Clinical trial NCT01971450: Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension
Official title: Prospective Multicentre Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension, Pulmonary
Keywords: Non-interventional
Ventavis
Iloprost
Pulmonary hypertension
Compliance
Russian Federation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-10-29
Enrollment: 89
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: Male and female patients ≥ 18 years old with PH, treated with Ventavis and for which the inclusion and exclusion criteria are fulfilled, are eligible for enrolment into the study.

Brief summary: Local, prospective, multicenter, non-comparative, non-interventional, observational study. It is planed to assess compliance of patients with PH (pulmonary hypertension) with the physician's recommendation in real practice.


Eligibility criteria: Inclusion Criteria:

* Male and female patients ≥ 18 years old
* Diagnosis of PH
* Planned or current treatment with Ventavis (not more than 6 month)

Exclusion Criteria:

* Contraindications for the use of Ventavis in accordance with the local product information

Primary outcomes:
measure: Number of days without any drug administration at all
timeFrame: Up to 12 months
measure: Number of fully inhaled doses in relation to the total number of inhalations per day
timeFrame: Up to 12 months
measure: Number of missed doses per day as recommended
timeFrame: Up to 12 months
measure: Number of actually inhaled doses per day vs. the recommended number of inhalations - either as recommended by the treating physician or as recommended by the label
timeFrame: Up to 12 months
Secondary outcomes:
measure: 6 minute walking distance test (MWDT) value
timeFrame: Up to 12 months
measure: Score on dyspnea Borg CR (category ratio) 10 scale
timeFrame: Up to 12 months
measure: Patients' quality of life, assessed by validated questionnaire
timeFrame: Up to 12 months
measure: Assessment of the structural changes in the lungs using X-ray examination of the lungs
timeFrame: Up to 12 months
measure: Assessment of the structural changes in the lungs using spirography
timeFrame: Up to 12 months
measure: Assessment of lung haemodynamics using the data of echocardiography
timeFrame: Up to 12 months
measure: Assessment of lung haemodynamics using the data of catheterization
timeFrame: Up to 12 months
measure: Reason for omission of inhalation as assessed by the physician
timeFrame: Up to 12 months
measure: Concomitant medication for other indications than pulmonary hypertension
timeFrame: Up to 12 months
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 12 months
measure: Severity of AEs
timeFrame: Up to 12 months
measure: AE relation to treatment
timeFrame: Up to 12 months
measure: AE treatment
timeFrame: Up to 12 months
measure: AE outcomes
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Multiple Locations
country: Russian Federation
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: