Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide

• Sponsor: Duke University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02170519
• Collaborator: (none)
• Enrollment: 27
• Arms: 2
• Duration (Months): 28

Study Details

Study Description

Brief Summary

Acute secondary pulmonary hypertension (PH) often leads to dysfunction of the right ventricle (RV) and can be a significant cause of patient morbidity and mortality. Selective pulmonary vasodilation with inhaled nitric oxide (INO) has become the treatment of choice for this condition. The evidence supporting INO safety and efficacy under these circumstances is sparse, however, and is largely extrapolated from the use of INO in neonatal pulmonary hypertension. Moreover, the high cost and potential toxicity of INO makes the therapy far from ideal. Emerging evidence suggests that inhaled aerosolized prostacyclins such as iloprost may be a favorable alternative therapy.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Hypertension	Drug: Inhaled Iloprost	Phase 4

Detailed Description

Phase 1- In the original study, 3 doses of Iloprost were given. This was revised after 5 subjects were enrolled in order to study the effects of continuous delivery over a longer period of time.

Phase 2 - All remaining subjects received Iloprost as a continuous treatment.

The study was designed for an enrollment of 200 subjects and was ended early.

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phase 2: Inhaled Iloprost continuous Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.	Drug: Inhaled Iloprost; A 20 mcg dose of Iloprost will be given initially.; Other Names: Ventavis
Experimental: Phase 1: Inhaled Iloprost 3 doses Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.	Drug: Inhaled Iloprost; A 20 mcg dose of Iloprost will be given initially.; Other Names: Ventavis

Outcome Measures

Primary Outcome Measures

1. Percent Change in Oxygen Saturation (SpO2) From Baseline [30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours]

   Readings were taken from the medical record and the data may not have been present at the exact time frames.

2. Percent Change in Oxygen Saturation (SpO2) From Baseline [dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)]

3. Change in Mean Heart Rate From Baseline [30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours]

4. Change in Mean Heart Rate From Baseline [dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)]

5. Number of Treatment Failures [as long as subject was on drug up to approximately 24 hours]

   Treatment failure is defined as Central venous pressure (CVP) ≥ 20 mm Hg and any one of the following: Cardiac Index (CI) >/= 1.8 L/min/m2 Administration of >/=0.1 ug/kg/min Epinephrine or Norepinephrine MAP </= 50 mmHg (or as appropriate for age in pediatrics). SvO2</= 55% (or < 45% for patients with R to L intracardiac shunting and, thus, cyanosis at baseline.}

6. Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline [30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours]

7. Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline [dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)]

Secondary Outcome Measures

1. Change in Cardiac Output (CO) From Baseline [30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours]

2. Change in Cardiac Output (CO) From Baseline [dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)]

3. Change in Mean Venous Oxygen Saturation (SvO2) From Baseline [30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours]

   SvO2 represents an average of all the venous oxygen saturations of the various organs and tissues.

4. Change in Mean Venous Oxygen Saturation (SvO2) From Baseline [dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Clinical evidence of pulmonary hypertension (PH) requiring INO therapy as prescribed by the attending physician.

2. Indwelling arterial catheter.

3. Signed informed consent

Exclusion Criteria:

1. Clinically unstable circulatory condition requiring epinephrine > 0.1 mcg/kg/min or levophed, or already meeting treatment failure criteria (see section 5.3 below)

2. Known hypersensitivity to prostacyclin compounds

3. Patients receiving sildenafil or bosentan

4. Refusal by the attending physician

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Neil MacIntyre, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02170519
• Other Study ID Numbers: Pro00013737
• First Posted: Jun 23, 2014
• Last Update Posted: Aug 26, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by Duke University: pulmonary hypertension
• Additional relevant MeSH terms: Hypertension, Pulmonary; Hypertension; Iloprost

Study Results

Participant Flow

Arm/Group Title	Phase 2: Inhaled Iloprost Continuous	Phase 1: Inhaled Iloprost 3 Doses
Arm/Group Description	Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy. Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.	Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose. Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
Period Title: Overall Study
STARTED	22	5
COMPLETED	22	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Phase 2: Inhaled Iloprost Continuous	Phase 1: Inhaled Iloprost 3 Doses	Total
Arm/Group Description	Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy. Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.	Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose. Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.	Total of all reporting groups
Overall Participants	22	5	27
Age, Customized (participants) [Number]
>18 years	21 95.5%	5 100%	26 96.3%
<=18 years	1 4.5%	0 0%	1 3.7%
Sex: Female, Male (Count of Participants)
Female	14 63.6%	1 20%	15 55.6%
Male	8 36.4%	4 80%	12 44.4%
Region of Enrollment (participants) [Number]
United States	22 100%	5 100%	27 100%

Outcome Measures

1. Primary Outcome

Title	Percent Change in Oxygen Saturation (SpO2) From Baseline
Description	Readings were taken from the medical record and the data may not have been present at the exact time frames.
Time Frame	30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours

Outcome Measure Data

Analysis Population Description

Phase 2 subjects

Arm/Group Title	Phase 2: Inhaled Iloprost Continuous
Arm/Group Description	Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy. Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
Measure Participants	22
30 mins after initial dose	-0.4 (1.7)
2 hours	-0.8 (2.8)
4 hours	-1.2 (2.9)
6 hours	-0.2 (3.6)
8 hours	-0.7 (3.1)
10 hours	-0.9 (3.0)
12 hours	-0.9 (3.7)
18 hours	-1.5 (5.6)
24 hours	1.7 (6.4)

2. Primary Outcome

Title	Percent Change in Oxygen Saturation (SpO2) From Baseline
Time Frame	dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)

Outcome Measure Data

Analysis Population Description

Phase 1 subjects

Arm/Group Title	Phase 1: Inhaled Iloprost 3 Doses
Arm/Group Description	Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO). Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
Measure Participants	5
dose 1	-0.4 (0.6)
dose 2	-0.4 (1.6)
dose 3	0.0 (2.9)
combined therapy	0.2 (2.4)
end INO	0.4 (1.6)

3. Primary Outcome

Title	Change in Mean Heart Rate From Baseline
Time Frame	30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours

Outcome Measure Data

Analysis Population Description

Phase 2 subjects

Arm/Group Title	Phase 2: Inhaled Iloprost Continuous
Arm/Group Description	Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy. Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
Measure Participants	22
30 mins after initial dose	-1.8 (4.4)
2 hours	-1.1 (6.6)
4 hours	4.2 (18.7)
6 hours	0.8 (12.5)
8 hours	-1.0 (13.7)
10 hours	2.2 (14.3)
12 hours	-2.9 (12.0)
18 hours	-4.0 (12.6)
24 hours	-9.9 (16.1)

4. Primary Outcome

Title	Change in Mean Heart Rate From Baseline
Time Frame	dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)

Outcome Measure Data

Analysis Population Description

Phase 1 subjects

Arm/Group Title	Phase 1: Inhaled Iloprost 3 Doses
Arm/Group Description	Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO). Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
Measure Participants	5
dose 1	0.9 (4.8)
dose 2	2.5 (4.5)
dose 3	0.7 (6.7)
combined therapy	0.9 (7.8)
end INO	-0.2 (8.9)

5. Secondary Outcome

Title	Change in Cardiac Output (CO) From Baseline
Time Frame	30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours

Outcome Measure Data

Analysis Population Description

Phase 2 subjects: 4 subjects did not have a swan ganz catheter. 1 subject had a swan ganz catheter, but measurement was unattainable.

Arm/Group Title	Phase 2: Inhaled Iloprost Continuous
Arm/Group Description	Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy. Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
Measure Participants	17
30 mins after initial dose	16.2 (25.6)
2 hours	3.4 (20.5)
4 hours	21.2 (31.1)
6 hours	14.3 (43.1)
8 hours	12.5 (55.1)
10 hours	9.3 (43.3)
12 hours	8.9 (38.8)
18 hours	36.6 (68.9)
24 hours	4.4 (27.9)

6. Secondary Outcome

Title	Change in Cardiac Output (CO) From Baseline
Time Frame	dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)

