A randomised controlled trial of Dabigatran Etexilate on airway inflammation and coagulation in severe corticosteroid dependent asthma. - ARTDECO

Academisch Medisch Centrum0 个研究点目标入组 36 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•Age >= 18 years
•Non-smoking patients, or patients who stopped smoking more than 12 months ago and KCO >= 90% pred.
•Able to give written and dated informed consent prior to any study-specific procedures
•All patients have previous evidence of variable airways obstruction within the last 5 yrs, as documented by at least one of the following:
•*- Reversibility in forced expiratory volume in one second (FEV1) of >=9% predicted after 4 puffs of
•a 100 µg salbutamol dose-aerosol, administered via a spacer.
•*- A mean diurnal variation in peak expiratory flow (PEF) >=15% (highest PEF*lowest PEF) per
•mean PEF on >=4 days per week for a minimum of 2 weeks.
•*- An increase in FEV1 of >=400 mL after a course of prednisolone 0.5 mg•kg*1•day*1 for 14
•*- A provocative concentration causing a 20% fall in FEV1 with histamine or methacholine <8
•On stable doses of oral and inhaled corticosteroids during the previous 4 weeks and during the study.
•No other clinically significant abnormality on history and clinical examination
•Severe asthma according to the criteria of the International Consensus of the Innovative Medicine Initiative (IMI)
•High- and ultrahigh dose of ICS (Fluticasone >=1000 µg/day or equivalent drug) with continuous use of oral corticosteroids (>=5 mg/day).
•Sputum eosinophil count > 3% of the total cell count.

•Women who are pregnant or lactating or who have a positive urine pregnancy test at screening
•Ongoing use of tobacco products of any kind.
•Ex-smoking patients with reduced diffusion capacity: KCO < 90% pred.
•Use of omalizumab during the last 6 months before randomization
•Use of heparin, LMWH, NSAID or vitamin K antagonists.
•Any bleeding diathesis
•History of acute intracranial disease or haemorrhagic stroke
•Major surgery, trauma, uncontrolled hypertension, or myocardial infarction in the past 3 months
•Gastrointestinal or urogenital bleeding, or ulcer disease in the past 6 months
•Severe liver disease
•Alanine or aspartate aminotransferase concentrations greater than two times the upper limit of
•the normal range in the past month
•Severe renal insufficiency (creatinine clearance less than 30 mL/min)
•Active malignant disease
•Participation in any clinical investigational drug treatment protocol within the preceding 30 days
•Unwillingness or inability to comply with the study protocol for any other reason

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