Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension

Completed

• Conditions: Hypertension, Pulmonary
• Interventions: Drug: Iloprost (Ventavis, BAYQ6256)

• Registration Number: NCT01971450
• Lead Sponsor: Bayer

Brief Summary

Local, prospective, multicenter, non-comparative, non-interventional, observational study. It is planed to assess compliance of patients with PH (pulmonary hypertension) with the physician's recommendation in real practice.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-20
• Study First Submitted QC: 2013-10-24
• Study First Posted: 2013-10-29
• Study Start: 2013-11-21
• Primary Completion: 2017-06-28
• Study Completion: 2018-04-18
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• Male and female patients ≥ 18 years old
• Diagnosis of PH
• Planned or current treatment with Ventavis (not more than 6 month)

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Exclusion Criteria

• Contraindications for the use of Ventavis in accordance with the local product information

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Iloprost	Iloprost (Ventavis, BAYQ6256)	The patients with pulmonary hypertension with inhaled treatment with Ventavis according to routine practice meeting the criteria of inclusion.

Primary Outcome Measures

Name	Time	Method
Number of days without any drug administration at all	Up to 12 months
Number of missed doses per day as recommended	Up to 12 months
Number of fully inhaled doses in relation to the total number of inhalations per day	Up to 12 months
Number of actually inhaled doses per day vs. the recommended number of inhalations - either as recommended by the treating physician or as recommended by the label	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
Score on dyspnea Borg CR (category ratio) 10 scale	Up to 12 months
Patients' quality of life, assessed by validated questionnaire	Up to 12 months
Assessment of lung haemodynamics using the data of echocardiography	Up to 12 months
Severity of AEs	Up to 12 months
AE relation to treatment	Up to 12 months
Reason for omission of inhalation as assessed by the physician	Up to 12 months
Assessment of the structural changes in the lungs using X-ray examination of the lungs	Up to 12 months
6 minute walking distance test (MWDT) value	Up to 12 months
Assessment of the structural changes in the lungs using spirography	Up to 12 months
Concomitant medication for other indications than pulmonary hypertension	Up to 12 months
Number of participants with adverse events (AEs)	Up to 12 months
AE treatment	Up to 12 months
Assessment of lung haemodynamics using the data of catheterization	Up to 12 months
AE outcomes	Up to 12 months