Inhaled Iloprost in Mild Asthma

This study has been completed.
Sponsor:
Collaborator:
Actelion
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01209533
First received: September 23, 2010
Last updated: August 1, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Asthma
Drug: Iloprost
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Inhaled Iloprost in Mild Asthma

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • PD20FEV1 methacholine [ Time Frame: two weeks ] [ Designated as safety issue: No ]
    Provocative dose of methacholine resulting in a 20% fall in FEV1 from baseline


Secondary Outcome Measures:
  • asthma related symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Asthma quality of life questionnaire; Juniper

  • asthma control [ Time Frame: 4wks ] [ Designated as safety issue: No ]
    Juniper asthma control test score

  • FEV1 [ Time Frame: 2wks ] [ Designated as safety issue: No ]
    Forced expiratory flow in one second

  • Exhaled nitric oxide [ Time Frame: 2 wks ] [ Designated as safety issue: No ]
    Measurement of exhaled nitric oxide

  • Interleukin 17 [ Time Frame: 2wks ] [ Designated as safety issue: No ]
    ELISA measurement of serum interleukin 17


Estimated Enrollment: 24
Study Start Date: September 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Iloprost
    Inhaled iloprost 2.5 or 5 micrograms four times daily for 14 days
    Other Name: Ventavis
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209533

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37064
Sponsors and Collaborators
Vanderbilt University
Actelion
Investigators
Principal Investigator: James Sheller, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: J.R. Sheller, M.D., Vanderbilt University
ClinicalTrials.gov Identifier: NCT01209533     History of Changes
Other Study ID Numbers: 100637
Study First Received: September 23, 2010
Last Updated: August 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Iloprost
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 16, 2014