AzTrials
AzTrials

AsthmaPhase 3NCT03052517

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

A Phase 3 study testing QAW039 150 mg and QAW039 450 mg in people with Asthma, run by Novartis Pharmaceuticals at 347 sites in 42 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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)… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
QAW039 150 mg and QAW039 450 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,538 participants
Where
347 sitesin 42 countries
Study dates
21 Mar 2017to 16 Mar 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

347 sites in 42 countries.

347 sites in 42 countries

United States46 sites

  • Novartis Investigative Site

    Altoona, Pennsylvania, 16602

  • Novartis Investigative Site

    Asheville, North Carolina, 28801

  • Novartis Investigative Site

    Bangor, Maine, 04401

  • Novartis Investigative Site

    Bellevue, Nebraska, 68123

  • Novartis Investigative Site

    Bellingham, Washington, 98225

  • Novartis Investigative Site

    Birmingham, Alabama, 35209

  • Novartis Investigative Site

    Boerne, Texas, 78006

  • Novartis Investigative Site

    Colorado Springs, Colorado, 80907

  • Novartis Investigative Site

    Columbia, Maryland, 21044

  • Novartis Investigative Site

    Columbus, Ohio, 43215

  • Novartis Investigative Site

    Denver, Colorado, 80230

  • Novartis Investigative Site

    East Providence, Rhode Island, 02941

  • Novartis Investigative Site

    Edmond, Oklahoma, 73034

  • Novartis Investigative Site

    Encinitas, California, 92024

  • Novartis Investigative Site

    Fort Worth, Texas, 76244

  • Novartis Investigative Site

    Gastonia, North Carolina, 28054

  • Novartis Investigative Site

    La Vista, Nebraska, 68128

  • Novartis Investigative Site

    Lafayette, Colorado, 80026

  • Novartis Investigative Site

    Louisville, Kentucky, 40215

  • Novartis Investigative Site

    Marietta, Georgia, 30060

  • Novartis Investigative Site

    McKinney, Texas, 75069

  • Novartis Investigative Site

    Medford, Oregon, 97504

  • Novartis Investigative Site

    Miami, Florida, 33176

  • Novartis Investigative Site

    Missoula, Montana, 59804

  • Novartis Investigative Site

    Newport Beach, California, 92663

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73120

  • Novartis Investigative Site

    Omaha, Nebraska, 68131

  • Novartis Investigative Site

    Omaha, Nebraska, 68134

  • Novartis Investigative Site

    Orange, California, 92868

  • Novartis Investigative Site

    Overland Park, Kansas, 66210

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15221

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15241

  • Novartis Investigative Site

    Plano, Texas, 75093

  • Novartis Investigative Site

    Richmond, Virginia, 23225

  • Novartis Investigative Site

    San Antonio, Texas, 78205

  • Novartis Investigative Site

    San Diego, California, 92117

  • Novartis Investigative Site

    Spokane, Washington, 99204

  • Novartis Investigative Site

    Stockton, California, 95207

  • Novartis Investigative Site

    Tamarac, Florida, 33321

  • Novartis Investigative Site

    The Bronx, New York, 10459

  • Novartis Investigative Site

    Waldorf, Maryland, 20602

  • Novartis Investigative Site

    Walnut Creek, California, 94598

  • Novartis Investigative Site

    Westminster, California, 92683

  • Novartis Investigative Site

    Winter Park, Florida, 32789

  • Novartis Investigative Site

    Ypsilanti, Michigan, 48197

  • Novartis Investigative Site

    Zachary, Louisiana, 70791

Other trials in United States

Japan46 sites

  • Novartis Investigative Site

    Chikushino-shi, Fukuoka, 818-8502

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 104-0031

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 104-8560

  • Novartis Investigative Site

    Chuo-ku, Tokyo, 103-0003

  • Novartis Investigative Site

    Chuo-ku, Tokyo, 103-0028

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 811-1394

  • Novartis Investigative Site

    Habikino, Osaka, 583 8588

  • Novartis Investigative Site

    Hamamatsu, Shizuoka, 431-3192

  • Novartis Investigative Site

    Himeji, Hyōgo, 672-8064

  • Novartis Investigative Site

    Hiroshima, Hiroshima, 734-8530

  • Novartis Investigative Site

    Iizuka, Fukuoka, 820-8505

  • Novartis Investigative Site

    Kagoshima, Kagoshima-ken, 890 8520

  • Novartis Investigative Site

    Kashihara, Nara, 634 8522

  • Novartis Investigative Site

    Kasuga, Fukuoka, 816-0813

  • Novartis Investigative Site

    Kishiwada, Osaka, 596-8501

  • Novartis Investigative Site

    Kiyose, Tokyo, 204-8585

  • Novartis Investigative Site

    Koga, Fukuoka, 811 3195

  • Novartis Investigative Site

    Kōshi, Kumamoto, 861-1196

  • Novartis Investigative Site

    Matsusaka, Mie-ken, 515-8544

  • Novartis Investigative Site

    Matsuyama, Ehime, 790-0024

  • Novartis Investigative Site

    Matsuyama, Ehime, 790-8524

  • Novartis Investigative Site

    Mizunami, Gifu, 509 6134

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 466 8560

  • Novartis Investigative Site

    Naka-gun, Ibaraki, 319-1113

  • Novartis Investigative Site

    Ōta-ku, Tokyo, 145 0063

  • Novartis Investigative Site

    Sagamihara, Kanagawa, 228-8522

  • Novartis Investigative Site

    Sagamihara, Kanagawa, 229-1103

  • Novartis Investigative Site

    Sakaidechō, Kagawa-ken, 762-8550

  • Novartis Investigative Site

    Sapporo, Hokkaido, 062-0931

  • Novartis Investigative Site

    Sapporo, Hokkaido, 064-0804

  • Novartis Investigative Site

    Sendai, Miyagi, 980-0871

  • Novartis Investigative Site

    Sendai, Miyagi, 984-8560

  • Novartis Investigative Site

    Setagaya-ku, Tokyo, 157006

  • Novartis Investigative Site

    Setagaya-Ku, Tokyo, 157-0072

  • Novartis Investigative Site

    Shinagawa-ku, Tokyo, 142-8666

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo, 162 8655

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 169-0073

  • Novartis Investigative Site

    tabashi City, Tokyo, 173-8610

  • Novartis Investigative Site

    Takamatsu, Kagawa-ken, 761-8073

  • Novartis Investigative Site

    Tokyo, Shibuya Ku, 150 0013

  • Novartis Investigative Site

    Toshima Ku, Tokyo, 170 0003

  • Novartis Investigative Site

    Tsu, Mie-ken, 514-0125

  • Novartis Investigative Site

    Yanagawa, Fukuoka, 832-0059

  • Novartis Investigative Site

    Yokohama, Kanagawa, 223-0059

  • Novartis Investigative Site

    Yokohama, Kanagawa, 232 0024

  • Novartis Investigative Site

    Yokohama, Kanagawa, 234-0054

Other trials in Japan

Argentina23 sites

  • Novartis Investigative Site

    Berazategui, Buenos Aires, 1888

  • Novartis Investigative Site

    Buenos Aires, C1012AAR

  • Novartis Investigative Site

    Buenos Aires, C1125ABE

  • Novartis Investigative Site

    Buenos Aires, C1425FVH

  • Novartis Investigative Site

    CABA, Buenos Aires, C1056ABJ

  • Novartis Investigative Site

    CABA, Buenos Aires, C1122AAK

  • Novartis Investigative Site

    CABA, Buenos Aires, C1425BEN

  • Novartis Investigative Site

    CABA, Buenos Aires, C1426ABP

  • Novartis Investigative Site

    Córdoba, X5003DCE

  • Novartis Investigative Site

    Lanus, Buenos Aires, B8000XAV

  • Novartis Investigative Site

    Mar del Plata, Buenos Aires, 7600

  • Novartis Investigative Site

    Mendoza, 5500

  • Novartis Investigative Site

    Mendoza, M5500CBA

  • Novartis Investigative Site

    Ranelagh, Partido de Berazate, Buenos Aires, 1884

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000AII

