Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma
NCT ID: NCT01716754
Last Updated: 2017-08-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
471 participants
INTERVENTIONAL
2012-12-31
2016-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma
NCT02336425
A Study Evaluating the Efficacy of QGE031 Compared to Omalizumab in Patients With Allergic Asthma
NCT01703312
Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma
NCT00046748
Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma
NCT00870584
Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201
NCT02075008
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
QGE031 240 mg every 2 weeks (q2w)
Participants received QGE031 240 mg subcutaneously (s.c.) q2w for 16 weeks.
QGE031
QGE031 was supplied as 120 mg liquid in vial per 1 mL
QGE031 240 mg q4w
Participants received QGE031 240 mg s.c. q4w for 16 weeks.
QGE031
QGE031 was supplied as 120 mg liquid in vial per 1 mL
QGE031 180 mg q2w
Participants received QGE031 180 mg s.c. q2w for 16 weeks.
QGE031
QGE031 was supplied as 120 mg liquid in vial per 1 mL
QGE031 120 mg q2w
Participants received QGE031 120 mg s.c. q2w for 16 weeks.
QGE031
QGE031 was supplied as 120 mg liquid in vial per 1 mL
QGE031 36 mg q2w
Participants received QGE031 36 mg s.c. q2w for 16 weeks.
QGE031
QGE031 was supplied as 120 mg liquid in vial per 1 mL
QGE031 12 mg q2w
Participants received QGE031 12 mg s.c. q2w for 16 weeks.
QGE031
QGE031 was supplied as 120 mg liquid in vial per 1 mL
Omalizumab (as per locally approved dosing table)
Participants received omalizumab as per locally approved dosing table s.c. q2w or q4w for 16 weeks.
Omalizumab
Omalizumab was supplied as 150 mg lyophilisate in vial
Placebo to QGE031 240 mg q2w
Participants received matching placebo to QGE031 240 mg s.c. q2w for 16 weeks.
Placebo
Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL
Placebo to QGE031 240 mg q4w
Participants received placebo to QGE031 240 mg s.c. q2w for 16 weeks.
Placebo
Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL
Placebo to QGE031 180 mg q2w
Participants received QGE031 180 mg s.c. q2w for 16 weeks.
Placebo
Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL
Placebo to QGE031 120 mg q2w
Participants received QGE031 120 mg s.c. q2w for 16 weeks.
Placebo
Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL
Placebo to QGE031 36 mg q2w
Participants received QGE031 36 mg s.c. q2w for 16 weeks.
Placebo
Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL
Placebo to QGE031 12 mg q2w
Participants received QGE031 12 mg s.c. q2w for 16 weeks.
Placebo
Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL
Placebo to omalizumab
Participants received placebo to omalizumab s.c. q2w or q4w for 16 weeks.
Placebo
Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
QGE031
QGE031 was supplied as 120 mg liquid in vial per 1 mL
Omalizumab
Omalizumab was supplied as 150 mg lyophilisate in vial
Placebo
Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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).
Exclusion Criteria
* Use of tobacco products within the previous 6 months (Social occasional smokers may be included).
* Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Fresno, California, United States
Novartis Investigative Site
Hawaiian Gardens, California, United States
Novartis Investigative Site
Riverside, California, United States
Novartis Investigative Site
San Jose, California, United States
Novartis Investigative Site
Vista, California, United States
Novartis Investigative Site
Evansville, Indiana, United States
Novartis Investigative Site
Owensboro, Kentucky, United States
Novartis Investigative Site
Columbia, Maryland, United States
Novartis Investigative Site
Waldorf, Maryland, United States
Novartis Investigative Site
Novi, Michigan, United States
Novartis Investigative Site
Minneapolis, Minnesota, United States
Novartis Investigative Site
Omaha, Nebraska, United States
Novartis Investigative Site
Papillion, Nebraska, United States
Novartis Investigative Site
Brooklyn, New York, United States
Novartis Investigative Site
Mineola, New York, United States
Novartis Investigative Site
Cincinnati, Ohio, United States
Novartis Investigative Site
Lincoln, Rhode Island, United States
Novartis Investigative Site
Mt. Pleasant, South Carolina, United States
Novartis Investigative Site
Summerville, South Carolina, United States
Novartis Investigative Site
Salt Lake City, Utah, United States
Novartis Investigative Site
Fairfax, Virginia, United States
Novartis Investigative Site
Everett, Washington, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
Mar del Plata, Buenos Aires, Argentina
Novartis Investigative Site
CABA, Buenos Aires F.D., Argentina
Novartis Investigative Site
Santa Fe, Rosario, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, Argentina
Novartis Investigative Site
Buenos Aires, , Argentina
Novartis Investigative Site
Buenos Aires, , Argentina
Novartis Investigative Site
Mendoza, , Argentina
Novartis Investigative Site
Mendoza, , Argentina
Novartis Investigative Site
Santa Fe, , Argentina
Novartis Investigative Site
Ottawa, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Saint-Charles-Borromée, Quebec, Canada
Novartis Investigative Site
Québec, , Canada
Novartis Investigative Site
Brno, Czech Republic, Czechia
Novartis Investigative Site
Trutnov, Czech Republic, Czechia
Novartis Investigative Site
Teplice, CZE, Czechia
Novartis Investigative Site
Brno, , Czechia
Novartis Investigative Site
Břeclav, , Czechia
Novartis Investigative Site
Tábor, , Czechia
Novartis Investigative Site
Helsinki, , Finland
Novartis Investigative Site
Tampere, , Finland
Novartis Investigative Site
Turku, , Finland
Novartis Investigative Site
Le Kremlin-Bicêtre, , France
Novartis Investigative Site
Marseille, , France
Novartis Investigative Site
Montpellier, , France
Novartis Investigative Site
Strasbourg, , France
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Homburg, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Mainz, , Germany
Novartis Investigative Site
Roth, , Germany
Novartis Investigative Site
Rüdersdorf, , Germany
Novartis Investigative Site
Guatemala City, GTM, Guatemala
Novartis Investigative Site
Guatemala City, GTM, Guatemala
Novartis Investigative Site
Guatemala City, , Guatemala
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Debrecen, , Hungary
Novartis Investigative Site
Pécs, , Hungary
Novartis Investigative Site
Törökbálint, , Hungary
Novartis Investigative Site
Panjim, Goa, India
Novartis Investigative Site
Karamsad, Gujarat, India
Novartis Investigative Site
Dhantoli, Nagpur, India
Novartis Investigative Site
Haifa, , Israel
Novartis Investigative Site
Jerusalem, , Israel
Novartis Investigative Site
Jerusalem, , Israel
Novartis Investigative Site
Kfar Saba, , Israel
Novartis Investigative Site
Petah Tikva, , Israel
Novartis Investigative Site
Rehovot, , Israel
Novartis Investigative Site
Messina, ME, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Padua, PD, Italy
Novartis Investigative Site
Pisa, PI, Italy
Novartis Investigative Site
Reggio Emilia, RE, Italy
Novartis Investigative Site
Verona, VR, Italy
Novartis Investigative Site
Guadalajara, Jalisco, Mexico
Novartis Investigative Site
México, D.F., Mexico City, Mexico
Novartis Investigative Site
Panama City, , Panama
Novartis Investigative Site
Bialystok, , Poland
Novartis Investigative Site
Lodz, , Poland
Novartis Investigative Site
Coimbra, , Portugal
Novartis Investigative Site
Lisbon, , Portugal
Novartis Investigative Site
Lisbon, , Portugal
Novartis Investigative Site
Porto, , Portugal
Novartis Investigative Site
Vila Nova de Gaia, , Portugal
Novartis Investigative Site
Bucharest, District 1, Romania
Novartis Investigative Site
Bucharest, District 3, Romania
Novartis Investigative Site
Bucharest, District 3, Romania
Novartis Investigative Site
Constanța, Jud. Constanta, Romania
Novartis Investigative Site
Bucharest, ROM, Romania
Novartis Investigative Site
Brasov, , Romania
Novartis Investigative Site
Brasov, , Romania
Novartis Investigative Site
Brasov, , Romania
Novartis Investigative Site
Bucharest, , Romania
Novartis Investigative Site
Bucharest, , Romania
Novartis Investigative Site
Cluj-Napoca, , Romania
Novartis Investigative Site
Cluj-Napoca, , Romania
Novartis Investigative Site
Piteşti, , Romania
Novartis Investigative Site
Barnaul, , Russia
Novartis Investigative Site
Chelyabinsk, , Russia
Novartis Investigative Site
Chelyabinsk, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
N.Novgorod, , Russia
Novartis Investigative Site
Nizhny Novgorod, , Russia
Novartis Investigative Site
Penza, , Russia
Novartis Investigative Site
Ryazan, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saratov, , Russia
Novartis Investigative Site
Yaroslavl, , Russia
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Bratislava, Slovak Republic, Slovakia
Novartis Investigative Site
Nitra, Slovak Republic, Slovakia
Novartis Investigative Site
Bardejov, , Slovakia
Novartis Investigative Site
Bratislava, , Slovakia
Novartis Investigative Site
Košice, , Slovakia
Novartis Investigative Site
Prievidza, , Slovakia
Novartis Investigative Site
Ružomberok, , Slovakia
Novartis Investigative Site
Trenčín, , Slovakia
Novartis Investigative Site
Cape Town, , South Africa
Novartis Investigative Site
Cape Town, , South Africa
Novartis Investigative Site
Durban, , South Africa
Novartis Investigative Site
Bucheon-si, Gyeonggi-do, South Korea
Novartis Investigative Site
Suwon, Gyeonggi-do, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Cheongju-si, North Chungcheong, South Korea
Novartis Investigative Site
Gwangju, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Aydin, , Turkey (Türkiye)
Novartis Investigative Site
Fatih / Istanbul, , Turkey (Türkiye)
Novartis Investigative Site
Istanbul, , Turkey (Türkiye)
Novartis Investigative Site
Istanbul, , Turkey (Türkiye)
Novartis Investigative Site
Izmir, , Turkey (Türkiye)
Novartis Investigative Site
Mersin, , Turkey (Türkiye)
Novartis Investigative Site
Bradford, West Yorkshire, United Kingdom
Novartis Investigative Site
Birmingham, , United Kingdom
Novartis Investigative Site
East Yorkshire, , United Kingdom
Novartis Investigative Site
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-002298-69
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CQGE031B2201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.