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Registry of Stable Hypercapnic Chronic Obstructive Pulmonary Disease Treated With Non-Invasive Ventilation (HOmeVent)

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ClinicalTrials.gov Identifier: NCT02811588
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : February 20, 2017
Sponsor:
Collaborator:
CRI-The Clinical Research Institute GmbH
Information provided by (Responsible Party):
ResMed

Brief Summary:
The prevalence of chronic respiratory disease, including chronic obstructive pulmonary disease (COPD), is increasing in industrialized countries. Over the next decade deaths from COPD are projected to increase by more than 30% and COPD will become the third leading cause of death worldwide by 2030. There is robust scientific evidence that non-invasive ventilation (NIV) therapy is an effective option for most COPD patients hospitalized with acute hypercapnic respiratory failure secondary to an acute disease exacerbation. More recently, NIV has been shown to significantly improve survival and quality of life in COPD patients with chronic stable hypercapnic disease. These data represent an important advance in the field, and indicate that usage of NIV in patients with chronic stable hypercapnic COPD should increase. Such an increase would be expected to improve patient outcomes and have a beneficial impact on the significant healthcare burden incurred by these patients. However, the proportion of stable COPD patients with chronic hypercapnia is unknown. In addition, using NIV at home to treat COPD patients with hypercapnic (type 2) respiratory failure has not often been considered previously and there is a paucity of data regarding NIV usage patterns over time in this setting.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Device: Non-invasive ventilation

Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Registry of Stable Hypercapnic Chronic Obstructive Pulmonary Disease Treated With Non-Invasive Ventilation - HOmeVent Registry
Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort Intervention/treatment
Screening phase: normocapnic group
Normocapnic COPD patients
Screening phase: hypercapnic group
Hypercapnic COPD patients
Treatment phase: control group
Hypercapnic COPD patients in whom NIV is not indicated or who have contraindication(s) for, or refuse, NIV treatment.
Treatment phase: non-invasive ventilation group
Hypercapnic COPD patients in whom NIV is indicated and who accept NIV treatment.
Device: Non-invasive ventilation



Primary Outcome Measures :
  1. Prevalence of hypercapnia in patients with GOLD stage 3 and 4 COPD. [ Time Frame: July 2017 ]

Secondary Outcome Measures :
  1. Patterns of NIV use: NIV settings (modes, pressure, etc.), time to initiate NIV and compliance. [ Time Frame: July 2017 ]


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
GOLD stage 3 or 4 COPD
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • GOLD stage 3 or 4 COPD
  • pCO2 value available not older than one month
  • Ability to fully understand the study information and willing to give informed consent

Exclusion Criteria:

  • Existing treatment with NIV

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): NCT02811588


Contacts
Contact: Pierre-Charles Neuzeret pierre-charles.neuzeret@resmed.com

Locations
Germany
Universitätsklinik Aachen Recruiting
Aachen, Germany, 52074
Contact: Michael Dreher, Prof    +49 2418 088763    mdreher@ukaachen.de   
Kliniken der Stadt Köln Recruiting
Cologne, Germany, 51109
Contact: Wolfram Windisch, Prof    +49 221 890718929    WindischW@kliniken-koeln.de   
Klinikum St. Georg - Robert Koch Klinik - Zentrum für Pneumologie Recruiting
Leipzig, Germany
Contact: Thomas Köhnlein, Prof    +49 341 4232100    thomas.koehnlein@sanktgeorg.de   
Sponsors and Collaborators
ResMed
CRI-The Clinical Research Institute GmbH

Additional Information:
Publications of Results:
Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT02811588     History of Changes
Other Study ID Numbers: CA5 - NIV COPD Registry EU
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypercapnia
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms