Status:
COMPLETED
Inhaled Iloprost in Mild Asthma
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
Actelion
Conditions:
Asthma
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of the study is to determine if inhaled iloprost given four times daily can improve symptoms and lung function in adults with mild asthma.
Detailed Description
Animal studies have suggested that prostacyclin may downregulate allergic inflammation, thus providing the scientific basis for trials of inhaled prostacyclin agonists such as iloprost for the treatme...
Eligibility Criteria
Inclusion
- Age 18-60
- History of asthma controlled by inhaled rescue medication (albuterol, levalbuterol etc) and/or inhaled corticosteroids
- Ability to give informed consent
- Ability to perform pulmonary function tests
- Ability to tolerate the initial Ventavis inhalation
- Ability to comply with the study protocol
Exclusion
- Cigarette smoking
- Concomitant serious disease such as diabetes, hypertension, coronary heart disease, other lung disease, cancer (other than skin cancer)
- Pregnancy or lack of contraception (hormonal or barrier)
- Allergies or intolerance to inhaled iloprost
- Participation in other ongoing research studies
- Any psychological problem that the investigators believe might interfere with the conduct of the investigation.
- Cigarette smoking
- History of bleeding disorder, use of anticoagulants
- Viral upper respiratory tract infection within the last 6 weeks
- Table of upper limit for steroid use Beclomethasone dipropionate HFA-MDI 480 Budesonide DPI 1200 Flunisolide HFA-MDI 640 Fluticasone HFA-MDI 440 Fluticasone DPI 500 Mometasone DPI 440 Triamcinolone 1500 (Table adapted from EPR3, daily doses are in micrograms) Asthmatics requiring higher doses of inhaled corticosteroids than those given above, or using oral steroids, leukotriene modifiers, mast cell stabilizers, omalizumab, theophylline or long acting beta agonists will be excluded.
- .Any screening laboratory blood test value outside the normal range will exclude the individual from the study, though an isolated abnormal value could be retested at an interval of no less than a week.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01209533
Start Date
September 1 2010
End Date
July 1 2011
Last Update
August 3 2011
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37064