Chronic Obstructive Pulmonary DiseaseATMOFLOWNCT02504814
Physiological and Clinical Changes in NHF Therapy
A study testing Nasal Highflow (NHF) in people with Chronic Obstructive Pulmonary Disease and Hypercapnia, run by University of Leipzig at 1 site in Germany.
Trial summary
The study explores the changes in pressure, volume and in hypercapnia in patients with COPD and ILD. The investigators will use different application forms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Hypercapnia, Interstitital Lung Disease
- What is being tested?
- Nasal Highflow (NHF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2011to Jun 2018
- 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
- COPD, ILD
Who cannot join
- Unstable disease
Trial locations and contacts
1 site in 1 country.
About this study
The study explores the changes in pressure, volume and in hypercapnia in patients with COPD and ILD. The investigators will use different application forms.
- Being tested
- Nasal Highflow (NHF)
- Keywords
- nasal high flow
- 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 Highflow (NHF)Device
Also called TNI softflow50
changes in breathing physiology in NHF
| Study group | Role | What they receive |
|---|---|---|
| ventilatory effects | Experimental | measuring mean airway pressure, breathing volumes and decrease in hypercapnia Receives: Device: Nasal Highflow (NHF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in mean airway pressure (mbar)
Measured: 1 month
changes in tidal and minute volume (l)
Measured: 1 month
changes in breathing frequency (beats/ minute)
Measured: 1 month
Secondary outcomes (1)
changes in partial pressure of carbon dioxide (CO2) in arterial blood (pCO2)
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJun 2011
- Primary completionJun 2018
- Study completionJun 2018
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Bräunlich, MD, University of Leipzig
- Investigators
- Jens Bräunlich, MD, Study director, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504814
- Sponsor's protocol ID
- 414-14-06102014
- Acronym
- ATMOFLOW
- Status last verified
- Feb 2019
- First submitted
- 27 May 2015
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Braunlich J, Mauersberger F, Wirtz H. Effectiveness of nasal highflow in hypercapnic COPD patients is flow and leakage dependent. BMC Pulm Med. 2018 Jan 24;18(1):14. doi: 10.1186/s12890-018-0576-x.
PubMed 29368599
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Clinical Changes in NHF Therapy
- ClinicalTrials.gov ID
- NCT02504814
- Acronym / sponsor ID
- ATMOFLOW / 414-14-06102014
- Keywords
- nasal high flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 22 Jul 2015 (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 study explores the changes in pressure, volume and in hypercapnia in patients with COPD and ILD. The investigators will use different application forms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ventilatory effects | Experimental | Device: Nasal Highflow (NHF)measuring mean airway pressure, breathing volumes and decrease in hypercapnia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COPD, ILD
Key exclusion criteria (1 listed)
- Unstable disease
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 Highflow (NHF)Also: TNI softflow50changes in breathing physiology in NHF | Device | ventilatory effects |
Primary outcome
changes in mean airway pressure (mbar)
Time frame: 1 month
changes in tidal and minute volume (l)
Time frame: 1 month
changes in breathing frequency (beats/ minute)
Time frame: 1 month
1 secondary outcome
changes in partial pressure of carbon dioxide (CO2) in arterial blood (pCO2)
Time frame: 4 month
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 18 Feb 2019.
- Derived from this study: PubMed 29368599Braunlich J, Mauersberger F, Wirtz H. Effectiveness of nasal highflow in hypercapnic COPD patients is flow and leakage dependent. BMC Pulm Med. 2018 Jan 24;18(1):14. doi: 10.1186/s12890-018-0576-x.
Related trials for Chronic Obstructive Pulmonary Disease
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
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 Bräunlich, MD study director
University of Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Highflow (NHF) in people with Chronic Obstructive Pulmonary Disease and Hypercapnia, run by University of Leipzig at 1 site 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 1 inclusion and 1 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 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
changes in mean airway pressure (mbar) (time frame: 1 month). The study lists 3 primary outcomes in all. 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 NCT02504814, 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 18 Feb 2019.