Iloprost Power Disc-15 in Pulmonary Arterial Hypertension (INHALE-15)

This study has been terminated.
(sponsor's decision)
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00723554
First received: July 24, 2008
Last updated: March 27, 2013
Last verified: March 2013
Results First Received: January 14, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pulmonary Arterial Hypertension
Interventions: Drug: Iloprost PD-6
Drug: Iloprost PD-15

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled at 22 U.S. centers

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Adults with pulmonary arterial hypertension (PAH) who were using Ventavis (Iloprost) Inhalation Solution Delivered by I-Neb Utilizing Power Disc-6 (PD-6) were enrolled

Reporting Groups
  Description
Iloprost iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).

Participant Flow:   Overall Study
    Iloprost  
STARTED     63  
COMPLETED     34  
NOT COMPLETED     29  
Adverse Event                 12  
Investigator's judgement                 5  
Inhaled medication other than iloprost                 4  
Withdrawal of consent                 3  
Not specified                 3  
Lost to Follow-up                 1  
Non-compliance                 1  



  Baseline Characteristics
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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
Iloprost iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).

Baseline Measures
    Iloprost  
Number of Participants  
[units: participants]
  63  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     35  
>=65 years     28  
Age  
[units: years]
Mean ± Standard Deviation
  59.9  ± 12.91  
Gender  
[units: participants]
 
Female     58  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     63  



  Outcome Measures
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1.  Primary:   Number of Patients Reporting Treatment-emergent Adverse Events (AEs)   [ Time Frame: From the first dose to last dose of investigational product, an average of approximately 268 days, plus 48 hours ]

2.  Primary:   Number of Patients Who Discontinued Iloprost PD-15 Treatment Due to an AE   [ Time Frame: From the first dose of investigational product to study discontinuation, an average of approximately 268 days ]

3.  Primary:   Number of Patients Reporting Treatment-emergent Serious AEs   [ Time Frame: From the first to last dose of investigational product, an average of approximately 268 days, plus 48 hours ]

4.  Primary:   Systolic Blood Pressure - Iloprost PD-6 (Period 1)   [ Time Frame: Day 1 ]

5.  Primary:   Systolic Blood Pressure - Iloprost PD-15 (Period 2)   [ Time Frame: Day 28 ]

6.  Primary:   Systolic Blood Pressure - Iloprost PD-15 (Period 3)   [ Time Frame: an average of approximately 268 days ]

7.  Primary:   Change in Systolic Blood Pressure - (Period 1 to Period 2)   [ Time Frame: Day 1 and Day 28 ]

8.  Primary:   Change in Systolic Blood Pressure - (Period 1 to Period 3)   [ Time Frame: Day 1 and End of study visit, an average of approximately 268 days ]

9.  Primary:   Diastolic Blood Pressure - Iloprost PD-6 (Period 1)   [ Time Frame: Day 1 ]

10.  Primary:   Diastolic Blood Pressure - Iloprost PD-15 (Period 2)   [ Time Frame: Day 28 ]

11.  Primary:   Diastolic Blood Pressure - Iloprost PD-15 (Period 3)   [ Time Frame: an average of approximately 268 days ]

12.  Primary:   Change in Diastolic Blood Pressure - (Period 1 to Period 2)   [ Time Frame: Day 1 and Day 28 ]

13.  Primary:   Change in Diastolic Blood Pressure - (Period 1 to Period 3)   [ Time Frame: Day 1 and End of study visit, an average of approximately 268 days ]

14.  Primary:   Heart Rate - Iloprost PD-6 (Period 1)   [ Time Frame: Day 1 ]

15.  Primary:   Heart Rate - Iloprost PD-15 (Period 2)   [ Time Frame: Day 28 ]

16.  Primary:   Heart Rate - Iloprost PD-15 (Period 3)   [ Time Frame: an average of approximately 268 days ]

17.  Primary:   Change in Heart Rate - (Period 1 to Period 2)   [ Time Frame: Day 1 and Day 28 ]

18.  Primary:   Change in Heart Rate - (Period 1 to Period 3)   [ Time Frame: Day 1 and End of study visit, an average of approximately 268 days ]

19.  Secondary:   Average Inhalation Time - Iloprost PD-6 (Period 1)   [ Time Frame: average of approximately 28 days ]

20.  Secondary:   Average Inhalation Time - Iloprost PD-15 (Period 2)   [ Time Frame: average of approximately 28 days ]

21.  Secondary:   Average Inhalation Time - Iloprost PD-15 (Period 3)   [ Time Frame: average of approximately 240 days ]

22.  Secondary:   Change in Average Inhalation Time - (Period 1 to Period 2)   [ Time Frame: average approximately 56 days ]

23.  Secondary:   Average Number of Days of Dosing - Iloprost PD-6 (Period 1)   [ Time Frame: average of approximately 28 days ]

24.  Secondary:   Average Number of Days of Dosing - Iloprost PD-15 (Period 2)   [ Time Frame: average of approximately 28 days ]

25.  Secondary:   Average Number of Days of Dosing - Iloprost PD-15 (Period 3)   [ Time Frame: average of approximately 240 days ]

26.  Secondary:   Change in Average Number of Days of Dosing - (Period 1 to Period 2)   [ Time Frame: average approximately 56 days ]

27.  Secondary:   Average Number of Daily Doses - Iloprost PD-6 (Period 1)   [ Time Frame: average of approximately 28 days ]

28.  Secondary:   Average Number of Daily Doses - Iloprost PD-15 (Period 2)   [ Time Frame: average of approximately 28 days ]

29.  Secondary:   Average Number of Daily Doses - Iloprost PD-15 (Period 3)   [ Time Frame: average of approximately 240 days ]

30.  Secondary:   Change in Average Number of Daily Doses - (Period 1 to Period 2)   [ Time Frame: average approximately 56 days ]

31.  Secondary:   Percentage of Complete Doses Delivered - Iloprost PD-6 (Period 1)   [ Time Frame: average of approximately 28 days ]

32.  Secondary:   Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 2)   [ Time Frame: average of approximately 28 days ]

33.  Secondary:   Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 3)   [ Time Frame: average of approximately 240 days ]

34.  Secondary:   Change in Percentage of Complete Doses Delivered - (Period 1 to Period 2)   [ Time Frame: average approximately 56 days ]

35.  Secondary:   New York Health Association (NYHA) Functional Class - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)   [ Time Frame: average of approximately 28 days ]

36.  Secondary:   NYHA Functional Class - Iloprost PD-15 (Period 2, Day 28)   [ Time Frame: average of approximately 28 days ]

37.  Secondary:   NYHA Functional Class - Iloprost PD-15 (Period 3, End of Study Visit))   [ Time Frame: average of approximately 268 days ]

38.  Secondary:   Number of Patients With Improved, no Change, or Worsening of NYHA Functional Class - (Period 1, Prior to First Dose With Iloprost PD-15 to Period 2, Day 28)   [ Time Frame: average approximately 28 days ]

39.  Secondary:   Number of Patients With Improved, no Change, or Worsening of NYHA Functional Class - (Period 1, Prior to First Dose With Iloprost PD-15 to Period 3, End of Study Visit)   [ Time Frame: average approximately 268 days ]

40.  Secondary:   Patient Global Self Assessment - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)   [ Time Frame: average of approximately 28 days ]

41.  Secondary:   Patient Global Self Assessment - Iloprost PD-15 (Period 2, Day 28)   [ Time Frame: average of approximately 28 days ]

42.  Secondary:   Patient Global Self Assessment - Iloprost PD-15 (Period 3, End of Study Visit))   [ Time Frame: average of approximately 268 days ]

43.  Secondary:   Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 2, Day 28   [ Time Frame: average of approximately 28 days ]

44.  Secondary:   Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 3, End of Study Visit   [ Time Frame: average of approximately 268 days ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT 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.


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.  


Results Point of Contact:  
Name/Title: Wade Benton, PharmD/ Director, Medical Affairs Veletri and Ventavis
Organization: Actelion Pharmaceuticals, US, Inc.
phone: (650) 624-6900
e-mail: wade.benton@actelion.com


No publications provided


Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00723554     History of Changes
Other Study ID Numbers: AC-063A402
Study First Received: July 24, 2008
Results First Received: January 14, 2013
Last Updated: March 27, 2013
Health Authority: United States: Food and Drug Administration