A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Participants With Asthma

February 21, 2020 updated by: Novartis Pharmaceuticals

A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Patients With Asthma

The purpose of the trial is to evaluate the efficacy and safety of two different doses of QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses (MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic participants as determined by pulmonary function testing, and effects on asthma control

Study Overview

Status

Completed

Conditions

Asthma

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2216

Phase

Phase 3

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

Bulgaria
- - Pleven, Bulgaria, 5800
    - Novartis Investigative Site
  - Plovdiv, Bulgaria, 4002
    - Novartis Investigative Site
  - Ruse, Bulgaria, 7002
    - Novartis Investigative Site
  - Sofia, Bulgaria, 1431
    - Novartis Investigative Site
  - Sofia, Bulgaria, 1407
    - Novartis Investigative Site
  - Sofia, Bulgaria
    - Novartis Investigative Site
  - Stara Zagora, Bulgaria, 6000
    - Novartis Investigative Site
  - Troyan, Bulgaria, 5600
    - Novartis Investigative Site
- BGR
  - Plovdiv, BGR, Bulgaria, 4000
    - Novartis Investigative Site
  - Varna, BGR, Bulgaria, 9000
    - Novartis Investigative Site
  - Vidin, BGR, Bulgaria, 3703
    - Novartis Investigative Site
China
- - Beijing, China, 100730
    - Novartis Investigative Site
  - Beijing, China, 100029
    - Novartis Investigative Site
  - Beijing, China, 100191
    - Novartis Investigative Site
  - Chengdu, China, 610083
    - Novartis Investigative Site
  - Chongqing, China, 400038
    - Novartis Investigative Site
  - Guang Zhou, China, 510080
    - Novartis Investigative Site
  - Guangzhou, China, 510000
    - Novartis Investigative Site
  - Guangzhou, China, 510180
    - Novartis Investigative Site
  - Nanchang, China, 330006
    - Novartis Investigative Site
  - Shanghai, China, 200433
    - Novartis Investigative Site
  - Shanghai, China, 200092
    - Novartis Investigative Site
  - Tianjin, China, 300052
    - Novartis Investigative Site
- Beijing
  - Beijing, Beijing, China, 100730
    - Novartis Investigative Site
  - Beijing, Beijing, China, 100044
    - Novartis Investigative Site
- Fujian
  - Fuzhou, Fujian, China, 350025
    - Novartis Investigative Site
- Guangdong
  - Guang Zhou, Guangdong, China, 510120
    - Novartis Investigative Site
- Hainan
  - Haikou, Hainan, China, 570311
    - Novartis Investigative Site
- Hebei
  - Shijiazhuang, Hebei, China, 050000
    - Novartis Investigative Site
- Hubei
  - Wuhan, Hubei, China, 430030
    - Novartis Investigative Site
- Hunan
  - Changsha, Hunan, China, 410011
    - Novartis Investigative Site
- Jiangsu
  - Nanjing, Jiangsu, China, 210029
    - Novartis Investigative Site
  - Nanjing, Jiangsu, China, 210006
    - Novartis Investigative Site
  - Nanjing, Jiangsu, China, 210009
    - Novartis Investigative Site
  - Suzhou, Jiangsu, China, 215006
    - Novartis Investigative Site
- Jilin
  - Chang Chun, Jilin, China, 130021
    - Novartis Investigative Site
- Liaoning
  - Shenyang, Liaoning, China, 110000
    - Novartis Investigative Site
  - Shenyang, Liaoning, China, 110003
    - Novartis Investigative Site
  - Shenyang, Liaoning, China, 110011
    - Novartis Investigative Site
- Shanghai
  - Shanghai, Shanghai, China, 200032
    - Novartis Investigative Site
- Shanxi
  - Xian, Shanxi, China, 710061
    - Novartis Investigative Site
- Sichuan
  - Chengdu, Sichuan, China, 610041
    - Novartis Investigative Site
- Zhejiang
  - Hangzhou, Zhejiang, China, 310014
    - Novartis Investigative Site
  - Hangzhou, Zhejiang, China, 310006
    - Novartis Investigative Site
Croatia
- - Petrinja, Croatia, 44250
    - Novartis Investigative Site
  - Rijeka, Croatia, 51000
    - Novartis Investigative Site
  - Zadar, Croatia, 23000
    - Novartis Investigative Site
  - Zagreb, Croatia, 10000
    - Novartis Investigative Site
- HRV
  - Varazdin, HRV, Croatia, 42000
    - Novartis Investigative Site
  - Zagreb, HRV, Croatia, 10 000
    - Novartis Investigative Site
Czechia
- - Breclav, Czechia, 690 02
    - Novartis Investigative Site
  - Cesky Krumlov, Czechia, 381 01
    - Novartis Investigative Site
  - Kutna Hora, Czechia, 28401
    - Novartis Investigative Site
  - Novy Bor, Czechia, 47301
    - Novartis Investigative Site
  - Plzen, Czechia, 323 00
    - Novartis Investigative Site
  - Praha 8, Czechia, 182 00
    - Novartis Investigative Site
  - Rokycany, Czechia, 337 22
    - Novartis Investigative Site
  - Tabor, Czechia, 390 01
    - Novartis Investigative Site
- CZE
  - Ostrava, CZE, Czechia, 709 00
    - Novartis Investigative Site
  - Plzen, CZE, Czechia, 301 00
    - Novartis Investigative Site
  - Teplice, CZE, Czechia, 415 01
    - Novartis Investigative Site
- Czech Republic
  - Beroun, Czech Republic, Czechia, 266 01
    - Novartis Investigative Site
  - Boskovice, Czech Republic, Czechia, 680 01
    - Novartis Investigative Site
  - Jablonec nad Nisou, Czech Republic, Czechia, 466 01
    - Novartis Investigative Site
  - Jindrichuv Hradec, Czech Republic, Czechia, 377 01
    - Novartis Investigative Site
  - Kurim, Czech Republic, Czechia, 66434
    - Novartis Investigative Site
  - Praha, Czech Republic, Czechia, 14800
    - Novartis Investigative Site
  - Teplice, Czech Republic, Czechia, 415 01
    - Novartis Investigative Site
  - Varnsdorf, Czech Republic, Czechia, 40747
    - Novartis Investigative Site
Egypt
- - Alexandria, Egypt, 21131
    - Novartis Investigative Site
Estonia
- - Tallinn, Estonia, 13619
    - Novartis Investigative Site
  - Tartu, Estonia, 51014
    - Novartis Investigative Site
Germany
- - Ahlen, Germany, 59229
    - Novartis Investigative Site
  - Bamberg, Germany, 96049
    - Novartis Investigative Site
  - Berlin, Germany, 12203
    - Novartis Investigative Site
  - Berlin, Germany, 13086
    - Novartis Investigative Site
  - Berlin, Germany, 10717
    - Novartis Investigative Site
  - Berlin, Germany, 10367
    - Novartis Investigative Site
  - Berlin, Germany, 12627
    - Novartis Investigative Site
  - Berlin, Germany, 13156
    - Novartis Investigative Site
  - Berlin, Germany, 10787
    - Novartis Investigative Site
  - Berlin, Germany, 10969
    - Novartis Investigative Site
  - Berlin, Germany, 12157
    - Novartis Investigative Site
  - Berlin, Germany, 12159
    - Novartis Investigative Site
  - Berlin, Germany, 10119
    - Novartis Investigative Site
  - Berlin, Germany, 13057
    - Novartis Investigative Site
  - Berlin, Germany, 13187
    - Novartis Investigative Site
  - Berlin, Germany, 10247
    - Novartis Investigative Site
  - Bochum, Germany, D-44787
    - Novartis Investigative Site
  - Boehlen, Germany, 04564
    - Novartis Investigative Site
  - Bonn, Germany, 53119
    - Novartis Investigative Site
  - Delitzsch, Germany, 04509
    - Novartis Investigative Site
  - Dresden, Germany, 01069
    - Novartis Investigative Site
  - Dueren, Germany, 52349
    - Novartis Investigative Site
  - Düsseldorf, Germany, 40211
    - Novartis Investigative Site
  - Erlangen, Germany, 91052
    - Novartis Investigative Site
  - Frankfurt, Germany, 60313
    - Novartis Investigative Site
  - Frankfurt, Germany, 60389
    - Novartis Investigative Site
  - Furstenwalde, Germany, 15517
    - Novartis Investigative Site
  - Halle, Germany, 06108
    - Novartis Investigative Site
  - Hamburg, Germany, 20354
    - Novartis Investigative Site
  - Hamburg, Germany, 22299
    - Novartis Investigative Site
  - Hamburg, Germany, 22143
    - Novartis Investigative Site
  - Hamburg, Germany, 22335
    - Novartis Investigative Site
  - Hannover, Germany, 30173
    - Novartis Investigative Site
  - Hochstadt, Germany, 91315
    - Novartis Investigative Site
  - Kassel, Germany, 34121
    - Novartis Investigative Site
  - Leipzig, Germany, 04207
    - Novartis Investigative Site
  - Leipzig, Germany, 04103
    - Novartis Investigative Site
  - Leipzig, Germany, 04275
    - Novartis Investigative Site
  - Leipzig, Germany, 04109
    - Novartis Investigative Site
  - Lubeck, Germany, 23552
    - Novartis Investigative Site
  - Ludwigsburg, Germany, 71640
    - Novartis Investigative Site
  - Marburg, Germany, D-35037
    - Novartis Investigative Site
  - Mittweida, Germany, 09648
    - Novartis Investigative Site
  - Muenchen, Germany, 81377
    - Novartis Investigative Site
  - Neu Isenburg, Germany, 63263
    - Novartis Investigative Site
  - Neuss, Germany, 41462
    - Novartis Investigative Site
  - Potsdam, Germany, 14467
    - Novartis Investigative Site
  - Potsdam, Germany, 14469
    - Novartis Investigative Site
  - Rheine, Germany, 48431
    - Novartis Investigative Site
  - Rudersdorf, Germany, 15562
    - Novartis Investigative Site
  - Schleswig, Germany, 24837
    - Novartis Investigative Site
  - Schwedt, Germany, 16303
    - Novartis Investigative Site
  - Weinheim, Germany, 69469
    - Novartis Investigative Site
  - Witten, Germany, 58452
    - Novartis Investigative Site
- Niedersachsen
  - Peine, Niedersachsen, Germany, 31224
    - Novartis Investigative Site
- Rheinland-Pfalz
  - Koblenz, Rheinland-Pfalz, Germany, 56068
    - Novartis Investigative Site
Guatemala
- - Guatemala City, Guatemala, 01010
    - Novartis Investigative Site
  - Guatemala City, Guatemala, 01011
    - Novartis Investigative Site
  - Guatemala City, Guatemala, 01057
    - Novartis Investigative Site
- GTM
  - Guatemala City, GTM, Guatemala, 01010
    - Novartis Investigative Site
  - Guatemala City, GTM, Guatemala, 01011
    - Novartis Investigative Site
- Gautemala
  - Ciudad, Gautemala, Guatemala, 01010
    - Novartis Investigative Site
Hungary
- - Balassagyarmat, Hungary, 2660
    - Novartis Investigative Site
  - Budapest, Hungary, 1134
    - Novartis Investigative Site
  - Budapest, Hungary, 1106
    - Novartis Investigative Site
  - Cegled, Hungary, 2700
    - Novartis Investigative Site
  - Csorna, Hungary, H-9300
    - Novartis Investigative Site
  - Dombovar, Hungary, 7200
    - Novartis Investigative Site
  - Godollo, Hungary, 2100
    - Novartis Investigative Site
  - Hatvan, Hungary, 3000
    - Novartis Investigative Site
  - Komarom, Hungary, 2900
    - Novartis Investigative Site
  - Miskolc, Hungary, 3526
    - Novartis Investigative Site
  - Mosdos, Hungary, 7257
    - Novartis Investigative Site
  - Szarvas, Hungary, 5540
    - Novartis Investigative Site
  - Szeged, Hungary, 6720
    - Novartis Investigative Site
  - Szeged, Hungary, 6722
    - Novartis Investigative Site
  - Szigetvar, Hungary, 7900
    - Novartis Investigative Site
  - Szombathely, Hungary, 9700
    - Novartis Investigative Site
- HUN
  - Budapest, HUN, Hungary, 1204
    - Novartis Investigative Site
  - Budapest, HUN, Hungary, 1037
    - Novartis Investigative Site
  - Budapest, HUN, Hungary, 1089
    - Novartis Investigative Site
  - Budapest, HUN, Hungary, 1117
    - Novartis Investigative Site
  - Gyor, HUN, Hungary, 9024
    - Novartis Investigative Site
  - Hajdunanas, HUN, Hungary, 4080
    - Novartis Investigative Site
  - Mako, HUN, Hungary, 6900
    - Novartis Investigative Site
  - Miskolc, HUN, Hungary, 3529
    - Novartis Investigative Site
  - Puspokladany, HUN, Hungary, 4150
    - Novartis Investigative Site
  - Szazhalombatta, HUN, Hungary, 2440
    - Novartis Investigative Site
India
- - New Delhi, India, 110029
    - Novartis Investigative Site
- Delhi
  - New Delhi, Delhi, India, 110007
    - Novartis Investigative Site
- Gujarat
  - Ahmedabad, Gujarat, India, 380016
    - Novartis Investigative Site
  - Ahmedabad, Gujarat, India, 380 008
    - Novartis Investigative Site
  - Vadodara, Gujarat, India, 390021
    - Novartis Investigative Site
- Karnataka
  - Mysore, Karnataka, India, 570001
    - Novartis Investigative Site
- Kerala
  - Kozhikode, Kerala, India, 673008
    - Novartis Investigative Site
- Maharashtra
  - Mumbai, Maharashtra, India, 400601
    - Novartis Investigative Site
  - Nagpur, Maharashtra, India, 440010
    - Novartis Investigative Site
  - Nagpur, Maharashtra, India, 440012
    - Novartis Investigative Site
  - Nagpur, Maharashtra, India, 440019
    - Novartis Investigative Site
  - Pune, Maharashtra, India, 411007
    - Novartis Investigative Site
- Punjab
  - Mohali, Punjab, India, 160 062
    - Novartis Investigative Site
- Rajasthan
  - Jaipur, Rajasthan, India, 302013
    - Novartis Investigative Site
  - Jaipur, Rajasthan, India, 302023
    - Novartis Investigative Site
  - Jaipur, Rajasthan, India, 302001
    - Novartis Investigative Site
  - Jaipur, Rajasthan, India, 302020
    - Novartis Investigative Site
- Telangana
  - Hyderabad, Telangana, India, 500082
    - Novartis Investigative Site
- Uttar Pradesh
  - Lucknow, Uttar Pradesh, India, 226003
    - Novartis Investigative Site
Ireland
- - County Limerick, Ireland, V94 F858
    - Novartis Investigative Site
  - Dublin, Ireland, DUBLIN 8
    - Novartis Investigative Site
- Cork
  - Wilton, Cork, Ireland
    - Novartis Investigative Site
Japan
- Chiba
  - Ichihara-city, Chiba, Japan, 299-0111
    - Novartis Investigative Site
- Fukuoka
  - Fukuoka-city, Fukuoka, Japan, 819-8555
    - Novartis Investigative Site
  - Kasuga-city, Fukuoka, Japan, 816-0813
    - Novartis Investigative Site
  - Yanagawa-city, Fukuoka, Japan, 832-0059
    - Novartis Investigative Site
- Hokkaido
  - Obihiro-city, Hokkaido, Japan, 080-0013
    - Novartis Investigative Site
- Hyogo
  - Himeji-city, Hyogo, Japan, 672-8064
    - Novartis Investigative Site
  - Himeji-city, Hyogo, Japan, 671-0102
    - Novartis Investigative Site
- Ibaraki
  - Naka-gun, Ibaraki, Japan, 319-1113
    - Novartis Investigative Site
- Kanagawa
  - Atsugi-city, Kanagawa, Japan, 243-0034
    - Novartis Investigative Site
  - Kawasaki-city, Kanagawa, Japan, 255
    - Novartis Investigative Site
  - Yokohama, Kanagawa, Japan, 232-0064
    - Novartis Investigative Site
  - Yokohama-city, Kanagawa, Japan, 236-0004
    - Novartis Investigative Site
  - Yokohama-city, Kanagawa, Japan, 223-0059
    - Novartis Investigative Site
  - Yokohama-city, Kanagawa, Japan, 231-8682
    - Novartis Investigative Site
- Miyagi
  - Sendai-city, Miyagi, Japan, 980-0871
    - Novartis Investigative Site
- Okayama
  - Okayama-city, Okayama, Japan, 702-8055
    - Novartis Investigative Site
- Osaka
  - Kishiwada-city, Osaka, Japan, 596-8501
    - Novartis Investigative Site
  - Osaka city, Osaka, Japan, 530 0001
    - Novartis Investigative Site
  - Takatsuki-city, Osaka, Japan, 569-1192
    - Novartis Investigative Site
  - Toyonaka-city, Osaka, Japan
    - Novartis Investigative Site
  - Yao-city, Osaka, Japan, 581-0011
    - Novartis Investigative Site
- Saitama
  - Koshigaya-city, Saitama, Japan, 343-8555
    - Novartis Investigative Site
- Shibuya Ku
  - Tokyo, Shibuya Ku, Japan, 150 0013
    - Novartis Investigative Site
- Tokyo
  - Chuo ku, Tokyo, Japan, 103 0027
    - Novartis Investigative Site
  - Chuou-ku, Tokyo, Japan, 103-0028
    - Novartis Investigative Site
  - Itabashi-ku, Tokyo, Japan, 173-8610
    - Novartis Investigative Site
  - Setagaya-Ku, Tokyo, Japan, 157-0072
    - Novartis Investigative Site
  - Shinjuku-ku, Tokyo, Japan, 169-0073
    - Novartis Investigative Site
  - Shinjuku-ku, Tokyo, Japan, 162-0053
    - Novartis Investigative Site
  - Toshima ku, Tokyo, Japan, 170 0003
    - Novartis Investigative Site
  - Toshima-ku, Tokyo, Japan, 171-0014
    - Novartis Investigative Site
Korea, Republic of
- - Incheon, Korea, Republic of, 403-720
    - Novartis Investigative Site
- Chungcheongbuk Do
  - Cheongju si, Chungcheongbuk Do, Korea, Republic of, 28644
    - Novartis Investigative Site
- Gangwon-do
  - Wonju, Gangwon-do, Korea, Republic of, 26427
    - Novartis Investigative Site
- Gyeonggi Do
  - Bundang Gu, Gyeonggi Do, Korea, Republic of, 13620
    - Novartis Investigative Site
- Gyeonggi-Do
  - Bucheon-Si, Gyeonggi-Do, Korea, Republic of, 14584
    - Novartis Investigative Site
- Korea
  - Seoul, Korea, Korea, Republic of, 08308
    - Novartis Investigative Site
  - Seoul, Korea, Korea, Republic of, 03312
    - Novartis Investigative Site
- Seocho Gu
  - Seoul, Seocho Gu, Korea, Republic of, 06591
    - Novartis Investigative Site
Latvia
- - Daugavpils, Latvia, LV-5401
    - Novartis Investigative Site
  - Riga, Latvia, LV 1002
    - Novartis Investigative Site
  - Riga, Latvia, LV-1001
    - Novartis Investigative Site
- LV
  - Riga, LV, Latvia, 1011
    - Novartis Investigative Site
Lithuania
- - Kaunas, Lithuania, LT-49449
    - Novartis Investigative Site
  - Siauliai, Lithuania, LT-76231
    - Novartis Investigative Site
  - Utena, Lithuania, LT-28151
    - Novartis Investigative Site
  - Vilnius, Lithuania, LT-09108
    - Novartis Investigative Site
- LTU
  - Kaunas, LTU, Lithuania, LT-48259
    - Novartis Investigative Site
Mexico
- - Mexico, Mexico, 07760
    - Novartis Investigative Site
- Baja California
  - Mexicali, Baja California, Mexico, 21100
    - Novartis Investigative Site
- Distrito Federal
  - Ciudad de Mexico, Distrito Federal, Mexico, 06700
    - Novartis Investigative Site
  - Mexico, Distrito Federal, Mexico, 14050
    - Novartis Investigative Site
Poland
- - Aleksandrow Odzki, Poland, 95-070
    - Novartis Investigative Site
  - Biaystok, Poland, 15-430
    - Novartis Investigative Site
  - Bielsko-Biala, Poland, 43-300
    - Novartis Investigative Site
  - Elblag, Poland, 82-300
    - Novartis Investigative Site
  - Inowroclaw, Poland, 88-100
    - Novartis Investigative Site
  - Katowice, Poland, 40 085
    - Novartis Investigative Site
  - Krakow, Poland, 30033
    - Novartis Investigative Site
  - Lodz, Poland, 90-302
    - Novartis Investigative Site
  - Ostrow Wielkopolski, Poland, 63-400
    - Novartis Investigative Site
  - Sopot, Poland, 81-741
    - Novartis Investigative Site
  - Warsaw, Poland, 01518
    - Novartis Investigative Site
  - Zawadzkie, Poland, 47-120
    - Novartis Investigative Site
- POL
  - Lodz, POL, Poland, 91-110
    - Novartis Investigative Site
  - Wejherowo, POL, Poland, 84-200
    - Novartis Investigative Site
Romania
- - Arad, Romania, 310013
    - Novartis Investigative Site
  - Bacau, Romania, 600114
    - Novartis Investigative Site
  - Bragadiru, Romania, 077025
    - Novartis Investigative Site
  - Braila, Romania, 810003
    - Novartis Investigative Site
  - Brasov, Romania, 500051
    - Novartis Investigative Site
  - Bucharest, Romania, 020125
    - Novartis Investigative Site
  - Bucuresti, Romania, 012363
    - Novartis Investigative Site
  - Bucuresti, Romania, 050554
    - Novartis Investigative Site
  - Cluj Napoca, Romania, 400371
    - Novartis Investigative Site
  - Cluj Napoca, Romania, 400275
    - Novartis Investigative Site
  - Cluj-Napoca, Romania, 400371
    - Novartis Investigative Site
  - Codlea, Romania, 505100
    - Novartis Investigative Site
  - Craiova, Romania, 200515
    - Novartis Investigative Site
  - Ramnicu Valcea, Romania, 240564
    - Novartis Investigative Site
  - Suceava, Romania, 720284
    - Novartis Investigative Site
  - Targu Mures, Romania, 540072
    - Novartis Investigative Site
- Jud Iasi
  - Iasi, Jud Iasi, Romania, 700732
    - Novartis Investigative Site
- Jud. Constanta
  - Constanta, Jud. Constanta, Romania, 900002
    - Novartis Investigative Site
- Jud.Dolj
  - Craiova, Jud.Dolj, Romania, 200341
    - Novartis Investigative Site
- ROM
  - Bucharest, ROM, Romania, 12071
    - Novartis Investigative Site
  - Craiova, ROM, Romania, 200712
    - Novartis Investigative Site
  - Craiova, ROM, Romania, 000000
    - Novartis Investigative Site
  - Deva, ROM, Romania, 330084
    - Novartis Investigative Site
  - Timisoara, ROM, Romania, 300298
    - Novartis Investigative Site
- Timis
  - Timisoara, Timis, Romania, 300310
    - Novartis Investigative Site
Russian Federation
- - Chelyabinsk, Russian Federation, 454021
    - Novartis Investigative Site
  - Chelyabinsk, Russian Federation, 454076
    - Novartis Investigative Site
  - Kazan, Russian Federation, 420012
    - Novartis Investigative Site
  - Krasnoyarsk, Russian Federation, 660022
    - Novartis Investigative Site
  - Moscow, Russian Federation, 105275
    - Novartis Investigative Site
  - Moscow, Russian Federation, 119192
    - Novartis Investigative Site
  - N.Novgorod, Russian Federation, 603126
    - Novartis Investigative Site
  - Novosibirsk, Russian Federation, 630047
    - Novartis Investigative Site
  - Novosibirsk, Russian Federation, 630099
    - Novartis Investigative Site
  - Penza, Russian Federation, 440067
    - Novartis Investigative Site
  - Petrozavodsk, Russian Federation, 185019
    - Novartis Investigative Site
  - Pyatigorsk, Russian Federation, 357538
    - Novartis Investigative Site
  - Ryazan, Russian Federation, 390026
    - Novartis Investigative Site
  - Ryazan, Russian Federation, 390039
    - Novartis Investigative Site
  - Saint Petersburg, Russian Federation, 191123
    - Novartis Investigative Site
  - Saint-Petersburg, Russian Federation, 192257
    - Novartis Investigative Site
  - Saratov, Russian Federation, 410012
    - Novartis Investigative Site
  - Saratov, Russian Federation, 410053
    - Novartis Investigative Site
  - Smolensk, Russian Federation, 214031
    - Novartis Investigative Site
  - Smolensk, Russian Federation, 214006
    - Novartis Investigative Site
  - St Petersburg, Russian Federation, 191015
    - Novartis Investigative Site
  - St Petersburg, Russian Federation, 194291
    - Novartis Investigative Site
  - St Petersburg, Russian Federation, 194354
    - Novartis Investigative Site
  - St Petersburg, Russian Federation, 194223
    - Novartis Investigative Site
  - St Petersburg, Russian Federation, 190044
    - Novartis Investigative Site
  - St Petersburg, Russian Federation, 191180
    - Novartis Investigative Site
  - St-Petersburg, Russian Federation, 193312
    - Novartis Investigative Site
  - St-Petersburg, Russian Federation, 194291
    - Novartis Investigative Site
  - St.Petersburg, Russian Federation, 196240
    - Novartis Investigative Site
  - Stavropol, Russian Federation, 355000
    - Novartis Investigative Site
  - Volgograd, Russian Federation, 400120
    - Novartis Investigative Site
  - Vologodonsk, Russian Federation, 347382
    - Novartis Investigative Site
  - Yaroslavl, Russian Federation, 150003
    - Novartis Investigative Site
  - Yaroslavl, Russian Federation, 150000
    - Novartis Investigative Site
  - Yaroslavl, Russian Federation, 150023
    - Novartis Investigative Site
  - Yaroslavl, Russian Federation, 150040
    - Novartis Investigative Site
  - Yekaterinburg, Russian Federation, 620137
    - Novartis Investigative Site
Serbia
- - Belgrade, Serbia, 11000
    - Novartis Investigative Site
  - Beograd, Serbia, 11000
    - Novartis Investigative Site
  - Kragujevac, Serbia, 34000
    - Novartis Investigative Site
  - Nis, Serbia, 18000
    - Novartis Investigative Site
  - Sremska Kamenica, Serbia, 21204
    - Novartis Investigative Site
Slovakia
- - Bardejov, Slovakia, 085 01
    - Novartis Investigative Site
  - Bratislava, Slovakia, 85101
    - Novartis Investigative Site
  - Cadca, Slovakia, 022 01
    - Novartis Investigative Site
  - Ilava, Slovakia, 1901
