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

Asthma Clinical Trial

Official title:

A 2-treatment Period, Randomized, Placebo-controlled, Multicenter Parallel-group Study to Assess the Safety of QAW039 When Added to Existing Asthma Therapy in GINA Steps 3, 4 and 5 Patients With Uncontrolled Asthma.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03052517
• Other study ID #: CQAW039A2315
• Secondary ID: 2016-001560-11
• Status: Terminated
• Phase: Phase 3
• Start date: March 21, 2017
• Est. completion date: March 16, 2020

Study information

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

Clinical Trial Summary

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

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

1. Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration of exposure, and

2. New patients who had not previously participated in a study of QAW039, permitting an increase in the number of patients with long-term exposure to QAW039.

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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2538
• Est. completion date: March 16, 2020
• Est. primary completion date: February 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

Patients completing a prior Phase 3 study of QAW039:

• Informed consent and assent (if applicable).

• Completion of the Treatment Period (on blinded study drug) of a prior Phase 3 study of QAW039.

• Patient is able to safely continue into the study as judged by the investigator.

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

• Written informed consent.

• A diagnosis of asthma,uncontrolled on GINA 3/4/5 asthma medication.

• Evidence of airway reversibility or airway hyper- reactivity.

• FEV1 of =85% of the predicted normal value.

• An ACQ score =1.5 prior to entering the study.

Exclusion Criteria:

Patients completing a prior phase 3 study of QAW039:

• Pregnant or nursing (lactating) women.

• Women of child-bearing potential unless they are using basic methods of contraception during dosing of study drug

• Patients who did not complete the Treatment Period on blinded study drug of the prior QAW039 study they participated in.

• Inability to comply with all study requirements.

• Patient who experienced a serious and drug-related AE in the prior QAW039 study they participated in.

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

• Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.

• Subjects who have participated in another trial of QAW039 (i.e.-the patient was randomized in another study).

• A QTcF (Fridericia) =450 msec (male) or =460 msec (female).

• History of malignancy with the exception of local basal cell carcinoma of the skin

• Pregnant or nursing (lactating) women.

• Serious co-morbidities.

• Patients on greater than 20 mg of simvastatin> 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin. Statin doses less than or equal to these doses as well as other statins will be permitted during the study.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• QAW039 150 mg
One tablet of QAW039 150 mg once daily
• QAW039 450 mg
One tablet of QAW039 450 mg once daily
• Placebo
One tablet of Placebo once daily

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Berazategui	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Lanus	Buenos Aires
Argentina	Novartis Investigative Site	Mar del Plata	Buenos Aires
Argentina	Novartis Investigative Site	Mendoza
Argentina	Novartis Investigative Site	Mendoza
Argentina	Novartis Investigative Site	Ranelagh, Partido De Berazate	Buenos Aires
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Salta
Argentina	Novartis Investigative Site	San Miguel de Tucuman	Tucuman
Argentina	Novartis Investigative Site	San Miguel de Tucuman	Tucuman
Argentina	Novartis Investigative Site	Santa Fe	Rosario
Argentina	Novartis Investigative Site	Santa Fe
Argentina	Novartis Investigative Site	Santa Rosa	La Pampa
Australia	Novartis Investigative Site	Clayton	Victoria
Australia	Novartis Investigative Site	Footscray	Victoria
Australia	Novartis Investigative Site	Melbourne	Victoria
Austria	Novartis Investigative Site	Feldkirch
Austria	Novartis Investigative Site	Vienna
Austria	Novartis Investigative Site	Wien
Belgium	Novartis Investigative Site	Aalst
Belgium	Novartis Investigative Site	Brussel
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Eghezee
Belgium	Novartis Investigative Site	Erpent
Belgium	Novartis Investigative Site	Herentals
Belgium	Novartis Investigative Site	Kortrijk
Belgium	Novartis Investigative Site	Liege
Brazil	Novartis Investigative Site	Blumenau	Santa Catarina
Brazil	Novartis Investigative Site	Goiania	GO
Brazil	Novartis Investigative Site	Porto Alegre	Porto Alegre RS
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Brazil	Novartis Investigative Site	Sao Bernardo do Campo	SP
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	Sorocaba	SP
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Ruse
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Stara Zagora
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Vancouver	British Columbia
Canada	Novartis Investigative Site	Vancouver
Canada	Novartis Investigative Site	Windsor	Ontario
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Chang Chun	Jilin
China	Novartis Investigative Site	Chengdu	Sichuan
China	Novartis Investigative Site	Chongqing
China	Novartis Investigative Site	Guang Zhou	Guang Dong Province
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shenyang	Liaoning
China	Novartis Investigative Site	Shenyang	Liaoning
China	Novartis Investigative Site	Shijiazhuang	Hebei
China	Novartis Investigative Site	Xian	Shanxi
Colombia	Novartis Investigative Site	Bogota
Colombia	Novartis Investigative Site	Bucaramanga
Colombia	Novartis Investigative Site	Ibague	Tolima
Czechia	Novartis Investigative Site	Brno
Czechia	Novartis Investigative Site	Jindrichuv Hradec	Czech Republic
Czechia	Novartis Investigative Site	Karlovy Vary
Czechia	Novartis Investigative Site	Mlada Boleslav
Czechia	Novartis Investigative Site	Teplice	Czech Republic
Czechia	Novartis Investigative Site	Teplice	CZE
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tartu
Finland	Novartis Investigative Site	Helsinki
France	Novartis Investigative Site	Dijon
France	Novartis Investigative Site	Le Kremlin Bicetre
France	Novartis Investigative Site	Lyon Cedex 04
France	Novartis Investigative Site	Marseille
France	Novartis Investigative Site	Montpellier cedex 5	Herault
France	Novartis Investigative Site	Nantes
France	Novartis Investigative Site	Paris cedex 18
France	Novartis Investigative Site	Strasbourg Cedex
Germany	Novartis Investigative Site	Aschaffenburg
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Cottbus	Sachsen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Landsberg
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Witten
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Thessaloniki	GR
Guatemala	Novartis Investigative Site	Gautemala City	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
Hungary	Novartis Investigative Site	Budaors	HUN
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Godollo
Hungary	Novartis Investigative Site	Gyor	HUN
Hungary	Novartis Investigative Site	Hajdunanas	HUN
Hungary	Novartis Investigative Site	Komarom
Hungary	Novartis Investigative Site	Mako
Hungary	Novartis Investigative Site	Pecs
Hungary	Novartis Investigative Site	Puspokladany	HUN
Hungary	Novartis Investigative Site	Siofok
Hungary	Novartis Investigative Site	Szazhalombatta	HUN
Hungary	Novartis Investigative Site	Szeged
Hungary	Novartis Investigative Site	Torokbalint
India	Novartis Investigative Site	Ahmedabad	Gujarat
India	Novartis Investigative Site	Bikaner	Rajasthan
India	Novartis Investigative Site	Coimbatore	Tamil Nadu
India	Novartis Investigative Site	DehraDun	Uttarakhand
India	Novartis Investigative Site	Jaipur	Rajasthan
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Pune	Maharashtra
India	Novartis Investigative Site	Vadodara	Gujarat
Israel	Novartis Investigative Site	Ashkelon
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Petach Tikva
Israel	Novartis Investigative Site	Rehovot
Japan	Novartis Investigative Site	Chikushino-city	Fukuoka
Japan	Novartis Investigative Site	Chuo ku	Tokyo
Japan	Novartis Investigative Site	Chuo ku	Tokyo
Japan	Novartis Investigative Site	Chuo-ku	Tokyo
Japan	Novartis Investigative Site	Chuo-ku	Tokyo
Japan	Novartis Investigative Site	Fukuoka city	Fukuoka
Japan	Novartis Investigative Site	Habikino city	Osaka
Japan	Novartis Investigative Site	Hamamatsu-city	Shizuoka
Japan	Novartis Investigative Site	Himeji-city	Hyogo
Japan	Novartis Investigative Site	Hiroshima-city	Hiroshima
Japan	Novartis Investigative Site	Iizuka-city	Fukuoka
Japan	Novartis Investigative Site	Itabashi-ku	Tokyo
Japan	Novartis Investigative Site	Kagoshima city	Kagoshima
Japan	Novartis Investigative Site	Kashihara city	Nara
Japan	Novartis Investigative Site	Kasuga-city	Fukuoka
Japan	Novartis Investigative Site	Kishiwada-city	Osaka
Japan	Novartis Investigative Site	Kiyose-city	Tokyo
Japan	Novartis Investigative Site	Koga city	Fukuoka
Japan	Novartis Investigative Site	Koshi-city	Kumamoto
Japan	Novartis Investigative Site	Matsusaka-city	Mie
Japan	Novartis Investigative Site	Matsuyama-city	Ehime
Japan	Novartis Investigative Site	Matsuyama-city	Ehime
Japan	Novartis Investigative Site	Mizunami-city	Gifu
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Naka-gun	Ibaraki
Japan	Novartis Investigative Site	Ota-ku	Tokyo
Japan	Novartis Investigative Site	Sagamihara-city	Kanagawa
Japan	Novartis Investigative Site	Sagamihara-city	Kanagawa
Japan	Novartis Investigative Site	Sakaide	Kagawa
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sendai-city	Miyagi
Japan	Novartis Investigative Site	Sendai-city	Miyagi
Japan	Novartis Investigative Site	Setagaya-Ku	Tokyo
Japan	Novartis Investigative Site	Setagaya-ku	Tokyo
Japan	Novartis Investigative Site	Shinagawa-ku	Tokyo
Japan	Novartis Investigative Site	Shinjuku ku	Tokyo
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Takamatsu-city	Kagawa
Japan	Novartis Investigative Site	Tokyo	Shibuya Ku
Japan	Novartis Investigative Site	Toshima ku	Tokyo
Japan	Novartis Investigative Site	Tsu-city	Mie
Japan	Novartis Investigative Site	Yanagawa-city	Fukuoka
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Japan	Novartis Investigative Site	Yokohama city	Kanagawa
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Latvia	Novartis Investigative Site	Daugavpils
Latvia	Novartis Investigative Site	Riga
Lebanon	Novartis Investigative Site	Ashrafieh
Lebanon	Novartis Investigative Site	Beirut
Lebanon	Novartis Investigative Site	El Chouf	LBN
Lithuania	Novartis Investigative Site	Kaunas	LTU
Lithuania	Novartis Investigative Site	Kaunas	LT
Lithuania	Novartis Investigative Site	Kaunas	LT
Lithuania	Novartis Investigative Site	Klaipeda
Lithuania	Novartis Investigative Site	Vilnius
Lithuania	Novartis Investigative Site	Vilnius	LTU
Malaysia	Novartis Investigative Site	Kota Bharu	Kelantan
Malaysia	Novartis Investigative Site	Kuantan	Pahang
Malaysia	Novartis Investigative Site	Taiping	Perak
Mexico	Novartis Investigative Site	Guadalajara	Jalisco
Mexico	Novartis Investigative Site	Guadalajara Jalisco	Jalisco
Mexico	Novartis Investigative Site	Rio De Janeiro
Netherlands	Novartis Investigative Site	Arnhem
Netherlands	Novartis Investigative Site	Leeuwarden
Peru	Novartis Investigative Site	Cercado De Lima	Lima
Peru	Novartis Investigative Site	Cusco
Peru	Novartis Investigative Site	Lima
Peru	Novartis Investigative Site	Piura
Peru	Novartis Investigative Site	San Isidro	Lima
Peru	Novartis Investigative Site	San Martin de Porres	Lima
Philippines	Novartis Investigative Site	Bulacan
Philippines	Novartis Investigative Site	Iloilo City
Philippines	Novartis Investigative Site	Lipa City	Batangas
Philippines	Novartis Investigative Site	Manila
Philippines	Novartis Investigative Site	Quezon City
Philippines	Novartis Investigative Site	Quezon City	Manila
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Kielce
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Strzelce Opolskie
Puerto Rico	Novartis Investigative Site	San Juan
Romania	Novartis Investigative Site	Bragadiru
Romania	Novartis Investigative Site	Brasov
Romania	Novartis Investigative Site	Brasov
Romania	Novartis Investigative Site	Brasov
Romania	Novartis Investigative Site	Brasov
Romania	Novartis Investigative Site	Bucharest	District 3
Romania	Novartis Investigative Site	Cluj Napoca
Romania	Novartis Investigative Site	Cluj-Napoca
Romania	Novartis Investigative Site	Constanta	ROM
Romania	Novartis Investigative Site	Deva
Romania	Novartis Investigative Site	Timisoara	Timis
Russian Federation	Novartis Investigative Site	Barnaul
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Izhevsk
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Nizhnii Novgorod
Russian Federation	Novartis Investigative Site	Penza
Russian Federation	Novartis Investigative Site	Perm
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	Sestroretsk
Russian Federation	Novartis Investigative Site	Smolensk
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	Stavropol
Russian Federation	Novartis Investigative Site	Yaroslavl
Russian Federation	Novartis Investigative Site	Yekaterinburg
Saudi Arabia	Novartis Investigative Site	Jeddah
Serbia	Novartis Investigative Site	Belgrade
Serbia	Novartis Investigative Site	Belgrade
Serbia	Novartis Investigative Site	Kragujevac
Serbia	Novartis Investigative Site	Nis
Serbia	Novartis Investigative Site	Sremska Kamenica
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Slovakia	Novartis Investigative Site	Bardejov	Slovak Republic
Slovakia	Novartis Investigative Site	Bojnice	Slovak Republic
Slovakia	Novartis Investigative Site	Kezmarok
Slovakia	Novartis Investigative Site	Komarno
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Levice
Slovakia	Novartis Investigative Site	Levice
Slovakia	Novartis Investigative Site	Poprad
Slovakia	Novartis Investigative Site	Presov
Slovakia	Novartis Investigative Site	Spisska Nova Ves
Slovakia	Novartis Investigative Site	Zilina
Spain	Novartis Investigative Site	Barcelona	Vic
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Girona
Spain	Novartis Investigative Site	Guadalajara
Spain	Novartis Investigative Site	Jerez	Cadiz
Spain	Novartis Investigative Site	Laredo	Cantabria
Spain	Novartis Investigative Site	Lugo	Galicia
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Marbella	Andalucia
Spain	Novartis Investigative Site	Palma de Mallorca	Islas Baleares
Spain	Novartis Investigative Site	Santiago de Compostela
Spain	Novartis Investigative Site	Zaragoza
Switzerland	Novartis Investigative Site	Liestal
Switzerland	Novartis Investigative Site	Lugano
Taiwan	Novartis Investigative Site	Taichung
Turkey	Novartis Investigative Site	Adana
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Bursa
Turkey	Novartis Investigative Site	Istanbul	TUR
Turkey	Novartis Investigative Site	Mersin
Turkey	Novartis Investigative Site	Yenisehir/Izmir
United Kingdom	Novartis Investigative Site	Bradford	West Yorkshire
United Kingdom	Novartis Investigative Site	Cambridge	Cambrigdeshire
United Kingdom	Novartis Investigative Site	Chertsey	Surrey
United Kingdom	Novartis Investigative Site	East Yorkshire
United Kingdom	Novartis Investigative Site	Leicester
United Kingdom	Novartis Investigative Site	Plymouth	Devon
United States	Novartis Investigative Site	Altoona	Pennsylvania
United States	Novartis Investigative Site	Asheville	North Carolina
United States	Novartis Investigative Site	Bangor	Maine
United States	Novartis Investigative Site	Bellevue	Nebraska
United States	Novartis Investigative Site	Bellingham	Washington
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Boerne	Texas
United States	Novartis Investigative Site	Bronx	New York
United States	Novartis Investigative Site	Colorado Springs	Colorado
United States	Novartis Investigative Site	Columbia	Maryland
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	East Providence	Rhode Island
United States	Novartis Investigative Site	Edmond	Oklahoma
United States	Novartis Investigative Site	Encinitas	California
United States	Novartis Investigative Site	Fort Worth	Texas
United States	Novartis Investigative Site	Gastonia	North Carolina
United States	Novartis Investigative Site	La Vista	Nebraska
United States	Novartis Investigative Site	Lafayette	Colorado
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Marietta	Georgia
United States	Novartis Investigative Site	McKinney	Texas
United States	Novartis Investigative Site	Medford	Oregon
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Missoula	Montana
United States	Novartis Investigative Site	Newport Beach	California
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Orange	California
United States	Novartis Investigative Site	Overland Park	Kansas
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Plano	Texas
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	Spokane	Washington
United States	Novartis Investigative Site	Stockton	California
United States	Novartis Investigative Site	Tamarac	Florida
United States	Novartis Investigative Site	Waldorf	Maryland
United States	Novartis Investigative Site	Walnut Creek	California
United States	Novartis Investigative Site	Westminster	California
United States	Novartis Investigative Site	Winter Park	Florida
United States	Novartis Investigative Site	Ypsilanti	Michigan
United States	Novartis Investigative Site	Zachary	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Colombia,  Czechia,  Estonia,  Finland,  France,  Germany,  Greece,  Guatemala,  Hungary,  India,  Israel,  Japan,  Latvia,  Lebanon,  Lithuania,  Malaysia,  Mexico,  Netherlands,  Peru,  Philippines,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Saudi Arabia,  Serbia,  Singapore,  Slovakia,  Spain,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model	Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs. For this Outcome Measure, AE up to week 52 are reported.	52 weeks
Primary	Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model	Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs	156 weeks
Primary	Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model	Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs. For this Outcome Measure, AE up to week 52 are reported.	52 weeks
Primary	Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 156 - Cox Regression Model	Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs.	156 weeks
Primary	Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 52 - Cox Regression Model	Adverse events leading to study treatment discontinuation starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs leading to study treatment discontinuation. For this Outcome Measure, AE up to week 52 are reported.	52 weeks
Primary	Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 156 - Cox Regression Model	Adverse events leading to study treatment discontinuation starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs leading to study treatment discontinuation	156 weeks
Secondary	Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model	The number of patients per patient year of follow-up having a treatment emergent adverse event, categorized by system organ class. Treatment emergent adverse events are defined as an AEs starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE)	52 weeks
Secondary	Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model	The number of patients per patient year of follow-up having a treatment emergent adverse event, categorized by system organ class. Treatment emergent adverse events are defined as an AEs starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE)	156 weeks
Secondary	Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 52	The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs.	52 weeks
Secondary	Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 156	The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs.	156 weeks
Secondary	Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 52	Number of treatment emergent severe asthma exacerbation episodes requiring hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours) per person year of follow-up. Treatment emergent severe asthma exacerbation episodes are defined as episodes occurring on or after the day of the first intake of study drug and until the day of last intake of study drug +7 days (30 days in the case of a serious AE).; Rate of exacerbations per person year = total number of exacerbations / total number of treatment years	52 weeks
Secondary	Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 156	Number of treatment emergent severe asthma exacerbation episodes requiring hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours) per person year of follow-up. Treatment emergent severe asthma exacerbation episodes are defined as episodes occurring on or after the day of the first intake of study drug and until the day of last intake of study drug +7 days (30 days in the case of a serious AE).; Rate of exacerbations per person year = total number of exacerbations / total number of treatment years	156 weeks