Clinical trial of dabigatran on airway inflammation and coagulation in severe asthma.
Suspended
- Conditions
- asthmadabigatran etexilateairway inflammationblood coagulation
- Registration Number
- NL-OMON29666
- Lead Sponsor
- Academic Medical Centre, Department of Respiratory Medicine, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
1. Age ≥ 18 years;
2. Non-smoking patients, or patients who stopped smoking more than 12 months ago and smoked 10 pack years or less;
Exclusion Criteria
1. Women who are pregnant or lactating or who have a positive urine pregnancy test at screening;
2. Ongoing use of tobacco products of any kind or previous usage with a total pack year ≥ 10 years;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point will be: The change in sputum eosinophilia between baseline and after 12 weeks use of dabigatran etexilate.
- Secondary Outcome Measures
Name Time Method Secondary endpoints will be:<br /><br>1. Changes in markers of hemostasis and inflammation in blood, induced sputum and exhaled breath;<br /><br>2. Changes in spirometry and asthma control questionaire (ACQ).