative Site

Incheon, 21431, South Korea

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Seoul, 05505, South Korea

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Novartis Investigative Site

Marbella, Andalusia, 29603, Spain

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Málaga, Andalusia, 29010, Spain

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Novartis Investigative Site

Laredo, Cantabria, 39770, Spain

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Novartis Investigative Site

Pozuelo de Alarcón, Madrid, 28223, Spain

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Novartis Investigative Site

Barcelona, Vic, 08500, Spain

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Novartis Investigative Site

Barcelona, 08006, Spain

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Novartis Investigative Site

Barcelona, 08540, Spain

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Girona, 17005, Spain

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Novartis Investigative Site

Santiago de Compostela, 1506, Spain

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Novartis Investigative Site

Zaragoza, 50009, Spain

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Novartis Investigative Site

Lund, SE-221 85, Sweden

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Novartis Investigative Site

Umeå, 907 40, Sweden

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Novartis Investigative Site

Visby, 621 50, Sweden

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Novartis Investigative Site

Bab Saadoun, 1007, Tunisia

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Haiphong, 180000, Vietnam

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Hanoi, 100000, Vietnam

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Novartis Investigative Site

Ho Chi Minh City, 700000, Vietnam

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Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com
• A Pediatric Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Conditions

Asthma

Interventions

fevipiprant

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis pharmaceutical

Novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 21, 2017
• Study Start: October 31, 2017
• Primary Completion: July 5, 2019
• Study Completion: August 1, 2019
• Last Updated: January 13, 2026
• Results First Posted: February 28, 2020

Record last verified: 2025-12

Locations

IN (6); IT (5); SE (3); IL (4); CA (4); CO (4); RU (14); PE (6); HU (7); TU (1); DE (8); US (45); PR (1); KR (9); VN (3); BU (4); ES (10); BR (8)