Evaluation of Inhaled Iloprost Effects Using the Breelib Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension

NCT03293407 | Completed

• 1 other identifier: 19398
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of the observational VENTASTEP study was to investigate the association between changes in clinical outcome measures and changes in device outcome measures in PAH patients using the new Breelib nebulizer in a real life setting. The study was not designed to investigate or confirm the effectiveness and safety of iloprost.

Conditions

Hypertension, Pulmonary

Keywords

Pulmonary arterial hypertension; PAH

Outcome Measures

Primary Outcomes (13)

• Change of Six-minute walking distance (6MWD)

  Clinical outcome measured by study nurse.

  Baseline and 3 months

• Change of laboratory results of the biomarkers NT-pro BNP/BNP

  Baseline and 3 months

• Change of Health related Quality of Life-EuroQol five dimensions questionnaire (EQ-5D)

  Baseline and 3 months

• Change of World Health Organization functional class

  Baseline and 3 months

• Change of Distance Walked per day

  Baseline and 3 months

• Change of Number of Steps per day

  Baseline and 3 months

• Change of number of floors climbed (10 feet) per day

  Baseline and 3 months

• Change of time spent at home per day

  Baseline and 3 months

• Change of number of relevant location changes per day

  Baseline and 3 months

• Change of number of times leaving home per day

  Baseline and 3 months

• Change of number of times standing up per day

  Baseline and 3 months

• Change of 6MWD

  Device based outcome measured by smart device.

  Baseline and 3 months

• Heart rates during baseline and observation period

  Up to 3 months

Secondary Outcomes (7)

• The average daily inhalation duration per session

  Up to 3 months

• The average number of daily inhalations

  Up to 3 months

• Change of sleep quality

  Baseline and 3 months

• Incidence of AEs

  Up to 3 months after first inhalation

• Change of heart rate during 6MWD

  Baseline and 3 months

Study Arms (1)

BAYQ6256_Ventavis

Patients with pulmonary hypertension who agree to be treated with Ventavis (Iloprost) at the discretion of physician

Drug: Iloprost (Ventavis, BAYQ6256); Device: Breelib nebulizer

Interventions

Iloprost (Ventavis, BAYQ6256) DRUG

Using Breelib device

BAYQ6256_Ventavis

Breelib nebulizer DEVICE

Used for inhalation of Ventavis

BAYQ6256_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

Patients with pulmonary hypertension at intermediate risk and WHO FC III who failed to respond adequately to initial therapy with one or more PAH drugs or who clinically deteriorated after initial treatment response and for whom a therapy escalation with Ventavis (Iloprost) has been agreed by patient and physician.

You may qualify if:

• Ventavis-treatment naïve patients aged ≥18 years at initiation of Ventavis (Iloprost) therapy diagnosed with pulmonary arterial hypertension WHO FC III
• Patients who are planned to be treated with Ventavis (Iloprost) and where the decision to use the Breelib has been agreed by physician and patient
• Patients who are willing to wear a smart watch (iWatch2) over the observation period of 3 months ± 2 weeks
• Signed informed consent

You may not qualify if:

• Patients allergic to Nickel and Methacrylates
• Patients participating in an investigational program with interventions outside of routine clinical practice

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many Locations

Multiple Locations, Germany

Location

Related Publications (2)

• Mueller C, Stollfuss B, Roitenberg A, Harder J, Richter MJ. Evaluation of Clinical Outcomes and Simultaneous Digital Tracking of Daily Physical Activity, Heart Rate, and Inhalation Behavior in Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost: Protocol for the Observational VENTASTEP Study. JMIR Res Protoc. 2019 Apr 15;8(4):e12144. doi: 10.2196/12144.

  PMID: 30985279 BACKGROUND

• Stollfuss B, Richter M, Dromann D, Klose H, Schwaiblmair M, Gruenig E, Ewert R, Kirchner MC, Kleinjung F, Irrgang V, Mueller C. Digital Tracking of Physical Activity, Heart Rate, and Inhalation Behavior in Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost: Observational Study (VENTASTEP). J Med Internet Res. 2021 Oct 8;23(10):e25163. doi: 10.2196/25163.

  PMID: 34623313 DERIVED

Related Links

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

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Interventions

Iloprost

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 26, 2017
• Study Start: February 1, 2018
• Primary Completion: October 9, 2019
• Study Completion: January 20, 2020
• Last Updated: May 26, 2021

Record last verified: 2021-05

Locations

DE (1)