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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01894035
First received: July 3, 2013
Last updated: September 29, 2014
Last verified: September 2014
  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.


Condition Intervention
Pulmonary Hypertension
Drug: Ventavis (Iloprost, BAYQ6256)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Percentage of compliant patients [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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.


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

Estimated Enrollment: 15
Study Start Date: September 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Ventavis (Iloprost, BAYQ6256)
Patients Diagnosed with Pulmonary Arterial Hypertension, Functional Class NYHA/WHO III, for whom was prescribed inhaled Iloprost.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01894035

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Portugal
Recruiting
Many Locations, Portugal
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01894035     History of Changes
Other Study ID Numbers: 16755, VE1310PT
Study First Received: July 3, 2013
Last Updated: September 29, 2014
Health Authority: Portugal: Health Ethic Committee
Portugal: National Data Protection Committee

Keywords provided by Bayer:
Pulmonary Hypertension
Ventavis
Patient compliance

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Iloprost
Cardiovascular Agents
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 22, 2014