Effectiveness of TNI vs. BiPAP in Chronic Global Insufficiency in COPD Patients (TIBICO)

November 14, 2018 updated by: Jens Bräunlich, MD, University of Leipzig

Effectiveness of TNI (Nasal High-flow) vs. BiPAP (Biphasic Positive Airway Pressure) in Chronic Global Insufficiency in COPD (Chronic Obstructive Pulmonary Disease) Patients

The purpose of this trial ist to investigate the difference of the efficacy of two systems for breath support in patients with COPD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The trial consists of 12 weeks of therapy that is divided into two sections. In the first 6-week section patients receive treatment with either TNI or BiPAP and in the second 6-week section treatment is changed. The starting therapy is allocated to the patients via randomisation and should be started directly after the baseline visit.

The treatment and the follow-up period end with the second visit after the second treatment section and the patient decides which device he/she wants to use further.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bergisch Gladbach, Germany, 51465
        • Evangelisches Krankenhaus Bergisch Gladbach, Pneumologie
      • Berlin, Germany, 14165
        • HELIOS Klinikum Emil von Behring, Klinik für Pneumologie
      • Hamburg, Germany, 21079
        • Asklepios Klinik Harburg, Lungenheilkunde (Pneumologie) im Thoraxzentrum, Sektion Pneumologische Intensiv- u. Beatmungsmedizin
      • Wangen im Allgäu, Germany, 88239
        • Waldburg-Zeil Kliniken, Fachkliniken Wangen, Lungenzentrum Süd-West
    • Bayern
      • Donaustauf, Bayern, Germany, 93093
        • Klinik Donaustauf, Zentrum für Pneumologie
      • Muenchen-Gauting, Bayern, Germany, 82131
        • Asklepios Fachkliniken München-Gauting, Klinik für Intensivmedizin und Langzeitbeatmung
      • Nürnberg, Bayern, Germany, 90419
        • Klinikum Nürnberg Nord, Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin
      • Rosenheim, Bayern, Germany, 83022
        • RoMed Klinikum Rosenheim, Medizinische Klinik III, Pneumologie
    • Hessen
      • Kassel, Hessen, Germany, 34127
        • Marienkrankenhaus Kassel gGmbH, Medizinische Klinik / Pneumologie
    • Niedersachsen
      • Bovenden, Niedersachsen, Germany, 37120
        • Evangelisches Krankenhaus Göttingen-Weende gGmbH, Abteilung für Pneumologie
    • Nordrhein-Westfalen
      • Schmallenberg, Nordrhein-Westfalen, Germany, 57392
        • Fachkrankenhaus Kloster Grafschaft GmbH, Schlafmedizin & häusliche Beatmung
      • Solingen, Nordrhein-Westfalen, Germany, 42699
        • Diakonisches Werk Bethanien e.V, Klinik für Pneumologie
    • Sachsen
      • Leipzig, Sachsen, Germany, 04107
        • Universitätsklinikum Leipzig, Department für Innere Medizin, Neurologie und Dermatologie
    • Thueringen
      • Bad Berka, Thueringen, Germany, 99437
        • Zentralklinik Bad Berka GmbH, Klinik für Pneumologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • presence of COPD with chronic respiratory global insufficiency
  • chronic day-hypercapnia with pCO2 >= 50 mmHg and typical symptoms of ventilatory insufficiency OR patients with exacerbation (after abate of acute symptomatology) with documented hypercapnia >= 50 mmHG on preliminary findings
  • age 18 or older
  • the patient or caretaker must be able to operate the device after a specific training
  • patient must be willing to use the nHF-/BiPAP-device for the whole trial period for at least 5 hours/day
  • patient must be able to answer the questionnaires
  • written informed consent is obtained

Exclusion Criteria:

