Inhaled Iloprost in Mild Asthma

Asthma Clinical Trial

Official title:

Inhaled Iloprost in Mild Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209533
• Other study ID #: 100637
• Status: Completed
• Phase: Phase 0
• First received: September 23, 2010
• Last updated: August 1, 2011
• Start date: September 2010
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Iloprost
Inhaled iloprost 2.5 or 5 micrograms four times daily for 14 days

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Actelion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PD20FEV1 methacholine	Provocative dose of methacholine resulting in a 20% fall in FEV1 from baseline	two weeks	No
Secondary	asthma related symptoms	Asthma quality of life questionnaire; Juniper	4 weeks	No
Secondary	asthma control	Juniper asthma control test score	4wks	No
Secondary	FEV1	Forced expiratory flow in one second	2wks	No
Secondary	Exhaled nitric oxide	Measurement of exhaled nitric oxide	2 wks	No
Secondary	Interleukin 17	ELISA measurement of serum interleukin 17	2wks	No