Dose Finding Study for QAW039 in Asthma

December 11, 2020 updated by: Novartis Pharmaceuticals

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1043

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1115AAB
        • Novartis Investigative Site
      • Buenos Aires, Argentina, C1125ABE
        • Novartis Investigative Site
      • Mendoza, Argentina, 5500
        • Novartis Investigative Site
      • Santa Fe, Argentina, S3000FIL
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1122AAK
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1425BEN
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, B8000XAV
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1186ACB
        • Novartis Investigative Site
      • Florencio Varela, Buenos Aires, Argentina, B2705XAE
        • Novartis Investigative Site
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Novartis Investigative Site
      • Quilmes, Buenos Aires, Argentina, B1878FNR
        • Novartis Investigative Site
    • Rosario
      • Santa Fe, Rosario, Argentina, S2000DBS
        • Novartis Investigative Site
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
        • Novartis Investigative Site
  • Austria
      • Feldbach, Austria, 8330
        • Novartis Investigative Site
      • Grieskirchen, Austria, 4710
        • Novartis Investigative Site
      • Linz, Austria, 4020
        • Novartis Investigative Site
      • Thalheim bei Wels, Austria, 4600
        • Novartis Investigative Site
      • Vienna, Austria, 1210
        • Novartis Investigative Site
  • Bulgaria
      • Plovdiv, Bulgaria, 400
        • Novartis Investigative Site
      • Ruse, Bulgaria, 7002
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1431
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1463
        • Novartis Investigative Site
      • Varna, Bulgaria, 9020
        • Novartis Investigative Site
  • Canada
      • Quebec, Canada, GIV 4M6
        • Novartis Investigative Site
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4G2
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M4V 1R2
        • Novartis Investigative Site
  • Colombia
      • Armenia, Colombia
        • Novartis Investigative Site
      • Barranquilla, Colombia
        • Novartis Investigative Site
      • Bogotá, Colombia
        • Novartis Investigative Site
      • Medellín, Colombia
        • Novartis Investigative Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Novartis Investigative Site
  • France
      • Ferolles-Attily, France, 77150
        • Novartis Investigative Site
      • Lyon cedex 04, France, 69317
        • Novartis Investigative Site
      • Montpellier, France, 34059
        • Novartis Investigative Site
      • Paris, France, 75006
        • Novartis Investigative Site
      • Pessac, France, 33604
        • Novartis Investigative Site
      • Reims, France, 51092
        • Novartis Investigative Site
      • Strasbourg Cedex, France, 67091
        • Novartis Investigative Site
      • Tarbes Cedex, France, 65013
        • Novartis Investigative Site
  • Greece
    • GR
      • Athens, GR, Greece, 115 27
        • Novartis Investigative Site
      • Heraklion - Crete, GR, Greece, 711 10
        • Novartis Investigative Site
      • Thessaloniki, GR, Greece, 570 10
        • Novartis Investigative Site
  • Guatemala
      • Antigua Guatemala, Guatemala
        • Novartis Investigative Site
      • Guatemala City, Guatemala, 01010
        • Novartis Investigative Site
      • Guatemala City, Guatemala, 01015
        • Novartis Investigative Site
  • Hungary
      • Balassagyarmat, Hungary, 2660
        • Novartis Investigative Site
      • Debrecen, Hungary, 4032
        • Novartis Investigative Site
      • Deszk, Hungary, 6772
        • Novartis Investigative Site
      • Gyor, Hungary, 9024
        • Novartis Investigative Site
      • Mosonmagyarovar, Hungary, 9200
        • Novartis Investigative Site
      • Nyiregyhaza, Hungary, 4400
        • Novartis Investigative Site
      • Százhalombatta, Hungary, 2440
        • Novartis Investigative Site
      • Torokbalint, Hungary, 2045
        • Novartis Investigative Site
  • India
      • Nagpur - Maharashtra, India, 440012
        • Novartis Investigative Site
    • Goa
      • Panjim, Goa, India, 403 002
        • Novartis Investigative Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380007
        • Novartis Investigative Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 010
        • Novartis Investigative Site
      • Mysore, Karnataka, India, 570004
        • Novartis Investigative Site
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452001
        • Novartis Investigative Site
    • Maharashtra
      • Nagpur, Maharashtra, India, 440 012
        • Novartis Investigative Site
      • Pune, Maharashtra, India, 411 014
        • Novartis Investigative Site
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Novartis Investigative Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302017
        • Novartis Investigative Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 006
        • Novartis Investigative Site
      • Coimbatore, Tamil Nadu, India, 641004
        • Novartis Investigative Site
  • Italy
    • FI
      • Firenze, FI, Italy, 50134
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italy, 56124
        • Novartis Investigative Site
    • PR
      • Parma, PR, Italy, 43100
        • Novartis Investigative Site
  • Japan
      • Fukuoka, Japan, 811-1394
        • Novartis Investigative Site
      • Hiroshima, Japan, 732-0052
        • Novartis Investigative Site
      • Kochi, Japan, 780-8077
        • Novartis Investigative Site
      • Kyoto, Japan, 612-0026
        • Novartis Investigative Site
      • Osaka, Japan, 560-0005
        • Novartis Investigative Site
    • Aichi
      • Nishio-city, Aichi, Japan, 445-8510
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka-city, Fukuoka, Japan, 819-8555
        • Novartis Investigative Site
      • Kasuga-city, Fukuoka, Japan, 816-0813
        • Novartis Investigative Site
      • Kitakyushu, Fukuoka, Japan, 802-0083
        • Novartis Investigative Site
      • Kitakyushu, Fukuoka, Japan, 820-0052
        • Novartis Investigative Site
      • Yanagawa, Fukuoka, Japan, 832-0059
        • Novartis Investigative Site
    • Gifu
      • Mizunami-city, Gifu, Japan, 509-6134
        • Novartis Investigative Site
    • Hiroshima
      • Hatsukaichi-city, Hiroshima, Japan, 739-0402
        • Novartis Investigative Site
    • Hokkaido
      • Asahikawa-city, Hokkaido, Japan, 070-8644
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 062-8618
        • Novartis Investigative Site
      • Sapporo-city, Hokkaido, Japan, 060-0061
        • Novartis Investigative Site
    • Hyogo
      • Himeji-city, Hyogo, Japan, 672-8064
        • Novartis Investigative Site
    • Ibaraki
      • Higashiibaraki-gun, Ibaraki, Japan, 311-3193
        • Novartis Investigative Site
      • Hitachi-city, Ibaraki, Japan, 317-0077
        • Novartis Investigative Site
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-0853
        • Novartis Investigative Site
    • Kagawa
      • Sakaide, Kagawa, Japan, 762-0031
        • Novartis Investigative Site
    • Kanagawa
      • Kawasaki-city, Kanagawa, Japan, 210-0852
        • Novartis Investigative Site
      • Sagamihara-city, Kanagawa, Japan, 228-8522
        • Novartis Investigative Site
      • Yokohama-city, Kanagawa, Japan, 231-8682
        • Novartis Investigative Site
    • Miyagi
      • Sendai-city, Miyagi, Japan, 983-8520
        • Novartis Investigative Site
    • Okayama
      • Kurashiki-city, Okayama, Japan, 712-8064
        • Novartis Investigative Site
      • Tsukubo-gun, Okayama, Japan, 701-0304
        • Novartis Investigative Site
    • Osaka
      • Habikino city, Osaka, Japan, 583-8588
        • Novartis Investigative Site
      • Kishiwada, Osaka, Japan, 596-8501
        • Novartis Investigative Site
      • Osakasayama, Osaka, Japan, 589-0022
        • Novartis Investigative Site
    • Saitama
      • Koshigaya-city, Saitama, Japan, 343-0851
        • Novartis Investigative Site
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 430-8525
        • Novartis Investigative Site
      • Hamamatsu, Shizuoka, Japan, 434-8511
        • Novartis Investigative Site
      • Hamamatsu-city, Shizuoka, Japan, 430-8558
        • Novartis Investigative Site
    • Tokyo
      • Chiyoda-ku, Tokyo, Japan, 1020083
        • Novartis Investigative Site
      • Chuo-ku, Tokyo, Japan, 103-0028
        • Novartis Investigative Site
      • Chuo-ku, Tokyo, Japan, 103-0027
        • Novartis Investigative Site
      • Edogawa-ku, Tokyo, Japan, 134-0083
        • Novartis Investigative Site
      • Itabashi-ku, Tokyo, Japan, 173-8610
        • Novartis Investigative Site
      • Kiyose-city, Tokyo, Japan, 204-8585
        • Novartis Investigative Site
      • Minato-ku, Tokyo, Japan, 108-8606
        • Novartis Investigative Site
      • Setagaya-ku, Tokyo, Japan, 158-0097
        • Novartis Investigative Site
      • Tachikawa, Tokyo, Japan, 190-0013
        • Novartis Investigative Site
      • Taito, Tokyo, Japan, 111-0052
        • Novartis Investigative Site
      • Toshima-ku, Tokyo, Japan, 171-0014
        • Novartis Investigative Site
  • Mexico
    • Baja California
      • Mexicali, Baja California, Mexico, 21100
        • Novartis Investigative Site
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 14050
        • Novartis Investigative Site
      • Mexico, Distrito Federal, Mexico, 03020
        • Novartis Investigative Site
      • México, Distrito Federal, Mexico, 14080
        • Novartis Investigative Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44130
        • Novartis Investigative Site
      • Guadalajara, Jalisco, Mexico, 44280
        • Novartis Investigative Site
      • Zapopan, Jalisco, Mexico, 45040
        • Novartis Investigative Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64718
        • Novartis Investigative Site
  • Netherlands
      • Almelo, Netherlands, 7609 PP
        • Novartis Investigative Site
      • Harderwijk, Netherlands, 3840 AC
        • Novartis Investigative Site
  • Peru
    • Lima
      • Cercado De Lima, Lima, Peru, 01
        • Novartis Investigative Site
      • Jesus Maria, Lima, Peru, 11
        • Novartis Investigative Site
      • Miraflores, Lima, Peru, 18
        • Novartis Investigative Site
      • San Borja, Lima, Peru, 41
        • Novartis Investigative Site
      • San Isidro, Lima, Peru, 27
        • Novartis Investigative Site
      • Santiago de Surco, Lima, Peru, 33
        • Novartis Investigative Site
  • Poland
      • Katowice, Poland, 40-752
        • Novartis Investigative Site
      • Krakow, Poland, 31-159
        • Novartis Investigative Site
  • Romania
      • Arad, Romania, 310013
        • Novartis Investigative Site
      • Arad, Romania, 310086
        • Novartis Investigative Site
      • Bucharest, Romania, 050159
        • Novartis Investigative Site
      • Deva, Romania, 330162
        • Novartis Investigative Site
    • District 1
      • Bucharest, District 1, Romania, 10457
        • Novartis Investigative Site
      • Bucharest, District 1, Romania, 11475
        • Novartis Investigative Site
    • District 3
      • Bucharest, District 3, Romania, 030317
        • Novartis Investigative Site
    • Dolj
      • Craiova, Dolj, Romania, 200515
        • Novartis Investigative Site
    • Jud. Iasi
      • Iasi, Jud. Iasi, Romania, 700115
        • Novartis Investigative Site
  • Russian Federation
      • Barnaul, Russian Federation, 656045
        • Novartis Investigative Site
      • Barnaul, Russian Federation, 656024
        • Novartis Investigative Site
      • Chelyabinsk, Russian Federation, 454021
        • Novartis Investigative Site
      • Chelyabinsk, Russian Federation, 454047
        • Novartis Investigative Site
      • Moscow, Russian Federation, 119992
        • Novartis Investigative Site
      • Moscow, Russian Federation, 125315
        • Novartis Investigative Site
      • Ryazan, Russian Federation, 390026
        • Novartis Investigative Site
      • St. Petersburg, Russian Federation, 194354
        • Novartis Investigative Site
      • St.-Petersburg, Russian Federation, 193231
        • Novartis Investigative Site
      • Yaroslavl, Russian Federation, 150003
        • Novartis Investigative Site
  • South Africa
      • Amanzimtoti, South Africa, 4126
        • Novartis Investigative Site
      • Benoni, South Africa
        • Novartis Investigative Site
      • Cape Town, South Africa, 7531
        • Novartis Investigative Site
      • Cape Town, South Africa, 7925
        • Novartis Investigative Site
      • Durban, South Africa, 4001
        • Novartis Investigative Site
      • Gatesville, South Africa, 7764
        • Novartis Investigative Site
      • Port Elizabeth, South Africa, 6001
        • Novartis Investigative Site
      • Pretoria, South Africa, 0181
        • Novartis Investigative Site
      • Pretoria, South Africa, 0001
        • Novartis Investigative Site
  • Turkey
      • Fatih / Istanbul, Turkey, 34098
        • Novartis Investigative Site
      • Istanbul, Turkey, 34093
        • Novartis Investigative Site
      • Istanbul, Turkey, 34854
        • Novartis Investigative Site
      • Izmir, Turkey, 35040
        • Novartis Investigative Site
      • Mersin, Turkey, 33079
        • Novartis Investigative Site
      • Yenisehir/Izmir, Turkey, 35110
        • Novartis Investigative Site
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Novartis Investigative Site
      • Glasgow - Scotland, United Kingdom, G12 OYN
        • Novartis Investigative Site
    • Newcastle
      • Newcastle Upon Tyne, Newcastle, United Kingdom, NE7 7DN
        • Novartis Investigative Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Novartis Investigative Site
    • California
      • Encinitas, California, United States, 92024
        • Novartis Investigative Site
      • Huntington Beach, California, United States, 92647
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90048
        • Novartis Investigative Site
      • Orange, California, United States, 92868
        • Novartis Investigative Site
      • Riverside, California, United States, 92506
        • Novartis Investigative Site
      • San Diego, California, United States, 92123
        • Novartis Investigative Site
      • San Diego, California, United States, 92120
        • Novartis Investigative Site
      • San Jose, California, United States, 95117
        • Novartis Investigative Site
      • San Mateo, California, United States, 94401
        • Novartis Investigative Site
