COPDPhase 1STIT-2NCT01693146
STIT-2: Evaluation of Safety and Efficacy of Short-time TNI® Treatment in Patients With COPD and Hypercapnia
A Phase 1 study testing Nasal oxygen insufflation with a TNI® 20 oxy device and Nasal insufflation of oxygen in people with COPD and Hypercapnia, run by Medical University Innsbruck at 4 sites in 3 countries.
Trial summary
Evaluation of Safety and Efficacy of Short time TNI Treatment in Patients with COPD and hypercapnia. Acute testing of oxygen demand using TNI vs. standard oxygen application in stable COPD patients with hypercapnia. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- COPD, Hypercapnia
- What is being tested?
- Nasal oxygen insufflation with a TNI® 20 oxy device and Nasal insufflation of oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Dec 2011to Dec 2013
- Phase
- Phase 1
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients with an indication for long-term oxygen therapy (LTOT)
- Presence of hypercapnia at rest without oxygen supplementation (PaCO2 > 45 mmHg)
- Age 30 - 85 years
- Functional GOLD class: COPD GOLD IV as defined by the following:
- FEV1/FVC < 70% and a Post-bronchodilator FEV1 < 30% or FEV1 < 50% and a PaO2 < 60 mmHg and/or PaCO2 > 50 mmHg
Who cannot join
- Clinical instability of the patient
- No lung function testing possible
- Exacerbation within the last 14 days prior to inclusion into the study
- Serious concomitant diseases that may jeopardize the inclusion of the patient into the study from the investigator's point of view
- Severe anaemia, defined by a haemoglobin <8.5 G/L
- Participation of the patient in any other ongoing study
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites, 2 recruiting
- Not yet recruiting
Pneumologie, Medizinische Klinik und Poliklinik I, University of Dresden
Dresden, D-01307
Michael Halank, MD, 0049 351 458 - 4721
Gert Höffken, MD
- Recruiting
Klinik für Innere Medizin V, Universitätsklinikum Homburg, University of Homburg/Saar
Homburg, D-66424
Heinrike Wilkens, MD, 0049 6841 16-23633
Austria1 site, 1 recruiting
- Recruiting
Christian Kähler
Innsbruck, A-6020
Christian M Kaehler, MD, 004351250423255, c.m.kaehler@i-med.ac.at
Switzerland1 site, 1 recruiting
- Recruiting
Klinik und Poliklinik für Pneumologie, Inselspital Berne, University of Berne
Bern, CH-3010
Thomas Geiser, MD, 0031 632 34 90
About this study
Official title: Evaluation of Safety and Efficacy of Short-time TNI® Treatment in Patients With COPD and Hypercapnia Acute Testing of Oxygen Demand Using TNI® vs. Standard Insufflation in COPD Patients With Hypercapnia at Rest
Evaluation of Safety and Efficacy of Short time TNI Treatment in Patients with COPD and hypercapnia.
Acute testing of oxygen demand using TNI vs. standard oxygen application in stable COPD patients with hypercapnia.
Read the detailed description
TNI, the nasal insufflation of a high flow of warm, humidified air, is an extremely comfortable and uncomplicated alternative to numerous other approaches in non-invasive ventilation (NIV). Up to now, NIV therapy could only be applied by masks with the associated complications as patients could not tolerate high airflow delivered by a thin nasal cannula without humidification and warming, thus causing concomitant negative effects. The new therapy TNI shows a high rate of acceptance by children, too.
At present, there are two different types of devices available for nasal insufflation in clinics:
TNI 20s, an air humidifier for clinical compressed air, and the TNI20 oxy, an air humidifier for clinical compressed air, which can be combined with oxygen.
TNI 20 oxy The system, which is unique throughout the world, is optimized for the application of flows of up to 20L/min and fulfils the minimum requirements of the "American Society of Testing and Materials" for a high flow air humidifier in the non-invasive application of 10 mg H2O/L (equivalent to about 60% rel. humidity at an ambient temperature of 22°C) for the air humidity. The warming of the air flow by 5-15°C can be adjusted relative to the ambient temperature. Condensation is prevented in the nasal applicator by heating the tube as far as the nostrils. The device automatically controls humidity and temperature depending on the prevailing ambient conditions. The TNI®20s can be attached to the hospital infrastructure by means of a standard pressure regulator.
In another ongoing study (STIT-1) TNI 20 oxy was evaluated for its safety in COPD patients without hypercapnia. In a first interim analysis which included 14 patients high flow oxygen delivery was safe.
- Conditions
- COPD, Hypercapnia
- Being tested
- Nasal oxygen insufflation with a TNI® 20 oxy device, Nasal insufflation of oxygen
- Keywords
- Oxygen, High Flow, COPD, Hypercapnia
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal oxygen insufflation with a TNI® 20 oxy deviceDevice
Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min
Nasal insufflation of oxygenDevice
Nasal insufflation of oxygen starting at at flow of 0.5 L/min.
| Study group | Role | What they receive |
|---|---|---|
| Nasal insufflation of oxygen | Active comparator | Nasal insufflation of oxygen starting at at flow of 0.5 L/min. Receives: Device: Nasal insufflation of oxygen |
| Nasal oxygen insufflation with a TNI® 20 oxy device | Active comparator | Device: TNI®20 oxy Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min Receives: Device: Nasal oxygen insufflation with a TNI® 20 oxy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2
Change in the partial oxygen pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
Measured: 60 min
Secondary outcomes (4)
O2%
Change in the oxygen saturation in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
Measured: 60 min
PaCO2
Change in the PaCO2 in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
Measured: 60 min
AaDO2
Change in the AaDO2 in the peripheral blood at a defined oxygen flow rate (L/min)
Measured: 60 min
RV and TLC
No increase in the residual volume (RV) and the total lung capacity (TLC) > 15% of the mean actual value at visits 1 and 2 (measurement 60 + 10 minutes after oxygen insufflation with a TNI system).
Measured: 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- TNI Medical AG
- Responsible party
- Principal investigator, Univ.-Prof. Dr. Christian M. Kaehler, Medical University Innsbruck
- Investigators
- Christian M Kaehler, MD, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693146
- Sponsor's protocol ID
- UN4484
- Other IDs
- UN4484
- Acronym
- STIT-2
- Status last verified
- Sep 2012
- First submitted
- 14 Sep 2012
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Vogelsinger H, Halank M, Braun S, Wilkens H, Geiser T, Ott S, Stucki A, Kaehler CM. Efficacy and safety of nasal high-flow oxygen in COPD patients. BMC Pulm Med. 2017 Nov 17;17(1):143. doi: 10.1186/s12890-017-0486-3.
PubMed 29149867
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of Short-time TNI® Treatment in Patients With COPD and Hypercapnia Acute Testing of Oxygen Demand Using TNI® vs. Standard Insufflation in COPD Patients With Hypercapnia at Rest
- ClinicalTrials.gov ID
- NCT01693146
- Acronym / sponsor ID
- STIT-2 / UN4484
- Conditions
- COPD, Hypercapnia
- Keywords
- Oxygen, High Flow, COPD, Hypercapnia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Collaborators
- TNI Medical AG
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 26 Sep 2012 (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.
Evaluation of Safety and Efficacy of Short time TNI Treatment in Patients with COPD and hypercapnia.
Acute testing of oxygen demand using TNI vs. standard oxygen application in stable COPD patients with hypercapnia.
Detailed description
TNI, the nasal insufflation of a high flow of warm, humidified air, is an extremely comfortable and uncomplicated alternative to numerous other approaches in non-invasive ventilation (NIV). Up to now, NIV therapy could only be applied by masks with the associated complications as patients could not tolerate high airflow delivered by a thin nasal cannula without humidification and warming, thus causing concomitant negative effects. The new therapy TNI shows a high rate of acceptance by children, too.
At present, there are two different types of devices available for nasal insufflation in clinics:
TNI 20s, an air humidifier for clinical compressed air, and the TNI20 oxy, an air humidifier for clinical compressed air, which can be combined with oxygen.
TNI 20 oxy The system, which is unique throughout the world, is optimized for the application of flows of up to 20L/min and fulfils the minimum requirements of the "American Society of Testing and Materials" for a high flow air humidifier in the non-invasive application of 10 mg H2O/L (equivalent to about 60% rel. humidity at an ambient temperature of 22°C) for the air humidity. The warming of the air flow by 5-15°C can be adjusted relative to the ambient temperature. Condensation is prevented in the nasal applicator by heating the tube as far as the nostrils. The device automatically controls humidity and temperature depending on the prevailing ambient conditions. The TNI®20s can be attached to the hospital infrastructure by means of a standard pressure regulator.
In another ongoing study (STIT-1) TNI 20 oxy was evaluated for its safety in COPD patients without hypercapnia. In a first interim analysis which included 14 patients high flow oxygen delivery was safe.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal insufflation of oxygen | Active comparator | Device: Nasal insufflation of oxygenNasal insufflation of oxygen starting at at flow of 0.5 L/min. |
| Nasal oxygen insufflation with a TNI® 20 oxy device | Active comparator | Device: Nasal oxygen insufflation with a TNI® 20 oxy deviceDevice: TNI®20 oxy Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- COPD patients with an indication for long-term oxygen therapy (LTOT)
- Presence of hypercapnia at rest without oxygen supplementation (PaCO2 > 45 mmHg)
- Age 30 - 85 years
- Functional GOLD class: COPD GOLD IV as defined by the following:
- FEV1/FVC < 70% and a Post-bronchodilator FEV1 < 30% or FEV1 < 50% and a PaO2 < 60 mmHg and/or PaCO2 > 50 mmHg
Key exclusion criteria (6 listed)
- Clinical instability of the patient
- No lung function testing possible
- Exacerbation within the last 14 days prior to inclusion into the study
- Serious concomitant diseases that may jeopardize the inclusion of the patient into the study from the investigator's point of view
- Severe anaemia, defined by a haemoglobin <8.5 G/L
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 |
|---|---|---|
| Nasal oxygen insufflation with a TNI® 20 oxy deviceNasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min | Device | Nasal oxygen insufflation with a TNI® 20 oxy device |
| Nasal insufflation of oxygenNasal insufflation of oxygen starting at at flow of 0.5 L/min. | Device | Nasal insufflation of oxygen |
Primary outcome
PaO2
Time frame: 60 min
Change in the partial oxygen pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
4 secondary outcomes
O2%
Time frame: 60 min
PaCO2
Time frame: 60 min
AaDO2
Time frame: 60 min
RV and TLC
Time frame: 60 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2012.
- Derived from this study: PubMed 29149867Vogelsinger H, Halank M, Braun S, Wilkens H, Geiser T, Ott S, Stucki A, Kaehler CM. Efficacy and safety of nasal high-flow oxygen in COPD patients. BMC Pulm Med. 2017 Nov 17;17(1):143. doi: 10.1186/s12890-017-0486-3.
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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.
Christian M Kaehler, MD principal investigator
Medical University Innsbruck
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nasal oxygen insufflation with a TNI® 20 oxy device and Nasal insufflation of oxygen in people with COPD and Hypercapnia, run by Medical University Innsbruck at 4 sites in 3 countries.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Austria, Switzerland. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian M Kaehler, MD (004351250423255, c.m.kaehler@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2 (time frame: 60 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01693146, which also lists 1 linked publication.
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 26 Sep 2012.