Inhaled Iloprost in Mild Asthma

NCT01209533 | Completed Early Phase 1 DMC

• 1 other identifier: 100637
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

• PD20FEV1 methacholine

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

  two weeks

Secondary Outcomes (5)

• asthma related symptoms

  4 weeks

• asthma control

  4wks

• FEV1

  2wks

• Exhaled nitric oxide

  2 wks

• Interleukin 17

  2wks

Interventions

Iloprost DRUG

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

Also known as: Ventavis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• Actelion: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37064, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• James Sheller, M.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: September 27, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 3, 2011

Record last verified: 2011-08

Locations

US (1)