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000BRH

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000JKR

  • Novartis Investigative Site

    Salta, 4000

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, 4000

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, T4000IFL

  • Novartis Investigative Site

    Santa Fe, Rosario, S2000DBS

  • Novartis Investigative Site

    Santa Fe, S3000FIL

  • Novartis Investigative Site

    Santa Rosa, La Pampa Province, 6300

Other trials in Argentina

Russia16 sites

  • Novartis Investigative Site

    Barnaul, 656024

  • Novartis Investigative Site

    Chelyabinsk, 454021

  • Novartis Investigative Site

    Izhevsk, 426061

  • Novartis Investigative Site

    Moscow, 115478

  • Novartis Investigative Site

    Moscow, 125315

  • Novartis Investigative Site

    Nizhny Novgorod, 603126

  • Novartis Investigative Site

    Penza, 440067

  • Novartis Investigative Site

    Perm, 614068

  • Novartis Investigative Site

    Ryazan, 390039

  • Novartis Investigative Site

    Saint Petersburg, 191186

  • Novartis Investigative Site

    Saint Petersburg, 194354

  • Novartis Investigative Site

    Sestroretsk, 197706

  • Novartis Investigative Site

    Smolensk

  • Novartis Investigative Site

    Stavropol, 355000

  • Novartis Investigative Site

    Yaroslavl, 150054

  • Novartis Investigative Site

    Yekaterinburg, 620109

Other trials in Russia

Spain15 sites

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Barcelona, Vic, 08500

  • Novartis Investigative Site

    Barcelona, 08006

  • Novartis Investigative Site

    Girona, 17005

  • Novartis Investigative Site

    Guadalajara, 19002

  • Novartis Investigative Site

    Jerez de la Frontera, Cadiz, 11407

  • Novartis Investigative Site

    Laredo, Cantabria, 39770

  • Novartis Investigative Site

    Lugo, Galicia, 27003

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Málaga, Andalusia, 29009

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Marbella, Andalusia, 29603

  • Novartis Investigative Site

    Palma de Mallorca, Balearic Islands, 07010

  • Novartis Investigative Site

    Santiago de Compostela, 15706

  • Novartis Investigative Site

    Zaragoza, 50009

Other trials in Spain

Hungary13 sites

  • Novartis Investigative Site

    Budaörs, HUN, 2040

  • Novartis Investigative Site

    Budapest, 1106

  • Novartis Investigative Site

    Gödöllő, 2100

  • Novartis Investigative Site

    Győr, HUN, 9024

  • Novartis Investigative Site

    Hajdúnánás, HUN, 4080

  • Novartis Investigative Site

    Komárom, 2900

  • Novartis Investigative Site

    Makó, 6900

  • Novartis Investigative Site

    Pécs, 7635

  • Novartis Investigative Site

    Püspökladány, HUN, 4150

  • Novartis Investigative Site

    Siófok, 8600

  • Novartis Investigative Site

    Százhalombatta, HUN, 2440

  • Novartis Investigative Site

    Szeged, 6722

  • Novartis Investigative Site

    Törökbálint, 2045

Other trials in Hungary

China12 sites

  • Novartis Investigative Site

    Beijing, 100050

  • Novartis Investigative Site

    Changchun, Jilin, 130021

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

  • Novartis Investigative Site

    Chongqing, 400037

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510120

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210006

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210009

  • Novartis Investigative Site

    Shanghai, 200433

  • Novartis Investigative Site

    Shenyang, Liaoning, 110000

  • Novartis Investigative Site

    Shenyang, Liaoning, 110003

  • Novartis Investigative Site

    Shijiazhuang, Hebei, 050000

  • Novartis Investigative Site

    Xian, Shanxi, 710061

Other trials in China

Germany11 sites

  • Novartis Investigative Site

    Aschaffenburg, 63739

  • Novartis Investigative Site

    Berlin, 10717

  • Novartis Investigative Site

    Berlin, 10969

  • Novartis Investigative Site

    Berlin, 12159

  • Novartis Investigative Site

    Berlin, 12203

  • Novartis Investigative Site

    Cottbus, Saxony, 03050

  • Novartis Investigative Site

    Frankfurt, 60389

  • Novartis Investigative Site

    Frankfurt, 60596

  • Novartis Investigative Site

    Landsberg, 86899

  • Novartis Investigative Site

    Leipzig, 04357

  • Novartis Investigative Site

    Witten, 58452

Other trials in Germany

Romania11 sites

  • Novartis Investigative Site

    Bragadiru, 077025

  • Novartis Investigative Site

    Brasov, 500051

  • Novartis Investigative Site

    Brasov, 500086

  • Novartis Investigative Site

    Brasov, 500283

  • Novartis Investigative Site

    Brasov, 500366

  • Novartis Investigative Site

    Bucharest, District 3, 030303

  • Novartis Investigative Site

    Cluj-Napoca, 400139

  • Novartis Investigative Site

    Cluj-Napoca, 400371

  • Novartis Investigative Site

    Constanța, ROM, 900412

  • Novartis Investigative Site

    Deva, 330162

  • Novartis Investigative Site

    Timișoara, Timiș County, 300310

Other trials in Romania

Slovakia11 sites

  • Novartis Investigative Site

    Bardejov, Slovak Republic, 085 01

  • Novartis Investigative Site

    Bojnice, Slovak Republic, 972 01

  • Novartis Investigative Site

    Kežmarok, 060 01

  • Novartis Investigative Site

    Komárno, 945 01

  • Novartis Investigative Site

    Košice, 040 01

  • Novartis Investigative Site

    Levice, 934 01

  • Novartis Investigative Site

    Levice, 93401

  • Novartis Investigative Site

    Poprad, 058 01

  • Novartis Investigative Site

    Prešov, 080 01

  • Novartis Investigative Site

    Spišská Nová Ves, 052 01

  • Novartis Investigative Site

    Žilina, 01207

Other trials in Slovakia

Brazil9 sites

  • Novartis Investigative Site

    Blumenau, Santa Catarina, 89030101

  • Novartis Investigative Site

    Goiânia, Goiás, 74110-030

  • Novartis Investigative Site

    Porto Alegre, Porto Alegre RS, 90610 000

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 21941-590

  • Novartis Investigative Site

    São Bernardo do Campo, São Paulo, 09715 090

  • Novartis Investigative Site

    São Paulo, São Paulo, 05403 000

  • Novartis Investigative Site

    São Paulo, São Paulo, 05437 010

  • Novartis Investigative Site

    Sorocaba, São Paulo

Other trials in Brazil

Canada9 sites

  • Novartis Investigative Site

    Montreal, Quebec, H3G 1L5

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1E2

  • Novartis Investigative Site

    Montreal, Quebec, H4J 1C5

  • Novartis Investigative Site

    Québec, G1V 4W2

  • Novartis Investigative Site

    Toronto, Ontario, M6H 3M2

  • Novartis Investigative Site

    Toronto, Ontario, M9V 4B4

  • Novartis Investigative Site

    Vancouver, British Columbia, V6Z 1Y6

  • Novartis Investigative Site

    Vancouver

  • Novartis Investigative Site

    Windsor, Ontario, N8X 5A6

Other trials in Canada

Belgium8 sites

  • Novartis Investigative Site

    Aalst, 9300

  • Novartis Investigative Site

    Brussels, 1000

  • Novartis Investigative Site

    Brussels, 1020

  • Novartis Investigative Site

    Éghezée, 5310

  • Novartis Investigative Site

    Erpent, 5100

  • Novartis Investigative Site

    Herentals, 2200

  • Novartis Investigative Site

    Kortrijk, 8500

  • Novartis Investigative Site

    Liège, 4000

Other trials in Belgium

France8 sites

  • Novartis Investigative Site

    Dijon, 21000

  • Novartis Investigative Site

    Le Kremlin-Bicêtre, 94275

  • Novartis Investigative Site

    Lyon, 69317

  • Novartis Investigative Site

    Marseille, 13015

  • Novartis Investigative Site

    Montpellier, Herault, 34059

  • Novartis Investigative Site

    Nantes, 44093

  • Novartis Investigative Site

    Paris, 75877

  • Novartis Investigative Site

    Strasbourg, 67091

Other trials in France

India8 sites

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380 060

  • Novartis Investigative Site

    Bikaner, Rajasthan, 334 001

  • Novartis Investigative Site

    Coimbatore, Tamil Nadu, 641 045

  • Novartis Investigative Site

    Dehradun, Uttarakhand, 248001

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302039

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440015

  • Novartis Investigative Site

    Pune, Maharashtra, 411014

  • Novartis Investigative Site

    Vadodara, Gujarat, 390022

Other trials in India

Israel7 sites

  • Novartis Investigative Site

    Ashkelon, 78278

  • Novartis Investigative Site

    Haifa, 310 9601

  • Novartis Investigative Site

    Haifa, 3436212

  • Novartis Investigative Site

    Jerusalem, 91031

  • Novartis Investigative Site

    Jerusalem, 91120

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Rehovot, 76100

Other trials in Israel

Czechia6 sites

  • Novartis Investigative Site

    Brno, 615 00

  • Novartis Investigative Site

    Jindřichův Hradec, Czech Republic, 377 01

  • Novartis Investigative Site

    Karlovy Vary, 360 17

  • Novartis Investigative Site

    Mladá Boleslav, 293 50

  • Novartis Investigative Site

    Teplice, Czech Republic, 415 01

  • Novartis Investigative Site

    Teplice, CZE, 415 01

Other trials in Czechia

Greece6 sites

  • Novartis Investigative Site

    Athens, GR, 115 25

  • Novartis Investigative Site

    Athens, GR, 115 27

  • Novartis Investigative Site

    Athens, 115 21

  • Novartis Investigative Site

    Athens, 115 27

  • Novartis Investigative Site

    Athens, 175 62

  • Novartis Investigative Site

    Thessaloniki, GR, 570 10

Other trials in Greece

Lithuania6 sites

  • Novartis Investigative Site

    Kaunas, LTU, LT 50161

  • Novartis Investigative Site

    Kaunas, LT, LT-45130

  • Novartis Investigative Site

    Kaunas, LT, LT-50128

  • Novartis Investigative Site

    Klaipėda, LT-92231

  • Novartis Investigative Site

    Vilnius, LTU, LT-10207

  • Novartis Investigative Site

    Vilnius, LT-04129

Other trials in Lithuania

Peru6 sites

  • Novartis Investigative Site

    Cusco, 84

  • Novartis Investigative Site

    Lima, 1

  • Novartis Investigative Site

    Lima Cercado, Lima region, 01

  • Novartis Investigative Site

    Piura, 2000

  • Novartis Investigative Site

    San Isidro, Lima region, 27

  • Novartis Investigative Site

    San Martín de Porres, Lima region, 31

Other trials in Peru

Philippines6 sites

  • Novartis Investigative Site

    Bulacan, 3020

  • Novartis Investigative Site

    Iloilo City, 5000

  • Novartis Investigative Site

    Lipa City, Batangas, 4217

  • Novartis Investigative Site

    Manila, 1000

  • Novartis Investigative Site

    Quezon City, Manila, 1100

  • Novartis Investigative Site

    Quezon City, 1100

Other trials in Philippines

Poland6 sites

  • Novartis Investigative Site

    Bialystok, 15-010

  • Novartis Investigative Site

    Kielce, 25-371

  • Novartis Investigative Site

    Poznan, 60-214

  • Novartis Investigative Site

    Poznan, 60-693

  • Novartis Investigative Site

    Poznan, 60-823

  • Novartis Investigative Site

    Strzelce Opolskie, 47 100

Other trials in Poland

Turkey (Türkiye)6 sites

  • Novartis Investigative Site

    Adana, 01330

  • Novartis Investigative Site

    Ankara, 06100

  • Novartis Investigative Site

    Bursa, 16059

  • Novartis Investigative Site

    Istanbul, TUR, 34098

  • Novartis Investigative Site

    Mersin, 33343

  • Novartis Investigative Site

    Yenisehir/Izmir, 35110

Other trials in Turkey (Türkiye)

United Kingdom6 sites

  • Novartis Investigative Site

    Bradford, West Yorkshire, BD9 6RJ

  • Novartis Investigative Site

    Cambridge, Cambrigdeshire, CB2 0QQ

  • Novartis Investigative Site

    Chertsey, Surrey, KT16 0PZ

  • Novartis Investigative Site

    East Yorkshire, HU16 5JQ

  • Novartis Investigative Site

    Leicester, LE3 9QP

  • Novartis Investigative Site

    Plymouth, Devon, PL6 8DH

Other trials in United Kingdom

Guatemala5 sites

  • Novartis Investigative Site

    Gautemala City, Gautemala, 01010

  • Novartis Investigative Site

    Guatemala City, GTM, 01010

  • Novartis Investigative Site

    Guatemala City, GTM, 01011

  • Novartis Investigative Site

    Guatemala City, 01010

  • Novartis Investigative Site

    Guatemala City, 01011

Other trials in Guatemala

Serbia5 sites

  • Novartis Investigative Site

    Belgrade, 11000

  • Novartis Investigative Site

    Belgrade, 11070

  • Novartis Investigative Site

    Kamenitz, 21204

  • Novartis Investigative Site

    Kragujevac, 34000

  • Novartis Investigative Site

    Niš, 18000

Other trials in Serbia

Bulgaria4 sites

  • Novartis Investigative Site

    Pleven, 5800

  • Novartis Investigative Site

    Rousse, 7002

  • Novartis Investigative Site

    Sofia, 1000

  • Novartis Investigative Site

    Stara Zagora, 6000

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Australia3 sites

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Austria3 sites

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Colombia3 sites

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Lebanon3 sites

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Malaysia3 sites

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Mexico3 sites

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Latvia2 sites

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Netherlands2 sites

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Singapore2 sites

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Finland1 site

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Taiwan1 site

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About this study

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.

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:

Read more
  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.

Read the 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.

Conditions
Asthma
Being tested
QAW039 150 mg, QAW039 450 mg, Placebo
Keywords
Asthma, QAW039, allergic asthma, allergy triggered asthma, reactive asthma, asthma attack, difficulty breathing
Medical subject headings
Asthma, Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QAW039 150 mgDrug

    One tablet of QAW039 150 mg once daily

  • QAW039 450 mgDrug

    One tablet of QAW039 450 mg once daily

  • PlaceboDrug

    One tablet of Placebo once daily

Study groups in NCT03052517
Study groupRoleWhat they receive
QAW039 150mgExperimentalQAW039 Dose 1 once daily
Receives: Drug: QAW039 150 mg
QAW039 450 mgExperimentalQAW039 Dose 2 once daily
Receives: Drug: QAW039 450 mg
PlaceboPlacebo comparatorPlacebo once daily
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model

    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.

    Measured: 52 weeks

  2. Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model

    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

    Measured: 156 weeks

  3. Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model

    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.

    Measured: 52 weeks

  4. Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 156 - Cox Regression Model

    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.

    Measured: 156 weeks

  5. Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 52 - Cox Regression Model

    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.

    Measured: 52 weeks

  6. Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 156 - Cox Regression Model

    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

    Measured: 156 weeks

Secondary outcomes (6)

  1. Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model

    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)

    Measured: 52 weeks

  2. Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model

    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)

    Measured: 156 weeks

  3. Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 52

    The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs.

    Measured: 52 weeks

  4. Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 156

    The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs.

    Measured: 156 weeks

  5. Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 52

    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

    Measured: 52 weeks

  6. Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 156

    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

    Measured: 156 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2017
  2. Study start21 Mar 2017
  3. Primary completion19 Feb 2020
  4. Study completion16 Mar 2020

Why it stopped: Company Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,538 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03052517
Sponsor's protocol ID
CQAW039A2315
Other IDs
2016-001560-11, 2016
Status last verified
Sep 2020
First submitted
23 Jan 2017
Last updated
12 Oct 2020
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Maspero J, Agache IO, Kamei T, Yoshida M, Boone B, Felser JM, Kawakami F, Knorr B, Lawrence D, Lehmann T, Wang W, Pedinoff AJ. Long-term safety and exploratory efficacy of fevipiprant in patients with inadequately controlled asthma: the SPIRIT randomised clinical trial. Respir Res. 2021 Dec 11;22(1):311. doi: 10.1186/s12931-021-01904-8.

    PubMed 34895218

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QAW039 150 mg and QAW039 450 mg in people with Asthma, run by Novartis Pharmaceuticals at 347 sites in 42 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 347 sites in United States, Japan, Argentina, Russia, Spain and 37 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model (time frame: 52 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03052517, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.

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