Examination of Ventavis (Iloprost) Inhalation Behavior Using the I-Neb AAD System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 μg/mL (V10) to 20 μg/mL (V20)

NCT02826252 | Completed

• 1 other identifier: 18838
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to examine inhalation behavior in patients enrolled in the German Ventavis patient support program Ventaplus when these patients are switched from Ventavis (Iloprost) 10 μg/mL to Ventavis (Iloprost) 20 μg/mL formulation.

Conditions

Hypertension, Pulmonary

Keywords

Pulmonary Arterial Hypertension (PAH)

Outcome Measures

Primary Outcomes (2)

• Number of inhalations on Iloprost 10 ug/mL and 20 ug/mL

  Up to 6 months

• Number of delivered doses (none/partial/full) on Iloprost 10 ug/mL and 20 ug/mL

  Up to 6 months

Secondary Outcomes (1)

• Inhalation durations (min) per session on Iloprost 10 ug/mL and 20 ug/mL

  Up to 6 months

Study Arms (1)

Ventavis

The study will be conducted in patients who are enrolled in the German Ventavis patient support program Ventaplus.

Drug: Iloprost,(Ventavis, BAYQ6256); Device: I-Neb AAD system

Interventions

Iloprost,(Ventavis, BAYQ6256) DRUG

Ventavis (Iloprost) nebulizer solution for inhalation as 10 μg/mL (V10) and 20 μg/mL (V20).

Ventavis

I-Neb AAD system DEVICE

Nebulizer, allows digital recording of inhalation data such as doses, inhalations per day and duration of inhalation (per day) etc.

Ventavis

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

The study will be conducted in patients who are enrolled in the German Ventavis patient support program Ventaplus which is executed for Bayer by the company Contra Care GmbH, Nürnberg. Patients who are enrolled in the program and repeatedly experienced extended inhalation times with Ventavis (Iloprost) 10 μg/mL which could possibly result in incomplete inhalations, are currently being switched to Ventavis (Iloprost) 20 μg/mL by their physician.

You may qualify if:

• Patients aged ≥18 years at time of signing informed consent.
• Patients, diagnosed with group 1 PAH.
• Patients must be enrolled in the German Ventavis patient support program Ventaplus.
• Patients who either already switched from V10 to V20 therapy or who agreed to do so according to their physician's decision.
• Patients must have been on V10 therapy for at least 2 weeks.
• Written informed consent must be obtained.

You may not qualify if:

• \- participation in other clinical or interventional study.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Germany

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 7, 2016
• Study Start: September 15, 2016
• Primary Completion: November 15, 2016
• Study Completion: January 24, 2017
• Last Updated: March 15, 2017

Record last verified: 2017-03

Locations

DE (1)