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

Pulmonary Hypertension Clinical Trial

— COMPHI  

Official title:

Study to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894035
• Other study ID #: 16755
• Secondary ID: VE1310PT
• Status: Completed
• First received: July 3, 2013
• Last updated: April 5, 2018
• Start date: September 23, 2013
• Est. completion date: April 13, 2017

Study information

• Verified date: March 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 13, 2017
• Est. primary completion date: July 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• Iloprost (Ventavis, BAYQ 6256)
Patients Diagnosed with Pulmonary Arterial Hypertension, Functional Class NYHA/WHO III, for whom was prescribed inhaled Iloprost.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Portugal, 

Outcome

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

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