Inhaled Iloprost in Mild Asthma

August 1, 2011 updated by: Vanderbilt University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37064
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PD20FEV1 methacholine
Time Frame: two weeks
Provocative dose of methacholine resulting in a 20% fall in FEV1 from baseline
two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
asthma related symptoms
Time Frame: 4 weeks
Asthma quality of life questionnaire; Juniper
4 weeks
asthma control
Time Frame: 4wks
Juniper asthma control test score
4wks
FEV1
Time Frame: 2wks
Forced expiratory flow in one second
2wks
Exhaled nitric oxide
Time Frame: 2 wks
Measurement of exhaled nitric oxide
2 wks
Interleukin 17
Time Frame: 2wks
ELISA measurement of serum interleukin 17
2wks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

Actelion

Investigators

  • Principal Investigator: James Sheller, M.D., Vanderbilt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

September 23, 2010

First Submitted That Met QC Criteria

September 23, 2010

First Posted (Estimate)

September 27, 2010

Study Record Updates

Last Update Posted (Estimate)

August 3, 2011

Last Update Submitted That Met QC Criteria

August 1, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100637

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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