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

NCT03215758 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CQAW039A23162017-001273-16
• Study Type: interventional
• Target: 675
• Locations: 10 countries
• Sites: 110

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 at Week 12

  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.

  Week 12

Secondary Outcomes (3)

• Change From Baseline in Daytime Asthma Symptom Score

  12 weeks

• Change From Baseline in Daily Use of SABA

  12 weeks

• Change From Baseline in Asthma Quality of Life (AQLQ+12) Score

  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 (110)

Novartis Investigative Site

Flagstaff, Arizona, 86001, United States

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Phoenix, Arizona, 85006, United States

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Huntington Beach, California, 92647, United States

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Long Beach, California, 90808, United States

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Los Angeles, California, 90025, United States

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Novartis Investigative Site

Mission Viejo, California, 92691, United States

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Mountain View, California, 94040, United States

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Orange, California, 92868, United States

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Roseville, California, 95661, United States

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Walnut Creek, California, 94598, United States

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Denver, Colorado, 80206, United States

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Tamarac, Florida, 33321, United States

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Winter Park, Florida, 32789, United States

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Albany, Georgia, 31707, United States

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Dacula, Georgia, 30019, United States

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Honolulu, Hawaii, 96814, United States

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Lihue, Hawaii, 96766, United States

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Overland Park, Kansas, 66210, United States

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Louisville, Kentucky, 40215, United States

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Columbia, Missouri, 65203, United States

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Rolla, Missouri, 65401, United States

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Missoula, Montana, 59808, United States

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Bellevue, Nebraska, 68123, United States

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La Vista, Nebraska, 68128, United States

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Skillman, New Jersey, 08558, United States

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Asheville, North Carolina, 28801, United States

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Gastonia, North Carolina, 28054, United States

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High Point, North Carolina, 27262, United States

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Cincinnati, Ohio, 45231, United States

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Edmond, Oklahoma, 73034, United States

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Eugene, Oregon, 97401-4043, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 97213, United States

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Portland, Oregon, 97220, United States

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Rapid City, South Dakota, 57701, United States

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Boerne, Texas, 78006, United States

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Dallas, Texas, 75231, United States

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El Paso, Texas, 79903, United States

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Fort Worth, Texas, 76109, United States

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McKinney, Texas, 75069, United States

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Seattle, Washington, 98122-4379, United States

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Greenfield, Wisconsin, 53228, United States

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Berazategui, Buenos Aires, 1888, Argentina

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CABA, Buenos Aires, C1056ABJ, Argentina

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CABA, Buenos Aires, C1122AAK, Argentina

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CABA, Buenos Aires, C1425BEN, Argentina

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CABA, Buenos Aires, C1426ABP, Argentina

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Lanús, Buenos Aires, B8000XAV, Argentina

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Mar del Plata, Buenos Aires, 7600, Argentina

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Santa Rosa, La Pampa Province, 6300, Argentina

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Buenos Aires, Nueve De Julio, B6500BWQ, Argentina

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Santa Fe, Rosario, S2000DBS, Argentina

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Rosario, Santa Fe Province, S2000BRH, Argentina

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Rosario, Santa Fe Province, S2000JKR, Argentina

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San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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San Miguel de Tucumán, Tucumán Province, T4000IFL, Argentina

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Buenos Aires, C1012AAR, Argentina

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Buenos Aires, C1125ABE, Argentina

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Córdoba, X5003DCE, Argentina

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Mendoza, 5500, Argentina

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Mendoza, M5500CBA, Argentina

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Salta, 4000, Argentina

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Peine, Lower Saxony, 31224, Germany

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Cottbus, Saxony, 03050, Germany

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Aschaffenburg, 63739, Germany

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Bamberg, 96049, Germany

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Berlin, 12157, Germany

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Berlin, 12203, Germany

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Fürstenwalde, 15517, Germany

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Gauting, 82131, Germany

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Leipzig, 04275, Germany

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Lübeck, 23552, Germany

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Prien A Chiemsee, 83209, Germany

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Rüdersdorf, 15562, Germany

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Schleswig, 24837, Germany

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Schwerin, 19055, Germany

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Witten, 58452, Germany

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Budaörs, HUN, 2040, Hungary

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Ajka, 8400, Hungary

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Budapest, 1125, Hungary

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Debrecen, 4032, Hungary

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Gödöllő, 2100, Hungary

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Szeged, 6722, Hungary

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Culiacán, Sinaloa, 80230, Mexico

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Río de Janeiro, 06700, Mexico

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Lipa City, Batangas, 4217, Philippines

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Quezon City, Manila, 1100, Philippines

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Iloilo City, 5000, Philippines

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Manila, 1000, Philippines

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Riyadh, SAU, 11525, Saudi Arabia

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Novartis Investigative Site

Jeddah, 21423, Saudi Arabia

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Bardejov, Slovak Republic, 085 01, Slovakia

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Kežmarok, 060 01, Slovakia

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Michalovce, 071 01, Slovakia

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Poprad, 058 01, Slovakia

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Prešov, 080 01, Slovakia

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Spišská Nová Ves, 052 01, Slovakia

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Žilina, 01207, Slovakia

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Tygerberg, Cape Town, 7505, South Africa

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Cape Town, 7500, South Africa

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Chatsworth, 4092, South Africa

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Durban, 4001, South Africa

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Pretoria, 0183, South Africa

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Novartis Investigative Site

Istanbul, TUR, 34098, Turkey (Türkiye)

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Adana, 01330, Turkey (Türkiye)

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Ankara, 06100, Turkey (Türkiye)

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Novartis Investigative Site

Istanbul, 34020, Turkey (Türkiye)

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Mersin, 33343, Turkey (Türkiye)

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Talas / Kayseri, 38039, Turkey (Türkiye)

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Novartis Investigative Site

Yenisehir/Izmir, 35110, Turkey (Türkiye)

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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 www.novctrd.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 12, 2017
• Study Start: November 1, 2017
• Primary Completion: July 2, 2019
• Study Completion: July 30, 2019
• Last Updated: January 13, 2026
• Results First Posted: February 12, 2020

Record last verified: 2025-12

Locations

DE (15); PH (4); US (42); HU (6); SL (7); ZA (5); SA (2); ME (2); TU (7); AR (20)