Skip to main content
OpenTrials
Completed

NCT Number: NCT01781052

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ventavis (Iloprost, BAYQ6256)

Drug

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.

Primary outcomes

  1. Compliance for each subject assessed by the mean daily number of inhalations of Ventavis.

    Time frame: Up to 12 months

Secondary outcomes

  1. Compliance for each subject assessed by the mean daily number of inhalations of Ventavis

    Time frame: Up to 6 months

  2. Total distance (meters) walked within 6 minutes assessed by the 6 Minutes Walking Distance Test

    Time frame: 6 and 12 months

  3. Dyspnea Borg Category Ration 10 Scale values

    Time frame: 6 and 12 months

  4. Quality of Life (EQ5D and LPH [Living with Pulmonary Hypertension] questionnaires)

    Time frame: 6 and 12 months

  5. 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

  6. Population characteristics

    Time frame: At baseline

    sociodemography, clinical aspects, risk factors

Other outcomes

  1. Adverse events

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: DAILY

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jan 31, 2013
Registry last updated
Dec 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.