      • Stockton, California, United States, 95207
        • Novartis Investigative Site
    • Colorado
      • Centennial, Colorado, United States, 80112
        • Novartis Investigative Site
      • Denver, Colorado, United States, 80230
        • Novartis Investigative Site
    • Florida
      • Sarasota, Florida, United States, 34233
        • Novartis Investigative Site
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Novartis Investigative Site
    • Illinois
      • River Forest, Illinois, United States, 60305
        • Novartis Investigative Site
    • Maine
      • Bangor, Maine, United States, 04401
        • Novartis Investigative Site
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • Novartis Investigative Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Novartis Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Novartis Investigative Site
      • Warrensburg, Missouri, United States, 64093
        • Novartis Investigative Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Novartis Investigative Site
      • Omaha, Nebraska, United States, 68130
        • Novartis Investigative Site
      • Papillion, Nebraska, United States, 68046
        • Novartis Investigative Site
    • New Jersey
      • Skillman, New Jersey, United States, 08558
        • Novartis Investigative Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Novartis Investigative Site
      • Columbus, Ohio, United States, 43213
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Novartis Investigative Site
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Novartis Investigative Site
      • Medford, Oregon, United States, 97504-8741
        • Novartis Investigative Site
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Novartis Investigative Site
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Novartis Investigative Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Novartis Investigative Site
      • Fort Worth, Texas, United States, 76132
        • Novartis Investigative Site
      • Waco, Texas, United States, 76712
        • Novartis Investigative Site
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo
EXPERIMENTAL: QAW039 po dose 1
Drug: QAW039
QAW039 po
EXPERIMENTAL: QAW039 po dose 2
Drug: QAW039
QAW039 po
EXPERIMENTAL: QAW039 po dose 3
Drug: QAW039
QAW039 po
EXPERIMENTAL: QAW039 po dose 4
Drug: QAW039
QAW039 po
EXPERIMENTAL: QAW039 po dose 5
Drug: QAW039
QAW039 po
EXPERIMENTAL: QAW039 po dose 6
Drug: QAW039
QAW039 po
EXPERIMENTAL: QAW039 po dose 7
Drug: QAW039
QAW039 po
EXPERIMENTAL: QAW039 po dose 8
Drug: QAW039
QAW039 po
EXPERIMENTAL: QAW039 po dose 9
Drug: QAW039
QAW039 po
EXPERIMENTAL: QAW039 po dose 10
Drug: QAW039
QAW039 po
EXPERIMENTAL: QAW039 po dose 11
Drug: QAW039
QAW039 po
EXPERIMENTAL: QAW039 po dose 12
Drug: QAW039
QAW039 po
EXPERIMENTAL: QAW039 po dose 13
Drug: QAW039
QAW039 po
ACTIVE_COMPARATOR: Montelukast po 10 mg
Comparator leukotriene receptor antagonist (LRTA)
Drug: Montelukast
Montelukast 10 mg po

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in trough Forced Expiratory Volume in 1 second (FEV1) from baseline to week 12
Time Frame: Baseline and 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.
Baseline and week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Asthma Control Questionnaire (ACQ) score from baseline to week 12
Time Frame: Baseline and 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.
Baseline and week 12
Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to weeks 2, 4 and 8.
Time Frame: Baseline, week 2, week 4 and week 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.
Baseline, week 2, week 4 and week 8
Change in the Asthma Control Questionnaire (ACQ) score from baseline to weeks 2, 4 and 8.
Time Frame: Baseline, week 2, week 4 and week 8
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.
Baseline, week 2, week 4 and week 8
Change in the dose response relationship among QAW039 doses with respect to Forced Expiratory Volume in 1 second (FEV1) after 12 weeks treatment.
Time Frame: Baseline and week 12
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.
Baseline and week 12
Comparison of vital signs, ECG, laboratory tests and adverse events across QAW039 doses and placebo.
Time Frame: Baseline and week 12
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.
Baseline and week 12
Comparison of efficacy of QAW039 with that of active comparator as an add-on therapy to Inhaled Corticosteroids (ICS)
Time Frame: Baseline and week 12
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.
Baseline and week 12
Assess the effect of QAW039 on asthma symptoms as measured by asthma control diary.
Time Frame: Baseline and week 12
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.
Baseline and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CQAW039A2206
  • 2011-001062-18 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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