Phase 2
Completed N=471
Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma
Source: ClinicalTrials.gov NCT01716754 ↗Enrolled (actual)
471
Serious AEs
3.9%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo — 63.16; 70.21; 69.17 Percentage of participants — p=0.576
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo |
63.16; 70.21; 69.17 | 0.576 |
| SECONDARY Change From Baseline in ACQ-7 Score |
-0.51; -0.48; -0.60; -0.68; -0.62; -0.78 | — |
| SECONDARY Percentage of Participants With a Change From Baseline in ACQ-7 Score Less Than -1.1 |
40.35; 34.04; 36.67 | 0.483 |
| SECONDARY Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score |
0.53; 0.66; 0.79; 0.44; 0.63; 0.48 | — |
| SECONDARY Change From Baseline in Mean Number of Puffs of Morning, Evening and Total Daily Asthma Rescue Medication |
-0.28; -0.34; -0.39; -0.31; -0.33; -0.33 | 0.604 |
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.
Data sourced from ClinicalTrials.gov (NCT01716754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.