Clinical trial NCT01894035: 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
Official title: Study to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Hypertension
Ventavis
Patient compliance
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-07-09
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients Diagnosed with Pulmonary Arterial Hypertension, Functional Class NYHA/WHO III, for whom the treating physician has chosen to initiate the treatment with inhaled iloprost using I-Neb as the device for inhalation since 1st of February of 2013.

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of compliant patients
timeFrame: Up to 12 months
Secondary outcomes:
measure: Observed treatment duration days
timeFrame: Up to 12 months
measure: Expected treatment duration days
timeFrame: Up to 12 months
measure: Changes in WHO/ NYHA Functional Class
timeFrame: Up to 12 months
measure: Change in 6 MWDT (6 minute walking distance test) scale value
timeFrame: Up to 12 months
measure: Change in Dyspnea Borg CR (category ratio) 10 scale value
timeFrame: Up to 12 months
measure: Quality of life using validated scales (EuroQol questionnaire [EQ-5D], Living with Pulmonary Hypertension questionnaire [LPH])
timeFrame: Up to 12 months
measure: Adjusted percentage treatment duration
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Multiple Locations
country: Portugal
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: