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

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

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

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 ]