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The Role of Gas Flow in Transnasal Pulmonary Aerosol Delivery: A Double-blinded, Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT03739359
Recruitment Status : Recruiting
First Posted : November 12, 2018
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
People's Liberation Army General Hospital
Information provided by (Responsible Party):
Rush University Medical Center

Brief 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 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.

Condition or disease Intervention/treatment Phase
COPD Asthma Other: nasal cannula gas flow Not Applicable

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%.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: Nebulization will be offered in a one room and pulmonary function test will be performed in the other room. Both patients and the pulmonary function test technician will be masked to the group.
Primary Purpose: Treatment
Official Title: Investigating the Role of Gas Flow in Transnasal Pulmonary Aerosol Delivery Via Nasal Cannula: A Double-blinded, Randomized Controlled Trial
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Active Comparator: Gas flow 50 L/min
In this group, nasal cannula gas flow will be set at 50 L/min.
Other: nasal cannula gas flow
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.

Experimental: GF:IF=1
In this group, nasal cannula gas flow will be set at each individual patient's own inspiratory flow (GF:IF=1)
Other: nasal cannula gas flow
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.

Experimental: GF:IF=0.5
In this group, nasal cannula gas flow will be set at 50% of each individual patient's own inspiratory flow (GF:IF=0.5)
Other: nasal cannula gas flow
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. the accumulative dose of albuterol required across groups to produce positive bronchodilation effects [ Time Frame: 120 minutes ]
    the accumulative dose of albuterol required to produce positive bronchodilation effects in each group

  2. the incidence of side effect (tachycardia) in each group [ Time Frame: 120 minutes ]
    the incidence of side effect (tachycardia) will be recorded in each group

  3. the incidence of side effect (tremor) in each group [ Time Frame: 120 minutes ]
    the incidence of side effect (tachycardia) will be recorded in each group



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739359


Contacts
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Contact: Jie Li, MS 312-947-0065 Jie_Li@rush.edu
Contact: Yibing Chen, MS chenyibing1128@126.com

Locations
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China, Beijing
People's Liberation Army General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Yibing Chen, MS         
Sponsors and Collaborators
Rush University Medical Center
People's Liberation Army General Hospital
Investigators
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Study Chair: Lixing Xie, MD People's Liberation Army General Hospital

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03739359     History of Changes
Other Study ID Numbers: HFNC-PFT-002
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Time Frame: 5 years following publication
Access Criteria: contacting the corresponding author

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Rush University Medical Center:
Nasal cannula
Aerosol therapy
Gas flow