    - Novartis Investigative Site
  - Komarno, Slovakia, 945 01
    - Novartis Investigative Site
  - Kosice, Slovakia, 040 01
    - Novartis Investigative Site
  - Kosice, Slovakia, 04001
    - Novartis Investigative Site
  - Kralovsky Chlmec, Slovakia, 077 01
    - Novartis Investigative Site
  - Levice, Slovakia, 034 01
    - Novartis Investigative Site
  - Liptovsky Mikulas, Slovakia, 031 23
    - Novartis Investigative Site
  - Presov, Slovakia, 080 01
    - Novartis Investigative Site
  - Prievidza, Slovakia, 97101
    - Novartis Investigative Site
  - Topolcany, Slovakia, 95501
    - Novartis Investigative Site
  - Zilina, Slovakia, 010 01
    - Novartis Investigative Site
  - Zilina, Slovakia, 01001
    - Novartis Investigative Site
- SVK
  - Poprad, SVK, Slovakia, 058 01
    - Novartis Investigative Site
- Slovak Republic
  - Bardejov, Slovak Republic, Slovakia, 085 01
    - Novartis Investigative Site
  - Bojnice, Slovak Republic, Slovakia, 972 01
    - Novartis Investigative Site
  - Bratislava, Slovak Republic, Slovakia, 83103
    - Novartis Investigative Site
  - Humenne, Slovak Republic, Slovakia, 066 01
    - Novartis Investigative Site
  - Kosice, Slovak Republic, Slovakia, 040 01
    - Novartis Investigative Site
  - Nitra, Slovak Republic, Slovakia, 949 01
    - Novartis Investigative Site
  - Skalica, Slovak Republic, Slovakia, 90901
    - Novartis Investigative Site
  - Spisska Nova Ves, Slovak Republic, Slovakia, 052 01
    - Novartis Investigative Site
  - Stropkov, Slovak Republic, Slovakia, 09101
    - Novartis Investigative Site
  - Surany, Slovak Republic, Slovakia, 942 01
    - Novartis Investigative Site
  - Velky Meder, Slovak Republic, Slovakia, 94201
    - Novartis Investigative Site
- Slovensko
  - Námestovo, Slovensko, Slovakia, 02901
    - Novartis Investigative Site
South Africa
- - Belleville, South Africa, 7530
    - Novartis Investigative Site
  - Cape Town, South Africa, 7531
    - Novartis Investigative Site
  - Cape Town, South Africa, 7925
    - Novartis Investigative Site
  - Cape Town, South Africa, 7700
    - Novartis Investigative Site
- Durban
  - Berea, Durban, South Africa, 4001
    - Novartis Investigative Site
- Western Cape
  - Panorama, Western Cape, South Africa, 7500
    - Novartis Investigative Site
United Kingdom
- - Blackpool, United Kingdom, FY5 3LF
    - Novartis Investigative Site
  - Denbighshire, United Kingdom, LL181DA
    - Novartis Investigative Site
  - Glasgow, United Kingdom, G20 0XA
    - Novartis Investigative Site
  - London, United Kingdom, EC14 7BE
    - Novartis Investigative Site
  - London, United Kingdom, SE5 8AD
    - Novartis Investigative Site
  - Rotherham, United Kingdom, S65 1DA
    - Novartis Investigative Site
  - Wiltshire, United Kingdom, SN15 2SB
    - Novartis Investigative Site
- Cornwall
  - Fowey, Cornwall, United Kingdom, PL23 1DT
    - Novartis Investigative Site
  - Liskeard, Cornwall, United Kingdom, PL14 3XA
    - Novartis Investigative Site
  - Torpoint, Cornwall, United Kingdom, PL11 2TB
    - Novartis Investigative Site
- Oxfordshire
  - Faringdon, Oxfordshire, United Kingdom, SN7 7YU
    - Novartis Investigative Site
- South Gloucestershire
  - Bristol, South Gloucestershire, United Kingdom, BS37 4AX
    - Novartis Investigative Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35244
    - Novartis Investigative Site
- California
  - Los Angeles, California, United States, 90025
    - Novartis Investigative Site
  - Orange, California, United States, 92868
    - Novartis Investigative Site
  - Riverside, California, United States, 92506
    - Novartis Investigative Site
  - San Diego, California, United States, 92117
    - Novartis Investigative Site
  - San Jose, California, United States, 95117
    - Novartis Investigative Site
  - Stockton, California, United States, 95207
    - Novartis Investigative Site
  - Westminster, California, United States, 92683
    - Novartis Investigative Site
- Colorado
  - Denver, Colorado, United States, 80230
    - Novartis Investigative Site
- Florida
  - Miami, Florida, United States, 33144
    - Novartis Investigative Site
  - Tallahassee, Florida, United States, 32308
    - Novartis Investigative Site
  - Winter Park, Florida, United States, 32789
    - Novartis Investigative Site
- Maryland
  - Baltimore, Maryland, United States, 21236
    - Novartis Investigative Site
  - Waldorf, Maryland, United States, 20602
    - Novartis Investigative Site
- Massachusetts
  - North Dartmouth, Massachusetts, United States, 02747-3322
    - Novartis Investigative Site
- Missouri
  - Saint Louis, Missouri, United States, 63141
    - Novartis Investigative Site
- Nebraska
  - Bellevue, Nebraska, United States, 68123
    - Novartis Investigative Site
- Nevada
  - Las Vegas, Nevada, United States, 89119
    - Novartis Investigative Site
- New Jersey
  - Skillman, New Jersey, United States, 08558
    - Novartis Investigative Site
- New York
  - Cortland, New York, United States, 13045
    - Novartis Investigative Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73120
    - Novartis Investigative Site
  - Tulsa, Oklahoma, United States, 74136
    - Novartis Investigative Site
- Oregon
  - Medford, Oregon, United States, 97504
    - Novartis Investigative Site
  - Portland, Oregon, United States, 97213
    - Novartis Investigative Site
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15241
    - Novartis Investigative Site
- South Carolina
  - North Charleston, South Carolina, United States, 29407
    - Novartis Investigative Site
- Texas
  - Boerne, Texas, United States, 78006
    - Novartis Investigative Site
  - El Paso, Texas, United States, 79903
    - Novartis Investigative Site
- Wisconsin
  - Greenfield, Wisconsin, United States, 53228
    - 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

Ages Eligible for Study

12 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Participants with a diagnosis of asthma, for a period of at least 1 year prior to Visit 1 (Screening)
Participants who have used medium or high dose inhaled corticosteroids (ICS) or low dose of long acting beta-2 agonist (LABA)/ICS combinations for asthma for at least 3 months and at stable doses for at least 1 month prior to Visit 1
Participants must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (prior to double-blind treatment) and qualify for treatment with medium or high dose LABA/ICS
Pre-bronchodilator ≥ 50% Forced expiratory volume in 1 second (FEV1) of < 85 % of the predicted normal value for the participants after withholding bronchodilators at both Visit 101 and 102, according to American Thoracic Society/European Respiratory Society (ATS/ERS) criteria.
Withholding period of bronchodilators prior to spirometry: short acting beta-2 agonist (SABA) for ≥ 6 hours and FDC or free combinations of ICS/LABA for ≥ 48 hours, short acting anticholinergics (SAMA) for ≥ 8 hours, xanthines >=07 days
A one-time repeat/re-testing of percent predicted FEV1 (prebronchodilator FEV1) is allowed at Visit 101 and at Visit 102.

Spacer devices are permitted for reversibility testing only.

-Participants who demonstrate an increase in FEV1 of 12% and 200 mL within 30 minutes after administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose) at Visit 101 All participants must perform a reversibility test at Visit 101

If reversibility is not demonstrated at Visit 101:

Reversibility should be repeated once-
Participants may be permitted to enter the study with historical evidence of reversibility that was performed according to ATS/ERS guidelines within 2 years prior to Visit 1
Alternatively, participants may be permitted to enter the study with a historical positive bronchoprovocation test that was performed within 2 years prior to Visit 1.

Exclusion Criteria:

Participants who have smoked or inhaled tobacco products within the 6 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years. This includes use of nicotine inhalers such as e-cigarettes at the time of Visit 1
Participants who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening)
Participants who have ever required intubation for a severe asthma attack/exacerbation.
Participants who have a clinical condition which is likely to be worsened by ICS administration (e.g. glaucoma, cataract and fragility fractures) who are according to investigator's medical judgment at risk participating in the study).
Participants who have had a respiratory tract infection or asthma worsening as determined by the investigator within 4 weeks prior to Visit 1 (Screening) or between Visit 1 and Visit 102. Participants may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
Participants with a history of chronic lung diseases other than asthma, including (but not limited to) Chronic Obstructive Pulmonary Disease (COPD), sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
Participants with severe narcolepsy and/or insomnia.
Participants who have a clinically significant electrocardiogram (ECG) abnormality at Visit 101 (Start of Run- In epoch) and at any time between Visit 101 and Visit 102 (including unscheduled ECG). ECG evidence of myocardial infarction at Visit 101 (via central reader) should be clinically assessed by the investigator with supportivedocumentation
Participants with a history of hypersensitivity to lactose, any of the study drugs or to similar drugs within the class including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof
Participants who have not achieved an acceptable spirometry results at Visit 101 in accordance with ATS/ERS criteria for acceptability and repeatability (rescreening allowed only once).

Repeat spirometry may be allowed once in an ad-hoc visit if the spirometry did not qualify due to ATS/ERS criteria. If the participant fails the repeat assessment, the participant may be rescreened once

Participants on Maintenance Immunotherapy (desensitization) for allergies or less than 3 months prior to Visit 101 or participants on Maintenance Immunotherapy for more than 3 months prior to Visit 101 but expected to change throughout the course of the study.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment and for 30 days after stopping of study treatment.
Long acting muscarinic antagonist (LAMA) use within 3 months prior to Visit 101

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: DOUBLE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QMF149 150/160 µg QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered once daily (o.d) via Concept1 inhaler in the evening.	Drug: Indacaterol acetate/Mometasone furoate Other Names: QMF149
Experimental: QMF149 150/320 µg QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d via Concept1 inhaler in the evening.	Drug: Indacaterol acetate/Mometasone furoate Other Names: QMF149
Active Comparator: MF 400 µg Mometasone furoate (MF) 400 μg was delivered o.d via Twisthaler® in the evening	Drug: Mometasone furoate
Active Comparator: Salmeterol /fluticasone 50/500 μg Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.	Drug: Salmeterol xinafoate/fluticasone propionate
Active Comparator: MF 800 μg MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.	Drug: Mometasone furoate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trough Forced Expiratory Volume in One Second (Trough FEV1) at Week 26 Time Frame: 26 weeks	Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration in Days of Asthma Exacerbations by Exacerbation Category Time Frame: Up to Week 52	The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.	Up to Week 52
Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category Time Frame: Up to Week 52	The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.	Up to Week 52
Percentage of Participants With Composite Endpoint of Serious Asthma Outcomes Time Frame: Up to Week 52	A composite endpoint of serious asthma outcomes is defined as asthma-related hospitalization, asthma-related intubation, or asthma-related death and was reviewed by the Adjudication Committee.	Up to Week 52
Asthma Control Questionnaire (ACQ-7) at Weeks 4, 12, 26 and 52 Time Frame: Weeks 4, 12, 26 and 52	The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means > 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means < 50% of predicted FEV1). The total score was calculated as the mean of all questions.	Weeks 4, 12, 26 and 52
Trough FEV1 at Week 52 Time Frame: Week 52	Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.	Week 52
Pre-dose FEV1 at Weeks 4 and 12 Time Frame: Weeks 4 (Day 30) and 12 (Day 86)	Pre-dose trough FEV1 is defined as average of the two FEV1 measurements taken 45 min and 15 min pre evening dose. It was assessed by performing spirometric assessment. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.	Weeks 4 (Day 30) and 12 (Day 86)
Post Dose FEV1 (5 Minutes-1 Hour) Time Frame: Up to Week 52 (Day 364)	Post-dose FEV1 measurements were analyzed at 5 minutes, 15 minutes, 30 minutes and 1 hour. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.	Up to Week 52 (Day 364)
Trough Forced Vital Capacity (FVC) Time Frame: Up to Week 52 (Day 365)	FVC is the total amount of air exhaled during the FEV test. Trough FVC is defined as average of the two FVC measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. It was assessed by performing spirometric assessment.	Up to Week 52 (Day 365)
Trough Forced Expiratory Flow (FEF)Between 25% and 75% of FVC (FEF25-75) Time Frame: Up to Week 52 (Day 365)	FEF is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. Trough FEF25-75% is defined as average of the two FEF25-75% measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. It was assessed by performing spirometric assessment.	Up to Week 52 (Day 365)
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment Time Frame: Up to Weeks 26 and 52	PEF is a person's maximum speed of expiration. All the participants were instructed to record PEF twice daily using a mini Peak Flow Meter device, once in the morning (before taking the morning dose) and once approximately 12 h later in the evening (before taking the evening dose). At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the e-PEF/diary. The best of 3 values were used.	Up to Weeks 26 and 52
Percentage of Participants Achieving the Minimal Important Difference (MID) ACQ ≥ 0.5 at Weeks 26 and 52 Time Frame: Weeks 26 (Day 183) and 52 (Day 364)	Change from baseline in ACQ-7 scores of ≤ 0.5 was defined as minimal clinically important difference and were considered clinically meaningful. The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means > 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means < 50% of predicted FEV1). The total score was calculated as the mean of all questions	Weeks 26 (Day 183) and 52 (Day 364)
Change From Baseline in Percentage of Asthma Symptoms Free Days Time Frame: Up to Week 52	All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. Asthma symptoms free days are days with no daytime symptoms, no night-time awakenings and no symptoms on awakening. The daytime asthma symptom score was based on the daily e-diary recordings by participants with respect to shortness of breath, wheeze, cough, chest tightness, and impact on usual daily activities due to symptoms.	Up to Week 52
Change Form Baseline in Percentage of Days With no Daytime Symptoms Time Frame: Up to Week 52	All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. For days with no daytime symptoms, all 5 evening questions must have a score = 0 with respect to shortness of breath, wheeze, cough, chest tightness and impact on usual daily activities due to symptoms, each with scores from 0 (no problems) to 4 (very severe problems).	Up to Week 52
Change From Baseline in Percentage of Nights With no Night-time Awakenings Time Frame: Up to Week 52	All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for nights with no night-time awakenings was "How did you sleep last night?" had to be answered with "I did not wake up because of any breathing problems" with scores from 0 (no problem)-4 (very severe problems).	Up to Week 52
Change Form Baseline in Percentage of Mornings With no Symptoms on Awakening Time Frame: Up to Week 52	All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for mornings with no symptoms on awakening was "Did you have asthma symptoms upon awakening in the morning?" to be answered with "None" with scores from 0 (no problem)-4 (very severe problems).	Up to Week 52
Rescue Medication Usage Time Frame: Up to Weeks 26 and 52	All participants were given salbutamol/albuterol to use as rescue medication throughout the study along with e-Diary to record rescue medication use. The number of puffs of rescue medication during the past 12 hours is recorded twice (morning/evening) by the participant prior to taking study medication. The mean daily number of puffs of rescue medication use will be calculated for each participant, done separately for morning (night-time), evening (daytime), and daily (night-time plus daytime) rescue medication use	Up to Weeks 26 and 52
Time to First Asthma Exacerbation by Exacerbation Category Time Frame: Up to Week 52	The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.	Up to Week 52
Time to First Hospitalization for Asthma Exacerbation Time Frame: Up to Week 52	The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.	Up to Week 52
Annual Rate of Asthma Exacerbations by Exacerbation Category Time Frame: Up to Week 52	The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.	Up to Week 52
Time in Days to Permanent Discontinuation of Study Medication Due to Asthma Exacerbations Time Frame: Up to Week 52	The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.	Up to Week 52
Percentage of Participants Who Permanently Discontinued Study Medication Due to Asthma Exacerbations Time Frame: Up to Week 52		Up to Week 52
Total Amounts of Systemic Corticosteroids (in Doses) Used to Treat Asthma Exacerbations Time Frame: Up to Week 52	The treatment of asthma exacerbations including the initiation of systemic corticosteroids were done according to investigator's or treating physician's medical judgement and in line with national and international recommendations. If systemic corticosteroids were required, a participant could return to the study after successfully completing a taper of approximately 7-10 days.	Up to Week 52
Change From Baseline in Percentage of Rescue Medication Free Days Time Frame: Up to Weeks 26 and 52	All participants were given salbutamol/albuterol to use as rescue medication throughout the study along with e-Diary to record rescue medication use. Rescue medication free days is defined as any day where the participant did not use any puffs of rescue medication during daytime and night-time.	Up to Weeks 26 and 52
Asthma Quality of Life Questionnaire (AQLQ) Time Frame: Up to Week 52 (Day 364)	AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with a recall time of two weeks and each question to be answered on a 7-point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). It consists of 4 domains: Symptoms = Mean of Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30 (12 items) Activity limitation = Mean of Items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32 (11 items) Emotional function = Mean of Items 7, 13, 15, 21, 27 (5 items) Environmental stimuli = Mean of Items 9, 17, 23, 26 (4 items) Overall Score = Mean of Items 1 to 32 (32 items)	Up to Week 52 (Day 364)
Trough FEV1 Measured After 26 Weeks of Treatment Time Frame: Week 26	Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.	Week 26
Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) Time Frame: Approximately up to 56 weeks	An AE is any untoward medical occurrence (i.e., any unfavorable and unintended sign including abnormal laboratory findings, symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. An SAE is defined as any adverse event (appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s) or medical conditions(s) which meets any one of the following criteria: is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant, i.e. defined as an event that jeopardizes the participants or may require medical or surgical intervention.	Approximately up to 56 weeks

