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Health Condition(s) or Problem
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Asthma
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Lay Summary
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This study is designed to investigate the efficacy and safety of QBX258 in subjects with
moderate to severe asthma.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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Who cannot enter the trial
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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What will happen
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Drug; QBX258; QBX258 intravenous infusion every 4 weeks for up to 4 doses total; QBX258 - Active; Drug; Placebo; Placebo to QBX258 intravenous infusion every 4 weeks up to 4 doses total; Placebo
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Primary aim
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Change in Asthma Control Questionnaire score
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Secondary Aim
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Change in Forced Expiratory Volume in one second (FEV1); Baseline and 26 weeks; No; Change in Asthma Quality of Life Questionnaire score; Baseline and 12 weeks; No; Morning and evening peak expiratory flow rate; Baseline and 26 weeks; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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London, Manchester
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