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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554786
• Other study ID #: CQVM149B2301
• Secondary ID: 2015-002529-21
• Status: Completed
• Phase: Phase 3
• Start date: December 29, 2015
• Est. completion date: June 28, 2019

Study information

• Verified date: February 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2216
• Est. completion date: June 28, 2019
• Est. primary completion date: November 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Indacaterol acetate/Mometasone furoate

• Mometasone furoate

• Salmeterol xinafoate/fluticasone propionate

Locations

Country	Name	City	State
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Plovdiv
Bulgaria	Novartis Investigative Site	Plovdiv	BGR
Bulgaria	Novartis Investigative Site	Ruse
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Stara Zagora
Bulgaria	Novartis Investigative Site	Troyan
Bulgaria	Novartis Investigative Site	Varna	BGR
Bulgaria	Novartis Investigative Site	Vidin	BGR
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing	Beijing
China	Novartis Investigative Site	Beijing	Beijing
China	Novartis Investigative Site	Chang Chun	Jilin
China	Novartis Investigative Site	Changsha	Hunan
China	Novartis Investigative Site	Chengdu	Sichuan
China	Novartis Investigative Site	Chengdu
China	Novartis Investigative Site	Chongqing
China	Novartis Investigative Site	Fuzhou	Fujian
China	Novartis Investigative Site	Guang Zhou	Guangdong
China	Novartis Investigative Site	Guang Zhou
China	Novartis Investigative Site	Guangzhou
China	Novartis Investigative Site	Guangzhou
China	Novartis Investigative Site	Haikou	Hainan
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Nanchang
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Shanghai	Shanghai
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shenyang	Liaoning
China	Novartis Investigative Site	Shenyang	Liaoning
China	Novartis Investigative Site	Shenyang	Liaoning
China	Novartis Investigative Site	Shijiazhuang	Hebei
China	Novartis Investigative Site	Suzhou	Jiangsu
China	Novartis Investigative Site	Tianjin
China	Novartis Investigative Site	Wuhan	Hubei
China	Novartis Investigative Site	Xian	Shanxi
Croatia	Novartis Investigative Site	Petrinja
Croatia	Novartis Investigative Site	Rijeka
Croatia	Novartis Investigative Site	Varazdin	HRV
Croatia	Novartis Investigative Site	Zadar
Croatia	Novartis Investigative Site	Zagreb
Croatia	Novartis Investigative Site	Zagreb	HRV
Czechia	Novartis Investigative Site	Beroun	Czech Republic
Czechia	Novartis Investigative Site	Boskovice	Czech Republic
Czechia	Novartis Investigative Site	Breclav
Czechia	Novartis Investigative Site	Cesky Krumlov
Czechia	Novartis Investigative Site	Jablonec nad Nisou	Czech Republic
Czechia	Novartis Investigative Site	Jindrichuv Hradec	Czech Republic
Czechia	Novartis Investigative Site	Kurim	Czech Republic
Czechia	Novartis Investigative Site	Kutna Hora
Czechia	Novartis Investigative Site	Novy Bor
Czechia	Novartis Investigative Site	Ostrava	CZE
Czechia	Novartis Investigative Site	Plzen	CZE
Czechia	Novartis Investigative Site	Plzen
Czechia	Novartis Investigative Site	Praha	Czech Republic
Czechia	Novartis Investigative Site	Praha 8
Czechia	Novartis Investigative Site	Rokycany
Czechia	Novartis Investigative Site	Tabor
Czechia	Novartis Investigative Site	Teplice	CZE
Czechia	Novartis Investigative Site	Teplice	Czech Republic
Czechia	Novartis Investigative Site	Varnsdorf	Czech Republic
Egypt	Novartis Investigative Site	Alexandria
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tartu
Germany	Novartis Investigative Site	Ahlen
Germany	Novartis Investigative Site	Bamberg
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Boehlen
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Delitzsch
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dueren
Germany	Novartis Investigative Site	Düsseldorf
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Furstenwalde
Germany	Novartis Investigative Site	Halle
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hochstadt
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Koblenz	Rheinland-Pfalz
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Lubeck
Germany	Novartis Investigative Site	Ludwigsburg
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Mittweida
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Neu Isenburg
Germany	Novartis Investigative Site	Neuss
Germany	Novartis Investigative Site	Peine	Niedersachsen
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Rheine
Germany	Novartis Investigative Site	Rudersdorf
Germany	Novartis Investigative Site	Schleswig
Germany	Novartis Investigative Site	Schwedt
Germany	Novartis Investigative Site	Weinheim
Germany	Novartis Investigative Site	Witten
Guatemala	Novartis Investigative Site	Ciudad	Gautemala
Guatemala	Novartis Investigative Site	Guatemala City	GTM
Guatemala	Novartis Investigative Site	Guatemala City	GTM
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Guatemala City
Hungary	Novartis Investigative Site	Balassagyarmat
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest	HUN
Hungary	Novartis Investigative Site	Budapest	HUN
Hungary	Novartis Investigative Site	Budapest	HUN
Hungary	Novartis Investigative Site	Budapest	HUN
Hungary	Novartis Investigative Site	Cegled
Hungary	Novartis Investigative Site	Csorna
Hungary	Novartis Investigative Site	Dombovar
Hungary	Novartis Investigative Site	Godollo
Hungary	Novartis Investigative Site	Gyor	HUN
Hungary	Novartis Investigative Site	Hajdunanas	HUN
Hungary	Novartis Investigative Site	Hatvan
Hungary	Novartis Investigative Site	Komarom
Hungary	Novartis Investigative Site	Mako	HUN
Hungary	Novartis Investigative Site	Miskolc	HUN
Hungary	Novartis Investigative Site	Miskolc
Hungary	Novartis Investigative Site	Mosdos
Hungary	Novartis Investigative Site	Puspokladany	HUN
Hungary	Novartis Investigative Site	Szarvas
Hungary	Novartis Investigative Site	Szazhalombatta	HUN
Hungary	Novartis Investigative Site	Szeged
Hungary	Novartis Investigative Site	Szeged
Hungary	Novartis Investigative Site	Szigetvar
Hungary	Novartis Investigative Site	Szombathely
India	Novartis Investigative Site	Ahmedabad	Gujarat
India	Novartis Investigative Site	Ahmedabad	Gujarat
India	Novartis Investigative Site	Hyderabad	Telangana
India	Novartis Investigative Site	Jaipur	Rajasthan
India	Novartis Investigative Site	Jaipur	Rajasthan
India	Novartis Investigative Site	Jaipur	Rajasthan
India	Novartis Investigative Site	Jaipur	Rajasthan
India	Novartis Investigative Site	Kozhikode	Kerala
India	Novartis Investigative Site	Lucknow	Uttar Pradesh
India	Novartis Investigative Site	Mohali	Punjab
India	Novartis Investigative Site	Mumbai	Maharashtra
India	Novartis Investigative Site	Mysore	Karnataka
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	New Delhi	Delhi
India	Novartis Investigative Site	New Delhi
India	Novartis Investigative Site	Pune	Maharashtra
India	Novartis Investigative Site	Vadodara	Gujarat
Ireland	Novartis Investigative Site	County Limerick
Ireland	Novartis Investigative Site	Dublin
Ireland	Novartis Investigative Site	Wilton	Cork
Japan	Novartis Investigative Site	Atsugi-city	Kanagawa
Japan	Novartis Investigative Site	Chuo ku	Tokyo
Japan	Novartis Investigative Site	Chuou-ku	Tokyo
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Himeji-city	Hyogo
Japan	Novartis Investigative Site	Himeji-city	Hyogo
Japan	Novartis Investigative Site	Ichihara-city	Chiba
Japan	Novartis Investigative Site	Itabashi-ku	Tokyo
Japan	Novartis Investigative Site	Kasuga-city	Fukuoka
Japan	Novartis Investigative Site	Kawasaki-city	Kanagawa
Japan	Novartis Investigative Site	Kishiwada-city	Osaka
Japan	Novartis Investigative Site	Koshigaya-city	Saitama
Japan	Novartis Investigative Site	Naka-gun	Ibaraki
Japan	Novartis Investigative Site	Obihiro-city	Hokkaido
Japan	Novartis Investigative Site	Okayama-city	Okayama
Japan	Novartis Investigative Site	Osaka city	Osaka
Japan	Novartis Investigative Site	Sendai-city	Miyagi
Japan	Novartis Investigative Site	Setagaya-Ku	Tokyo
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Takatsuki-city	Osaka
Japan	Novartis Investigative Site	Tokyo	Shibuya Ku
Japan	Novartis Investigative Site	Toshima ku	Tokyo
Japan	Novartis Investigative Site	Toshima-ku	Tokyo
Japan	Novartis Investigative Site	Toyonaka-city	Osaka
Japan	Novartis Investigative Site	Yanagawa-city	Fukuoka
Japan	Novartis Investigative Site	Yao-city	Osaka
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Korea, Republic of	Novartis Investigative Site	Bucheon-Si	Gyeonggi-Do
Korea, Republic of	Novartis Investigative Site	Bundang Gu	Gyeonggi Do
Korea, Republic of	Novartis Investigative Site	Cheongju si	Chungcheongbuk Do
Korea, Republic of	Novartis Investigative Site	Incheon
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Seocho Gu
Korea, Republic of	Novartis Investigative Site	Wonju	Gangwon-do
Latvia	Novartis Investigative Site	Daugavpils
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Riga	LV
Lithuania	Novartis Investigative Site	Kaunas	LTU
Lithuania	Novartis Investigative Site	Kaunas
Lithuania	Novartis Investigative Site	Siauliai
Lithuania	Novartis Investigative Site	Utena
Lithuania	Novartis Investigative Site	Vilnius
Mexico	Novartis Investigative Site	Ciudad de Mexico	Distrito Federal
Mexico	Novartis Investigative Site	Mexicali	Baja California
Mexico	Novartis Investigative Site	Mexico	Distrito Federal
Mexico	Novartis Investigative Site	Mexico
Poland	Novartis Investigative Site	Aleksandrow Odzki
Poland	Novartis Investigative Site	Biaystok
Poland	Novartis Investigative Site	Bielsko-Biala
Poland	Novartis Investigative Site	Elblag
Poland	Novartis Investigative Site	Inowroclaw
Poland	Novartis Investigative Site	Katowice
Poland	Novartis Investigative Site	Krakow
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Lodz	POL
Poland	Novartis Investigative Site	Ostrow Wielkopolski
Poland	Novartis Investigative Site	Sopot
Poland	Novartis Investigative Site	Warsaw
Poland	Novartis Investigative Site	Wejherowo	POL
Poland	Novartis Investigative Site	Zawadzkie
Romania	Novartis Investigative Site	Arad
Romania	Novartis Investigative Site	Bacau
Romania	Novartis Investigative Site	Bragadiru
Romania	Novartis Investigative Site	Braila
Romania	Novartis Investigative Site	Brasov
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucharest	ROM
Romania	Novartis Investigative Site	Bucuresti
Romania	Novartis Investigative Site	Bucuresti
Romania	Novartis Investigative Site	Cluj Napoca
Romania	Novartis Investigative Site	Cluj Napoca
Romania	Novartis Investigative Site	Cluj-Napoca
Romania	Novartis Investigative Site	Codlea
Romania	Novartis Investigative Site	Constanta	Jud. Constanta
Romania	Novartis Investigative Site	Craiova	Jud.Dolj
Romania	Novartis Investigative Site	Craiova	ROM
Romania	Novartis Investigative Site	Craiova	ROM
Romania	Novartis Investigative Site	Craiova
Romania	Novartis Investigative Site	Deva	ROM
Romania	Novartis Investigative Site	Iasi	Jud Iasi
Romania	Novartis Investigative Site	Ramnicu Valcea
Romania	Novartis Investigative Site	Suceava
Romania	Novartis Investigative Site	Targu Mures
Romania	Novartis Investigative Site	Timisoara	ROM
Romania	Novartis Investigative Site	Timisoara	Timis
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Krasnoyarsk
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	N.Novgorod
Russian Federation	Novartis Investigative Site	Novosibirsk
Russian Federation	Novartis Investigative Site	Novosibirsk
Russian Federation	Novartis Investigative Site	Penza
Russian Federation	Novartis Investigative Site	Petrozavodsk
Russian Federation	Novartis Investigative Site	Pyatigorsk
Russian Federation	Novartis Investigative Site	Ryazan
Russian Federation	Novartis Investigative Site	Ryazan
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saint-Petersburg
Russian Federation	Novartis Investigative Site	Saratov
Russian Federation	Novartis Investigative Site	Saratov
Russian Federation	Novartis Investigative Site	Smolensk
Russian Federation	Novartis Investigative Site	Smolensk
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	St-Petersburg
Russian Federation	Novartis Investigative Site	St-Petersburg
Russian Federation	Novartis Investigative Site	St.Petersburg
Russian Federation	Novartis Investigative Site	Stavropol
Russian Federation	Novartis Investigative Site	Volgograd
Russian Federation	Novartis Investigative Site	Vologodonsk
Russian Federation	Novartis Investigative Site	Yaroslavl
Russian Federation	Novartis Investigative Site	Yaroslavl
Russian Federation	Novartis Investigative Site	Yaroslavl
Russian Federation	Novartis Investigative Site	Yaroslavl
Russian Federation	Novartis Investigative Site	Yekaterinburg
Serbia	Novartis Investigative Site	Belgrade
Serbia	Novartis Investigative Site	Beograd
Serbia	Novartis Investigative Site	Kragujevac
Serbia	Novartis Investigative Site	Nis
Serbia	Novartis Investigative Site	Sremska Kamenica
Slovakia	Novartis Investigative Site	Bardejov	Slovak Republic
Slovakia	Novartis Investigative Site	Bardejov
Slovakia	Novartis Investigative Site	Bojnice	Slovak Republic
Slovakia	Novartis Investigative Site	Bratislava	Slovak Republic
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Cadca
Slovakia	Novartis Investigative Site	Humenne	Slovak Republic
Slovakia	Novartis Investigative Site	Ilava
Slovakia	Novartis Investigative Site	Komarno
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Kosice	Slovak Republic
Slovakia	Novartis Investigative Site	Kralovsky Chlmec
Slovakia	Novartis Investigative Site	Levice
Slovakia	Novartis Investigative Site	Liptovsky Mikulas
Slovakia	Novartis Investigative Site	Námestovo	Slovensko
Slovakia	Novartis Investigative Site	Nitra	Slovak Republic
Slovakia	Novartis Investigative Site	Poprad	SVK
Slovakia	Novartis Investigative Site	Presov
Slovakia	Novartis Investigative Site	Prievidza
Slovakia	Novartis Investigative Site	Skalica	Slovak Republic
Slovakia	Novartis Investigative Site	Spisska Nova Ves	Slovak Republic
Slovakia	Novartis Investigative Site	Stropkov	Slovak Republic
Slovakia	Novartis Investigative Site	Surany	Slovak Republic
Slovakia	Novartis Investigative Site	Topolcany
Slovakia	Novartis Investigative Site	Velky Meder	Slovak Republic
Slovakia	Novartis Investigative Site	Zilina
Slovakia	Novartis Investigative Site	Zilina
South Africa	Novartis Investigative Site	Belleville
South Africa	Novartis Investigative Site	Berea	Durban
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Panorama	Western Cape
United Kingdom	Novartis Investigative Site	Blackpool
United Kingdom	Novartis Investigative Site	Bristol	South Gloucestershire
United Kingdom	Novartis Investigative Site	Denbighshire
United Kingdom	Novartis Investigative Site	Faringdon	Oxfordshire
United Kingdom	Novartis Investigative Site	Fowey	Cornwall
United Kingdom	Novartis Investigative Site	Glasgow
United Kingdom	Novartis Investigative Site	Liskeard	Cornwall
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Rotherham
United Kingdom	Novartis Investigative Site	Torpoint	Cornwall
United Kingdom	Novartis Investigative Site	Wiltshire
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Bellevue	Nebraska
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Boerne	Texas
United States	Novartis Investigative Site	Cortland	New York
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	El Paso	Texas
United States	Novartis Investigative Site	Greenfield	Wisconsin
United States	Novartis Investigative Site	Las Vegas	Nevada
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Medford	Oregon
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	North Charleston	South Carolina
United States	Novartis Investigative Site	North Dartmouth	Massachusetts
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Orange	California
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Riverside	California
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	San Jose	California
United States	Novartis Investigative Site	Skillman	New Jersey
United States	Novartis Investigative Site	Stockton	California
United States	Novartis Investigative Site	Tallahassee	Florida
United States	Novartis Investigative Site	Tulsa	Oklahoma
United States	Novartis Investigative Site	Waldorf	Maryland
United States	Novartis Investigative Site	Westminster	California
United States	Novartis Investigative Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Bulgaria,  China,  Croatia,  Czechia,  Egypt,  Estonia,  Germany,  Guatemala,  Hungary,  India,  Ireland,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough Forced Expiratory Volume in One Second (Trough FEV1) at 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.	26 weeks
Secondary	Asthma Control Questionnaire (ACQ-7) at 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
Secondary	Trough FEV1 at 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
Secondary	Pre-dose FEV1 at Weeks 4 and 12	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)
Secondary	Post Dose FEV1 (5 Minutes-1 Hour)	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)
Secondary	Trough Forced Vital Capacity (FVC)	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)
Secondary	Trough Forced Expiratory Flow (FEF)Between 25% and 75% of FVC (FEF25-75)	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)
Secondary	Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment	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
Secondary	Percentage of Participants Achieving the Minimal Important Difference (MID) ACQ = 0.5 at Weeks 26 and 52	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)
Secondary	Change From Baseline in Percentage of Asthma Symptoms Free Days	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
Secondary	Change Form Baseline in Percentage of Days With no Daytime Symptoms	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
Secondary	Change From Baseline in Percentage of Nights With no Night-time Awakenings	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
Secondary	Change Form Baseline in Percentage of Mornings With no Symptoms on Awakening	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
Secondary	Rescue Medication Usage	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
Secondary	Time to First Asthma Exacerbation by Exacerbation Category	The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.	Up to Week 52
Secondary	Time to First Hospitalization for Asthma Exacerbation	The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.	Up to Week 52
Secondary	Annual Rate of Asthma Exacerbations by Exacerbation Category	The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.	Up to Week 52
Secondary	Duration in Days of Asthma Exacerbations by Exacerbation Category	The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.	Up to Week 52
Secondary	Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category	The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.	Up to Week 52
Secondary	Time in Days to Permanent Discontinuation of Study Medication Due to Asthma Exacerbations	The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.	Up to Week 52
Secondary	Percentage of Participants Who Permanently Discontinued Study Medication Due to Asthma Exacerbations		Up to Week 52
Secondary	Total Amounts of Systemic Corticosteroids (in Doses) Used to Treat Asthma Exacerbations	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
Secondary	Change From Baseline in Percentage of Rescue Medication Free Days	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
Secondary	Asthma Quality of Life Questionnaire (AQLQ)	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)
Secondary	Trough FEV1 Measured After 26 Weeks of Treatment	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
Secondary	Percentage of Participants With Composite Endpoint of Serious Asthma Outcomes	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
Secondary	Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)	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