Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma
- Registration Number
- NCT01716754
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 471
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description QGE031 120 mg q2w QGE031 Participants received QGE031 120 mg s.c. q2w for 16 weeks. QGE031 240 mg every 2 weeks (q2w) QGE031 Participants received QGE031 240 mg subcutaneously (s.c.) q2w for 16 weeks. QGE031 240 mg q4w QGE031 Participants received QGE031 240 mg s.c. q4w for 16 weeks. QGE031 180 mg q2w QGE031 Participants received QGE031 180 mg s.c. q2w for 16 weeks. QGE031 36 mg q2w QGE031 Participants received QGE031 36 mg s.c. q2w for 16 weeks. QGE031 12 mg q2w QGE031 Participants received QGE031 12 mg s.c. q2w for 16 weeks. Omalizumab (as per locally approved dosing table) Omalizumab Participants received omalizumab as per locally approved dosing table s.c. q2w or q4w for 16 weeks. Placebo to QGE031 180 mg q2w Placebo Participants received QGE031 180 mg s.c. q2w for 16 weeks. Placebo to QGE031 120 mg q2w Placebo Participants received QGE031 120 mg s.c. q2w for 16 weeks. Placebo to QGE031 240 mg q2w Placebo Participants received matching placebo to QGE031 240 mg s.c. q2w for 16 weeks. Placebo to QGE031 240 mg q4w Placebo Participants received placebo to QGE031 240 mg s.c. q2w for 16 weeks. Placebo to QGE031 36 mg q2w Placebo Participants received QGE031 36 mg s.c. q2w for 16 weeks. Placebo to QGE031 12 mg q2w Placebo Participants received QGE031 12 mg s.c. q2w for 16 weeks. Placebo to omalizumab Placebo Participants received placebo to omalizumab s.c. q2w or q4w for 16 weeks.
- Primary Outcome Measures
Name Time Method Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo Week 16 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
Name Time Method Change From Baseline in ACQ-7 Score Baseline, Weeks 4, 8, 12, 16 and 28 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 Week 16 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 Baseline, Week 16, Week 28 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 Baseline, Week 16 Participants recorded their use of rescue medication into an electronic diary (eDiary). A negative change from baseline indicates improvement.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇬🇧Southampton, United Kingdom