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

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Drug: Iloprost (Ventavis, BAYQ 6256)

• Registration Number: NCT01894035
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2013-07-03
• Study First Posted: 2013-07-09
• Study Start: 2013-09-23
• Primary Completion: 2016-07-20
• Study Completion: 2017-04-13
• Status Verified: 2018-03
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Iloprost (Ventavis, BAYQ 6256)	-

Primary Outcome Measures

Name	Time	Method
Percentage of compliant patients	Up to 12 months	The compliance will be assessed by the mean daily number of Inhalations and mean daily dose of Ventavis at around months 6 and 12 for each patient (Data will be collected via the I-neb Insight). For this observational study, a patient is considered compliant if the mean daily number of inhalations and mean daily dose are within 80 to 120% of prescribed. Otherwise, the patient will be considered as non-compliant.

Secondary Outcome Measures

Name	Time	Method
Changes in WHO/ NYHA Functional Class	Up to 12 months
Adjusted percentage treatment duration	Up to 12 months
Observed treatment duration days	Up to 12 months
Expected treatment duration days	Up to 12 months
Change in 6 MWDT (6 minute walking distance test) scale value	Up to 12 months
Change in Dyspnea Borg CR (category ratio) 10 scale value	Up to 12 months
Quality of life using validated scales (EuroQol questionnaire [EQ-5D], Living with Pulmonary Hypertension questionnaire [LPH])	Up to 12 months