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 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.
|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.|
- 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.
- 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 ]
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Drug: Ventavis (Iloprost, BAYQ6256)
Patients Diagnosed with Pulmonary Arterial Hypertension, Functional Class NYHA/WHO III, for whom was prescribed inhaled Iloprost.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01894035
|Many Locations, Portugal|
|Study Director:||Bayer Study Director||Bayer|