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Completed

NCT Number: NCT01209533

Inhaled Iloprost in Mild Asthma

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37064, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

ILOPROST

Drug

Inhaled iloprost 2.5 or 5 micrograms four times daily for 14 days

Other names: Ventavis

Primary outcomes

  1. PD20FEV1 methacholine

    Time frame: two weeks

    Provocative dose of methacholine resulting in a 20% fall in FEV1 from baseline

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • Actelion

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 27, 2010
Registry last updated
Aug 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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