Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients (DAILY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01781052
First received: January 22, 2013
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

This prospective, non-interventional, multi-center study documents observational data on subjects under routine treatment of Pulmonary Arterial Hypertension, functional class III with inhaled Iloprost administered with I-Neb AAD (Adaptive Aerosol Delivery) device. The observation period for each subject covers a one year treatment period with inhaled Ventavis. For each subject, the investigator or a delegate collects data as defined in the case report form at an initial visit, routine follow-up visit at 6 months and final visit at 12 months.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: DAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Compliance of Ventavis use for each subject assessed by the mean daily number of inhalations and mean daily dose of Ventavis. [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compliance of Ventavis use for each subject assessed by the mean daily number of inhalations and mean daily dose of Ventavis [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Total distance (meters) walked within 6 minutes assessed by the 6 Minutes Walking Distance Test [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Dyspnea Borg Category Ration 10 Scale values [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Quality of Life (EQ5D and LPH [Living with Pulmonary Hypertension] questionnaires) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Investigator and patient satisfaction in the use of I-neb Insight tool assessed by a five level likert scale [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Ventavis (Iloprost, BAYQ6256)
Initial dose: 2.5 µg per inhalation session; 6-9 inhalations/day. Dose can be increased to up to 5.0 µg per inhalation session.

  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 aged ≥18 years and diagnosed with PAH (Pulmonary Arterial Hypertension), WHO/NYHA functional class III, Group I of the Dana point Pulmonary Hypertension Classification and newly Treated with Ventavis or treated with Ventavis for less than 6 months, with I-Neb AAD device for the application.

Criteria

Inclusion Criteria:

  • Male or female subjects aged ≥18 years
  • Newly Treated with Ventavis or treated with Ventavis for less than 6 months, with I Neb AAD device for the application, as described in the SmPC (Summary of Product Characteristics), complemented by the Insight
  • With Pulmonary Arterial Hypertension, Group I of the Dana point Pulmonary Hypertension Classification.
  • WHO (World Health Organization) /NYHA (New York Heart Association) Functional class III
  • Able and willing to give written informed consent for participation in the study

Exclusion Criteria:

Key contra indications:

  • Hypersensitivity to the active substance or to any of the excipients.
  • Conditions where the effects of Ventavis on platelets might increase the risk of haemorrhage (e.g. active peptic ulcers, trauma, intracranial haemorrhage).
  • Severe coronary heart disease or unstable angina;
  • Myocardial infarction within the last six months;
  • Decompensated cardiac failure if not under close medical supervision;
  • Severe arrhythmias;
  • Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months.
  • Pulmonary hypertension due to venous occlusive disease.
  • Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension
  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: NCT01781052

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

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01781052     History of Changes
Other Study ID Numbers: 16133, VE1210FR, 2011/00416
Study First Received: January 22, 2013
Last Updated: July 29, 2014
Health Authority: France: none

Keywords provided by Bayer:
Iloprost Compliance

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

ClinicalTrials.gov processed this record on August 20, 2014