Collaborators and Investigators

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

Sponsor

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

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 (Actual)

December 29, 2015

Primary Completion (Actual)

November 21, 2018

Study Completion (Actual)

June 28, 2019

Study Registration Dates

First Submitted

September 9, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (Estimate)

September 18, 2015

Study Record Updates

Last Update Posted (Actual)

March 5, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

QMF149, Mometasone furoate (MF), asthma

Other Study ID Numbers

CQVM149B2301
2015-002529-21 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Asthma

Vanderbilt University Medical Center

Not yet recruiting

Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations

Asthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; Status

United States
University of California, San Francisco

Completed

User-Friendly Spirometer and Mobile App for Self-Management and Home Monitoring of Asthma Patients

Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic

United States
SingHealth Polyclinics

Not yet recruiting

Remote Patient Monitoring Solution for Chronic Respiratory Disease Management

Asthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
Johann Wolfgang Goethe University Hospital

Completed

Exercise Challenge in a Cold Chamber

Exercise-induced Asthma

Germany
Universita di Verona

Completed

Time-Effect of Montelukast Protection (TEMPE)

Asthma | Exercise-Induced Asthma

Italy
Parc de Salut Mar

Active, not recruiting

Asthma Research in Children and Adolescents (ARCA)

Asthma in Children | Persistent Asthma | Asthma Exacerbation

Spain
Forest Laboratories

Completed

Study of Oglemilast for the Prevention of Asthma.

Exercise-Induced Asthma

United States
Organon and Co

Completed

Exercise Induced Bronchoconstriction (0476-359)

Asthma, Exercise-induced
Brunel University
Karolinska Institutet

Unknown

Mediator Release During Exercise-induced Bronchoconstriction

Exercise Induced Asthma

United Kingdom
Johann Wolfgang Goethe University Hospital

Completed

Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation

Exercise-induced Asthma

Germany

Clinical Trials on Mometasone furoate

Teva Pharmaceuticals USA

Completed

Clinical Equivalence Study of Mometasone Nasal Spray, 50 Mcg/Actuation

Seasonal Allergic Rhinitis
Padagis LLC

Completed

Randomized Study to Compare the Bioavailability of Three Mometasone Furoate 0.1% Topical Lotions

Healthy
Eurofarma Laboratorios S.A.

Completed

A Clinical Trial About Treatment of Mild to Moderate Persistent Alergic Rhinnitis With Test or Reference Mometasone (PUMA)

Mild to Moderate Persistent Allergic Rhinitis

Brazil
Massachusetts General Hospital
Merck Sharp & Dohme LLC; Massachusetts Eye and Ear Infirmary

Terminated

An Open-label Study to Identify Molecular Markers of Steroid Resistance (MERK2)

Nasal Polyps

United States
Montefiore Medical Center

Withdrawn

Topical Steroids & Bacterial Decolonization for Radiation Dermatitis

Radiation Dermatitis

United States
University of Florida
GlaxoSmithKline; Food and Drug Administration (FDA)

Completed

Sensitivity of Pharmacokinetics to Differences in Particle Size Distribution of Suspension-based Nasal Sprays

Hypersensitivity

United States
GlaxoSmithKline

Completed

Long Term Safety Of GW685698X Via Nasal Biopsy

Rhinitis, Allergic, Perennial

Netherlands, Belgium
Novartis Pharmaceuticals

Completed

Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma

Asthma

Germany, Slovakia, Bulgaria, Canada, Poland, Korea, Republic of, Netherlands, Japan
Novartis Pharmaceuticals

Completed

Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma

Mild Asthma

Germany, India, Korea, Republic of, Poland, South Africa, Estonia, Italy, Russian Federation, Thailand, Latvia, Lithuania, Colombia, Hungary, Peru, Philippines, Slovakia, Bulgaria, Vietnam, Japan, Malaysia, Chile, Sweden
James J. Peters Veterans Affairs Medical Center
Kessler Institute for Rehabilitation

Unknown

Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury

Spinal Cord Injury

United States

A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Participants With Asthma

A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Patients With Asthma

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Asthma

Clinical Trials on Mometasone furoate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations