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Dose Finding Study for QAW039 in Asthma

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

QAW039

Montelukast

Placebo

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, QAW039

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Physician diagnosis of asthma, as per the Global Initiative for Asthma (GINA) (2009) guidelines, and currently prescribed Inhaled Corticosteroids (ICS) therapy.
Patients with a pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) value of 40% to 80% of individual predicted value.
Patients should be allergic or atopic, as diagnosed historically or prior to entry into the study.
Patients who are demonstrated to have reversible airway obstruction or airways hyper-reactivity or have shown either of such responses in previous test(s) within the last year.
An Asthma Control Questionnaire (ACQ) score ≥ 1.5 at randomization.

Exclusion Criteria:

Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL).
Patients with serious co-morbidities including uncontrolled diabetes (HbA1c≥8%), heart failure, cancer, neurodegenerative diseases, rheumatoid arthritis and other autoimmune diseases, other lung diseases including chronic bronchitis, chronic obstructive pulmonary diseases or emphysema or other conditions characterized by eosinophilia and pulmonary symptoms (i.e. Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, eosinophilic pneumonia, etc.).
Acute illness other than asthma at the start of the study
History of life-threatening asthma, including a history of significant hypercarbia (pCO2>45mmHg), prior intubation, respiratory arrest, or seizures as a result of asthma.
Patients who have had a respiratory tract infection within 4 weeks of the screening visit. Patients who develop a respiratory tract infection between screening and the randomization visit must be screen failed, and may be permitted to re-enroll at a later date.
Current smokers or ex-smokers who stopped smoking within 6 months prior to screening or have a smoking history of ≥ 10 pack years.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

QAW039 po dose 1

QAW039 po dose 2

QAW039 po dose 3

QAW039 po dose 4

QAW039 po dose 5

QAW039 po dose 6

QAW039 po dose 7

QAW039 po dose 8

QAW039 po dose 9

QAW039 po dose 10

QAW039 po dose 11

QAW039 po dose 12

QAW039 po dose 13

Montelukast po 10 mg

Placebo

Arm Description

Comparator leukotriene receptor antagonist (LRTA)

Outcomes

Primary Outcome Measures

Change in trough Forced Expiratory Volume in 1 second (FEV1) from baseline to week 12

Forced Expiratory Volume in 1 second (FEV1) (measured in litters), and the trough measurement is taken 24 hours after morning dose on the previous day.

Secondary Outcome Measures

Change in Asthma Control Questionnaire (ACQ) score from baseline to week 12

The Asthma Control Questionnaire (ACQ) is a validated questionnaire consisting of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 assessing the patients Forced Expiratory Volume in 1 second (FEV1) result against the predicted result for a person of similar age and stature. Each item is graded on a scale of 0-6, and a mean score of 1.5 or greater is considered to demonstrate inadequate asthma control in this trial. The minimal important difference that is considered clinically important is a change of 0.5 in the mean score.

Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to weeks 2, 4 and 8.

Forced Expiratory Volume in 1 second (FEV1) (measured in litters), and the measurement is taken 24 hours after the morning dose on the previous day.

Change in the Asthma Control Questionnaire (ACQ) score from baseline to weeks 2, 4 and 8.

Change in the dose response relationship among QAW039 doses with respect to Forced Expiratory Volume in 1 second (FEV1) after 12 weeks treatment.

Forced Expiratory Volume in 1 second (FEV1) (measured in litters), and the measurement is taken 24 hours after the morning dose on the previous day.

Comparison of vital signs, ECG, laboratory tests and adverse events across QAW039 doses and placebo.

Comparisons of vital signs (i.e. systolic and diastolic blood pressure, pulse rate), ECG (e.g. quantitative assessments - heart rate, QTcF, PRS, PR intervals), laboratory tests (haematology, clinical chemistry and urinalysis) and adverse events across QAW039 doses and placebo.

Comparison of efficacy of QAW039 with that of active comparator as an add-on therapy to Inhaled Corticosteroids (ICS)

Forced Expiratory Volume in 1 second (FEV1) measurement taken 24 hours after the morning dose on the previous day. The Asthma Control Questionnaire (ACQ)consisting of 7 items: 5 on system assessment, 1 on rescue bronchodilator use and 1 assessing the patients for FEV1 result against the predicted result for a person of similar age and stature. Each item is graded on a scale of 0-6, and a mean score of 1.5 or greater is considered to demonstrate inadequate asthma control in this trial. The minimal important difference that is considered clinically important is a change of 0.5 in the mean score.

Assess the effect of QAW039 on asthma symptoms as measured by asthma control diary.

The asthma control diary mimics the Asthma Control Questionnaire (ACQ), but is recorded daily by the patient, rather than at each visit. As for the ACQ, the ACD consists of 7 questions.

Full Information

NCT ID

NCT01437735

First Posted

September 14, 2011

Last Updated

December 11, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01437735

Brief Title

Dose Finding Study for QAW039 in Asthma

Official Title

A Randomized, Placebo-controlled, Dose-ranging, Multi-centre Trial of QAW039 (1-450 mg p.o.), to Investigate the Effect on FEV1 and ACQ in Patients With Moderate-to-severe, Persistent, Allergic Asthma, Inadequately Controlled With ICS Therapy.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study aims to demonstrate a clinically significant improvement in Forced Expiratory Volume in one second (FEV1) in moderate to severe allergic asthmatics inadequately controlled by Inhaled Corticosteroid (ICS) therapy. Patients will be treated with QAW039, an active comparator, or placebo. This will be a randomized, placebo-controlled, dose-ranging, multi-centre trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, QAW039

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1043 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QAW039 po dose 1

Arm Type

Experimental

Arm Title

QAW039 po dose 2

Arm Type

Experimental

Arm Title

QAW039 po dose 3

Arm Type

Experimental

Arm Title

QAW039 po dose 4

Arm Type

Experimental

Arm Title

QAW039 po dose 5

Arm Type

Experimental

Arm Title

QAW039 po dose 6

Arm Type

Experimental

Arm Title

QAW039 po dose 7

Arm Type

Experimental

Arm Title

QAW039 po dose 8

Arm Type

Experimental

Arm Title

QAW039 po dose 9

Arm Type

Experimental

Arm Title

QAW039 po dose 10

Arm Type

Experimental

Arm Title

QAW039 po dose 11

Arm Type

Experimental

Arm Title

QAW039 po dose 12

Arm Type

Experimental

Arm Title

QAW039 po dose 13

Arm Type

Experimental

Arm Title

Montelukast po 10 mg

Arm Type

Active Comparator

Arm Description

Comparator leukotriene receptor antagonist (LRTA)

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

QAW039

Intervention Description

QAW039 po

Intervention Type

Drug

Intervention Name(s)

Montelukast

Intervention Description

Montelukast 10 mg po

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Change in trough Forced Expiratory Volume in 1 second (FEV1) from baseline to week 12

Description

Forced Expiratory Volume in 1 second (FEV1) (measured in litters), and the trough measurement is taken 24 hours after morning dose on the previous day.

Time Frame

Baseline and week 12

Secondary Outcome Measure Information:

Title

Change in Asthma Control Questionnaire (ACQ) score from baseline to week 12

Description

Time Frame

Baseline and week 12

Title

Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to weeks 2, 4 and 8.

Description

Forced Expiratory Volume in 1 second (FEV1) (measured in litters), and the measurement is taken 24 hours after the morning dose on the previous day.

Time Frame

Baseline, week 2, week 4 and week 8

Title

Change in the Asthma Control Questionnaire (ACQ) score from baseline to weeks 2, 4 and 8.

Description

Time Frame

Baseline, week 2, week 4 and week 8

Title

Change in the dose response relationship among QAW039 doses with respect to Forced Expiratory Volume in 1 second (FEV1) after 12 weeks treatment.

Description

Forced Expiratory Volume in 1 second (FEV1) (measured in litters), and the measurement is taken 24 hours after the morning dose on the previous day.

Time Frame

Baseline and week 12

Title

Comparison of vital signs, ECG, laboratory tests and adverse events across QAW039 doses and placebo.

Description

Time Frame

Baseline and week 12

Title

Comparison of efficacy of QAW039 with that of active comparator as an add-on therapy to Inhaled Corticosteroids (ICS)

Description

Time Frame

Baseline and week 12

Title

Assess the effect of QAW039 on asthma symptoms as measured by asthma control diary.

Description

The asthma control diary mimics the Asthma Control Questionnaire (ACQ), but is recorded daily by the patient, rather than at each visit. As for the ACQ, the ACD consists of 7 questions.

Time Frame

Baseline and week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Physician diagnosis of asthma, as per the Global Initiative for Asthma (GINA) (2009) guidelines, and currently prescribed Inhaled Corticosteroids (ICS) therapy. Patients with a pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) value of 40% to 80% of individual predicted value. Patients should be allergic or atopic, as diagnosed historically or prior to entry into the study. Patients who are demonstrated to have reversible airway obstruction or airways hyper-reactivity or have shown either of such responses in previous test(s) within the last year. An Asthma Control Questionnaire (ACQ) score ≥ 1.5 at randomization. Exclusion Criteria: Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL). Patients with serious co-morbidities including uncontrolled diabetes (HbA1c≥8%), heart failure, cancer, neurodegenerative diseases, rheumatoid arthritis and other autoimmune diseases, other lung diseases including chronic bronchitis, chronic obstructive pulmonary diseases or emphysema or other conditions characterized by eosinophilia and pulmonary symptoms (i.e. Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, eosinophilic pneumonia, etc.). Acute illness other than asthma at the start of the study History of life-threatening asthma, including a history of significant hypercarbia (pCO2>45mmHg), prior intubation, respiratory arrest, or seizures as a result of asthma. Patients who have had a respiratory tract infection within 4 weeks of the screening visit. Patients who develop a respiratory tract infection between screening and the randomization visit must be screen failed, and may be permitted to re-enroll at a later date. Current smokers or ex-smokers who stopped smoking within 6 months prior to screening or have a smoking history of ≥ 10 pack years.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85251

Country

United States

Facility Name

Novartis Investigative Site

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

Facility Name

Novartis Investigative Site

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92647

Country

United States

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Novartis Investigative Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Novartis Investigative Site

City

Riverside

State/Province

California

ZIP/Postal Code

92506

Country

United States

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Novartis Investigative Site

City

San Jose

State/Province

California

ZIP/Postal Code

95117

Country

United States

Facility Name

Novartis Investigative Site

City

San Mateo

State/Province

California

ZIP/Postal Code

94401

Country

United States

Facility Name

Novartis Investigative Site

City

Stockton

State/Province

California

ZIP/Postal Code

95207

Country

United States

Facility Name

Novartis Investigative Site

City

Centennial

State/Province

Colorado

ZIP/Postal Code

80112

Country

United States

Facility Name

Novartis Investigative Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Novartis Investigative Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34233

Country

United States

Facility Name

Novartis Investigative Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406

Country

United States

Facility Name

Novartis Investigative Site

City

River Forest

State/Province

Illinois

ZIP/Postal Code

60305

Country

United States

Facility Name

Novartis Investigative Site

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Novartis Investigative Site

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

Novartis Investigative Site

City

North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747

Country

United States

Facility Name

Novartis Investigative Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55402

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Novartis Investigative Site

City

Warrensburg

State/Province

Missouri

ZIP/Postal Code

64093

Country

United States

Facility Name

Novartis Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68130

Country

United States

Facility Name

Novartis Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

Novartis Investigative Site

City

Papillion

State/Province

Nebraska

ZIP/Postal Code

68046

Country

United States

Facility Name

Novartis Investigative Site

City

Skillman

State/Province

New Jersey

ZIP/Postal Code

08558

Country

United States

Facility Name

Novartis Investigative Site

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Facility Name

Novartis Investigative Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Novartis Investigative Site

City

Lake Oswego

State/Province

Oregon

ZIP/Postal Code

97035

Country

United States

Facility Name

Novartis Investigative Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504-8741

Country

United States

Facility Name

Novartis Investigative Site

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16507

Country

United States

Facility Name

Novartis Investigative Site

City

Lincoln

State/Province

Rhode Island

ZIP/Postal Code

02865

Country

United States

Facility Name

Novartis Investigative Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Novartis Investigative Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76132

Country

United States

Facility Name

Novartis Investigative Site

City

Waco

State/Province

Texas

ZIP/Postal Code

76712

Country

United States

Facility Name

Novartis Investigative Site

City

South Burlington

State/Province

Vermont

ZIP/Postal Code

05403

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

B8000XAV

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1122AAK

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1186ACB

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1425BEN

Country

Argentina

Facility Name

Novartis Investigative Site

City

Florencio Varela

State/Province

Buenos Aires

ZIP/Postal Code

B2705XAE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mar del Plata

State/Province

Buenos Aires

ZIP/Postal Code

7600

Country

Argentina

Facility Name

Novartis Investigative Site

City

Quilmes

State/Province

Buenos Aires

ZIP/Postal Code

B1878FNR

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Fe

State/Province

Rosario

ZIP/Postal Code

S2000DBS

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1115AAB

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1125ABE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Fe

ZIP/Postal Code

S3000FIL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Feldbach

ZIP/Postal Code

8330

Country

Austria

Facility Name

Novartis Investigative Site

City

Grieskirchen

ZIP/Postal Code

4710

Country

Austria

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

Novartis Investigative Site

City

Thalheim bei Wels

ZIP/Postal Code

4600

Country

Austria

Facility Name

Novartis Investigative Site

City

Vienna

ZIP/Postal Code

1210

Country

Austria

Facility Name

Novartis Investigative Site

City

Plovdiv

ZIP/Postal Code

400

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Ruse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1463

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Varna

ZIP/Postal Code

9020

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4G2

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4V 1R2

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

GIV 4M6

Country

Canada

Facility Name

Novartis Investigative Site

City

Bogota

State/Province

Cundinamarca

Country

Colombia

Facility Name

Novartis Investigative Site

City

Armenia

Country

Colombia

Facility Name

Novartis Investigative Site

City

Barranquilla

Country

Colombia

Facility Name

Novartis Investigative Site

City

Bogotá

Country

Colombia

Facility Name

Novartis Investigative Site

City

Medellín

Country

Colombia

Facility Name

Novartis Investigative Site

City

Ferolles-Attily

ZIP/Postal Code

77150

Country

France

Facility Name

Novartis Investigative Site

City

Lyon cedex 04

ZIP/Postal Code

69317

Country

France

Facility Name

Novartis Investigative Site

City

Montpellier

ZIP/Postal Code

34059

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75006

Country

France

Facility Name

Novartis Investigative Site

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

Novartis Investigative Site

City

Reims

ZIP/Postal Code

51092

Country

France

Facility Name

Novartis Investigative Site

City

Strasbourg Cedex

ZIP/Postal Code

67091

Country

France

Facility Name

Novartis Investigative Site

City

Tarbes Cedex

ZIP/Postal Code

65013

Country

France

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Heraklion - Crete

State/Province

ZIP/Postal Code

711 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

570 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Antigua Guatemala

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01015

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Balassagyarmat

ZIP/Postal Code

2660

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Deszk

ZIP/Postal Code

6772

Country

Hungary

Facility Name

Novartis Investigative Site

City

Gyor

ZIP/Postal Code

9024

Country

Hungary

Facility Name

Novartis Investigative Site

City

Mosonmagyarovar

ZIP/Postal Code

9200

Country

Hungary

Facility Name

Novartis Investigative Site

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Novartis Investigative Site

City

Százhalombatta

ZIP/Postal Code

2440

Country

Hungary

Facility Name

Novartis Investigative Site

City

Torokbalint

ZIP/Postal Code

2045

Country

Hungary

Facility Name

Novartis Investigative Site

City

Panjim

State/Province

Goa

ZIP/Postal Code

403 002

Country

India

Facility Name

Novartis Investigative Site

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380007

Country

India

Facility Name

Novartis Investigative Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560 010

Country

India

Facility Name

Novartis Investigative Site

City

Mysore

State/Province

Karnataka

ZIP/Postal Code

570004

Country

India

Facility Name

Novartis Investigative Site

City

Indore

State/Province

Madhya Pradesh

ZIP/Postal Code

452001

Country

India

Facility Name

Novartis Investigative Site

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

440 012

Country

India

Facility Name

Novartis Investigative Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411 014

Country

India

Facility Name

Novartis Investigative Site

City

Ludhiana

State/Province

Punjab

ZIP/Postal Code

141001

Country

India

Facility Name

Novartis Investigative Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302017

Country

India

Facility Name

Novartis Investigative Site

City

Chennai

State/Province

Tamil Nadu

ZIP/Postal Code

600 006

Country

India

Facility Name

Novartis Investigative Site

City

Coimbatore

State/Province

Tamil Nadu

ZIP/Postal Code

641004

Country

India

Facility Name

Novartis Investigative Site

City

Nagpur - Maharashtra

ZIP/Postal Code

440012

Country

India

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50134

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

State/Province

ZIP/Postal Code

56124

Country

Italy

Facility Name

Novartis Investigative Site

City

Parma

State/Province

ZIP/Postal Code

43100

Country

Italy

Facility Name

Novartis Investigative Site

City

Nishio-city

State/Province

Aichi

ZIP/Postal Code

445-8510

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka-city

State/Province

Fukuoka

ZIP/Postal Code

819-8555

Country

Japan

Facility Name

Novartis Investigative Site

City

Kasuga-city

State/Province

Fukuoka

ZIP/Postal Code

816-0813

Country

Japan

Facility Name

Novartis Investigative Site

City

Kitakyushu

State/Province

Fukuoka

ZIP/Postal Code

802-0083

Country

Japan

Facility Name

Novartis Investigative Site

City

Kitakyushu

State/Province

Fukuoka

ZIP/Postal Code

820-0052

Country

Japan

Facility Name

Novartis Investigative Site

City

Yanagawa

State/Province

Fukuoka

ZIP/Postal Code

832-0059

Country

Japan

Facility Name

Novartis Investigative Site

City

Mizunami-city

State/Province

Gifu

ZIP/Postal Code

509-6134

Country

Japan

Facility Name

Novartis Investigative Site

City

Hatsukaichi-city

State/Province

Hiroshima

ZIP/Postal Code

739-0402

Country

Japan

Facility Name

Novartis Investigative Site

City

Asahikawa-city

State/Province

Hokkaido

ZIP/Postal Code

070-8644

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo-city

State/Province

Hokkaido

ZIP/Postal Code

060-0061

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

062-8618

Country

Japan

Facility Name

Novartis Investigative Site

City

Himeji-city

State/Province

Hyogo

ZIP/Postal Code

672-8064

Country

Japan

Facility Name

Novartis Investigative Site

City

Higashiibaraki-gun

State/Province

Ibaraki

ZIP/Postal Code

311-3193

Country

Japan

Facility Name

Novartis Investigative Site

City

Hitachi-city

State/Province

Ibaraki

ZIP/Postal Code

317-0077

Country

Japan

Facility Name

Novartis Investigative Site

City

Kanazawa

State/Province

Ishikawa

ZIP/Postal Code

920-0853

Country

Japan

Facility Name

Novartis Investigative Site

City

Sakaide

State/Province

Kagawa

ZIP/Postal Code

762-0031

Country

Japan

Facility Name

Novartis Investigative Site

City

Kawasaki-city

State/Province

Kanagawa

ZIP/Postal Code

210-0852

Country

Japan

Facility Name

Novartis Investigative Site

City

Sagamihara-city

State/Province

Kanagawa

ZIP/Postal Code

228-8522

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama-city

State/Province

Kanagawa

ZIP/Postal Code

231-8682

Country

Japan

Facility Name

Novartis Investigative Site

City

Sendai-city

State/Province

Miyagi

ZIP/Postal Code

983-8520

Country

Japan

Facility Name

Novartis Investigative Site

City

Kurashiki-city

State/Province

Okayama

ZIP/Postal Code

712-8064

Country

Japan

Facility Name

Novartis Investigative Site

City

Tsukubo-gun

