Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension

NCT01971450 | Completed

• 2 other identifiers: 16777VE1311RU
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension, Pulmonary

Keywords

Non-interventional; Ventavis; Iloprost; Pulmonary hypertension; Compliance; Russian Federation

Outcome Measures

Primary Outcomes (4)

• Number of days without any drug administration at all

  Up to 12 months

• Number of fully inhaled doses in relation to the total number of inhalations per day

  Up to 12 months

• Number of missed doses per day as recommended

  Up to 12 months

• 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

  Up to 12 months

Secondary Outcomes (14)

• 6 minute walking distance test (MWDT) value

  Up to 12 months

• Score on dyspnea Borg CR (category ratio) 10 scale

  Up to 12 months

• Patients' quality of life, assessed by validated questionnaire

  Up to 12 months

• Assessment of the structural changes in the lungs using X-ray examination of the lungs

  Up to 12 months

• Assessment of the structural changes in the lungs using spirography

  Up to 12 months

Study Arms (1)

Iloprost

The patients with pulmonary hypertension with inhaled treatment with Ventavis according to routine practice meeting the criteria of inclusion.

Drug: Iloprost (Ventavis, BAYQ6256)

Interventions

Iloprost (Ventavis, BAYQ6256) DRUG

Iloprost

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Russia

Location

Related Links

• Click here to find results for studies related to Bayer products.

MeSH Terms

Conditions

Hypertension, Pulmonary; Patient Compliance

Interventions

Iloprost

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2013
• First Posted: October 29, 2013
• Study Start: November 21, 2013
• Primary Completion: June 28, 2017
• Study Completion: April 18, 2018
• Last Updated: March 26, 2019

Record last verified: 2019-03

Locations

RU (1)