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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01894035
• Date of registration: 03/07/2013
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: 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
• Scientific title: Study to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost.
• Date of first enrolment: September 23, 2013
• Target sample size: 13
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01894035
• Study type: Observational

Countries of recruitment

Portugal

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Intervention(s)

Drug: Iloprost (Ventavis, BAYQ 6256)

Primary Outcome(s)

Percentage of compliant patients [Time Frame: Up to 12 months]

Secondary Outcome(s)

Change in 6 MWDT (6 minute walking distance test) scale value [Time Frame: Up to 12 months]

Expected treatment duration days [Time Frame: Up to 12 months]

Changes in WHO/ NYHA Functional Class [Time Frame: Up to 12 months]

Observed treatment duration days [Time Frame: Up to 12 months]

Adjusted percentage treatment duration [Time Frame: Up to 12 months]

Change in Dyspnea Borg CR (category ratio) 10 scale value [Time Frame: Up to 12 months]

Quality of life using validated scales (EuroQol questionnaire [EQ-5D], Living with Pulmonary Hypertension questionnaire [LPH]) [Time Frame: Up to 12 months]

Secondary ID(s)

16755

VE1310PT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors