A randomised, double-blind (sponsor unblinded), placebocontrolled, parallel-group, multicentre study to evaluate the efficacy and safety of GSK2269557 administered in addition to standard of care in adult subjects diagnosed with an acute exacerbation of Chronic Obstructive Pulmonary Disease (PII116678) - PII116678

GlaxoSmithKline0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•Between 40 and 80 years of age inclusive.
•Confirmed diagnosis of COPD (GOLD guidelines) for at least 6 months.
•Post-bronchodilator FEV1/FVC < 0.7 and FEV1 <= 80 % of predicted, documented in the last 5 years.
•Acute exacerbation of COPD requiring an escalation in therapy to include corticosteroid and antibiotics. See protocol page 23-24 for details.
•Smoker or an ex-smoker with a smoking history of at least 10 pack years.
•Body weight >=45 kg and BMI within the range 18 - 32 kg/m2 (inclusive).
•Adequate contraception for females of childbearing potential. See protocol page 25-26 for details.

•Severe COPD exacerbation. To avoid recruitment of subjects with a severe COPD exacerbation, the presence of any one of the following severity criteria will render the subject ineligible for inclusion in the study:
•- Need for invasive mechanical ventilation (short term (< 48h) NIV or CPAP is acceptable)
•- Haemodynamic instability or clinically significant heart failure
•- Confusion
•- Clinically significant pneumonia, identified by chest X-ray (if available) or on the CT scan performed during screening. See protocol page 28 for more details.
•ECG indicative of an acute cardiac event or demonstrating a clinically significant arrhythmia requiring treatment.
•QTc prolongation. See protocol page 27 for details.
•Chronic treatment with macrolides; long term oxygen therapy (>15 hours/day).
•Chronic treatment with anti-TNF, anti-IL1, or any other immunosuppressive therapy within 60 days prior to dosing.
•Exposure to more than 4 investigational medicinal products within 12 months prior to the first dosing day.
•Pregnancy or breastfeeding

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