Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension inhaled therapy power disc-15
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 63
Healthy volunteers: no

Brief summary:
A Phase IIIb, Multicenter, Open-Label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 to Power Disc-15 With the I-neb® Adaptive Aerosol Delivery® System (I-neb® AAD®)

Detailed description:

Arms:
arm 1: The study enrolled patients who were already using iloprost with PD-6 without any safety or tolerability concerns, thereby facilitating a direct comparison of the PD-15 to the PD-6.

The single-arm design allowed each patient to serve as his/her own control

Interventions: intervention 1: Iloprost PD-6 intervention 2: Iloprost PD-15
Intervention descriptions: intervention 1: Period 1 (PD-6): study period defined as the 14 days prior to the first dose of study iloprost inhalation with PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-6 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day intervention 2: Period 2 (PD-15): study period between the administration of the first dose with PD-15 on Day 1 until Day 28 inclusive.

Period 3 (PD-15): study period from Day 29 until discontinuation of the PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-15 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day

Protocol document: