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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02555683
Other study ID # CQAW039A2307
Secondary ID 2015-002553-35
Status Completed
Phase Phase 3
First received
Last updated
Start date December 11, 2015
Est. completion date November 4, 2019

Study information

Verified date April 2020
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations:

- patient with inadequately controlled severe asthma and high eosinophil counts at baseline (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population)

- patients with inadequately controlled severe asthma (overall study population)

Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).


Description:

This study used a randomized, multicenter, double-blind, placebo-controlled parallel-group design in which QAW039 150 mg or QA039 450 mg or placebo was added to standard of care, GINA steps 4 and 5 asthma therapy.

The study included:

- Screening period of up to 2 weeks to assess eligibility;

- Run-in period of approximately 2 weeks and a maximum of 6 weeks on placebo to collect baseline data for efficacy variables and compliance with the Electronic Peak Flow/ eDiary device. Upon completion of the run-in period, all patients who met the eligibility criteria were randomized to one of three treatments: QAW039 150 mg or QAW039 450 mg or placebo once daily in a ratio of 1:1:1.

- Treatment period of 52 weeks (assessment period for all Primary and Secondary Outcome Measures). Clinic visits were scheduled approximately 4 weeks after randomization and then at approximately 8-week intervals during the active-treatment period. Phone calls occurred at specified time points between visits occurring at 8-week intervals. Patients who had successfully completed 52 weeks of treatment in this study were offered an optional participation in a safety study (CQAW039A2315).

- Follow-up period of 4 weeks, investigational and drug-free, following the last dose of study drug. A follow-up visit occurred approximately 4 weeks (i.e., approximately 30 days) following the last dose of study therapy to complete safety assessments and pregnancy testing (if applicable). the follow-up period applied to all patients except those patients who had entered the safety study (CQAW039A2315) directly after the Week 52 study visit.


Recruitment information / eligibility

Status Completed
Enrollment 894
Est. completion date November 4, 2019
Est. primary completion date October 21, 2019
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria:

- Written informed consent and assent (if applicable).

- Male and female patients aged =12 years (or =lower age limit allowed by health authority and/or ethics committee/institutional review board approvals).

- A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.

- Evidence of airway reversibility or airway hyper- reactivity.

- FEV1 of =80% of the predicted normal value for patients aged =18 years; FEV1 of =90% for patients aged 12 to <18 years

- An ACQ score =1.5.

- A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.

Exclusion Criteria:

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

- Subjects who have participated in another trial of QAW039.

- A QTcF (Fridericia) =450 msec (male) or =460 msec (female).

- History of malignancy with the exception of local basal cell carcinoma of the skin.

- Pregnant or nursing (lactating) women.

- Serious co-morbidities.

- Patients on greater than 20 mg of simvastatin, greater than 40 mg of atorvastatin, greater than 40 mg of pravastatin, or greater than 2 mg of pitavastatin

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
QAW039
QAW039 150 mg once daily
QAW039
QAW039 450 mg once daily
Placebo
Placebo once daily

Locations

Country Name City State
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Ciudad Autonoma de Bs As
Argentina Novartis Investigative Site San Miguel de Tucuman Tucuman
Australia Novartis Investigative Site Bedford Park South Australia
Australia Novartis Investigative Site Clayton Victoria
Australia Novartis Investigative Site Footscray Victoria
Australia Novartis Investigative Site Heidelberg Victoria
Australia Novartis Investigative Site Melbourne Victoria
Austria Novartis Investigative Site Amstetten
Austria Novartis Investigative Site Feldkirch
Austria Novartis Investigative Site Graz
Austria Novartis Investigative Site Innsbruck Tyrol
Austria Novartis Investigative Site Thalheim bei Wels
Austria Novartis Investigative Site Vienna
Austria Novartis Investigative Site Wien
Austria Novartis Investigative Site Wien
Belgium Novartis Investigative Site Aalst
Belgium Novartis Investigative Site Brussel
Belgium Novartis Investigative Site Bruxelles
Belgium Novartis Investigative Site Bruxelles
Belgium Novartis Investigative Site Eghezee
Belgium Novartis Investigative Site Erpent
Belgium Novartis Investigative Site Genk Limburg
Belgium Novartis Investigative Site Herentals
Belgium Novartis Investigative Site Kortrijk
Belgium Novartis Investigative Site Liege
Belgium Novartis Investigative Site Ottignies
Brazil Novartis Investigative Site Blumenau Santa Catarina
Brazil Novartis Investigative Site Florianopolis SC
Brazil Novartis Investigative Site Porto Alegre RS
Brazil Novartis Investigative Site Porto Alegre Porto Alegre RS
Brazil Novartis Investigative Site Rio de Janeiro RJ
Brazil Novartis Investigative Site Sao Bernardo do Campo SP
Brazil Novartis Investigative Site Sao Paulo SP
Brazil Novartis Investigative Site Sao Paulo SP
Brazil Novartis Investigative Site Sao Paulo SP
China Novartis Investigative Site Beijing
China Novartis Investigative Site Chang Chun Jilin
China Novartis Investigative Site Chengdu Sichuan
China Novartis Investigative Site Chengdu
China Novartis Investigative Site Chongqing
China Novartis Investigative Site Guang Zhou Guang Dong Province
China Novartis Investigative Site Haikou Hainan
China Novartis Investigative Site Hangzhou Zhejiang
China Novartis Investigative Site Nanchang Jiangxi
China Novartis Investigative Site Nanjing Jiangsu
China Novartis Investigative Site Nanjing Jiangsu
China Novartis Investigative Site Shanghai
China Novartis Investigative Site Shenyang Liaoning
China Novartis Investigative Site Shenyang Liaoning
China Novartis Investigative Site Shijiazhuang Hebei
China Novartis Investigative Site Tianjin
China Novartis Investigative Site Wuhan Hubei
China Novartis Investigative Site Xian Shanxi
Denmark Novartis Investigative Site Copenhagen NV
Estonia Novartis Investigative Site Tallinn
Estonia Novartis Investigative Site Tallinn
Estonia Novartis Investigative Site Tartu
Finland Novartis Investigative Site Helsinki
Finland Novartis Investigative Site HUS
Finland Novartis Investigative Site OYS
Finland Novartis Investigative Site Tampere
France Novartis Investigative Site Dijon
France Novartis Investigative Site Le Kremlin Bicetre
France Novartis Investigative Site Lyon Cedex 04
France Novartis Investigative Site Marseille
France Novartis Investigative Site Montpellier cedex 5 Herault
France Novartis Investigative Site Nantes
France Novartis Investigative Site Paris
France Novartis Investigative Site Reims Cedex
France Novartis Investigative Site Strasbourg Cedex
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Frankfurt
Germany Novartis Investigative Site Frankfurt
Germany Novartis Investigative Site Frankfurt
Germany Novartis Investigative Site Halle
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Heidelberg Baden-Württemberg
Germany Novartis Investigative Site Landsberg
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Magdeburg
Germany Novartis Investigative Site Mainz
Germany Novartis Investigative Site Marburg
Germany Novartis Investigative Site Neu Isenburg
Germany Novartis Investigative Site Rosenheim
Germany Novartis Investigative Site Rostock
Germany Novartis Investigative Site Rudersdorf
Germany Novartis Investigative Site Witten
Greece Novartis Investigative Site Thessaloniki GR
Guatemala Novartis Investigative Site Ciudad Gautemala
Guatemala Novartis Investigative Site Guatemala City GTM
Guatemala Novartis Investigative Site Guatemala City GTM
Guatemala Novartis Investigative Site Guatemala City
Guatemala Novartis Investigative Site Guatemala City
Hungary Novartis Investigative Site Eger HUN
Hungary Novartis Investigative Site Gyor HUN
Hungary Novartis Investigative Site Hajdunanas HUN
Hungary Novartis Investigative Site Komarom
Hungary Novartis Investigative Site Mako HUN
Hungary Novartis Investigative Site Pecs
Hungary Novartis Investigative Site Szazhalombatta HUN
Hungary Novartis Investigative Site Torokbalint Pest
Iceland Novartis Investigative Site Reykjavik
Ireland Novartis Investigative Site Dublin
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Latvia Novartis Investigative Site Daugavpils
Latvia Novartis Investigative Site Daugavpils
Latvia Novartis Investigative Site Riga
Lithuania Novartis Investigative Site Kaunas LTU
Lithuania Novartis Investigative Site Kaunas LT
Lithuania Novartis Investigative Site Kaunas
Lithuania Novartis Investigative Site Klaipeda
Lithuania Novartis Investigative Site Klaipeda LTU
Lithuania Novartis Investigative Site Vilnius LTU
Lithuania Novartis Investigative Site Vilnius LTU
Lithuania Novartis Investigative Site Vilnius LTU
Philippines Novartis Investigative Site Bulacan
Philippines Novartis Investigative Site Manila
Philippines Novartis Investigative Site Quezon City
Poland Novartis Investigative Site Bialystok
Poland Novartis Investigative Site Bialystok
Poland Novartis Investigative Site Biaystok
Poland Novartis Investigative Site Kielce POL
Poland Novartis Investigative Site Poznan
Poland Novartis Investigative Site Poznan
Poland Novartis Investigative Site Poznan
Poland Novartis Investigative Site Strzelce Opolskie
Romania Novartis Investigative Site Arad
Romania Novartis Investigative Site Bragadiru
Romania Novartis Investigative Site Brasov
Romania Novartis Investigative Site Brasov
Romania Novartis Investigative Site Brasov
Romania Novartis Investigative Site Brasov
Romania Novartis Investigative Site Bucharest
Romania Novartis Investigative Site Bucuresti
Romania Novartis Investigative Site Cluj Napoca
Romania Novartis Investigative Site Cluj Napoca
Romania Novartis Investigative Site Constanta ROM
Romania Novartis Investigative Site Deva
Romania Novartis Investigative Site Oradea
Romania Novartis Investigative Site Ploiesti Prahova
Romania Novartis Investigative Site Sangiorgiu De Mures
Romania Novartis Investigative Site Timisoara Timis
Singapore Novartis Investigative Site Singapore SGP
Singapore Novartis Investigative Site Singapore
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Spain Novartis Investigative Site Barcelona
Switzerland Novartis Investigative Site Basel
Switzerland Novartis Investigative Site Liestal
Switzerland Novartis Investigative Site Lugano
Switzerland Novartis Investigative Site St Gallen
Switzerland Novartis Investigative Site Zurich
United Kingdom Novartis Investigative Site Birmingham
United Kingdom Novartis Investigative Site Birmingham
United Kingdom Novartis Investigative Site Bradford West Yorkshire
United Kingdom Novartis Investigative Site Cambridge Cambrigdeshire
United Kingdom Novartis Investigative Site Cardiff
United Kingdom Novartis Investigative Site Chertsey
United Kingdom Novartis Investigative Site Darlington Durham
United Kingdom Novartis Investigative Site East Yorkshire
United Kingdom Novartis Investigative Site Leicester
United Kingdom Novartis Investigative Site London GBR
United Kingdom Novartis Investigative Site Nottingham
United Kingdom Novartis Investigative Site Plymouth
United Kingdom Novartis Investigative Site Sheffield South Yorkshire
United Kingdom Novartis Investigative Site Tyne And Wear
United Kingdom Novartis Investigative Site Wakefield
United Kingdom Novartis Investigative Site Wishaw
United States Novartis Investigative Site Bangor Maine
United States Novartis Investigative Site Bellevue Nebraska
United States Novartis Investigative Site Birmingham Alabama
United States Novartis Investigative Site Birmingham Alabama
United States Novartis Investigative Site Boerne Texas
United States Novartis Investigative Site Brandon Florida
United States Novartis Investigative Site Canton Ohio
United States Novartis Investigative Site Charlotte North Carolina
United States Novartis Investigative Site Cincinnati Ohio
United States Novartis Investigative Site Corning New York
United States Novartis Investigative Site Crowley Louisiana
United States Novartis Investigative Site East Providence Rhode Island
United States Novartis Investigative Site Fairfax Virginia
United States Novartis Investigative Site Gainesville Georgia
United States Novartis Investigative Site Gaithersburg Maryland
United States Novartis Investigative Site Gastonia North Carolina
United States Novartis Investigative Site Gilbert Arizona
United States Novartis Investigative Site Hawaiian Gardens California
United States Novartis Investigative Site Jefferson Hills Pennsylvania
United States Novartis Investigative Site Lincoln Nebraska
United States Novartis Investigative Site Litchfield Park Arizona
United States Novartis Investigative Site Little Rock Arkansas
United States Novartis Investigative Site Livonia Michigan
United States Novartis Investigative Site Marietta Georgia
United States Novartis Investigative Site Maumee Ohio
United States Novartis Investigative Site McKinney Texas
United States Novartis Investigative Site Monroe North Carolina
United States Novartis Investigative Site New Bern North Carolina
United States Novartis Investigative Site New Haven Connecticut
United States Novartis Investigative Site New Smyrna Beach Florida
United States Novartis Investigative Site New York New York
United States Novartis Investigative Site Newport Beach California
United States Novartis Investigative Site Oklahoma City Oklahoma
United States Novartis Investigative Site Omaha Nebraska
United States Novartis Investigative Site Orlando Florida
United States Novartis Investigative Site Orlando Florida
United States Novartis Investigative Site Ormond Beach Florida
United States Novartis Investigative Site Peoria Arizona
United States Novartis Investigative Site Picayune Mississippi
United States Novartis Investigative Site Pittsburgh Pennsylvania
United States Novartis Investigative Site Plano Texas
United States Novartis Investigative Site Redondo Beach California
United States Novartis Investigative Site Riverside California
United States Novartis Investigative Site San Antonio Texas
United States Novartis Investigative Site San Antonio Texas
United States Novartis Investigative Site Sebring Florida
United States Novartis Investigative Site Torrance California
United States Novartis Investigative Site Westminster California
United States Novartis Investigative Site White Marsh Maryland
United States Novartis Investigative Site Whiteville North Carolina
United States Novartis Investigative Site Wilmington North Carolina
United States Novartis Investigative Site Winston-Salem North Carolina
United States Novartis Investigative Site Winter Park Florida
United States Novartis Investigative Site Ypsilanti Michigan
United States Novartis Investigative Site Zachary Louisiana
Vietnam Novartis Investigative Site Hanoi
Vietnam Novartis Investigative Site Ho Chi Minh
Vietnam Novartis Investigative Site Ho Chi Minh VNM

