Multiple Locations, France
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
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)
DrugInitial 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
-
Compliance for each subject assessed by the mean daily number of inhalations of Ventavis.
Time frame: Up to 12 months
Secondary outcomes
-
Compliance for each subject assessed by the mean daily number of inhalations of Ventavis
Time frame: Up to 6 months
-
Total distance (meters) walked within 6 minutes assessed by the 6 Minutes Walking Distance Test
Time frame: 6 and 12 months
-
Dyspnea Borg Category Ration 10 Scale values
Time frame: 6 and 12 months
-
Quality of Life (EQ5D and LPH [Living with Pulmonary Hypertension] questionnaires)
Time frame: 6 and 12 months
-
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
-
Population characteristics
Time frame: At baseline
sociodemography, clinical aspects, risk factors
Other outcomes
-
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Utility of At-home Monitoring of Exercise Capacity by App-based 6-minute Walk Test
NCT03893500
Hypertension, Pulmonary, Lung Diseases
Stanford, California, United States
View Trial DetailsSatralizumab in the Treatment of Pulmonary Arterial Hypertension (SATISFY-JP Trial)
NCT05679570
Hypertension, Pulmonary, Lung Diseases
Kagoshima, Kagoshima-ken, Japan
View Trial DetailsVardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study
NCT04266197
Hypertension, Pulmonary, Lung Diseases
Birmingham, Alabama, United States
View Trial DetailsStudy of Cardiac MRI in the Follow up Assessment of Patients With PAH (EVITA)
NCT02845518
Cardiovascular Diseases, Hypertension
Vandœuvre-lès-Nancy, France
View Trial Details