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

A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: QAW039

• Study Type: Interventional
• Enrollment (Actual): 675
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1125ABE
    • Novartis Investigative Site
  • Buenos Aires, Argentina, C1012AAR
    • Novartis Investigative Site
  • Córdoba, Argentina, X5003DCE
    • Novartis Investigative Site
  • Mendoza, Argentina, 5500
    • Novartis Investigative Site
  • Mendoza, Argentina, M5500CBA
    • Novartis Investigative Site
  • Salta, Argentina, 4000
    • Novartis Investigative Site
  • Buenos Aires
    • Berazategui, Buenos Aires, Argentina, 1888
      • Novartis Investigative Site
    • CABA, Buenos Aires, Argentina, C1056ABJ
      • Novartis Investigative Site
    • CABA, Buenos Aires, Argentina, C1122AAK
      • Novartis Investigative Site
    • CABA, Buenos Aires, Argentina, C1425BEN
      • Novartis Investigative Site
    • CABA, Buenos Aires, Argentina, C1426ABP
      • Novartis Investigative Site
    • Lanús, Buenos Aires, Argentina, B8000XAV
      • Novartis Investigative Site
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Novartis Investigative Site
  • La Pampa Province
    • Santa Rosa, La Pampa Province, Argentina, 6300
      • Novartis Investigative Site
  • Nueve De Julio
    • Buenos Aires, Nueve De Julio, Argentina, B6500BWQ
      • Novartis Investigative Site
  • Rosario
    • Santa Fe, Rosario, Argentina, S2000DBS
      • Novartis Investigative Site
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2000JKR
      • Novartis Investigative Site
    • Rosario, Santa Fe Province, Argentina, S2000BRH
      • Novartis Investigative Site
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, T4000IFL
      • Novartis Investigative Site
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Novartis Investigative Site
• Germany
  • Aschaffenburg, Germany, 63739
    • Novartis Investigative Site
  • Bamberg, Germany, 96049
    • Novartis Investigative Site
  • Berlin, Germany, 12203
    • Novartis Investigative Site
  • Berlin, Germany, 12157
    • Novartis Investigative Site
  • Fürstenwalde, Germany, 15517
    • Novartis Investigative Site
  • Gauting, Germany, 82131
    • Novartis Investigative Site
  • Leipzig, Germany, 04275
    • Novartis Investigative Site
  • Lübeck, Germany, 23552
    • Novartis Investigative Site
  • Prien A Chiemsee, Germany, 83209
    • Novartis Investigative Site
  • Rudersdorf, Germany, 15562
    • Novartis Investigative Site
  • Schleswig, Germany, 24837
    • Novartis Investigative Site
  • Schwerin, Germany, 19055
    • Novartis Investigative Site
  • Witten, Germany, 58452
    • Novartis Investigative Site
  • Lower Saxony
    • Peine, Lower Saxony, Germany, 31224
      • Novartis Investigative Site
  • Saxony
    • Cottbus, Saxony, Germany, 03050
      • Novartis Investigative Site
• Hungary
  • Ajka, Hungary, 8400
    • Novartis Investigative Site
  • Budapest, Hungary, 1125
    • Novartis Investigative Site
  • Debrecen, Hungary, 4032
    • Novartis Investigative Site
  • Gödöllő, Hungary, 2100
    • Novartis Investigative Site
  • Szeged, Hungary, 6722
    • Novartis Investigative Site
  • HUN
    • Budaörs, HUN, Hungary, 2040
      • Novartis Investigative Site
• Mexico
  • Río de Janeiro, Mexico, 06700
    • Novartis Investigative Site
  • Sinaloa
    • Culiacán, Sinaloa, Mexico, 80230
      • Novartis Investigative Site
• Philippines
  • Iloilo City, Philippines, 5000
    • Novartis Investigative Site
  • Manila, Philippines, 1000
    • Novartis Investigative Site
  • Batangas
    • Lipa City, Batangas, Philippines, 4217
      • Novartis Investigative Site
  • Manila
    • Quezon City, Manila, Philippines, 1100
      • Novartis Investigative Site
• Saudi Arabia
  • Jeddah, Saudi Arabia, 21423
    • Novartis Investigative Site
  • SAU
    • Riyadh, SAU, Saudi Arabia, 11525
      • Novartis Investigative Site
• Slovakia
  • Kežmarok, Slovakia, 060 01
    • Novartis Investigative Site
  • Michalovce, Slovakia, 071 01
    • Novartis Investigative Site
  • Poprad, Slovakia, 058 01
    • Novartis Investigative Site
  • Prešov, Slovakia, 080 01
    • Novartis Investigative Site
  • Spišská Nová Ves, Slovakia, 052 01
    • Novartis Investigative Site
  • Žilina, Slovakia, 01207
    • Novartis Investigative Site
  • Slovak Republic
    • Bardejov, Slovak Republic, Slovakia, 085 01
      • Novartis Investigative Site
• South Africa
  • Cape Town, South Africa, 7500
    • Novartis Investigative Site
  • Chatsworth, South Africa, 4092
    • Novartis Investigative Site
  • Durban, South Africa, 4001
    • Novartis Investigative Site
  • Pretoria, South Africa, 0183
    • Novartis Investigative Site
  • Cape Town
    • Tygerberg, Cape Town, South Africa, 7505
      • Novartis Investigative Site
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01330
    • Novartis Investigative Site
  • Ankara, Turkey (Türkiye), 06100
    • Novartis Investigative Site
  • Istanbul, Turkey (Türkiye), 34020
    • Novartis Investigative Site
  • Mersin, Turkey (Türkiye), 33343
    • Novartis Investigative Site
  • Talas / Kayseri, Turkey (Türkiye), 38039
    • Novartis Investigative Site
  • Yenisehir/Izmir, Turkey (Türkiye), 35110
    • Novartis Investigative Site
  • TUR
    • Istanbul, TUR, Turkey (Türkiye), 34098
      • Novartis Investigative Site
• United States
  • Arizona
    • Flagstaff, Arizona, United States, 86001
      • Novartis Investigative Site
    • Phoenix, Arizona, United States, 85006
      • Novartis Investigative Site
  • California
    • Huntington Beach, California, United States, 92647
      • Novartis Investigative Site
    • Long Beach, California, United States, 90808
      • Novartis Investigative Site
    • Los Angeles, California, United States, 90025
      • Novartis Investigative Site
    • Mission Viejo, California, United States, 92691
      • Novartis Investigative Site
    • Mountain View, California, United States, 94040
      • Novartis Investigative Site
    • Orange, California, United States, 92868
      • Novartis Investigative Site
    • Roseville, California, United States, 95661
      • Novartis Investigative Site
    • Walnut Creek, California, United States, 94598
      • Novartis Investigative Site
  • Colorado
    • Denver, Colorado, United States, 80206
      • Novartis Investigative Site
  • Florida
    • Tamarac, Florida, United States, 33321
      • Novartis Investigative Site
    • Winter Park, Florida, United States, 32789
      • Novartis Investigative Site
  • Georgia
    • Albany, Georgia, United States, 31707
      • Novartis Investigative Site
    • Dacula, Georgia, United States, 30019
      • Novartis Investigative Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • Novartis Investigative Site
    • Lihue, Hawaii, United States, 96766
      • Novartis Investigative Site
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Novartis Investigative Site
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • Novartis Investigative Site
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Novartis Investigative Site
    • Rolla, Missouri, United States, 65401
      • Novartis Investigative Site
  • Montana
    • Missoula, Montana, United States, 59808
      • Novartis Investigative Site
  • Nebraska
    • Bellevue, Nebraska, United States, 68123
      • Novartis Investigative Site
    • La Vista, Nebraska, United States, 68128
      • Novartis Investigative Site
  • New Jersey
    • Skillman, New Jersey, United States, 08558
      • Novartis Investigative Site
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Novartis Investigative Site
    • Gastonia, North Carolina, United States, 28054
      • Novartis Investigative Site
    • High Point, North Carolina, United States, 27262
      • Novartis Investigative Site
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • Novartis Investigative Site
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • Novartis Investigative Site
  • Oregon
    • Eugene, Oregon, United States, 97401-4043
      • Novartis Investigative Site
    • Medford, Oregon, United States, 97504
      • Novartis Investigative Site
    • Portland, Oregon, United States, 97213
      • Novartis Investigative Site
    • Portland, Oregon, United States, 97220
      • Novartis Investigative Site
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Novartis Investigative Site
  • Texas
    • Boerne, Texas, United States, 78006
      • Novartis Investigative Site
    • Dallas, Texas, United States, 75231
      • Novartis Investigative Site
    • El Paso, Texas, United States, 79903
      • Novartis Investigative Site
    • Fort Worth, Texas, United States, 76109
      • Novartis Investigative Site
    • McKinney, Texas, United States, 75069
      • Novartis Investigative Site
  • Washington
    • Seattle, Washington, United States, 98122-4379
      • Novartis Investigative Site
  • Wisconsin
    • Greenfield, Wisconsin, United States, 53228
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo once daily	Drug: Placebo; Placebo once daily
Active Comparator: QAW039; QAW039 once daily	Drug: QAW039; QAW039 once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Daytime Asthma Symptom Score	Daytime asthma symptoms are evaluated through four questions and each of them will be rated on a scale of 0 to 6. Higher scores indicate more severe asthma-related symptoms. A mean score will be calculated for the responses to 4 questions.	12 weeks
Change From Baseline in Daily Use of SABA	Daily use of SABA (the number of rescue medication puffs taken in the previous 12 hours) was recorded using a patient electronic diary (referred to as eDiary or eDiary/ePEF). Patients were instructed to routinely complete the patient diary twice daily - at the same time each morning and each evening, approximately 12 hours apart.	12 weeks
Change From Baseline in Asthma Quality of Life (AQLQ+12) Score	AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses.	Week 12

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): July 2, 2019
• Study Completion (Actual): July 30, 2019

Study Registration Dates

• First Submitted: July 11, 2017
• First Submitted That Met QC Criteria: July 11, 2017
• First Posted (Actual): July 12, 2017

Study Record Updates

• Last Update Posted (Estimated): January 13, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: QAW039, uncontrolled asthma
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; fevipiprant
• Other Study ID Numbers: CQAW039A2316; 2017-001273-16 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No