A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

345

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

February 29, 2016

Study Completion Date

February 29, 2016

Conditions
Asthma
Interventions
DRUG

QAW039

QAW039 supplied as hard gelatin capsule in unit dose strength of 150 mg. Patient took 450 mg once daily (3 capsules taken with food in the morning) for the approximate period of the study (12 weeks)

DRUG

Placebo QAW039

Matching placebo for QAW039 supplied as hard gelatin capsule were identical in appearance to their active counterparts. Patients took 3 QAW039 matching placebo capsules once a day ( taken with food in the morning) for the approximate period of the study (12 weeks)

DRUG

Fluticasone 250 mcg

Fluticasone was supplied in inhalers with dose strength of 250 mcg. Patients took 250 mcg bid (morning and evening approximately 12 hours between doses) for a total dose of 500 mcg daily for the approximate period of the study (12 weeks).

DRUG

Fluticasone 100 mcg

Background therapy - fluticasone was supplied in inhalers with dose strength of 100 mcg. All patients in the study other than the Atopic Fluticasone 150 mcg arm were given the 100 mcg dose strength inhalers and took fluticasone 100 mcg bid (taken morning and evening with approximately 12 hours between doses) as background therapy for the approximate period of the study (12 weeks).

Trial Locations (76)

4000

Novartis Investigative Site, Liège

4001

Novartis Investigative Site, Durban

5100

Novartis Investigative Site, Erpent

7500

Novartis Investigative Site, Cape Town

7531

Novartis Investigative Site, Cape Town

7764

Novartis Investigative Site, Gatesville

7925

Novartis Investigative Site, Cape Town

8001

Novartis Investigative Site, Cape Town

10457

Novartis Investigative Site, Bucharest

10717

Novartis Investigative Site, Berlin

14584

Novartis Investigative Site, Bucheon-si

23552

Novartis Investigative Site, Lübeck

28207

Novartis Investigative Site, Charlotte

28644

Novartis Investigative Site, Cheongju-si

29407

Novartis Investigative Site, Charleston

34233

Novartis Investigative Site, Sarasota

42301

Novartis Investigative Site, Owensboro

45231

Novartis Investigative Site, Cincinnati

55402

Novartis Investigative Site, Minneapolis

58452

Novartis Investigative Site, Witten

60596

Novartis Investigative Site, Frankfurt

63128

Novartis Investigative Site, St Louis

63141

Novartis Investigative Site, St Louis

65187

Novartis Investigative Site, Wiesbaden

68046

Novartis Investigative Site, Papillion

80206

Novartis Investigative Site, Denver

80230

Novartis Investigative Site, Denver

80907

Novartis Investigative Site, Colorado Springs

90025

Novartis Investigative Site, Los Angeles

90048

Novartis Investigative Site, Los Angeles

90274

Novartis Investigative Site, Rolling Hills Estates

92024

Novartis Investigative Site, Encinitas

92123

Novartis Investigative Site, San Diego

92506

Novartis Investigative Site, Riverside

92647

Novartis Investigative Site, Huntington Beach

92691

Novartis Investigative Site, Mission Viejo

92868

Novartis Investigative Site, Orange

93551

Novartis Investigative Site, Palmdale

95117

Novartis Investigative Site, San Jose

95207

Novartis Investigative Site, Stockton

97213

Novartis Investigative Site, Portland

98104

Novartis Investigative Site, Seattle

200515

Novartis Investigative Site, Craiova

Novartis Investigative Site, Craiova

300736

Novartis Investigative Site, Timișoara

310013

Novartis Investigative Site, Arad

330162

Novartis Investigative Site, Deva

440010

Novartis Investigative Site, Nagpur

02747

Novartis Investigative Site, North Dartmouth

08558

Novartis Investigative Site, Skillman

97504-8741

Novartis Investigative Site, Medford

02865

Novartis Investigative Site, Lincoln

Unknown

Novartis Investigative Site, Barranquilla

Novartis Investigative Site, Bogotá

Novartis Investigative Site, Barranquilla

Novartis Investigative Site, Medellín

541 01

Novartis Investigative Site, Trutnov

500 05

Novartis Investigative Site, Hradec Králové

360 17

Novartis Investigative Site, Karlovy Vary-Stara Rokle

415 01

Novartis Investigative Site, Teplice

D-35037

Novartis Investigative Site, Marburg

04357

Novartis Investigative Site, Leipzig

500 068

Novartis Investigative Site, Hyderabad

403 002

Novartis Investigative Site, Panjim

400 012

Novartis Investigative Site, Nagpur

641 045

Novartis Investigative Site, Coimbatore

15-010

Novartis Investigative Site, Bialystok

15-044

Novartis Investigative Site, Bialystok

90-153

Novartis Investigative Site, Lodz

50-349

Novartis Investigative Site, Wroclaw

030303

Novartis Investigative Site, Bucharest

030317

Novartis Investigative Site, Bucharest

0181

Novartis Investigative Site, Pretoria

501-757

Novartis Investigative Site, Gwangju

443-721

Novartis Investigative Site, Suwon

06591

Novartis Investigative Site, Seoul

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY