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Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
QGE031
Omalizumab
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, asthma control, allergy, atopic, IgE, double-blind, placebo, omalizumab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • A diagnosis of allergic asthma , uncontrolled on current medication.
  • History of at least 1 asthma exacerbation during the last 1 year
  • Forced Expiratory Volume in one second (FEV1) of ≥ 40% and ≤ 80% of the predicted normal value; reversibility following administration of bronchodilator must also be demonstrated (historical positive reversibility or bronchoprovocation result can be used).

Key Exclusion Criteria:

  • Baseline IgE levels or body weight outside the omalizumab dosing table.
  • Use of tobacco products within the previous 6 months (Social occasional smokers may be included).
  • Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.

Sites / Locations

  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

QGE031 240 mg every 2 weeks (q2w)

QGE031 240 mg q4w

QGE031 180 mg q2w

QGE031 120 mg q2w

QGE031 36 mg q2w

QGE031 12 mg q2w

Omalizumab (as per locally approved dosing table)

Placebo to QGE031 240 mg q2w

Placebo to QGE031 240 mg q4w

Placebo to QGE031 180 mg q2w

Placebo to QGE031 120 mg q2w

Placebo to QGE031 36 mg q2w

Placebo to QGE031 12 mg q2w

Placebo to omalizumab

Arm Description

Participants received QGE031 240 mg subcutaneously (s.c.) q2w for 16 weeks.

Participants received QGE031 240 mg s.c. q4w for 16 weeks.

Participants received QGE031 180 mg s.c. q2w for 16 weeks.

Participants received QGE031 120 mg s.c. q2w for 16 weeks.

Participants received QGE031 36 mg s.c. q2w for 16 weeks.

Participants received QGE031 12 mg s.c. q2w for 16 weeks.

Participants received omalizumab as per locally approved dosing table s.c. q2w or q4w for 16 weeks.

Participants received matching placebo to QGE031 240 mg s.c. q2w for 16 weeks.

Participants received placebo to QGE031 240 mg s.c. q2w for 16 weeks.

Participants received QGE031 180 mg s.c. q2w for 16 weeks.

Participants received QGE031 120 mg s.c. q2w for 16 weeks.

Participants received QGE031 36 mg s.c. q2w for 16 weeks.

Participants received QGE031 12 mg s.c. q2w for 16 weeks.

Participants received placebo to omalizumab s.c. q2w or q4w for 16 weeks.

Outcomes

Primary Outcome Measures

Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo
The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.

Secondary Outcome Measures

Change From Baseline in ACQ-7 Score
The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7. A negative change from baseline indicates improvement.
Percentage of Participants With a Change From Baseline in ACQ-7 Score Less Than -1.1
The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score
The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to participants with asthma. The 32 items in the AQLQ were divided into four domain-specific scores and a total score as follows: Activity limitations = Mean of Items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32 (11 items); Symptoms = Mean of Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30 (12 items); Emotional function = Mean of Items 7, 13, 15, 21, 27 (5 items); Environmental stimuli = Mean of Items 9, 17, 23, 26 (4 items); and Overall Score = Mean of Items 1 to 32 (32 items). Each item of the AQLQ was equally weighted and scored along a 7-point scale, where 1 indicates maximal impairment and 7 indicates no impairment. Thus, higher scores indicate better asthma-related quality of life. The mean overall score ranged from 1 to 7. A positive change from baseline indicates improvement.
Change From Baseline in Mean Number of Puffs of Morning, Evening and Total Daily Asthma Rescue Medication
Participants recorded their use of rescue medication into an electronic diary (eDiary). A negative change from baseline indicates improvement.

Full Information

First Posted
October 19, 2012
Last Updated
August 7, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01716754
Brief Title
Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma
Official Title
A Multi-center, Randomized, Double-blind, Placebo and Active-controlled Study With Exploratory Dose-ranging to Investigate the Efficacy and Safety of 16 Weeks Treatment With Subcutaneous (s.c.) QGE031 in Asthma Patients Not Adequately Controlled With High-dose Inhaled Corticosteroids and Long Acting β2-agonists
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 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
This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab. Information from this study was planned to support the design of future studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, asthma control, allergy, atopic, IgE, double-blind, placebo, omalizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
471 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QGE031 240 mg every 2 weeks (q2w)
Arm Type
Experimental
Arm Description
Participants received QGE031 240 mg subcutaneously (s.c.) q2w for 16 weeks.
Arm Title
QGE031 240 mg q4w
Arm Type
Experimental
Arm Description
Participants received QGE031 240 mg s.c. q4w for 16 weeks.
Arm Title
QGE031 180 mg q2w
Arm Type
Experimental
Arm Description
Participants received QGE031 180 mg s.c. q2w for 16 weeks.
Arm Title
QGE031 120 mg q2w
Arm Type
Experimental
Arm Description
Participants received QGE031 120 mg s.c. q2w for 16 weeks.
Arm Title
QGE031 36 mg q2w
Arm Type
Experimental
Arm Description
Participants received QGE031 36 mg s.c. q2w for 16 weeks.
Arm Title
QGE031 12 mg q2w
Arm Type
Experimental
Arm Description
Participants received QGE031 12 mg s.c. q2w for 16 weeks.
Arm Title
Omalizumab (as per locally approved dosing table)
Arm Type
Active Comparator
Arm Description
Participants received omalizumab as per locally approved dosing table s.c. q2w or q4w for 16 weeks.
Arm Title
Placebo to QGE031 240 mg q2w
Arm Type
Placebo Comparator
Arm Description
Participants received matching placebo to QGE031 240 mg s.c. q2w for 16 weeks.
Arm Title
Placebo to QGE031 240 mg q4w
Arm Type
Placebo Comparator
Arm Description
Participants received placebo to QGE031 240 mg s.c. q2w for 16 weeks.
Arm Title
Placebo to QGE031 180 mg q2w
Arm Type
Placebo Comparator
Arm Description
Participants received QGE031 180 mg s.c. q2w for 16 weeks.
Arm Title
Placebo to QGE031 120 mg q2w
Arm Type
Placebo Comparator
Arm Description
Participants received QGE031 120 mg s.c. q2w for 16 weeks.
Arm Title
Placebo to QGE031 36 mg q2w
Arm Type
Placebo Comparator
Arm Description
Participants received QGE031 36 mg s.c. q2w for 16 weeks.
Arm Title
Placebo to QGE031 12 mg q2w
Arm Type
Placebo Comparator
Arm Description
Participants received QGE031 12 mg s.c. q2w for 16 weeks.
Arm Title
Placebo to omalizumab
Arm Type
Placebo Comparator
Arm Description
Participants received placebo to omalizumab s.c. q2w or q4w for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
QGE031
Intervention Description
QGE031 was supplied as 120 mg liquid in vial per 1 mL
Intervention Type
Drug
Intervention Name(s)
Omalizumab
Other Intervention Name(s)
Xolair
Intervention Description
Omalizumab was supplied as 150 mg lyophilisate in vial
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL
Primary Outcome Measure Information:
Title
Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo
Description
The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Change From Baseline in ACQ-7 Score
Description
The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7. A negative change from baseline indicates improvement.
Time Frame
Baseline, Weeks 4, 8, 12, 16 and 28
Title
Percentage of Participants With a Change From Baseline in ACQ-7 Score Less Than -1.1
Description
The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.
Time Frame
Week 16
Title
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score
Description
The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to participants with asthma. The 32 items in the AQLQ were divided into four domain-specific scores and a total score as follows: Activity limitations = Mean of Items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32 (11 items); Symptoms = Mean of Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30 (12 items); Emotional function = Mean of Items 7, 13, 15, 21, 27 (5 items); Environmental stimuli = Mean of Items 9, 17, 23, 26 (4 items); and Overall Score = Mean of Items 1 to 32 (32 items). Each item of the AQLQ was equally weighted and scored along a 7-point scale, where 1 indicates maximal impairment and 7 indicates no impairment. Thus, higher scores indicate better asthma-related quality of life. The mean overall score ranged from 1 to 7. A positive change from baseline indicates improvement.
Time Frame
Baseline, Week 16, Week 28
Title
Change From Baseline in Mean Number of Puffs of Morning, Evening and Total Daily Asthma Rescue Medication
Description
Participants recorded their use of rescue medication into an electronic diary (eDiary). A negative change from baseline indicates improvement.
Time Frame
Baseline, Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: A diagnosis of allergic asthma , uncontrolled on current medication. History of at least 1 asthma exacerbation during the last 1 year Forced Expiratory Volume in one second (FEV1) of ≥ 40% and ≤ 80% of the predicted normal value; reversibility following administration of bronchodilator must also be demonstrated (historical positive reversibility or bronchoprovocation result can be used). Key Exclusion Criteria: Baseline IgE levels or body weight outside the omalizumab dosing table. Use of tobacco products within the previous 6 months (Social occasional smokers may be included). Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Novartis Investigative Site
City
Hawaiian Gardens
State/Province
California
ZIP/Postal Code
90716
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
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Novartis Investigative Site
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Novartis Investigative Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
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
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Novartis Investigative Site
City
Waldorf
State/Province
Maryland
ZIP/Postal Code
20602
Country
United States
Facility Name
Novartis Investigative Site
City
Novi
State/Province
Michigan
ZIP/Postal Code
48375
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
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
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
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
Novartis Investigative Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
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
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Novartis Investigative Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Novartis Investigative Site
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Novartis Investigative Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Novartis Investigative Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Facility Name
Novartis Investigative Site
City
Everett
State/Province
Washington
ZIP/Postal Code
98208
Country
United States
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1122AAK
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Novartis Investigative Site
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Capital Federal
ZIP/Postal Code
C1430CKE
Country
Argentina
Facility Name
Novartis Investigative Site
City
Santa Fe
State/Province
Rosario
ZIP/Postal Code
S2000DBS
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000AII
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000CXH
Country
Argentina
Facility Name
Novartis Investigative Site
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
B1842DID
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1125ABE
Country
Argentina
Facility Name
Novartis Investigative Site
City
Mendoza
ZIP/Postal Code
M5500CBA
Country
Argentina
Facility Name
Novartis Investigative Site
City
Mendoza
ZIP/Postal Code
M5500FIK
Country
Argentina
Facility Name
Novartis Investigative Site
City
Santa Fe
ZIP/Postal Code
S3000FIL
Country
Argentina
Facility Name
Novartis Investigative Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4G2
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1L5
Country
Canada
Facility Name
Novartis Investigative Site
City
St-Charles-Borromée
State/Province
Quebec
ZIP/Postal Code
J6E 2B4
Country
Canada
Facility Name
Novartis Investigative Site
City
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
Facility Name
Novartis Investigative Site
City
Brno
State/Province
Czech Republic
ZIP/Postal Code
639 00
Country
Czechia
Facility Name
Novartis Investigative Site
City
Trutnov
State/Province
Czech Republic
ZIP/Postal Code
541 01
Country
Czechia
Facility Name
Novartis Investigative Site
City
Teplice
State/Province
CZE
ZIP/Postal Code
415 01
Country
Czechia
Facility Name
Novartis Investigative Site
City
Breclav
ZIP/Postal Code
690 02
Country
Czechia
Facility Name
Novartis Investigative Site
City
Brno
ZIP/Postal Code
615 00
Country
Czechia
Facility Name
Novartis Investigative Site
City
Tabor
ZIP/Postal Code
390 01
Country
Czechia
Facility Name
Novartis Investigative Site
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Novartis Investigative Site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Novartis Investigative Site
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
Novartis Investigative Site
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Novartis Investigative Site
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
Novartis Investigative Site
City
Montpellier
ZIP/Postal Code
34059
Country
France
Facility Name
Novartis Investigative Site
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Novartis Investigative Site
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04275
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Novartis Investigative Site
City
Roth
ZIP/Postal Code
91154
Country
Germany
Facility Name
Novartis Investigative Site
City
Rüdersdorf
ZIP/Postal Code
15562
Country
Germany
Facility Name
Novartis Investigative Site
City
Guatemala City
State/Province
GTM
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Novartis Investigative Site
City
Guatemala City
State/Province
GTM
ZIP/Postal Code
01011
Country
Guatemala
Facility Name
Novartis Investigative Site
City
Guatemala City
ZIP/Postal Code
01011
Country
Guatemala
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Novartis Investigative Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Novartis Investigative Site
City
Pecs
ZIP/Postal Code
7635
Country
Hungary
Facility Name
Novartis Investigative Site
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Novartis Investigative Site
City
Panjim
State/Province
Goa
ZIP/Postal Code
403 002
Country
India
Facility Name
Novartis Investigative Site
City
Karamsad
State/Province
Gujrat
ZIP/Postal Code
388325
Country
India
Facility Name
Novartis Investigative Site
City
Dhantoli
State/Province
Nagpur
ZIP/Postal Code
12
Country
India
Facility Name
Novartis Investigative Site
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Novartis Investigative Site
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Novartis Investigative Site
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Novartis Investigative Site
City
Kfar-Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Novartis Investigative Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Novartis Investigative Site
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
Facility Name
Novartis Investigative Site
City
Messina
State/Province
ME
ZIP/Postal Code
98125
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20123
Country
Italy
Facility Name
Novartis Investigative Site
City
Padova
State/Province
PD
ZIP/Postal Code
35128
Country
Italy
Facility Name
Novartis Investigative Site
City
Pisa
State/Province
PI
ZIP/Postal Code
56124
Country
Italy
Facility Name
Novartis Investigative Site
City
Reggio Emilia
State/Province
RE
ZIP/Postal Code
42123
Country
Italy
Facility Name
Novartis Investigative Site
City
Verona
State/Province
VR
ZIP/Postal Code
37126
Country
Italy
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
16499
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
08308
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
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
México, D.F.
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Novartis Investigative Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44130
Country
Mexico
Facility Name
Novartis Investigative Site
City
Panama City
Country
Panama
Facility Name
Novartis Investigative Site
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Novartis Investigative Site
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Novartis Investigative Site
City
Coimbra
ZIP/Postal Code
3041-853
Country
Portugal
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1169-024
Country
Portugal
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1749-035
Country
Portugal
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4100-180
Country
Portugal
Facility Name
Novartis Investigative Site
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
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
Constanta
State/Province
Jud. Constanta
ZIP/Postal Code
900002
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucharest
State/Province
ROM
ZIP/Postal Code
12071
Country
Romania
Facility Name
Novartis Investigative Site
City
Brasov
ZIP/Postal Code
500086
Country
Romania
Facility Name
Novartis Investigative Site
City
Brasov
ZIP/Postal Code
500112
Country
Romania
Facility Name
Novartis Investigative Site
City
Brasov
ZIP/Postal Code
500281
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucuresti
ZIP/Postal Code
011461
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucuresti
ZIP/Postal Code
050159
Country
Romania
Facility Name
Novartis Investigative Site
City
Cluj Napoca
ZIP/Postal Code
400139
Country
Romania
Facility Name
Novartis Investigative Site
City
Cluj-Napoca
ZIP/Postal Code
400371
Country
Romania
Facility Name
Novartis Investigative Site
City
Pitesti
ZIP/Postal Code
110114
Country
Romania
Facility Name
Novartis Investigative Site
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Chelyabinsk
ZIP/Postal Code
454000
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Chelyabinsk
ZIP/Postal Code
454021
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
125315
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
127018
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
N.Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Nizhny Novgorod
ZIP/Postal Code
603018
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Penza
ZIP/Postal Code
440026
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St-Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Novartis Investigative Site
City
Bratislava
State/Province
Slovak Republic
ZIP/Postal Code
831 03
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Nitra
State/Province
Slovak Republic
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Kosice
ZIP/Postal Code
04001
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Prievidza
ZIP/Postal Code
97101
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Ruzomberok
ZIP/Postal Code
034 26
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Trencin
ZIP/Postal Code
91101
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Cape Town
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Novartis Investigative Site
City
Cape Town
ZIP/Postal Code
7531
Country
South Africa
Facility Name
Novartis Investigative Site
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Novartis Investigative Site
City
Aydin
ZIP/Postal Code
09100
Country
Turkey
Facility Name
Novartis Investigative Site
City
Fatih / Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Novartis Investigative Site
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Novartis Investigative Site
City
Istanbul
ZIP/Postal Code
34854
Country
Turkey
Facility Name
Novartis Investigative Site
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Novartis Investigative Site
City
Mersin
ZIP/Postal Code
33079
Country
Turkey
Facility Name
Novartis Investigative Site
City
Bradford
State/Province
West Yorkshire
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
East Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma

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