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

NCT ID: NCT03226392

Last Updated: 2026-01-13

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

704 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-31

Study Completion Date

2019-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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QAW039

QAW039 once daily

Group Type ACTIVE_COMPARATOR

QAW039

Intervention Type DRUG

QAW039 once daily

Placebo

Placebo once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo once daily

Interventions

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QAW039

QAW039 once daily

Intervention Type DRUG

Placebo

Placebo once daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Andalusia, Alabama, United States

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Birmingham, Alabama, United States

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Tucson, Arizona, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

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Rolling Hills Estates, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Jose, California, United States

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Stockton, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Lafayette, Colorado, United States

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Miami, Florida, United States

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Miami Gardens, Florida, United States

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Tallahassee, Florida, United States

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Winter Park, Florida, United States

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Paducah, Kentucky, United States

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Columbia, Maryland, United States

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White Marsh, Maryland, United States

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North Dartmouth, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Warrensburg, Missouri, United States

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Omaha, Nebraska, United States

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Brooklyn, New York, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Marion, Ohio, United States

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Mayfield Heights, Ohio, United States

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Tulsa, Oklahoma, United States

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Altoona, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Mt. Pleasant, South Carolina, United States

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Dallas, Texas, United States

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New Braunfels, Texas, United States

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San Antonio, Texas, United States

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Murray, Utah, United States

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Newport News, Virginia, United States

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Spokane, Washington, United States

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Goiânia, Goiás, Brazil

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Porto Alegre, Porto Alegre RS, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Blumenau, Santa Catarina, Brazil

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São Bernardo do Campo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Sorocaba, São Paulo, Brazil

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Pleven, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Kingston, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Ibagué, Tolima Department, Colombia

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Bogota DC, , Colombia

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Bogotá, , Colombia

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Bucaramanga, , Colombia

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Berlin, , Germany

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Erlangen, , Germany

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Frankfurt, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Leipzig, , Germany

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Lübeck, , Germany

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Hajdúnánás, HUN, Hungary

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Kapuvár, HUN, Hungary

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Püspökladány, HUN, Hungary

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Budapest, , Hungary

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Pécs, , Hungary

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Siófok, , Hungary

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Szigetszentmiklós, , Hungary

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Ahmedabad, Gujarat, India

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Vadodara, Gujarat, India

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Nashik, Maharashtra, India

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Bikaner, Rajasthan, India

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Coimbatore, Tamil Nadu, India

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Dehradun, Uttarakhand, India

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Ashkelon, , Israel

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Haifa, , Israel

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Jerusalem, , Israel

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Rehovot, , Israel

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Brescia, BS, Italy

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Florence, FI, Italy

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Rozzano, MI, Italy

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Pisa, PI, Italy

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Milan, , Italy

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Lima Cercado, Lima region, Peru

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San Isidro, Lima region, Peru

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San Martín de Porres, Lima region, Peru

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Cusco, , Peru

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Lima, , Peru

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Piura, , Peru

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San Juan, , Puerto Rico

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Barnaul, , Russia

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Chelyabinsk, , Russia

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Moscow, , Russia

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Moscow, , Russia

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N.Novgorod, , Russia

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Penza, , Russia

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Perm, , Russia

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Ryazan, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Stavropol, , Russia

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Yaroslavl, , Russia

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Yekaterinburg, , Russia

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Wŏnju, Gangwon-do, South Korea

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Bucheon-si, Gyeonggi-do, South Korea

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Hwaseong-si, Gyeonggi-do, South Korea

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Suwon, Gyeonggi-do, South Korea

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Seoul, Korea, South Korea

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Seoul, Seocho Gu, South Korea

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Daegu, , South Korea

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Incheon, , South Korea

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Seoul, , South Korea

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Marbella, Andalusia, Spain

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Málaga, Andalusia, Spain

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Laredo, Cantabria, Spain

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Pozuelo de Alarcón, Madrid, Spain

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Barcelona, Vic, Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Girona, , Spain

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Santiago de Compostela, , Spain

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Zaragoza, , Spain

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Lund, , Sweden

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Umeå, , Sweden

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Visby, , Sweden

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Bab Saadoun, , Tunisia

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Haiphong, , Vietnam

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Hanoi, , Vietnam

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Ho Chi Minh City, , Vietnam

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Countries

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United States Brazil Bulgaria Canada Colombia Germany Hungary India Israel Italy Peru Puerto Rico Russia South Korea Spain Sweden Tunisia Vietnam

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=594

A Plain Language Trial Summary is available on novartisclinicaltrials.com

https://www.novctrd.com/ctrdweb/ppatientsummary/ppatientsummaries?periodicPatientSummaryId=483

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

Other Identifiers

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2017-001272-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQAW039A2317

Identifier Type: -

Identifier Source: org_study_id

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