Asthma
Conditions
Keywords
Asthma
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 treatment of asthma. This study will examine the tolerability of four times daily iloprost on asthma symptoms and pulmonary function over a two week treatment period.
Interventions
DRUGIloprost
Inhaled iloprost 2.5 or 5 micrograms four times daily for 14 days
Sponsors
Actelion
Vanderbilt University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-60 2. History of asthma controlled by inhaled rescue medication (albuterol, levalbuterol etc) and/or inhaled corticosteroids 3. Ability to give informed consent 4. Ability to perform pulmonary function tests 5. Ability to tolerate the initial Ventavis inhalation 6. Ability to comply with the study protocol
Exclusion criteria
1. Cigarette smoking 2. Concomitant serious disease such as diabetes, hypertension, coronary heart disease, other lung disease, cancer (other than skin cancer) 3. Pregnancy or lack of contraception (hormonal or barrier) 4. Allergies or intolerance to inhaled iloprost 5. Participation in other ongoing research studies 6. Any psychological problem that the investigators believe might interfere with the conduct of the investigation. 7. Cigarette smoking 8. History of bleeding disorder, use of anticoagulants 9. Viral upper respiratory tract infection within the last 6 weeks 10. 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. 11. .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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PD20FEV1 methacholine | two weeks | Provocative dose of methacholine resulting in a 20% fall in FEV1 from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| asthma related symptoms | 4 weeks | Asthma quality of life questionnaire; Juniper |
| asthma control | 4wks | Juniper asthma control test score |
| FEV1 | 2wks | Forced expiratory flow in one second |
| Exhaled nitric oxide | 2 wks | Measurement of exhaled nitric oxide |
| Interleukin 17 | 2wks | ELISA measurement of serum interleukin 17 |
Countries
United States
Outcome results
None listed