Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    03052517
Previous Study | Return to List | Next Study

Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03052517
Recruitment Status : Terminated (Company Decision)
First Posted : February 14, 2017
Results First Posted : October 12, 2020
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with moderate-to- severe asthma.

The purpose of this study was to provide long-term safety data for QAW039 150 mg once daily and 450 mg once daily, compared with placebo, when added to GINA steps 3, 4, and 5 standard-of-care asthma therapy (GINA 2020) in adult and adolescent (≥12 years) patients with moderate-to-severe asthma. The study included 2 cohorts of patients:

  1. Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration of exposure, and
  2. New patients who had not previously participated in a study of QAW039, permitting an increase in the number of patients with long-term exposure to QAW039.

By including these 2 categories of patients, the total number of patients treated with QAW039 as well as the duration of exposure to QAW039 treatment was substantially increased, supporting evaluation of the safety profile of QAW039.


Condition or disease Intervention/treatment Phase
Asthma Drug: QAW039 150 mg Drug: QAW039 450 mg Drug: Placebo Phase 3

Detailed Description:
The study comprised 2-treatment period. Treatment Period 1 was a 52-week, double-blind treatment period in which QAW039 450 mg or 150 mg or placebo was added to standard-of-care asthma therapy according to GINA guidelines. Treatment Period 2 was an optional 104-week, single-blind treatment period in which patients received QAW039 450 mg or 150 mg or placebo added to standard-of-care asthma therapy according to GINA guidelines.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2538 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 2-treatment Period, Randomized, Placebo-controlled, Multicenter Parallel-group Study to Assess the Safety of QAW039 When Added to Existing Asthma Therapy in GINA Steps 3, 4 and 5 Patients With Uncontrolled Asthma.
Actual Study Start Date : March 21, 2017
Actual Primary Completion Date : February 19, 2020
Actual Study Completion Date : March 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: QAW039 150mg
QAW039 Dose 1 once daily
Drug: QAW039 150 mg
One tablet of QAW039 150 mg once daily

Experimental: QAW039 450 mg
QAW039 Dose 2 once daily
Drug: QAW039 450 mg
One tablet of QAW039 450 mg once daily

Placebo Comparator: Placebo
Placebo once daily
Drug: Placebo
One tablet of Placebo once daily




Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model [ Time Frame: 52 weeks ]
    Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs. For this Outcome Measure, AE up to week 52 are reported.

  2. Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model [ Time Frame: 156 weeks ]
    Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs

  3. Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model [ Time Frame: 52 weeks ]
    Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs. For this Outcome Measure, AE up to week 52 are reported.

  4. Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 156 - Cox Regression Model [ Time Frame: 156 weeks ]
    Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs.

  5. Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 52 - Cox Regression Model [ Time Frame: 52 weeks ]
    Adverse events leading to study treatment discontinuation starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs leading to study treatment discontinuation. For this Outcome Measure, AE up to week 52 are reported.

  6. Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 156 - Cox Regression Model [ Time Frame: 156 weeks ]
    Adverse events leading to study treatment discontinuation starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs leading to study treatment discontinuation


Secondary Outcome Measures :
  1. Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model [ Time Frame: 52 weeks ]
    The number of patients per patient year of follow-up having a treatment emergent adverse event, categorized by system organ class. Treatment emergent adverse events are defined as an AEs starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE)

  2. Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model [ Time Frame: 156 weeks ]
    The number of patients per patient year of follow-up having a treatment emergent adverse event, categorized by system organ class. Treatment emergent adverse events are defined as an AEs starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE)

  3. Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 52 [ Time Frame: 52 weeks ]
    The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs.

  4. Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 156 [ Time Frame: 156 weeks ]
    The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs.

  5. Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 52 [ Time Frame: 52 weeks ]

    Number of treatment emergent severe asthma exacerbation episodes requiring hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours) per person year of follow-up. Treatment emergent severe asthma exacerbation episodes are defined as episodes occurring on or after the day of the first intake of study drug and until the day of last intake of study drug +7 days (30 days in the case of a serious AE).

    Rate of exacerbations per person year = total number of exacerbations / total number of treatment years


  6. Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 156 [ Time Frame: 156 weeks ]

    Number of treatment emergent severe asthma exacerbation episodes requiring hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours) per person year of follow-up. Treatment emergent severe asthma exacerbation episodes are defined as episodes occurring on or after the day of the first intake of study drug and until the day of last intake of study drug +7 days (30 days in the case of a serious AE).

    Rate of exacerbations per person year = total number of exacerbations / total number of treatment years




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients completing a prior Phase 3 study of QAW039:

  • Informed consent and assent (if applicable).
  • Completion of the Treatment Period (on blinded study drug) of a prior Phase 3 study of QAW039.
  • Patient is able to safely continue into the study as judged by the investigator.

Patients who have not previously participated in a study of QAW039:

  • Written informed consent.
  • A diagnosis of asthma,uncontrolled on GINA 3/4/5 asthma medication.
  • Evidence of airway reversibility or airway hyper- reactivity.
  • FEV1 of ≤85% of the predicted normal value.
  • An ACQ score ≥1.5 prior to entering the study.

Exclusion Criteria:

Patients completing a prior phase 3 study of QAW039:

  • Pregnant or nursing (lactating) women.
  • Women of child-bearing potential unless they are using basic methods of contraception during dosing of study drug
  • Patients who did not complete the Treatment Period on blinded study drug of the prior QAW039 study they participated in.
  • Inability to comply with all study requirements.
  • Patient who experienced a serious and drug-related AE in the prior QAW039 study they participated in.

Patients who have not previously participated in a study of QAW039:

  • 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 (i.e.-the patient was randomized in another study).
  • 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> 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin. Statin doses less than or equal to these doses as well as other statins will be permitted during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052517


Locations
Hide Hide 348 study locations
Layout table for location information
United States, Alabama
Novartis Investigative Site
Birmingham, Alabama, United States, 35209
United States, California
Novartis Investigative Site
Encinitas, California, United States, 92024
Novartis Investigative Site
Newport Beach, California, United States, 92663
Novartis Investigative Site
Orange, California, United States, 92868
Novartis Investigative Site
San Diego, California, United States, 92117
Novartis Investigative Site
Stockton, California, United States, 95207
Novartis Investigative Site
Walnut Creek, California, United States, 94598
Novartis Investigative Site
Westminster, California, United States, 92683
United States, Colorado
Novartis Investigative Site
Colorado Springs, Colorado, United States, 80907
Novartis Investigative Site
Denver, Colorado, United States, 80230
Novartis Investigative Site
Lafayette, Colorado, United States, 80026
United States, Florida
Novartis Investigative Site
Miami, Florida, United States, 33176
Novartis Investigative Site
Tamarac, Florida, United States, 33321
Novartis Investigative Site
Winter Park, Florida, United States, 32789
United States, Georgia
Novartis Investigative Site
Marietta, Georgia, United States, 30060
United States, Kansas
Novartis Investigative Site
Overland Park, Kansas, United States, 66210
United States, Kentucky
Novartis Investigative Site
Louisville, Kentucky, United States, 40215
United States, Louisiana
Novartis Investigative Site
Zachary, Louisiana, United States, 70791
United States, Maine
Novartis Investigative Site
Bangor, Maine, United States, 04401
United States, Maryland
Novartis Investigative Site
Columbia, Maryland, United States, 21044
Novartis Investigative Site
Waldorf, Maryland, United States, 20602
United States, Michigan
Novartis Investigative Site
Ypsilanti, Michigan, United States, 48197
United States, Montana
Novartis Investigative Site
Missoula, Montana, United States, 59804
United States, Nebraska
Novartis Investigative Site
Bellevue, Nebraska, United States, 68123
Novartis Investigative Site
La Vista, Nebraska, United States, 68128
Novartis Investigative Site
Omaha, Nebraska, United States, 68131
Novartis Investigative Site
Omaha, Nebraska, United States, 68134
United States, New York
Novartis Investigative Site
Bronx, New York, United States, 10459
United States, North Carolina
Novartis Investigative Site
Asheville, North Carolina, United States, 28801
Novartis Investigative Site
Gastonia, North Carolina, United States, 28054
United States, Ohio
Novartis Investigative Site
Columbus, Ohio, United States, 43215
United States, Oklahoma
Novartis Investigative Site
Edmond, Oklahoma, United States, 73034
Novartis Investigative Site
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Novartis Investigative Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
Novartis Investigative Site
Altoona, Pennsylvania, United States, 16602
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States, 15221
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States, 15241
United States, Rhode Island
Novartis Investigative Site
East Providence, Rhode Island, United States, 02941
United States, Texas
Novartis Investigative Site
Boerne, Texas, United States, 78006
Novartis Investigative Site
Fort Worth, Texas, United States, 76244
Novartis Investigative Site
McKinney, Texas, United States, 75069
Novartis Investigative Site
Plano, Texas, United States, 75093
Novartis Investigative Site
San Antonio, Texas, United States, 78205
United States, Virginia
Novartis Investigative Site
Richmond, Virginia, United States, 23225
United States, Washington
Novartis Investigative Site
Bellingham, Washington, United States, 98225
Novartis Investigative Site
Spokane, Washington, United States, 99204
Argentina
Novartis Investigative Site
Berazategui, Buenos Aires, Argentina, 1888
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1056ABJ
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1122AAK
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1425BEN
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1426ABP
Novartis Investigative Site
Lanus, Buenos Aires, Argentina, B8000XAV
Novartis Investigative Site
Mar del Plata, Buenos Aires, Argentina, 7600
Novartis Investigative Site
Ranelagh, Partido De Berazate, Buenos Aires, Argentina, 1884
Novartis Investigative Site
Santa Rosa, La Pampa, Argentina, 6300
Novartis Investigative Site
Santa Fe, Rosario, Argentina, S2000DBS
Novartis Investigative Site
Rosario, Santa Fe, Argentina, S2000AII
Novartis Investigative Site
Rosario, Santa Fe, Argentina, S2000BRH
Novartis Investigative Site
Rosario, Santa Fe, Argentina, S2000JKR
Novartis Investigative Site
San Miguel de Tucuman, Tucuman, Argentina, 4000
Novartis Investigative Site
San Miguel de Tucuman, Tucuman, Argentina, T4000IFL
Novartis Investigative Site
Buenos Aires, Argentina, C1012AAR
Novartis Investigative Site
Buenos Aires, Argentina, C1125ABE
Novartis Investigative Site
Buenos Aires, Argentina, C1425FVH
Novartis Investigative Site
Cordoba, Argentina, X5003DCE
Novartis Investigative Site
Mendoza, Argentina, 5500
Novartis Investigative Site
Mendoza, Argentina, M5500CBA
Novartis Investigative Site
Salta, Argentina, 4000
Novartis Investigative Site
Santa Fe, Argentina, S3000FIL
Australia, Victoria
Novartis Investigative Site
Clayton, Victoria, Australia, 3168
Novartis Investigative Site
Footscray, Victoria, Australia, 3011
Novartis Investigative Site
Melbourne, Victoria, Australia, 3004
Austria
Novartis Investigative Site
Feldkirch, Austria, 6800
Novartis Investigative Site
Vienna, Austria, A-1130
Novartis Investigative Site
Wien, Austria, A 1090
Belgium
Novartis Investigative Site
Aalst, Belgium, 9300
Novartis Investigative Site
Brussel, Belgium, 1020
Novartis Investigative Site
Bruxelles, Belgium, 1000
Novartis Investigative Site
Eghezee, Belgium, 5310
Novartis Investigative Site
Erpent, Belgium, 5100
Novartis Investigative Site
Herentals, Belgium, 2200
Novartis Investigative Site
Kortrijk, Belgium, 8500
Novartis Investigative Site
Liege, Belgium, 4000
Brazil
Novartis Investigative Site
Goiania, GO, Brazil, 74110-030
Novartis Investigative Site
Porto Alegre, Porto Alegre RS, Brazil, 90610 000
Novartis Investigative Site
Rio de Janeiro, RJ, Brazil, 21941-590
Novartis Investigative Site
Porto Alegre, RS, Brazil, 90020-090
Novartis Investigative Site
Blumenau, Santa Catarina, Brazil, 89030101
Novartis Investigative Site
Sao Bernardo do Campo, SP, Brazil, 09715 090
Novartis Investigative Site
Sao Paulo, SP, Brazil, 05403 000
Novartis Investigative Site
Sao Paulo, SP, Brazil, 05437 010
Novartis Investigative Site
Sorocaba, SP, Brazil
Bulgaria
Novartis Investigative Site
Pleven, Bulgaria, 5800
Novartis Investigative Site
Ruse, Bulgaria, 7002
Novartis Investigative Site
Sofia, Bulgaria, 1000
Novartis Investigative Site
Stara Zagora, Bulgaria, 6000
Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M6H 3M2
Novartis Investigative Site
Toronto, Ontario, Canada, M9V 4B4
Novartis Investigative Site
Windsor, Ontario, Canada, N8X 5A6
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H3G 1L5
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1E2
Novartis Investigative Site
Montreal, Quebec, Canada, H4J 1C5
Canada
Novartis Investigative Site
Quebec, Canada, G1V 4W2
Novartis Investigative Site
Vancouver, Canada
China, Guang Dong Province
Novartis Investigative Site
Guang Zhou, Guang Dong Province, China, 510120
China, Hebei
Novartis Investigative Site
Shijiazhuang, Hebei, China, 050000
China, Jiangsu
Novartis Investigative Site
Nanjing, Jiangsu, China, 210006
Novartis Investigative Site
Nanjing, Jiangsu, China, 210009
China, Jilin
Novartis Investigative Site
Chang Chun, Jilin, China, 130021
China, Liaoning
Novartis Investigative Site
Shenyang, Liaoning, China, 110000
Novartis Investigative Site
Shenyang, Liaoning, China, 110003
China, Shanxi
Novartis Investigative Site
Xian, Shanxi, China, 710061
China, Sichuan
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
China
Novartis Investigative Site
Beijing, China, 100050
Novartis Investigative Site
Chongqing, China, 400037
Novartis Investigative Site
Shanghai, China, 200433
Colombia
Novartis Investigative Site
Ibague, Tolima, Colombia, 730006
Novartis Investigative Site
Bogota, Colombia, 110221
Novartis Investigative Site
Bucaramanga, Colombia
Czechia
Novartis Investigative Site
Jindrichuv Hradec, Czech Republic, Czechia, 377 01
Novartis Investigative Site
Teplice, Czech Republic, Czechia, 415 01
Novartis Investigative Site
Teplice, CZE, Czechia, 415 01
Novartis Investigative Site
Brno, Czechia, 615 00
Novartis Investigative Site
Karlovy Vary, Czechia, 360 17
Novartis Investigative Site
Mlada Boleslav, Czechia, 293 50
Estonia
Novartis Investigative Site
Tallinn, Estonia, 13419
Novartis Investigative Site
Tartu, Estonia, 51014
Finland
Novartis Investigative Site
Helsinki, Finland, 00029
France
Novartis Investigative Site
Montpellier cedex 5, Herault, France, 34059
Novartis Investigative Site
Dijon, France, 21000
Novartis Investigative Site
Le Kremlin Bicetre, France, 94275
Novartis Investigative Site
Lyon Cedex 04, France, 69317
Novartis Investigative Site
Marseille, France, 13015
Novartis Investigative Site
Nantes, France, 44093
Novartis Investigative Site
Paris cedex 18, France, 75877
Novartis Investigative Site
Strasbourg Cedex, France, 67091
Germany
Novartis Investigative Site
Cottbus, Sachsen, Germany, 03050
Novartis Investigative Site
Aschaffenburg, Germany, 63739
Novartis Investigative Site
Berlin, Germany, 10717
Novartis Investigative Site
Berlin, Germany, 10969
Novartis Investigative Site
Berlin, Germany, 12159
Novartis Investigative Site
Berlin, Germany, 12203
Novartis Investigative Site
Frankfurt, Germany, 60389
Novartis Investigative Site
Frankfurt, Germany, 60596
Novartis Investigative Site
Landsberg, Germany, 86899
Novartis Investigative Site
Leipzig, Germany, 04357
Novartis Investigative Site
Witten, Germany, 58452
Greece
Novartis Investigative Site
Athens, GR, Greece, 115 25
Novartis Investigative Site
Athens, GR, Greece, 115 27
Novartis Investigative Site
Thessaloniki, GR, Greece, 570 10
Novartis Investigative Site
Athens, Greece, 115 21
Novartis Investigative Site
Athens, Greece, 115 27
Novartis Investigative Site
Athens, Greece, 175 62
Guatemala
Novartis Investigative Site
Gautemala City, Gautemala, Guatemala, 01010
Novartis Investigative Site
Guatemala City, GTM, Guatemala, 01010
Novartis Investigative Site
Guatemala City, GTM, Guatemala, 01011
Novartis Investigative Site
Guatemala City, Guatemala, 01010
Novartis Investigative Site
Guatemala City, Guatemala, 01011
Hungary
Novartis Investigative Site
Budaors, HUN, Hungary, 2040
Novartis Investigative Site
Gyor, HUN, Hungary, 9024
Novartis Investigative Site
Hajdunanas, HUN, Hungary, 4080
Novartis Investigative Site
Puspokladany, HUN, Hungary, 4150
Novartis Investigative Site
Szazhalombatta, HUN, Hungary, 2440
Novartis Investigative Site
Budapest, Hungary, 1106
Novartis Investigative Site
Godollo, Hungary, 2100
Novartis Investigative Site
Komarom, Hungary, 2900
Novartis Investigative Site
Mako, Hungary, 6900
Novartis Investigative Site
Pecs, Hungary, 7635
Novartis Investigative Site
Siofok, Hungary, 8600
Novartis Investigative Site
Szeged, Hungary, 6722
Novartis Investigative Site
Torokbalint, Hungary, 2045
India
Novartis Investigative Site
Ahmedabad, Gujarat, India, 380 060
Novartis Investigative Site
Vadodara, Gujarat, India, 390022
Novartis Investigative Site
Nagpur, Maharashtra, India, 440015
Novartis Investigative Site
Pune, Maharashtra, India, 411014
Novartis Investigative Site
Bikaner, Rajasthan, India, 334 001
Novartis Investigative Site
Jaipur, Rajasthan, India, 302039
Novartis Investigative Site
Coimbatore, Tamil Nadu, India, 641 045
Novartis Investigative Site
DehraDun, Uttarakhand, India, 248001
Israel
Novartis Investigative Site
Ashkelon, Israel, 78278
Novartis Investigative Site
Haifa, Israel, 310 9601
Novartis Investigative Site
Haifa, Israel, 3436212
Novartis Investigative Site
Jerusalem, Israel, 91031
Novartis Investigative Site
Jerusalem, Israel, 91120
Novartis Investigative Site
Petach Tikva, Israel, 49100
Novartis Investigative Site
Rehovot, Israel, 76100
Japan
Novartis Investigative Site
Nagoya, Aichi, Japan, 466 8560
Novartis Investigative Site
Matsuyama-city, Ehime, Japan, 790-0024
Novartis Investigative Site
Matsuyama-city, Ehime, Japan, 790-8524
Novartis Investigative Site
Chikushino-city, Fukuoka, Japan, 818-8502
Novartis Investigative Site
Fukuoka city, Fukuoka, Japan, 811-1394
Novartis Investigative Site
Iizuka-city, Fukuoka, Japan, 820-8505
Novartis Investigative Site
Kasuga-city, Fukuoka, Japan, 816-0813
Novartis Investigative Site
Koga city, Fukuoka, Japan, 811 3195
Novartis Investigative Site
Yanagawa-city, Fukuoka, Japan, 832-0059
Novartis Investigative Site
Mizunami-city, Gifu, Japan, 509 6134
Novartis Investigative Site
Hiroshima-city, Hiroshima, Japan, 734-8530
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 062-0931
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 064-0804
Novartis Investigative Site
Himeji-city, Hyogo, Japan, 672-8064
Novartis Investigative Site
Naka-gun, Ibaraki, Japan, 319-1113
Novartis Investigative Site
Sakaide, Kagawa, Japan, 762-8550
Novartis Investigative Site
Takamatsu-city, Kagawa, Japan, 761-8073
Novartis Investigative Site
Kagoshima city, Kagoshima, Japan, 890 8520
Novartis Investigative Site
Sagamihara-city, Kanagawa, Japan, 228-8522
Novartis Investigative Site
Sagamihara-city, Kanagawa, Japan, 229-1103
Novartis Investigative Site
Yokohama city, Kanagawa, Japan, 232 0024
Novartis Investigative Site
Yokohama-city, Kanagawa, Japan, 223-0059
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 234-0054
Novartis Investigative Site
Koshi-city, Kumamoto, Japan, 861-1196
Novartis Investigative Site
Matsusaka-city, Mie, Japan, 515-8544
Novartis Investigative Site
Tsu-city, Mie, Japan, 514-0125
Novartis Investigative Site
Sendai-city, Miyagi, Japan, 980-0871
Novartis Investigative Site
Sendai-city, Miyagi, Japan, 984-8560
Novartis Investigative Site
Kashihara city, Nara, Japan, 634 8522
Novartis Investigative Site
Habikino city, Osaka, Japan, 583 8588
Novartis Investigative Site
Kishiwada-city, Osaka, Japan, 596-8501
Novartis Investigative Site
Tokyo, Shibuya Ku, Japan, 150 0013
Novartis Investigative Site
Hamamatsu-city, Shizuoka, Japan, 431-3192
Novartis Investigative Site
Chuo ku, Tokyo, Japan, 104-0031
Novartis Investigative Site
Chuo ku, Tokyo, Japan, 104-8560
Novartis Investigative Site
Chuo-ku, Tokyo, Japan, 103-0003
Novartis Investigative Site
Chuo-ku, Tokyo, Japan, 103-0028
Novartis Investigative Site
Itabashi-ku, Tokyo, Japan, 173-8610
Novartis Investigative Site
Kiyose-city, Tokyo, Japan, 204-8585
Novartis Investigative Site
Ota-ku, Tokyo, Japan, 145 0063
Novartis Investigative Site
Setagaya-Ku, Tokyo, Japan, 157-0072
Novartis Investigative Site
Setagaya-ku, Tokyo, Japan, 157006
Novartis Investigative Site
Shinagawa-ku, Tokyo, Japan, 142-8666
Novartis Investigative Site
Shinjuku ku, Tokyo, Japan, 162 8655
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan, 169-0073
Novartis Investigative Site
Toshima ku, Tokyo, Japan, 170 0003
Latvia
Novartis Investigative Site
Daugavpils, Latvia, LV-5401
Novartis Investigative Site
Riga, Latvia, LV 1002
Lebanon
Novartis Investigative Site
El Chouf, LBN, Lebanon, 1503201002
Novartis Investigative Site
Ashrafieh, Lebanon, 166830
Novartis Investigative Site
Beirut, Lebanon, 166378
Lithuania
Novartis Investigative Site
Kaunas, LTU, Lithuania, LT 50161
Novartis Investigative Site
Vilnius, LTU, Lithuania, LT-10207
Novartis Investigative Site
Kaunas, LT, Lithuania, LT-45130
Novartis Investigative Site
Kaunas, LT, Lithuania, LT-50128
Novartis Investigative Site
Klaipeda, Lithuania, LT-92231
Novartis Investigative Site
Vilnius, Lithuania, LT-04129
Malaysia
Novartis Investigative Site
Kota Bharu, Kelantan, Malaysia, 15586
Novartis Investigative Site
Kuantan, Pahang, Malaysia, 25100
Novartis Investigative Site
Taiping, Perak, Malaysia, 34000
Mexico
Novartis Investigative Site
Guadalajara Jalisco, Jalisco, Mexico, 44220
Novartis Investigative Site
Guadalajara, Jalisco, Mexico, 44130
Novartis Investigative Site
Rio De Janeiro, Mexico, 06700
Netherlands
Novartis Investigative Site
Arnhem, Netherlands, 6815 AD
Novartis Investigative Site
Leeuwarden, Netherlands, 8934 AD
Peru
Novartis Investigative Site
Cercado De Lima, Lima, Peru, 01
Novartis Investigative Site
San Isidro, Lima, Peru, 27
Novartis Investigative Site
San Martin de Porres, Lima, Peru, 31
Novartis Investigative Site
Cusco, Peru, 84
Novartis Investigative Site
Lima, Peru, 1
Novartis Investigative Site
Piura, Peru, 2000
Philippines
Novartis Investigative Site
Lipa City, Batangas, Philippines, 4217
Novartis Investigative Site
Quezon City, Manila, Philippines, 1100
Novartis Investigative Site
Bulacan, Philippines, 3020
Novartis Investigative Site
Iloilo City, Philippines, 5000
Novartis Investigative Site
Manila, Philippines, 1000
Novartis Investigative Site
Quezon City, Philippines, 1100
Poland
Novartis Investigative Site
Bialystok, Poland, 15-010
Novartis Investigative Site
Kielce, Poland, 25-371
Novartis Investigative Site
Poznan, Poland, 60-214
Novartis Investigative Site
Poznan, Poland, 60-693
Novartis Investigative Site
Poznan, Poland, 60-823
Novartis Investigative Site
Strzelce Opolskie, Poland, 47 100
Puerto Rico
Novartis Investigative Site
San Juan, Puerto Rico, 00909
Romania
Novartis Investigative Site
Bucharest, District 3, Romania, 030303
Novartis Investigative Site
Constanta, ROM, Romania, 900412
Novartis Investigative Site
Timisoara, Timis, Romania, 300310
Novartis Investigative Site
Bragadiru, Romania, 077025
Novartis Investigative Site
Brasov, Romania, 500051
Novartis Investigative Site
Brasov, Romania, 500086
Novartis Investigative Site
Brasov, Romania, 500283
Novartis Investigative Site
Brasov, Romania, 500366
Novartis Investigative Site
Cluj Napoca, Romania, 400139
Novartis Investigative Site
Cluj-Napoca, Romania, 400371
Novartis Investigative Site
Deva, Romania, 330162
Russian Federation
Novartis Investigative Site
Barnaul, Russian Federation, 656024
Novartis Investigative Site
Chelyabinsk, Russian Federation, 454021
Novartis Investigative Site
Izhevsk, Russian Federation, 426061
Novartis Investigative Site
Moscow, Russian Federation, 115478
Novartis Investigative Site
Moscow, Russian Federation, 125315
Novartis Investigative Site
Nizhnii Novgorod, Russian Federation, 603126
Novartis Investigative Site
Penza, Russian Federation, 440067
Novartis Investigative Site
Perm, Russian Federation, 614068
Novartis Investigative Site
Ryazan, Russian Federation, 390039
Novartis Investigative Site
Saint Petersburg, Russian Federation, 194354
Novartis Investigative Site
Saint-Petersburg, Russian Federation, 191186
Novartis Investigative Site
Sestroretsk, Russian Federation, 197706
Novartis Investigative Site
Smolensk, Russian Federation
Novartis Investigative Site
St Petersburg, Russian Federation, 194354
Novartis Investigative Site
Stavropol, Russian Federation, 355000
Novartis Investigative Site
Yaroslavl, Russian Federation, 150054
Novartis Investigative Site
Yekaterinburg, Russian Federation, 620109
Saudi Arabia
Novartis Investigative Site
Jeddah, Saudi Arabia, 21423
Serbia
Novartis Investigative Site
Belgrade, Serbia, 11000
Novartis Investigative Site
Belgrade, Serbia, 11070
Novartis Investigative Site
Kragujevac, Serbia, 34000
Novartis Investigative Site
Nis, Serbia, 18000
Novartis Investigative Site
Sremska Kamenica, Serbia, 21204
Singapore
Novartis Investigative Site
Singapore, Singapore, 119228
Novartis Investigative Site
Singapore, Singapore, 529889
Slovakia
Novartis Investigative Site
Bardejov, Slovak Republic, Slovakia, 085 01
Novartis Investigative Site
Bojnice, Slovak Republic, Slovakia, 972 01
Novartis Investigative Site
Kezmarok, Slovakia, 060 01
Novartis Investigative Site
Komarno, Slovakia, 945 01
Novartis Investigative Site
Kosice, Slovakia, 040 01
Novartis Investigative Site
Levice, Slovakia, 934 01
Novartis Investigative Site
Levice, Slovakia, 93401
Novartis Investigative Site
Poprad, Slovakia, 058 01
Novartis Investigative Site
Presov, Slovakia, 080 01
Novartis Investigative Site
Spisska Nova Ves, Slovakia, 052 01
Novartis Investigative Site
Zilina, Slovakia, 01207
Spain
Novartis Investigative Site
Malaga, Andalucia, Spain, 29009
Novartis Investigative Site
Malaga, Andalucia, Spain, 29010
Novartis Investigative Site
Marbella, Andalucia, Spain, 29603
Novartis Investigative Site
Jerez, Cadiz, Spain, 11407
Novartis Investigative Site
Laredo, Cantabria, Spain, 39770
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08036
Novartis Investigative Site
Lugo, Galicia, Spain, 27003
Novartis Investigative Site
Palma de Mallorca, Islas Baleares, Spain, 07010
Novartis Investigative Site
Barcelona, Vic, Spain, 08500
Novartis Investigative Site
Barcelona, Spain, 08006
Novartis Investigative Site
Girona, Spain, 17005
Novartis Investigative Site
Guadalajara, Spain, 19002
Novartis Investigative Site
Madrid, Spain, 28046
Novartis Investigative Site
Santiago de Compostela, Spain, 15706
Novartis Investigative Site
Zaragoza, Spain, 50009
Switzerland
Novartis Investigative Site
Liestal, Switzerland, 4410
Novartis Investigative Site
Lugano, Switzerland, 6900
Taiwan
Novartis Investigative Site
Taichung, Taiwan, 40705
Turkey
Novartis Investigative Site
Istanbul, TUR, Turkey, 34098
Novartis Investigative Site
Adana, Turkey, 01330
Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Bursa, Turkey, 16059
Novartis Investigative Site
Mersin, Turkey, 33343
Novartis Investigative Site
Yenisehir/Izmir, Turkey, 35110
United Kingdom
Novartis Investigative Site
Cambridge, Cambrigdeshire, United Kingdom, CB2 0QQ
Novartis Investigative Site
Plymouth, Devon, United Kingdom, PL6 8DH
Novartis Investigative Site
Chertsey, Surrey, United Kingdom, KT16 0PZ
Novartis Investigative Site
Bradford, West Yorkshire, United Kingdom, BD9 6RJ
Novartis Investigative Site
East Yorkshire, United Kingdom, HU16 5JQ
Novartis Investigative Site
Leicester, United Kingdom, LE3 9QP
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Statistical Analysis Plan  [PDF] March 21, 2020
Study Protocol  [PDF] January 17, 2018

Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03052517    
Other Study ID Numbers: CQAW039A2315
2016-001560-11 ( EudraCT Number )
First Posted: February 14, 2017    Key Record Dates
Results First Posted: October 12, 2020
Last Update Posted: October 12, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Asthma
QAW039
allergic asthma
allergy triggered asthma
reactive asthma
asthma attack
difficulty breathing
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Indoleacetic Acids
Plant Growth Regulators
Growth Substances
Physiological Effects of Drugs