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

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ClinicalTrials.gov Identifier: NCT03293407
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
The main aim of the observational VENTASTEP study is to investigate the potential use of device-based measures as outcome-surrogates for clinical assessments in PAH-patients using the new Breelib nebulizer in a real life setting.

Condition or disease Intervention/treatment
Hypertension, Pulmonary Drug: Iloprost (Ventavis, BAYQ6256) Device: Breelib nebulizer

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ventavis® (Iloprost): Evaluation of Inhaled Iloprost Effects Using the Breelib™ Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020


Group/Cohort Intervention/treatment
BAYQ6256_Ventavis
Patients with pulmonary hypertension who agree to be treated with Ventavis (Iloprost) at the discretion of physician
Drug: Iloprost (Ventavis, BAYQ6256)
Using Breelib device

Device: Breelib nebulizer
Used for inhalation of Ventavis




Primary Outcome Measures :
  1. Change of Six-minute walking distance (6MWD) [ Time Frame: Baseline and 3 months ]
    Clinical outcome measured by study nurse.

  2. Change of laboratory results of the biomarkers NT-pro BNP/BNP [ Time Frame: Baseline and 3 months ]
  3. Change of Health related Quality of Life-EuroQol five dimensions questionnaire (EQ-5D) [ Time Frame: Baseline and 3 months ]
  4. Change of World Health Organization functional class [ Time Frame: Baseline and 3 months ]
  5. Change of Distance Walked per day [ Time Frame: Baseline and 3 months ]
  6. Changed of Number of Steps per day [ Time Frame: Baseline and 3 months ]
  7. Change of number of floors climbed (10 feet) per day [ Time Frame: Baseline and 3 months ]
  8. Change of time spent at home per day [ Time Frame: Baseline and 3 months ]
  9. Change of number of relevant location changes per day [ Time Frame: Baseline and 3 months ]
  10. Change of number of times leaving home per day [ Time Frame: Baseline and 3 months ]
  11. Change of number of times standing up per day [ Time Frame: Baseline and 3 months ]
  12. Change of 6MWD [ Time Frame: Baseline and 3 months ]
    Device based outcome measured by smart device.


Secondary Outcome Measures :
  1. The average daily inhalation duration per session [ Time Frame: Up to 3 months ]
  2. The average number of daily inhalations [ Time Frame: Up to 3 months ]
  3. Change of sleep quality [ Time Frame: Baseline and 3 months ]
    Measured by Pittsburgh Sleep Quality Index (PSQI).

  4. Incidence of AEs [ Time Frame: Up to 3 months after first inhalation ]
  5. Change of heart rate during 6MWD [ Time Frame: Baseline and 3 months ]
  6. The average daily proportion of complete/incomplete inhalations [ Time Frame: Up to 3 months ]
  7. The average association between physical activity level (wearable device based) and time to last inhalation [ Time Frame: Up to 3 months ]
  8. Heart rates during baseline and observation period [ Time Frame: Up to 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03293407


Contacts
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Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

Locations
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Germany
Many Locations Recruiting
Multiple Locations, Germany
Sponsors and Collaborators
Bayer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03293407     History of Changes
Other Study ID Numbers: 19398
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Pulmonary arterial hypertension
PAH

Additional relevant MeSH terms:
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Hypertension
Familial Primary Pulmonary Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents