Chronic Obstructive Pulmonary DiseaseAEROFLOWNCT02885103
Combination of NHF and Nebulizer on Lung Function in COPD
A study testing Nasal high flow (NHF) and Nebulizer in people with Chronic Obstructive Pulmonary Disease, run by University of Leipzig at 1 site in Germany.
Trial summary
This study will prove to concept of effectiveness of NHF in combination with a nebulizer on reversibility of lung function in COPD patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Nasal high flow (NHF) and Nebulizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2016to Nov 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- stable disease
- COPD
Who cannot join
- exacerbation
- right heart decompensation
- acute respiratory insufficiency
- acute disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Nasal Highflow in Combination With a Nebulizer on Reversibility in Lung Function in Patients With COPD
This study will prove to concept of effectiveness of NHF in combination with a nebulizer on reversibility of lung function in COPD patients.
Read the detailed description
Patients will inhale on day 1 with a nebulizer and on another day with combination of nebulizer an NHF in a randomised order.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Nasal high flow (NHF), Nebulizer
- Keywords
- NHF, nasal highflow
- 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.
Nasal high flow (NHF)Device
NHF will be combinated with a nebulizer. Inhalation will be done on nasal cavity.
NebulizerDevice
Inhalation will be done will Nebulizer and via mouth
| Study group | Role | What they receive |
|---|---|---|
| inhalation with nebulizer | Placebo comparator | inhalation with an nebulizer via mouth Receives: Device: Nebulizer |
| inhalation with nebulizer and NHF | Active comparator | inhalation with combination of nebulizer and nasal high flow (NHF) via nasal cavity Receives: Device: Nasal high flow (NHF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in forced expiratory volume in 1s (FEV1)
litre
Measured: 45 minutes
changes in breath way resistance (Rtot)
Measured: 45 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2017
- Study completionNov 2017
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 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
- Hubert Wirtz, MD, Study director, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885103
- Sponsor's protocol ID
- 349-15-24082015
- Acronym
- AEROFLOW
- Status last verified
- Mar 2018
- First submitted
- 22 Aug 2016
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Braunlich J, Wirtz H. Oral Versus Nasal High-Flow Bronchodilator Inhalation in Chronic Obstructive Pulmonary Disease. J Aerosol Med Pulm Drug Deliv. 2018 Aug;31(4):248-254. doi: 10.1089/jamp.2017.1432. Epub 2017 Dec 20.
PubMed 29261402
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nasal Highflow in Combination With a Nebulizer on Reversibility in Lung Function in Patients With COPD
- ClinicalTrials.gov ID
- NCT02885103
- Acronym / sponsor ID
- AEROFLOW / 349-15-24082015
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- NHF, nasal highflow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 31 Aug 2016 (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.
This study will prove to concept of effectiveness of NHF in combination with a nebulizer on reversibility of lung function in COPD patients.
Detailed description
Patients will inhale on day 1 with a nebulizer and on another day with combination of nebulizer an NHF in a randomised order.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inhalation with nebulizer | Placebo comparator | Device: Nebulizerinhalation with an nebulizer via mouth |
| inhalation with nebulizer and NHF | Active comparator | Device: Nasal high flow (NHF)inhalation with combination of nebulizer and nasal high flow (NHF) via nasal cavity |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- stable disease
- COPD
Key exclusion criteria (4 listed)
- exacerbation
- right heart decompensation
- acute respiratory insufficiency
- acute 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 high flow (NHF)NHF will be combinated with a nebulizer. Inhalation will be done on nasal cavity. | Device | inhalation with nebulizer and NHF |
| NebulizerInhalation will be done will Nebulizer and via mouth | Device | inhalation with nebulizer |
Primary outcome
changes in forced expiratory volume in 1s (FEV1)
Time frame: 45 minutes
litre
changes in breath way resistance (Rtot)
Time frame: 45 min
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 27 Mar 2018.
- Derived from this study: PubMed 29261402Braunlich J, Wirtz H. Oral Versus Nasal High-Flow Bronchodilator Inhalation in Chronic Obstructive Pulmonary Disease. J Aerosol Med Pulm Drug Deliv. 2018 Aug;31(4):248-254. doi: 10.1089/jamp.2017.1432. Epub 2017 Dec 20.
- Individual participant dataSharing planned: Undecided
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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.
Hubert Wirtz, 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 high flow (NHF) and Nebulizer in people with Chronic Obstructive Pulmonary Disease, 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 2 inclusion and 4 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 27 Mar 2018. 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. Some participants in this study may receive a placebo. 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 forced expiratory volume in 1s (FEV1) (time frame: 45 minutes). The study lists 2 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 NCT02885103, 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 27 Mar 2018.