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

NCT01894035 | Completed

• 2 other identifiers: 16755VE1310PT
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

Pulmonary Hypertension; Ventavis; Patient compliance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Observed treatment duration days

  Up to 12 months

• Expected treatment duration days

  Up to 12 months

• Changes in WHO/ NYHA Functional Class

  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

Study Arms (1)

Group 1

Drug: Iloprost (Ventavis, BAYQ 6256)

Interventions

Iloprost (Ventavis, BAYQ 6256) DRUG

Patients Diagnosed with Pulmonary Arterial Hypertension, Functional Class NYHA/WHO III, for whom was prescribed inhaled Iloprost.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients Diagnosed with Pulmonary Arterial Hypertension, Functional Class NYHA/WHO III, for whom the treating physician has chosen to initiate the treatment with inhaled iloprost using I-Neb as the device for inhalation since 1st of February of 2013.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Portugal

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Patient Compliance

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 9, 2013
• Study Start: September 23, 2013
• Primary Completion: July 20, 2016
• Study Completion: April 13, 2017
• Last Updated: April 9, 2018

Record last verified: 2018-03

Locations

PT (1)