Trial Condition(s):

Pulmonary hypertension

Non-interventional multi-center study on patients under routine treatment of Pulmonary Arterial Hypertension (PAH) with inhaled Iloprost using I-Neb as a device for inhalation (COMPHI)

Bayer Identifier:

16755

ClinicalTrials.gov Identifier:

NCT01894035

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This pilot, non-interventional, company-sponsored, multi-center study documents observational data on patients under routine treatment of Pulmonary Arterial Hypertension (PAH) with inhaled iloprost (using I-Neb device for the inhalation).
The planned study recruitment time is 18 months. The maximum follow up period in this study will be 12 months.
The data will be collected from patients who have initiated the treatment mentioned above (inhaled iloprost using I-Neb device) since February 1st, 2013.
Frequency of visits and procedures will be performed under routine conditions.
The primary objective of this study is to assess the compliance of patients with WHO/NYHA (World Health Organization/New York Heart Association) functional Class III Pulmonary Arterial Hypertension treated with Inhaled Iloprost in clinical practice, using the I-neb Insight tool.

Inclusion Criteria
-  Adult patients (age ≥ 18years old), male or female
 -  Diagnosis of Pulmonary Arterial Hypertension, Group I of the Dana Point Pulmonary Hypertension classification (Diagnosis made at the discretion of the attending investigator, including mPAP ≥ 25 mmHg at rest, as measured by right heart catheterization.)
 -  The treating physician has chosen to initiate the treatment with inhaled iloprost with I-Neb device for the application, as described in the Summary of Product characteristics (SmPC).
 -  WHO/NYHA functional class III
 -  Willing to participate in the study (Informed Consent Sign)
 -  Patients who received the first inhaled iloprost treatment with I-Neb from February 1st, 2013.
Exclusion Criteria
-  Any contraindication for the treatment with Ventavis as described in the Summary of Product characteristics (SmPC)      
-  Patients are not to be enrolled if they were treated with inhaled iloprost with I-Neb or any other device for the application in the past, before the start of the observation period (February 1st, 2013)

Trial Summary

Enrollment Goal
13
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Portugal

Status
Completed
 

Trial Design