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NCT01716754 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 471
- Enrollment target
NCT01716754: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01716754 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 471 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (254% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01716754, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 471 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG Omalizumab
- DRUG QGE031
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 471 participants |
| Start Date | 2012-12 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
What the finished NCT01716754 record still lists
NCT01716754 is an interventional study that assigns participants to a tested intervention. The registered 471 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (254% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01716754 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01716754 about?
NCT01716754 is a clinical study titled "Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma". 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...
What is the current status of trial NCT01716754?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 471 participants. The study started on 2012-12. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01716754?
The interventions under investigation include: Placebo (DRUG), Omalizumab (DRUG), QGE031 (DRUG).
Who is sponsoring clinical trial NCT01716754?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01716754's enrollment target sits among peer trials
471 78th of 2000 higher than 1,923 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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