State/Province

Okayama

ZIP/Postal Code

701-0304

Country

Japan

Facility Name

Novartis Investigative Site

City

Habikino city

State/Province

Osaka

ZIP/Postal Code

583-8588

Country

Japan

Facility Name

Novartis Investigative Site

City

Kishiwada

State/Province

Osaka

ZIP/Postal Code

596-8501

Country

Japan

Facility Name

Novartis Investigative Site

City

Osakasayama

State/Province

Osaka

ZIP/Postal Code

589-0022

Country

Japan

Facility Name

Novartis Investigative Site

City

Koshigaya-city

State/Province

Saitama

ZIP/Postal Code

343-0851

Country

Japan

Facility Name

Novartis Investigative Site

City

Hamamatsu-city

State/Province

Shizuoka

ZIP/Postal Code

430-8558

Country

Japan

Facility Name

Novartis Investigative Site

City

Hamamatsu

State/Province

Shizuoka

ZIP/Postal Code

430-8525

Country

Japan

Facility Name

Novartis Investigative Site

City

Hamamatsu

State/Province

Shizuoka

ZIP/Postal Code

434-8511

Country

Japan

Facility Name

Novartis Investigative Site

City

Chiyoda-ku

State/Province

Tokyo

ZIP/Postal Code

1020083

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

103-0027

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

103-0028

Country

Japan

Facility Name

Novartis Investigative Site

City

Edogawa-ku

State/Province

Tokyo

ZIP/Postal Code

134-0083

Country

Japan

Facility Name

Novartis Investigative Site

City

Itabashi-ku

State/Province

Tokyo

ZIP/Postal Code

173-8610

Country

Japan

Facility Name

Novartis Investigative Site

City

Kiyose-city

State/Province

Tokyo

ZIP/Postal Code

204-8585

Country

Japan

Facility Name

Novartis Investigative Site

City

Minato-ku

State/Province

Tokyo

ZIP/Postal Code

108-8606

Country

Japan

Facility Name

Novartis Investigative Site

City

Setagaya-ku

State/Province

Tokyo

ZIP/Postal Code

158-0097

Country

Japan

Facility Name

Novartis Investigative Site

City

Tachikawa

State/Province

Tokyo

ZIP/Postal Code

190-0013

Country

Japan

Facility Name

Novartis Investigative Site

City

Taito

State/Province

Tokyo

ZIP/Postal Code

111-0052

Country

Japan

Facility Name

Novartis Investigative Site

City

Toshima-ku

State/Province

Tokyo

ZIP/Postal Code

171-0014

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka

ZIP/Postal Code

811-1394

Country

Japan

Facility Name

Novartis Investigative Site

City

Hiroshima

ZIP/Postal Code

732-0052

Country

Japan

Facility Name

Novartis Investigative Site

City

Kochi

ZIP/Postal Code

780-8077

Country

Japan

Facility Name

Novartis Investigative Site

City

Kyoto

ZIP/Postal Code

612-0026

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka

ZIP/Postal Code

560-0005

Country

Japan

Facility Name

Novartis Investigative Site

City

Mexicali

State/Province

Baja California

ZIP/Postal Code

21100

Country

Mexico

Facility Name

Novartis Investigative Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

03020

Country

Mexico

Facility Name

Novartis Investigative Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

14050

Country

Mexico

Facility Name

Novartis Investigative Site

City

México

State/Province

Distrito Federal

ZIP/Postal Code

14080

Country

Mexico

Facility Name

Novartis Investigative Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44130

Country

Mexico

Facility Name

Novartis Investigative Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44280

Country

Mexico

Facility Name

Novartis Investigative Site

City

Zapopan

State/Province

Jalisco

ZIP/Postal Code

45040

Country

Mexico

Facility Name

Novartis Investigative Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64718

Country

Mexico

Facility Name

Novartis Investigative Site

City

Almelo

ZIP/Postal Code

7609 PP

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Harderwijk

ZIP/Postal Code

3840 AC

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Cercado De Lima

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Jesus Maria

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Miraflores

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

San Borja

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

San Isidro

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Santiago de Surco

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Katowice

ZIP/Postal Code

40-752

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

31-159

Country

Poland

Facility Name

Novartis Investigative Site

City

Bucharest

State/Province

District 1

ZIP/Postal Code

10457

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

State/Province

District 1

ZIP/Postal Code

11475

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

State/Province

District 3

ZIP/Postal Code

030317

Country

Romania

Facility Name

Novartis Investigative Site

City

Craiova

State/Province

Dolj

ZIP/Postal Code

200515

Country

Romania

Facility Name

Novartis Investigative Site

City

Iasi

State/Province

Jud. Iasi

ZIP/Postal Code

700115

Country

Romania

Facility Name

Novartis Investigative Site

City

Arad

ZIP/Postal Code

310013

Country

Romania

Facility Name

Novartis Investigative Site

City

Arad

ZIP/Postal Code

310086

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

050159

Country

Romania

Facility Name

Novartis Investigative Site

City

Deva

ZIP/Postal Code

330162

Country

Romania

Facility Name

Novartis Investigative Site

City

Barnaul

ZIP/Postal Code

656024

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Barnaul

ZIP/Postal Code

656045

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Chelyabinsk

ZIP/Postal Code

454021

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Chelyabinsk

ZIP/Postal Code

454047

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

119992

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

125315

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St.-Petersburg

ZIP/Postal Code

193231

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Amanzimtoti

ZIP/Postal Code

4126

Country

South Africa

Facility Name

Novartis Investigative Site

City

Benoni

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7531

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Novartis Investigative Site

City

Durban

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Novartis Investigative Site

City

Gatesville

ZIP/Postal Code

7764

Country

South Africa

Facility Name

Novartis Investigative Site

City

Port Elizabeth

ZIP/Postal Code

6001

Country

South Africa

Facility Name

Novartis Investigative Site

City

Pretoria

ZIP/Postal Code

0001

Country

South Africa

Facility Name

Novartis Investigative Site

City

Pretoria

ZIP/Postal Code

0181

Country

South Africa

Facility Name

Novartis Investigative Site

City

Fatih / Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34854

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35040

Country

Turkey

Facility Name

Novartis Investigative Site

City

Mersin

ZIP/Postal Code

33079

Country

Turkey

Facility Name

Novartis Investigative Site

City

Yenisehir/Izmir

ZIP/Postal Code

35110

Country

Turkey

Facility Name

Novartis Investigative Site

City

Newcastle Upon Tyne

State/Province

Newcastle

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bradford

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Glasgow - Scotland

ZIP/Postal Code

G12 OYN

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

28838980

Citation

Bateman ED, Guerreros AG, Brockhaus F, Holzhauer B, Pethe A, Kay RA, Townley RG. Fevipiprant, an oral prostaglandin DP2 receptor (CRTh2) antagonist, in allergic asthma uncontrolled on low-dose inhaled corticosteroids. Eur Respir J. 2017 Aug 24;50(2):1700670. doi: 10.1183/13993003.00670-2017. Print 2017 Aug.

Results Reference

derived

Links:

URL

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=13023

Description

Results for CQAW039A2206 from the Novartis Clinical Trials website

Learn more about this trial

Dose Finding Study for QAW039 in Asthma

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Dose Finding Study for QAW039 in Asthma

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial