COPD Chronic Obstructive Pulmonary DiseaseTIBICONCT02007772
Effectiveness of TNI vs. BiPAP in Chronic Global Insufficiency in COPD Patients
A study testing nHF and BiPAP in people with COPD Chronic Obstructive Pulmonary Disease, run by University of Leipzig at 14 sites in Germany.
Trial summary
The purpose of this trial ist to investigate the difference of the efficacy of two systems for breath support in patients with COPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Chronic Obstructive Pulmonary Disease
- What is being tested?
- nHF and BiPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 14 sitesGermany
- Study dates
- Jun 2011to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Germany14 sites
Zentralklinik Bad Berka GmbH, Klinik für Pneumologie
Bad Berka, Thuringia, 99437
Evangelisches Krankenhaus Bergisch Gladbach, Pneumologie
Bergisch Gladbach, 51465
HELIOS Klinikum Emil von Behring, Klinik für Pneumologie
Berlin, 14165
Evangelisches Krankenhaus Göttingen-Weende gGmbH, Abteilung für Pneumologie
Bovenden, Lower Saxony, 37120
Klinik Donaustauf, Zentrum für Pneumologie
Donaustauf, Bavaria, 93093
Asklepios Klinik Harburg, Lungenheilkunde (Pneumologie) im Thoraxzentrum, Sektion Pneumologische Intensiv- u. Beatmungsmedizin
Hamburg, 21079
Marienkrankenhaus Kassel gGmbH, Medizinische Klinik / Pneumologie
Kassel, Hesse, 34127
Universitätsklinikum Leipzig, Department für Innere Medizin, Neurologie und Dermatologie
Leipzig, Saxony, 04107
Asklepios Fachkliniken München-Gauting, Klinik für Intensivmedizin und Langzeitbeatmung
Muenchen-Gauting, Bavaria, 82131
Klinikum Nürnberg Nord, Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin
Nuremberg, Bavaria, 90419
RoMed Klinikum Rosenheim, Medizinische Klinik III, Pneumologie
Rosenheim, Bavaria, 83022
Fachkrankenhaus Kloster Grafschaft GmbH, Schlafmedizin & häusliche Beatmung
Schmallenberg, North Rhine-Westphalia, 57392
Diakonisches Werk Bethanien e.V, Klinik für Pneumologie
Solingen, North Rhine-Westphalia, 42699
Waldburg-Zeil Kliniken, Fachkliniken Wangen, Lungenzentrum Süd-West
Wangen, 88239
About this study
Official title: 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.
Read the 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.
- Being tested
- nHF, BiPAP
- Keywords
- COPD, nHF, BiPAP
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nHFDevice
Also called nasal high-flow
nasal high-flow is used over a period of 6 weeks (outpatient)
BiPAPDevice
BiPAP is used over a period of 6 weeks (outpatient)
| Study group | Role | What they receive |
|---|---|---|
| BiPAP breathing support | Active comparator | BiPAP is used over a period of 6 weeks (outpatient) Receives: Device: nHF; Device: BiPAP |
| nHF / TNI breathing support | Experimental | nasal high-flow is used over a period of 6 weeks (outpatient) Receives: Device: nHF; Device: BiPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in capillary CO2 carbon dioxide
The primary endpoint is the difference of the capillary pC02 between the treatment with nasal high-flow compared with the baseline value.
