COPD AsthmaNCT03739359
The Role of Gas Flow in Transnasal Pulmonary Aerosol Delivery: A Double-blinded, Randomized Controlled Trial
A study testing nasal cannula gas flow in people with COPD Asthma, run by Rush University Medical Center at 1 site in China.
Trial summary
Aerosol delivery via nasal cannula has gained increasing popularity, due to its combined benefits from aerosolized medication and heated warm oxygen therapy. In our previous in vitro study, we investigated the effects of the ratio of nasal cannula gas flow to subject's peak inspiratory flow (GF: IF) on the aerosol… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COPD Asthma
- What is being tested?
- nasal cannula gas flow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 1 Dec 2019
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with positive bronchodilator responses to four actuations of albuterol (Ventolin, GSK, UK) via MDI with VHC (OptiChamber Diamond, Philips, USA) will be eligible for enrollment. A positive bronchodilator response is defined in accordance with ATS/ERS guidelines as follows: an increase in FEV1 of ≥ 12% and absolute change ≥ 200 mL from baseline.
Who cannot join
- age ≥ 90 years old;
- pregnancy;
- pulmonary exacerbation within two weeks before enrollment;
- reluctant to participate;
- inability to complete the follow-up spirometry after each bronchodilator inhalation;
- resting heart rate > 100bpm;
- resting systolic blood pressure > 160mmHg or diastolic blood pressure > 110mmHg.
Trial locations and contacts
1 site in 1 country.
China1 site
People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100853
About this study
Official title: Investigating the Role of Gas Flow in Transnasal Pulmonary Aerosol Delivery Via Nasal Cannula: A Double-blinded, Randomized Controlled Trial
Aerosol delivery via nasal cannula has gained increasing popularity, due to its combined benefits from aerosolized medication and heated warm oxygen therapy. In our previous in vitro study, we investigated the effects of the ratio of nasal cannula gas flow to subject's peak inspiratory flow (GF: IF) on the aerosol lung deposition, and we found that aerosol deposition in lung increased as the GF: IF decreased with an optimal GF: IF between 0.1 to 0.5 producing a stable "lung" deposition in both quiet and distress breathing. Thus we aimed to further validate such an optimal GF: IF in patients with reversible airflow limitations by the delivery of bronchodilators. Adult COPD or asthma patients who met ATS/ERS criteria for bronchodilator response in pulmonary function lab will be recruited and consented. After a washout period (1-3 days), patients will receive an escalating doubling dosage (0.5, 1, 2, and 4mg) of albuterol in total volume of 2mL, delivered by mesh nebulizer via nasal cannula. Patients will be randomly assigned to inhale bronchodilator into 3 group using different flows: 50 L/min,GF: IF = 1.0, and GF: IF = 0.5.
Read the detailed description
Introduction Both in vitro and in vivo radiolabeled studies on nebulization via high flow nasal cannula (HFNC) showed that aerosol lung deposition decreased with the increasing nasal cannula gas flow, which, however, was not observed in patients with distressed breathing. In our previous in vitro study, we investigated the effects of the ratio of nasal cannula gas flow to subject's peak inspiratory flow (GF: IF) on the aerosol lung deposition, and we found that aerosol deposition in lung increased as the GF: IF decreased with an optimal GF: IF between 0.1 to 0.5 producing a stable "lung" deposition in both quiet and distress breathing. Thus we aimed to further validate such an optimal GF: IF in patients with reversible airflow limitations by the delivery of bronchodilators.
Methods and analysis COPD and asthma patients with positive response to four actuations of albuterol via metered dose inhaler (MDI) and valved holding chamber (VHC) will be enrolled and consented in the study. After a washout period (1-3 days), patients will be randomly assigned to three groups with different nasal cannula gas flow: 50L/min, GF: IF = 1.0, and GF: IF = 0.5. In each treatment arm, patients will firstly receive saline, then followed by an escalating doubling dosages (0.5, 1, 2, and 4mg) of albuterol in a total volume of 2mL, delivered by mesh nebulizer (VMN, Aerogen, Ireland) via heated nasal cannula at 37℃. An interval of 30 min will be maintained between two doses of albuterol, and pulmonary spirometry will be measured at baseline and after each dose. Titration will be terminated when an additional FEV1 improvement was < 5%.
- Conditions
- COPD Asthma
- Being tested
- nasal cannula gas flow
- Keywords
- Nasal cannula, Aerosol therapy, Gas flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal cannula gas flowOther
High flow nasal cannula (HFNC) is a relatively new oxygen device, which provides warmed and humidified oxygen for patients. When patients need to inhale aerosolized medication during HFNC, the nebulizer will be placed in-line in order to provide both treatments. This study will investigate the influence of three flow settings (50 L/min, GF:IF=1, GF:IF=0.5) on the clinical effects of nebulization.
| Study group | Role | What they receive |
|---|---|---|
| Gas flow 50 L/min | Active comparator | In this group, nasal cannula gas flow will be set at 50 L/min. Receives: Other: nasal cannula gas flow |
| GF:IF=1 | Experimental | In this group, nasal cannula gas flow will be set at each individual patient's own inspiratory flow (GF:IF=1) Receives: Other: nasal cannula gas flow |
| GF:IF=0.5 | Experimental | In this group, nasal cannula gas flow will be set at 50% of each individual patient's own inspiratory flow (GF:IF=0.5) Receives: Other: nasal cannula gas flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients who meet the positive criteria of responding to albuterol at the dose of 0.5mg
The number of patients in HFNC nebulization who respond to albuterol at the dose of 0.5mg
Measured: 30 minutes
The number of patients who meet the positive criteria of responding to albuterol at the dose of 1.5 mg
The number of patients in HFNC nebulization who respond to albuterol at the dose of 1.5mg
Measured: 60 minutes
The number of patients who meet the positive criteria of responding to albuterol at the dose of 3.5 mg
The number of patients in HFNC nebulization who respond to albuterol at the dose of 3.5mg
Measured: 90 minutes
The number of patients who meet the positive criteria of responding to albuterol at the dose of 7.5mg
The number of patients in HFNC nebulization who respond to albuterol at the dose of 7.5mg
Measured: 120 minutes
Secondary outcomes (3)
the accumulative dose of albuterol required across groups to produce positive bronchodilation effects
the accumulative dose of albuterol required to produce positive bronchodilation effects in each group
Measured: 120 minutes
the incidence of side effect (tachycardia) in each group
the incidence of side effect (tachycardia) will be recorded in each group
Measured: 120 minutes
the incidence of side effect (tremor) in each group
the incidence of side effect (tachycardia) will be recorded in each group
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start1 Feb 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COPD AsthmaStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- People's Liberation Army General Hospital
- Responsible party
- Sponsor
- Investigators
- Lixing Xie, MD, Study chair, People's Liberation Army General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739359
- Sponsor's protocol ID
- HFNC-PFT-002
- Status last verified
- Mar 2020
- First submitted
- 8 Nov 2018
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data after deidentification that underlie the reports reported in this article can be obtained by contacting the corresponding author. Data will be available immediately following publication and ending in 5 years.
Publications
Zhu Y, Yin H, Zhang R, Wei J. High-flow nasal cannula oxygen therapy versus conventional oxygen therapy in patients with acute respiratory failure: a systematic review and meta-analysis of randomized controlled trials. BMC Pulm Med. 2017 Dec 13;17(1):201. doi: 10.1186/s12890-017-0525-0.
PubMed 29237436Braunlich 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 29261402Gacouin A, Maamar A, Fillatre P, Sylvestre E, Dolan M, Le Tulzo Y, Tadie JM. Patients with preexisting psychiatric disorders admitted to ICU: a descriptive and retrospective cohort study. Ann Intensive Care. 2017 Dec;7(1):1. doi: 10.1186/s13613-016-0221-x. Epub 2017 Jan 3.
PubMed 28050894Ammar MA, Sasidhar M, Lam SW. Inhaled Epoprostenol Through Noninvasive Routes of Ventilator Support Systems. Ann Pharmacother. 2018 Dec;52(12):1173-1181. doi: 10.1177/1060028018782209. Epub 2018 Jun 12.
PubMed 29890848Dugernier J, Hesse M, Jumetz T, Bialais E, Roeseler J, Depoortere V, Michotte JB, Wittebole X, Ehrmann S, Laterre PF, Jamar F, Reychler G. Aerosol Delivery with Two Nebulizers Through High-Flow Nasal Cannula: A Randomized Cross-Over Single-Photon Emission Computed Tomography-Computed Tomography Study. J Aerosol Med Pulm Drug Deliv. 2017 Oct;30(5):349-358. doi: 10.1089/jamp.2017.1366. Epub 2017 May 2.
PubMed 28463044Li J, Luo J, Chen Y, Xie L, Fink JB. Effects of flow rate on transnasal pulmonary aerosol delivery of bronchodilators via high-flow nasal cannula for patients with COPD and asthma: protocol for a randomised controlled trial. BMJ Open. 2019 Jun 24;9(6):e028584. doi: 10.1136/bmjopen-2018-028584.
PubMed 31239304
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role of Gas Flow in Transnasal Pulmonary Aerosol Delivery Via Nasal Cannula: A Double-blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03739359
- Acronym / sponsor ID
- HFNC-PFT-002
- Conditions
- COPD Asthma
- Keywords
- Nasal cannula, Aerosol therapy, Gas flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- People's Liberation Army General Hospital
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 13 Nov 2018 (actual)
- 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.
Aerosol delivery via nasal cannula has gained increasing popularity, due to its combined benefits from aerosolized medication and heated warm oxygen therapy. In our previous in vitro study, we investigated the effects of the ratio of nasal cannula gas flow to subject's peak inspiratory flow (GF: IF) on the aerosol lung deposition, and we found that aerosol deposition in lung increased as the GF: IF decreased with an optimal GF: IF between 0.1 to 0.5 producing a stable "lung" deposition in both quiet and distress breathing. Thus we aimed to further validate such an optimal GF: IF in patients with reversible airflow limitations by the delivery of bronchodilators. Adult COPD or asthma patients who met ATS/ERS criteria for bronchodilator response in pulmonary function lab will be recruited and consented. After a washout period (1-3 days), patients will receive an escalating doubling dosage (0.5, 1, 2, and 4mg) of albuterol in total volume of 2mL, delivered by mesh nebulizer via nasal cannula. Patients will be randomly assigned to inhale bronchodilator into 3 group using different flows: 50 L/min,GF: IF = 1.0, and GF: IF = 0.5.
Detailed description
Introduction Both in vitro and in vivo radiolabeled studies on nebulization via high flow nasal cannula (HFNC) showed that aerosol lung deposition decreased with the increasing nasal cannula gas flow, which, however, was not observed in patients with distressed breathing. In our previous in vitro study, we investigated the effects of the ratio of nasal cannula gas flow to subject's peak inspiratory flow (GF: IF) on the aerosol lung deposition, and we found that aerosol deposition in lung increased as the GF: IF decreased with an optimal GF: IF between 0.1 to 0.5 producing a stable "lung" deposition in both quiet and distress breathing. Thus we aimed to further validate such an optimal GF: IF in patients with reversible airflow limitations by the delivery of bronchodilators.
Methods and analysis COPD and asthma patients with positive response to four actuations of albuterol via metered dose inhaler (MDI) and valved holding chamber (VHC) will be enrolled and consented in the study. After a washout period (1-3 days), patients will be randomly assigned to three groups with different nasal cannula gas flow: 50L/min, GF: IF = 1.0, and GF: IF = 0.5. In each treatment arm, patients will firstly receive saline, then followed by an escalating doubling dosages (0.5, 1, 2, and 4mg) of albuterol in a total volume of 2mL, delivered by mesh nebulizer (VMN, Aerogen, Ireland) via heated nasal cannula at 37℃. An interval of 30 min will be maintained between two doses of albuterol, and pulmonary spirometry will be measured at baseline and after each dose. Titration will be terminated when an additional FEV1 improvement was < 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gas flow 50 L/min | Active comparator | Other: nasal cannula gas flowIn this group, nasal cannula gas flow will be set at 50 L/min. |
| GF:IF=1 | Experimental | Other: nasal cannula gas flowIn this group, nasal cannula gas flow will be set at each individual patient's own inspiratory flow (GF:IF=1) |
| GF:IF=0.5 | Experimental | Other: nasal cannula gas flowIn this group, nasal cannula gas flow will be set at 50% of each individual patient's own inspiratory flow (GF:IF=0.5) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with positive bronchodilator responses to four actuations of albuterol (Ventolin, GSK, UK) via MDI with VHC (OptiChamber Diamond, Philips, USA) will be eligible for enrollment. A positive bronchodilator response is defined in accordance with ATS/ERS guidelines as follows: an increase in FEV1 of ≥ 12% and absolute change ≥ 200 mL from baseline.
Key exclusion criteria (7 listed)
- age ≥ 90 years old;
- pregnancy;
- pulmonary exacerbation within two weeks before enrollment;
- reluctant to participate;
- inability to complete the follow-up spirometry after each bronchodilator inhalation;
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 cannula gas flowHigh flow nasal cannula (HFNC) is a relatively new oxygen device, which provides warmed and humidified oxygen for patients. When patients need to inhale aerosolized medication during HFNC, the nebulizer will be placed in-line in order to provide both treatments. This study will investigate the influence of three flow settings (50 L/min, GF:IF=1, GF:IF=0.5) on the clinical effects of nebulization. | Other | GF:IF=0.5, GF:IF=1, Gas flow 50 L/min |
Primary outcome
The number of patients who meet the positive criteria of responding to albuterol at the dose of 0.5mg
Time frame: 30 minutes
The number of patients in HFNC nebulization who respond to albuterol at the dose of 0.5mg
The number of patients who meet the positive criteria of responding to albuterol at the dose of 1.5 mg
Time frame: 60 minutes
The number of patients in HFNC nebulization who respond to albuterol at the dose of 1.5mg
The number of patients who meet the positive criteria of responding to albuterol at the dose of 3.5 mg
Time frame: 90 minutes
The number of patients in HFNC nebulization who respond to albuterol at the dose of 3.5mg
The number of patients who meet the positive criteria of responding to albuterol at the dose of 7.5mg
Time frame: 120 minutes
The number of patients in HFNC nebulization who respond to albuterol at the dose of 7.5mg
3 secondary outcomes
the accumulative dose of albuterol required across groups to produce positive bronchodilation effects
Time frame: 120 minutes
the incidence of side effect (tachycardia) in each group
Time frame: 120 minutes
the incidence of side effect (tremor) in each group
Time frame: 120 minutes
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 11 Mar 2020.
- Results publication: PubMed 29237436Zhu Y, Yin H, Zhang R, Wei J. High-flow nasal cannula oxygen therapy versus conventional oxygen therapy in patients with acute respiratory failure: a systematic review and meta-analysis of randomized controlled trials. BMC Pulm Med. 2017 Dec 13;17(1):201. doi: 10.1186/s12890-017-0525-0.
- Results publication: 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.
- Results publication: PubMed 28050894Gacouin A, Maamar A, Fillatre P, Sylvestre E, Dolan M, Le Tulzo Y, Tadie JM. Patients with preexisting psychiatric disorders admitted to ICU: a descriptive and retrospective cohort study. Ann Intensive Care. 2017 Dec;7(1):1. doi: 10.1186/s13613-016-0221-x. Epub 2017 Jan 3.
- Results publication: PubMed 29890848Ammar MA, Sasidhar M, Lam SW. Inhaled Epoprostenol Through Noninvasive Routes of Ventilator Support Systems. Ann Pharmacother. 2018 Dec;52(12):1173-1181. doi: 10.1177/1060028018782209. Epub 2018 Jun 12.
- Results publication: PubMed 28463044Dugernier J, Hesse M, Jumetz T, Bialais E, Roeseler J, Depoortere V, Michotte JB, Wittebole X, Ehrmann S, Laterre PF, Jamar F, Reychler G. Aerosol Delivery with Two Nebulizers Through High-Flow Nasal Cannula: A Randomized Cross-Over Single-Photon Emission Computed Tomography-Computed Tomography Study. J Aerosol Med Pulm Drug Deliv. 2017 Oct;30(5):349-358. doi: 10.1089/jamp.2017.1366. Epub 2017 May 2.
- Derived from this study: PubMed 31239304Li J, Luo J, Chen Y, Xie L, Fink JB. Effects of flow rate on transnasal pulmonary aerosol delivery of bronchodilators via high-flow nasal cannula for patients with COPD and asthma: protocol for a randomised controlled trial. BMJ Open. 2019 Jun 24;9(6):e028584. doi: 10.1136/bmjopen-2018-028584.
- Individual participant dataSharing planned: Yes. Individual participant data after deidentification that underlie the reports reported in this article can be obtained by contacting the corresponding author. Data will be available immediately following publication and ending in 5 years.
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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.
Lixing Xie, MD study chair
People's Liberation Army General Hospital
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 cannula gas flow in people with COPD Asthma, run by Rush University Medical Center at 1 site in China.
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 7 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 11 Mar 2020. 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 China. 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?
The number of patients who meet the positive criteria of responding to albuterol at the dose of 0.5mg (time frame: 30 minutes). The study lists 4 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 NCT03739359, which also lists 6 linked publications.
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 11 Mar 2020.