check_circleStudy Completed

Pulmonary Hypertension

Bayer Identifier:

16755

ClinicalTrials.gov Identifier:

NCT01894035

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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.


  • - 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)

Trial summary

Enrollment Goal
13
Trial Dates
September 2013 - April 2017
Phase
N/A
Could I Receive a placebo
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Portugal

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Observed treatment duration days
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Expected treatment duration days
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Changes in WHO/ NYHA Functional Class
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Change in 6 MWDT (6 minute walking distance test) scale value
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Change in Dyspnea Borg CR (category ratio) 10 scale value
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Quality of life using validated scales (EuroQol questionnaire [EQ-5D], Living with Pulmonary Hypertension questionnaire [LPH])
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Adjusted percentage treatment duration
    date_rangeTime Frame:
    Up to 12 months

Trial design

Study to assess the compliance of patients with Pulmonary Arterial Hypertension treated with inhaled Iloprost.
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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