Measured: Baseline, 6 weeks, 12 weeks
Secondary outcomes (16)
difference in absolute change of capillary pCO2 (partial pressure of carbon dioxide ) compared with baseline
Measured: Baseline, 6 weeks, 12 weeks
frequency of occurrence of normocapnia after intervention
Normocapnia is therefore defined as capillary pCO2 <= 45 mmHg
Measured: Baseline, 6 weeks, 12 weeks
difference of the relative and absolute change of capillary pCO2 compared with baseline
Measured: Baseline, 6 weeks, 12 weeks
difference of the absolute change of SaO2 (arterial oxygen saturation) compared with baseline
Measured: Baseline, 6 weeks, 12 weeks
difference of the absolute and relative change of base excess compared with baseline
Measured: 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
Measured: baseline, 6 weeks, 12 weeks
difference of the absolute change of HCO3- (hydrogen carbonate / bicarbonate) compared with baseline
Measured: baseline, 6 weeks, 12 weeks
difference of HCO3- after treatment with nHF and of HC03- after treatment with BiPAP
Measured: baseline, 6 weeks, 12 weeks
difference of P0,1 after treatment with nHF and of P0,1 after treatment with BiPAP
Measured: baseline, 6 weeks, 12 weeks
difference of PImax after treatment with nHF and of PImax (maximal inspiratory pressure) after treatment with BiPAP
Measured: baseline, 6 weeks, 12 weeks
difference of P0,1/PImax after treatment with nHF and of P0,1/PImax after treatment with BiPAP
Measured: baseline, 6 weeks, 12 weeks
difference of the absolute change of the results of the 6-minutes walking test compared with baseline
Measured: baseline, 6 weeks, 12 weeks
difference of the absolute change of the disease-specific quality of life compared to baseline
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)
Measured: baseline, 6 weeks, 12 weeks
frequency of occurrence and type of adverse events under trial therapy (both arms)
Measured: baseline, 6 weeks, 12 weeks
difference of the values of user-friendliness of both devices
Measured: baseline, 6 weeks, 12 weeks
difference of the time both devices were used
Measured: baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startJun 2011
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- TNI Medical AG
- Responsible party
- Principal investigator, Jens Bräunlich, MD, University of Leipzig
- Investigators
- Jens Braeunlich, Dr., Study chair, Medical Faculty University Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007772
- Sponsor's protocol ID
- TIBICO
- Acronym
- TIBICO
- Status last verified
- Nov 2018
- First submitted
- 16 Sep 2013
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of TNI (Nasal High-flow) vs. BiPAP (Biphasic Positive Airway Pressure) in Chronic Global Insufficiency in COPD (Chronic Obstructive Pulmonary Disease) Patients
- ClinicalTrials.gov ID
- NCT02007772
- Acronym / sponsor ID
- TIBICO / TIBICO
- Keywords
- COPD, nHF, BiPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- TNI Medical AG
- Study start
- Jun 2011
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial ist to investigate the difference of the efficacy of two systems for breath support in patients with COPD.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BiPAP breathing support | Active comparator | Device: nHF, Device: BiPAPBiPAP is used over a period of 6 weeks (outpatient) |
| nHF / TNI breathing support | Experimental | Device: nHF, Device: BiPAPnasal high-flow is used over a period of 6 weeks (outpatient) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nHFAlso: nasal high-flownasal high-flow is used over a period of 6 weeks (outpatient) | Device | BiPAP breathing support, nHF / TNI breathing support |
| BiPAPBiPAP is used over a period of 6 weeks (outpatient) | Device | BiPAP breathing support, nHF / TNI breathing support |
Primary outcome
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.
16 secondary outcomes
difference in absolute change of capillary pCO2 (partial pressure of carbon dioxide ) compared with baseline
Time frame: Baseline, 6 weeks, 12 weeks
frequency of occurrence of normocapnia after intervention
Time frame: 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
difference of the absolute change of SaO2 (arterial oxygen saturation) compared with baseline
Time frame: 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
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
difference of the absolute change of HCO3- (hydrogen carbonate / bicarbonate) compared with baseline
Time frame: 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
difference of P0,1 after treatment with nHF and of P0,1 after treatment with BiPAP
Time frame: 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
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
difference of the absolute change of the results of the 6-minutes walking test compared with baseline
Time frame: 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
frequency of occurrence and type of adverse events under trial therapy (both arms)
Time frame: baseline, 6 weeks, 12 weeks
difference of the values of user-friendliness of both devices
Time frame: baseline, 6 weeks, 12 weeks
difference of the time both devices were used
Time frame: baseline, 6 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Braeunlich, Dr. study chair
Medical Faculty University Leipzig
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nHF and BiPAP in people with COPD Chronic Obstructive Pulmonary Disease, run by University of Leipzig at 14 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in capillary CO2 carbon dioxide (time frame: Baseline, 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.