Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Asthma
In brief
This study planned to assess the effect on the reduction in rate of severe asthma exacerbations of different dose levels of QGE031 in asthma patients that are inadequately controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid. However, this study was terminated due to the efficacy results from an interim analysis (at the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). Planned data analyses were not performed for this study due to the early termination and the very limited dataset (only 10 participants received study medication of the 440 participants planned).
Key facts
- Study ID
- NCT02336425
- Run by
- Novartis Pharmaceuticals
- People needed
- 10
- Starts
- 2015-09-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2017-08-11
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Novartis Investigative Site — Birmingham, Alabama, United States
- Novartis Investigative Site — Kingwood, Texas, United States
- Novartis Investigative Site — Plano, Texas, United States
- Novartis Investigative Site — Erpent, Belgium
- Novartis Investigative Site — Toronto, Ontario, Canada
- Novartis Investigative Site — Trois-Rivières, Quebec, Canada
- Novartis Investigative Site — Le Kremlin-Bicêtre, France
- Novartis Investigative Site — Cottbus, Saxony, Germany
- Novartis Investigative Site — Berlin, Germany
- Novartis Investigative Site — Frankfurt, Germany
- Novartis Investigative Site — Hamburg, Germany
- Novartis Investigative Site — Leipzig, Germany
- Novartis Investigative Site — Marburg, Germany
- Novartis Investigative Site — Münster, Germany
- Novartis Investigative Site — Miskolc, HUN, Hungary
- Novartis Investigative Site — Balassagyarmat, Hungary
- Novartis Investigative Site — Pisa, PI, Italy
- Novartis Investigative Site — Sapporo, Hokkaido, Japan
- Novartis Investigative Site — Sakaidechō, Kagawa-ken, Japan
- Novartis Investigative Site — Sagamihara, Kanagawa, Japan
- Novartis Investigative Site — Yokohama, Kanagawa, Japan
- Novartis Investigative Site — Yokohama, Kanagawa, Japan
- Novartis Investigative Site — Habikino, Osaka, Japan
- Novartis Investigative Site — Kishiwada, Osaka, Japan
- Novartis Investigative Site — Chuo-ku, Tokyo, Japan
Full record on ClinicalTrials.gov
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