severe asthma Severe refractory asthma
Conditions
Interventions
Patients will be randomized to receive dabigatran etexilate (once daily 220 mg
orally) or identical placebo for 12 weeks.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 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 days. *- A provocative concentration causing a 20% fall in FEV1 with histamine or methacholine =1000 µg/day or equivalent drug) with continuous use of oral corticosteroids (>=5 mg/day). • Sputum eosinophil count > 3% of the total cell count.
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint will be the change from baseline in percentage of eosinophils in induced sputum as a marker of anti-inflammatory activity after 3 months treatment with dabigatran etexilate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will be changes from baseline in asthma control, lung function, exhaled nitric oxide, and changes in markers of hemostasis and inflammation in blood and induced sputum. | — |
Countries
Netherlands
Outcome results
None listed