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  China,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Guatemala,  Hungary,  Iceland,  Ireland,  Latvia,  Lithuania,  Philippines,  Poland,  Romania,  Singapore,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours*); or death due to asthma. A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours). The high eosinophils subpopulation consists of all patients with blood eosinophil count = 250 cells/µL at baseline. Baseline, Week 52
Primary Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in Overall Population A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours*); or death due to asthma. A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours). Baseline, Week 52
Secondary Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in High Eosinophils Subpopulation The AQLQ+12 is comprised of a total of 32 individual questions that span a total of four domains: symptoms, activity limitation, emotional function, and environmental stimuli.
Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The AQLQ+12 yields individual domain scores, which is the mean of all items in each domain, and an overall score, which is the mean of all 32 individual responses. Higher scores indicate less impairment in health-related quality of life. The high eosinophils subpopulation consists of all patients with blood eosinophil count = 250 cells/µL at baseline.
52 weeks
Secondary Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in High Eosinophils Subpopulation The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the ACQ-5 score is the mean of the 5 questions: therefore, between 0 (totally controlled) and 6 (severely uncontrolled). The high eosinophils subpopulation consists of all patients with blood eosinophil count = 250 cells/µL at baseline. Baseline, Week 52
Secondary Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation 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. The high eosinophils subpopulation consists of all patients with blood eosinophil count = 250 cells/µL at baseline. Baseline, Week 52
Secondary Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in Overall Population The AQLQ+12 is comprised of a total of 32 individual questions that span a total of four domains: symptoms, activity limitation, emotional function, and environmental stimuli.
Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The AQLQ+12 yields individual domain scores, which is the mean of all items in each domain, and an overall score, which is the mean of all 32 individual responses. Higher scores indicate less impairment in health-related quality of life.
Baseline, Week 52
Secondary Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in Overall Population The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the ACQ-5 score is the mean of the 5 questions: therefore, between 0 (totally controlled) and 6 (severely uncontrolled). Baseline, Week 52
Secondary Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in Overall Population 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, Week 52
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