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Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide

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ClinicalTrials.gov Identifier: NCT02170519
Recruitment Status : Terminated (Project was completed)
First Posted : June 23, 2014
Results First Posted : August 26, 2014
Last Update Posted : August 26, 2014
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pulmonary Hypertension
Intervention Drug: Inhaled Iloprost
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase 2: Inhaled Iloprost Continuous Phase 1: Inhaled Iloprost 3 Doses
Hide 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
Arm/Group Title Phase 2: Inhaled Iloprost Continuous Phase 1: Inhaled Iloprost 3 Doses Total
Hide 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 Number of Baseline Participants 22 5 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 5 participants 27 participants
>18 years 21 5 26
<=18 years 1 0 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 5 participants 27 participants
Female
14
  63.6%
1
  20.0%
15
  55.6%
Male
8
  36.4%
4
  80.0%
12
  44.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 5 participants 27 participants
22 5 27
1.Primary Outcome
Title Percent Change in Oxygen Saturation (SpO2) From Baseline
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Phase 2 subjects
Arm/Group Title Phase 2: Inhaled Iloprost Continuous
Hide 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.

Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: percent change
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
Hide Description [Not Specified]
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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Phase 1 subjects
Arm/Group Title Phase 1: Inhaled Iloprost 3 Doses
Hide 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.

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: percent change
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
Hide Description [Not Specified]
Time Frame 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Phase 2 subjects
Arm/Group Title Phase 2: Inhaled Iloprost Continuous
Hide 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.

Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: percent change
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
Hide Description [Not Specified]
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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Phase 1 subjects
Arm/Group Title Phase 1: Inhaled Iloprost 3 Doses
Hide 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.

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: percent change
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.Primary Outcome
Title Number of Treatment Failures
Hide Description

Treatment failure is defined as Central venous pressure (CVP) ≥ 20 mm Hg and any one of the following:

  1. Cardiac Index (CI) >/= 1.8 L/min/m2
  2. Administration of >/=0.1 ug/kg/min Epinephrine or Norepinephrine
  3. MAP </= 50 mmHg (or as appropriate for age in pediatrics).
  4. 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase 2: Inhaled Iloprost Continuous Phase 1: Inhaled Iloprost 3 Doses
Hide 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.

Overall Number of Participants Analyzed 22 5
Measure Type: Number
Unit of Measure: participants
0 0
6.Primary Outcome
Title Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
Hide Description [Not Specified]
Time Frame 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: percent change
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)
7.Primary Outcome
Title Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
Hide Description [Not Specified]
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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Phase 1 subjects
Arm/Group Title Phase 1: Inhaled Iloprost 3 Doses
Hide 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.

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: percent change
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)
8.Secondary Outcome
Title Change in Cardiac Output (CO) From Baseline
Hide Description [Not Specified]
Time Frame 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: percent change
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)
9.Secondary Outcome
Title Change in Cardiac Output (CO) From Baseline
Hide Description [Not Specified]
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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Phase 1 subjects
Arm/Group Title Phase 1: Inhaled Iloprost 3 Doses
Hide 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.

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: percent change
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)
10.Secondary Outcome
Title Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: percent change
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
Hide Description [Not Specified]
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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Phase 1 subjects
Arm/Group Title Phase 1: Inhaled Iloprost 3 Doses
Hide 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.

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: percent change
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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase 2: Inhaled Iloprost Continuous Phase 1: Inhaled Iloprost 3 Doses
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Phase 2: Inhaled Iloprost Continuous Phase 1: Inhaled Iloprost 3 Doses
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase 2: Inhaled Iloprost Continuous Phase 1: Inhaled Iloprost 3 Doses
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/5 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Neil MacIntyre, MD
Organization: Duke University Medical Center
Phone: 919-681-2720
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02170519     History of Changes
Other Study ID Numbers: Pro00013737
First Submitted: June 19, 2014
First Posted: June 23, 2014
Results First Submitted: August 11, 2014
Results First Posted: August 26, 2014
Last Update Posted: August 26, 2014