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NCT Number: 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

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.

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Key information

Conditions

Pulmonary Hypertension Behavior Cardiovascular Diseases Health Behavior Hypertension Hypertension, Pulmonary Lung Diseases Patient Acceptance of Health Care Patient Compliance Respiratory Tract Diseases Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Portugal

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Iloprost (Ventavis, BAYQ 6256)

Drug

Patients Diagnosed with Pulmonary Arterial Hypertension, Functional Class NYHA/WHO III, for whom was prescribed inhaled Iloprost.

Primary outcomes

  1. Percentage of compliant patients

    Time frame: Up to 12 months

    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.

Secondary outcomes

  1. Observed treatment duration days

    Time frame: Up to 12 months

  2. Expected treatment duration days

    Time frame: Up to 12 months

  3. Changes in WHO/ NYHA Functional Class

    Time frame: Up to 12 months

  4. Change in 6 MWDT (6 minute walking distance test) scale value

    Time frame: Up to 12 months

  5. Change in Dyspnea Borg CR (category ratio) 10 scale value

    Time frame: Up to 12 months

  6. Quality of life using validated scales (EuroQol questionnaire [EQ-5D], Living with Pulmonary Hypertension questionnaire [LPH])

    Time frame: Up to 12 months

  7. Adjusted percentage treatment duration

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Study to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost.

Acronym: COMPHI

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jul 9, 2013
Registry last updated
Apr 9, 2018

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.

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