Back to resultsA Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
QAW039
Placebo QAW039
Fluticasone 250 mcg
Fluticasone 100 mcg
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Written informed consent must be obtained before any assessment is performed
- Patients with a diagnosis of persistent asthma (according to Global Initiative for Asthma 2011) for a period of at least 6 months prior to screening
- Patients with a pre-bronchodilator Forced Expiratory Volume In One Second (FEV1) value of 40% to 80% of individual predicted value at screening and prior to treatment
- An Asthma Control Questionnaire score ≥ 1.5 prior to treatment
- Demonstration of reversible airway obstruction
Exclusion Criteria:
- Pregnant or nursing (lactating) women
- Acute illness other than asthma at the start of the study
- Patients with clinically significant laboratory abnormalities at screening
- Patients with clinically significant condition which may compromise subject safety or interfere with study evaluation
- Use of other investigational drugs at the time of enrollment
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
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- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Placebo Comparator
Experimental
Active Comparator
Placebo Comparator
Arm Label
QAW039 450 mg qd Non-atopic
Placebo Non-atopic
QAW039 450 mg qd Atopic
Fluticasone 150 mcg bid Atopic
Placebo Atopic
Arm Description
QAW039 450 mg (3 capsules of QAW039 150 mg) qd combined with background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1.
Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with background ICS (100 μg fluticasone, bid). Non-atopic randomized in ratio of approximately 1:1.
QAW039 450 mg (3 capsules of QAW039 150 mg) qd combined with background ICS (100 μg fluticasone, bid). Atopic patients randomized in a ratio of approximate 1:1:1
Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with 150 μg ICS and with background ICS (100 μg fluticasone, bid). As a consequence total ICS was 250 μg fluticasone bid. Atopic patients randomized in ratio of approximately 1:1:1
Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with background ICS (100 μg fluticasone, bid). Atopic patients andomized in ratio of approximately 1:1:1
Outcomes
Primary Outcome Measures
Change From Baseline in Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.
Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).
Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug.
Secondary Outcome Measures
Change From Baseline in Trough FEV1 (L) in Atopic Patients at Week 12 - Full Analysis Set
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the FEV1 measurement taken prior to the first dose of randomized study drug.
Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).
Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug.
Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the FEV1 measurement taken prior to the first dose of randomized study drug.
Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).
Estimates are from a mixed effects model with treatment, subject population, treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug.
Change From Baseline in ACQ-6 Score at Week 12 Non-atopic and Atopic Patients at Week 12 - Full Analysis Set
ACQ-6 consists of:5 items on symptoms, 1 item on rescue bronchodilator use, and 1 item on airway caliber (FEV1 % predicted). The ACQ was fully validated, including a minimal important difference (MID) or smallest change that could be considered clinically important (0.5). The ACQ was self-administered at the clinic and patients scored each item on a 7-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled.' Study staff scored question 7 based on % predicted FEV1 (ideally pre-bronchodilator). The total score=average of first 6 questions. Baseline=the ACQ-6 measurement taken prior to first dose of randomized study drug. The single missing score was interpolated by utilizing prior or subsequent completions of the questionnaire. Estimates were from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline ACQ-6 and region as fixed effects and center nested within region as random effects.
Change From Baseline in ACQ-6 Score at Week 12 Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set
ACQ-6 consists of:5 items on symptoms, 1 item on rescue bronchodilator use, and 1 item on airway caliber (FEV1 % predicted). The ACQ was fully validated, including a minimal important difference (MID) or smallest change that could be considered clinically important (0.5). The ACQ was self-administered at the clinic and patients scored each item on a 7-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled.' Study staff scored question 7 based on % predicted FEV1 (ideally pre-bronchodilator). The total score=average of first 6 questions. Baseline=the ACQ-6 measurement taken prior to first dose of randomized study drug. The single missing score was interpolated by utilizing prior or subsequent completions of the questionnaire. Estimates were from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline ACQ-6 and region as fixed effects and center nested within region as random effects.
Full Information
NCT ID
NCT01836471
First Posted
April 17, 2013
Last Updated
January 30, 2017
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01836471
Brief Title
A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients
Official Title
A Double-blind, Placebo-controlled, Study Examining the Effect of Orally Administered QAW039 (450 mg QD) on FEV1 and ACQ in Non-atopic, Asthmatic Patients With a Baseline, Pre-bronchodilator FEV1 of 40-80% Predicted, Inadequately Controlled With Low Dose ICS Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study was to assess the clinical effect of QAW039 in non-atopic asthmatics taking low dose Inhaled Corticosteroid (ICS) as background therapy.
Detailed Description
This was a multi-centre, randomised, placebo-controlled, double blind, 3-arm study designed to compare the efficacy and safety of a once daily dose of QAW039 with placebo in non-atopic and atopic asthmatics both inadequately controlled despite receiving a low dose ICS background therapy, over a 12 week treatment period. Efficacy and safety of a once daily dose of QAW039 was also compared with an increased dose of ICS in atopic asthmatics taking low dose ICS as background therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
345 (Actual)
8. Arms, Groups, and Interventions
Arm Title
QAW039 450 mg qd Non-atopic
Arm Type
Experimental
Arm Description
QAW039 450 mg (3 capsules of QAW039 150 mg) qd combined with background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1.
Arm Title
Placebo Non-atopic
Arm Type
Placebo Comparator
Arm Description
Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with background ICS (100 μg fluticasone, bid). Non-atopic randomized in ratio of approximately 1:1.
Arm Title
QAW039 450 mg qd Atopic
Arm Type
Experimental
Arm Description
QAW039 450 mg (3 capsules of QAW039 150 mg) qd combined with background ICS (100 μg fluticasone, bid). Atopic patients randomized in a ratio of approximate 1:1:1
Arm Title
Fluticasone 150 mcg bid Atopic
Arm Type
Active Comparator
Arm Description
Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with 150 μg ICS and with background ICS (100 μg fluticasone, bid). As a consequence total ICS was 250 μg fluticasone bid. Atopic patients randomized in ratio of approximately 1:1:1
Arm Title
Placebo Atopic
Arm Type
Placebo Comparator
Arm Description
Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with background ICS (100 μg fluticasone, bid). Atopic patients andomized in ratio of approximately 1:1:1
Intervention Type
Drug
Intervention Name(s)
QAW039
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo QAW039
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Fluticasone 250 mcg
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Fluticasone 100 mcg
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change From Baseline in Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set
Description
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.
Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).
Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug.
Time Frame
baseline,12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Trough FEV1 (L) in Atopic Patients at Week 12 - Full Analysis Set
Description
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the FEV1 measurement taken prior to the first dose of randomized study drug.
Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).
Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug.
Time Frame
baseline,12 weeks
Title
Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set
Description
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the FEV1 measurement taken prior to the first dose of randomized study drug.
Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).
Estimates are from a mixed effects model with treatment, subject population, treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug.
Time Frame
baseline,12 weeks
Title
Change From Baseline in ACQ-6 Score at Week 12 Non-atopic and Atopic Patients at Week 12 - Full Analysis Set
Description
ACQ-6 consists of:5 items on symptoms, 1 item on rescue bronchodilator use, and 1 item on airway caliber (FEV1 % predicted). The ACQ was fully validated, including a minimal important difference (MID) or smallest change that could be considered clinically important (0.5). The ACQ was self-administered at the clinic and patients scored each item on a 7-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled.' Study staff scored question 7 based on % predicted FEV1 (ideally pre-bronchodilator). The total score=average of first 6 questions. Baseline=the ACQ-6 measurement taken prior to first dose of randomized study drug. The single missing score was interpolated by utilizing prior or subsequent completions of the questionnaire. Estimates were from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline ACQ-6 and region as fixed effects and center nested within region as random effects.
Time Frame
baseline,12 weeks
Title
Change From Baseline in ACQ-6 Score at Week 12 Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set
Description
ACQ-6 consists of:5 items on symptoms, 1 item on rescue bronchodilator use, and 1 item on airway caliber (FEV1 % predicted). The ACQ was fully validated, including a minimal important difference (MID) or smallest change that could be considered clinically important (0.5). The ACQ was self-administered at the clinic and patients scored each item on a 7-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled.' Study staff scored question 7 based on % predicted FEV1 (ideally pre-bronchodilator). The total score=average of first 6 questions. Baseline=the ACQ-6 measurement taken prior to first dose of randomized study drug. The single missing score was interpolated by utilizing prior or subsequent completions of the questionnaire. Estimates were from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline ACQ-6 and region as fixed effects and center nested within region as random effects.
Time Frame
baseline,12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent must be obtained before any assessment is performed
Patients with a diagnosis of persistent asthma (according to Global Initiative for Asthma 2011) for a period of at least 6 months prior to screening
Patients with a pre-bronchodilator Forced Expiratory Volume In One Second (FEV1) value of 40% to 80% of individual predicted value at screening and prior to treatment
An Asthma Control Questionnaire score ≥ 1.5 prior to treatment
Demonstration of reversible airway obstruction
Exclusion Criteria:
Pregnant or nursing (lactating) women
Acute illness other than asthma at the start of the study
Patients with clinically significant laboratory abnormalities at screening
Patients with clinically significant condition which may compromise subject safety or interfere with study evaluation
Use of other investigational drugs at the time of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Kay
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Novartis Investigative Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Novartis Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Novartis Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Novartis Investigative Site
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Novartis Investigative Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Novartis Investigative Site
City
Palmdale
State/Province
California
ZIP/Postal Code
93551
Country
United States
Facility Name
Novartis Investigative Site
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Novartis Investigative Site
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Novartis Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Novartis Investigative Site
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Novartis Investigative Site
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
Novartis Investigative Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Novartis Investigative Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Novartis Investigative Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Novartis Investigative Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Novartis Investigative Site
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Novartis Investigative Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Novartis Investigative Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Novartis Investigative Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Novartis Investigative Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Novartis Investigative Site
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Novartis Investigative Site
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
Novartis Investigative Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Novartis Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Novartis Investigative Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504-8741
Country
United States
Facility Name
Novartis Investigative Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Novartis Investigative Site
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Novartis Investigative Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Novartis Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Novartis Investigative Site
City
Erpent
ZIP/Postal Code
5100
Country
Belgium
Facility Name
Novartis Investigative Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
Novartis Investigative Site
City
Bogotá
State/Province
Cundinamarca
Country
Colombia
Facility Name
Novartis Investigative Site
City
Barranquilla
Country
Colombia
Facility Name
Novartis Investigative Site
City
Medellín
Country
Colombia
Facility Name
Novartis Investigative Site
City
Hradec Kralove
State/Province
CZE
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Karlovy Vary-Stara Rokle
State/Province
CZE
ZIP/Postal Code
360 17
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Teplice
State/Province
CZE
ZIP/Postal Code
415 01
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Trutnov
ZIP/Postal Code
541 01
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10717
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04357
Country
Germany
Facility Name
Novartis Investigative Site
City
Lübeck
ZIP/Postal Code
23552
Country
Germany
Facility Name
Novartis Investigative Site
City
Marburg
ZIP/Postal Code
D-35037
Country
Germany
Facility Name
Novartis Investigative Site
City
Wiesbaden
ZIP/Postal Code
65187
Country
Germany
Facility Name
Novartis Investigative Site
City
Witten
ZIP/Postal Code
58452
Country
Germany
Facility Name
Novartis Investigative Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 068
Country
India
Facility Name
Novartis Investigative Site
City
Panjim
State/Province
Goa
ZIP/Postal Code
403 002
Country
India
Facility Name
Novartis Investigative Site
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
400 012
Country
India
Facility Name
Novartis Investigative Site
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440010
Country
India
Facility Name
Novartis Investigative Site
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641 045
Country
India
Facility Name
Novartis Investigative Site
City
Cheongju-si
State/Province
Chungcheongbuk-do
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Bucheon-Si
State/Province
Gyeonggi-Do
ZIP/Postal Code
14584
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Bialystok
ZIP/Postal Code
15-010
Country
Poland
Facility Name
Novartis Investigative Site
City
Bialystok
ZIP/Postal Code
15-044
Country
Poland
Facility Name
Novartis Investigative Site
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Novartis Investigative Site
City
Wroclaw
ZIP/Postal Code
50-349
Country
Poland
Facility Name
Novartis Investigative Site
City
Bucuresti
State/Province
District 1
ZIP/Postal Code
10457
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucharest
State/Province
District 3
ZIP/Postal Code
030303
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucharest
State/Province
District 3
ZIP/Postal Code
030317
Country
Romania
Facility Name
Novartis Investigative Site
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200515
Country
Romania
Facility Name
Novartis Investigative Site
City
Arad
ZIP/Postal Code
310013
Country
Romania
Facility Name
Novartis Investigative Site
City
Craiova
ZIP/Postal Code
200515
Country
Romania
Facility Name
Novartis Investigative Site
City
Deva
ZIP/Postal Code
330162
Country
Romania
Facility Name
Novartis Investigative Site
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Novartis Investigative Site
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Novartis Investigative Site
City
Cape Town
ZIP/Postal Code
7531
Country
South Africa
Facility Name
Novartis Investigative Site
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Novartis Investigative Site
City
Cape Town
ZIP/Postal Code
8001
Country
South Africa
Facility Name
Novartis Investigative Site
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Novartis Investigative Site
City
Gatesville
ZIP/Postal Code
7764
Country
South Africa
Facility Name
Novartis Investigative Site
City
Pretoria
ZIP/Postal Code
0181
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients
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