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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.

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.

Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.


Participant Flow:   Overall Study
    Phase 2: Inhaled Iloprost Continuous   Phase 1: Inhaled Iloprost 3 Doses
STARTED   22   5 
COMPLETED   22   5 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.

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.

Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.

Total Total of all reporting groups

Baseline Measures
   Phase 2: Inhaled Iloprost Continuous   Phase 1: Inhaled Iloprost 3 Doses   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   5   27 
Age, Customized 
[Units: Participants]
     
>18 years   21   5   26 
<=18 years   1   0   1 
Gender 
[Units: Participants]
     
Female   14   1   15 
Male   8   4   12 
Region of Enrollment 
[Units: Participants]
     
United States   22   5   27 


  Outcome Measures

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

2.  Primary:   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) ]

3.  Primary:   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 ]

4.  Primary:   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) ]

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

6.  Primary:   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 ]

7.  Primary:   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) ]

8.  Secondary:   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 ]

9.  Secondary:   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) ]

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

11.  Secondary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: neil.macintyre@dm.duke.edu



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