Outcome Measure Data

Analysis Population Description

Phase 1 subjects

Arm/Group Title	Phase 1: Inhaled Iloprost 3 Doses
Arm/Group Description	Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO). Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
Measure Participants	5
dose 1	8.4 (33.7)
dose 2	-0.9 (36.3)
dose 3	8.7 (18.6)
combined therapy	2.5 (9.3)
end INO	-8.7 (20.9)

7. Primary Outcome

Title	Number of Treatment Failures
Description	Treatment failure is defined as Central venous pressure (CVP) ≥ 20 mm Hg and any one of the following: Cardiac Index (CI) >/= 1.8 L/min/m2 Administration of >/=0.1 ug/kg/min Epinephrine or Norepinephrine MAP </= 50 mmHg (or as appropriate for age in pediatrics). SvO2</= 55% (or < 45% for patients with R to L intracardiac shunting and, thus, cyanosis at baseline.}
Time Frame	as long as subject was on drug up to approximately 24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phase 2: Inhaled Iloprost Continuous	Phase 1: Inhaled Iloprost 3 Doses
Arm/Group Description	Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy. Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.	Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose. Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
Measure Participants	22	5
Number [participants]	0 0%	0 0%

8. Primary Outcome

Title	Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
Time Frame	30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours

Outcome Measure Data

Analysis Population Description

Phase 2 subjects: Measurement completed on subjects having a Swan Ganz catheter. 4 subjects did not have a swan ganz catheter.

Arm/Group Title	Phase 2: Inhaled Iloprost Continuous
Arm/Group Description	Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy. Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
Measure Participants	18
30 mins after initial dose	1.9 (9.6)
2 hours	-1.1 (19.1)
4 hours	3.1 (17.2)
6 hours	-1.9 (16.9)
8 hours	-3.2 (20.4)
10 hours	1.6 (12.7)
12 hours	1.3 (15.7)
18 hours	6.5 (17.1)
24 hours	7.0 (23.5)

9. Primary Outcome

Title	Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
Time Frame	dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)

Outcome Measure Data

Analysis Population Description

Phase 1 subjects

Arm/Group Title	Phase 1: Inhaled Iloprost 3 Doses
Arm/Group Description	Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO). Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
Measure Participants	5
dose 1	-0.9 (10)
dose 2	-6.5 (10.9)
dose 3	-10.2 (8.6)
combined therapy	-13.0 (9.6)
end INO	-9.3 (12.9)

10. Secondary Outcome

Title	Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
Description	SvO2 represents an average of all the venous oxygen saturations of the various organs and tissues.
Time Frame	30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours

Outcome Measure Data

Analysis Population Description

Phase 2 subjects: 4 subjects did not have a swan ganz catheter. 1 subject had a swan ganz catheter, but measurement was unattainable.

Arm/Group Title	Phase 2: Inhaled Iloprost Continuous
Arm/Group Description	Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy. Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
Measure Participants	17
30 mins after initial dose	1.5 (8.5)
2 hours	1.5 (9.6)
4 hours	1.3 (5.1)
6 hours	1.1 (7.4)
8 hours	1.4 (4.8)
10 hours	-3.4 (7.4)
12 hours	-1.6 (6.6)
18 hours	-0.5 (10.3)
24 hours	-3.0 (13.9)

11. Secondary Outcome

Title	Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
Time Frame	dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)

Outcome Measure Data

Analysis Population Description

Phase 1 subjects

Arm/Group Title	Phase 1: Inhaled Iloprost 3 Doses
Arm/Group Description	Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO). Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
Measure Participants	5
dose 1	-2.3 (2.3)
dose 2	-2.6 (5.5)
dose 3	-1.7 (7.5)
combined therapy	0.3 (6.0)
end INO	1.4 (2.0)

Adverse Events

Arm/Group Title	Phase 2: Inhaled Iloprost Continuous		Phase 1: Inhaled Iloprost 3 Doses
Arm/Group Description	Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy. Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.		Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose. Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
All Cause Mortality
	Phase 2: Inhaled Iloprost Continuous		Phase 1: Inhaled Iloprost 3 Doses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Phase 2: Inhaled Iloprost Continuous		Phase 1: Inhaled Iloprost 3 Doses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Phase 2: Inhaled Iloprost Continuous		Phase 1: Inhaled Iloprost 3 Doses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.