A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma
- Registration Number
- NCT01479595
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study is designed to investigate the efficacy and safety of QBX258 in subjects with moderate to severe asthma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- Patients with atopic asthma >1 year duration diagnosed according to the GINA guidelines.
- Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 39 kg/m2.
- Asthma which is not adequately controlled on current treatment, as demonstrated by an Asthma Control Questionnaire (ACQ) score of > 1.5.
- FEV1 40 to 90% of predicted.
- Diagnosed with COPD as defined by the GOLD guidelines
- Subjects who have had a respiratory tract infection within 4 weeks prior to screening.
- Women of child-bearing potential must use highly effective methods of contraception during dosing and for at least 18 weeks after last study drug administration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description QBX258 QBX258 Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total. Placebo Placebo Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
- Primary Outcome Measures
Name Time Method Change From Baseline in Asthma Control Questionnaire (ACQ) Score Baseline and 12 weeks The ACQ consists of 7 questions assessing symptoms, rescue medication use and lung function. Except for lung function (FEV1), each question was scored on a 7-point scale where 0 = no impairment and 6 = maximum impairment. Scores ranged between 0 totally controlled to 6 (severely uncontrolled). Participants with a score below 1.0 are considered to have adequately controlled asthma. Participants with a score above 1.0 were considered not to be well controlled. A negative change from baseline indicates improvement.
- Secondary Outcome Measures
Name Time Method Change in Forced Expiratory Volume in One Second (FEV1) Baseline and 12 weeks FEV1 was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
Change in Asthma Quality of Life Questionnaire (AQLQ) Score Baseline and 12 weeks The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. It consists of 4 domains: symptoms, emotions., exposure to environmental stimuli and activity limitation.
Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The scale ranges from 1 to 7. The overall AQLQ score was the mean response to all 32 questions. Higher scores represent better outcomes.Morning and Evening Peak Expiratory Flow (PEF) Rate Baseline and 12 weeks Morning and evening PEFs were recorded on an electronic diary (e-diary). PEF was assessed twice daily approximately 12 hours apart and the measurements were recorded in the e-diary.
Change From Baseline in Maximum Expiratory Flow Baseline and 12 weeks Maximum expiratory flow was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
Number of Participants With Anti-QAX576 Antibodies or Anti-VAK694 Antibodies 12 weeks Anti-QAX576 and anti-VAK694 antibodies in serum were analyzed.
Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the QAX576 Analyte days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183 Blood samples were obtained to measure Cmax,ss.
Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the VAK694 Analyte days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183 Blood samples were obtained to measure Cmax,ss.
Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the QAX576 Analyte days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183 Blood samples were obtained to measure Cmin,ss.
Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the VAK694 Analyte days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183 Blood samples were obtained to measure Cmin,ss.
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) baseline, 12 weeks FeNO was assessed as a measure of airway inflammation. An FeNO machine was used to obtain the FeNO measurements. FeNO measurements were obtained prior to the spirometry assessments.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇬🇧Manchester, United Kingdom