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Inhaled Iloprost in Mild Asthma

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ClinicalTrials.gov Identifier: NCT01209533
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : August 3, 2011
Sponsor:
Collaborator:
Actelion
Information provided by:
Vanderbilt University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Iloprost Early Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Inhaled Iloprost in Mild Asthma
Study Start Date : September 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Iloprost

Arms and Interventions
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Intervention Details:
  • Drug: Iloprost
    Inhaled iloprost 2.5 or 5 micrograms four times daily for 14 days
    Other Name: Ventavis

Outcome Measures
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Primary Outcome Measures :
  1. PD20FEV1 methacholine [ Time Frame: two weeks ]
    Provocative dose of methacholine resulting in a 20% fall in FEV1 from baseline


Secondary Outcome Measures :
  1. asthma related symptoms [ Time Frame: 4 weeks ]
    Asthma quality of life questionnaire; Juniper

  2. asthma control [ Time Frame: 4wks ]
    Juniper asthma control test score

  3. FEV1 [ Time Frame: 2wks ]
    Forced expiratory flow in one second

  4. Exhaled nitric oxide [ Time Frame: 2 wks ]
    Measurement of exhaled nitric oxide

  5. Interleukin 17 [ Time Frame: 2wks ]
    ELISA measurement of serum interleukin 17


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01209533


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37064
Sponsors and Collaborators
Vanderbilt University
Actelion
Investigators
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Principal Investigator: James Sheller, M.D. Vanderbilt University
More Information
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Responsible Party: J.R. Sheller, M.D., Vanderbilt University
ClinicalTrials.gov Identifier: NCT01209533    
Other Study ID Numbers: 100637
First Posted: September 27, 2010    Key Record Dates
Last Update Posted: August 3, 2011
Last Verified: August 2011
Keywords provided by Vanderbilt University:
Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents