Trial Condition(s):
Pulmonary hypertension
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)
Bayer Identifier:
16755
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial 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.
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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Portugal | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Trial Design
Study to assess the compliance of patients with Pulmonary Arterial Hypertension treated with inhaled Iloprost.
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Percentage of compliant patientsThe 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.Timeframe: Up to 12 months
Secondary Outcome
- Observed treatment duration daysTimeframe: Up to 12 months
- Expected treatment duration daysTimeframe: Up to 12 months
- Changes in WHO/ NYHA Functional ClassTimeframe: Up to 12 months
- Change in 6 MWDT (6 minute walking distance test) scale valueTimeframe: Up to 12 months
- Change in Dyspnea Borg CR (category ratio) 10 scale valueTimeframe: Up to 12 months
- Quality of life using validated scales (EuroQol questionnaire [EQ-5D], Living with Pulmonary Hypertension questionnaire [LPH])Timeframe: Up to 12 months
- Adjusted percentage treatment durationTimeframe: Up to 12 months
Additional Information
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