  • presence of acute respiratory insufficiency
  • exacerbation of type I or II in the last 4 weeks
  • conservative therapy including long-term oxygen therapy according to GOLD update 2011 is not exhausted
  • previous treatment with NIV (non-invasive ventilation) in the last 14 days
  • clinical instability or acute illness (e.g. acute myocardial infarction, tachycardial atrial fibrillation)
  • signs of cardial decompensation (e.g. edema in the lower limbs, pleural effusion)
  • other serious concomitant diseases, the assessment of eligibility is at the discretion of the investigator
  • contraindications for NIV
  • anamnestic suspicion or proven obstructive sleep apnea (OSA)
  • relevant systemic infections, assessment of eligibility is at the discretion of the investigator
  • BMI > 30
  • other additional pulmonary diseases of other genesis or diseases that affect breathing (e.g. mucoviscidosis, scoliosis, muscular diseases)
  • lack of compliance
  • participation in other interventional trials at the same time
  • pregnant or nursing women
  • fertile female patients without effective contraceptive measures during trial participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: BiPAP breathing support
BiPAP is used over a period of 6 weeks (outpatient)
Device: nHF
nasal high-flow is used over a period of 6 weeks (outpatient)
Other Names:
  • nasal high-flow
Device: BiPAP
BiPAP is used over a period of 6 weeks (outpatient)
EXPERIMENTAL: nHF / TNI breathing support
nasal high-flow is used over a period of 6 weeks (outpatient)
Device: nHF
nasal high-flow is used over a period of 6 weeks (outpatient)
Other Names:
  • nasal high-flow
Device: BiPAP
BiPAP is used over a period of 6 weeks (outpatient)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
difference in capillary CO2 carbon dioxide
Time Frame: Baseline, 6 weeks, 12 weeks
The primary endpoint is the difference of the capillary pC02 between the treatment with nasal high-flow compared with the baseline value.
Baseline, 6 weeks, 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
difference in absolute change of capillary pCO2 (partial pressure of carbon dioxide ) compared with baseline
Time Frame: Baseline, 6 weeks, 12 weeks
Baseline, 6 weeks, 12 weeks
frequency of occurrence of normocapnia after intervention
Time Frame: Baseline, 6 weeks, 12 weeks
Normocapnia is therefore defined as capillary pCO2 <= 45 mmHg
Baseline, 6 weeks, 12 weeks
difference of the relative and absolute change of capillary pCO2 compared with baseline
Time Frame: Baseline, 6 weeks, 12 weeks
Baseline, 6 weeks, 12 weeks
difference of the absolute change of SaO2 (arterial oxygen saturation) compared with baseline
Time Frame: Baseline, 6 weeks, 12 weeks
Baseline, 6 weeks, 12 weeks
difference of the absolute and relative change of base excess compared with baseline
Time Frame: Baseline, 6 weeks, 12 weeks
Baseline, 6 weeks, 12 weeks
difference of the values of base excess after treatment with nHF (nasal high-flow) and of base excess after treatment with BiPAP
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks
difference of the absolute change of HCO3- (hydrogen carbonate / bicarbonate) compared with baseline
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks
difference of HCO3- after treatment with nHF and of HC03- after treatment with BiPAP
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks
difference of P0,1 after treatment with nHF and of P0,1 after treatment with BiPAP
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks
difference of PImax after treatment with nHF and of PImax (maximal inspiratory pressure) after treatment with BiPAP
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks
difference of P0,1/PImax after treatment with nHF and of P0,1/PImax after treatment with BiPAP
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks
difference of the absolute change of the results of the 6-minutes walking test compared with baseline
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks
difference of the absolute change of the disease-specific quality of life compared to baseline
Time Frame: baseline, 6 weeks, 12 weeks
Quality of life is measured by SGQR (The St George's Respiratory Questionnaire), SRI (Severe Respiratory Insufficiency Questionnaire), a VAS referring to the general health status and the Borg-Scale (CR 10)
baseline, 6 weeks, 12 weeks
frequency of occurrence and type of adverse events under trial therapy (both arms)
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks
difference of the values of user-friendliness of both devices
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks
difference of the time both devices were used
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Leipzig

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
TNI Medical AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jens Braeunlich, Dr., Medical Faculty University Leipzig

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TIBICO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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