Evaluation on the Efficacy of Bronchodilator Nebulization Via High Flow Nasal Cannula

NCT ID: NCT03091504

Last Updated: 2018-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-04

Study Completion Date

2018-03-31

Brief Summary

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High-humidity nasal cannula (HFNC) has been shown to be effective in improving oxygenation and avoiding intubation in multiple randomized control trials, it is also suitable and feasible for long term use. Aerosol delivery via HFNC will minimize interruptions and improve patient compliance, bench study and radionuclide imaging study done in healthy volunteers demonstrated that aerosol can be effectively delivered using HFNC. This study aims to evaluate the efficacy of bronchodilator delivered via HFNC in chronic pulmonary obstructive disease or asthma patients.

Detailed Description

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Chronic obstructive pulmonary disease or asthma patients who have positive response in bronchodilator test will be consented and enrolled, patients come back for the second bronchodilator assessment within one to three days after the initial bronchodilator test. Albuterol with different concentration will be provided to the patients via HFNC, patients will be assessed by spirometry after each concentration until bronchodilator response is positive and does not improve after the next dose.

Conditions

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High Flow Nasal Cannula

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Albuterol via High flow nasal cannula

Enrolled patients inhale bronchodilator (Albuterol Sulfate) with different concentration via High flow nasal cannula, prepared albuterol concentrations are 0.5mg, 1.0mg, 2.0mg and 4.0mg, patients will be assessed by spirometry after each concentration until bronchodilator response is positive and does not improve after the next dose.

Group Type EXPERIMENTAL

High flow nasal cannula

Intervention Type DEVICE

High flow nasal cannula is a soft and flexible nasal prongs with adjustable head strap fits over the patient's ears, it delivers a broad variety of gas flows directly into the nares without gas jetting.

Albuterol Sulfate

Intervention Type DRUG

Albuterol is a short acting inhaled bronchodilator

Interventions

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High flow nasal cannula

High flow nasal cannula is a soft and flexible nasal prongs with adjustable head strap fits over the patient's ears, it delivers a broad variety of gas flows directly into the nares without gas jetting.

Intervention Type DEVICE

Albuterol Sulfate

Albuterol is a short acting inhaled bronchodilator

Intervention Type DRUG

Other Intervention Names

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Optiflow, Fisher Paykel Ventolin

Eligibility Criteria

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Inclusion Criteria

* Diagnose with COPD or asthma
* Bronchodilator test is positive (According to ATS guidelines, FEV1 change from initial more than 12% and FEV1 absolute change more than 200 mL);
* Age \> 18yrs and \< 90yrs

Exclusion Criteria

* Recent pulmonary exacerbation
* Mental disease
* Uncooperative
* Reluctant to participate
* Patients who are unable to come back to get the second spirometry within three days
* Contraindicated to Albuterol (Ventolin, GSK)

* Rest HR \> 100 beats/min
* Serum K+ \< 2.8 mmol/L
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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People's Hospital of Xinjiang Uygur Autonomous Region

OTHER

Sponsor Role collaborator

Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jie Li

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Minghua Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

People's Hospital of Xinjiang Uygur Autonomous Region

Locations

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People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, China

Site Status

Countries

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China

References

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Dailey PA, Harwood R, Walsh K, Fink JB, Thayer T, Gagnon G, Ari A. Aerosol Delivery Through Adult High Flow Nasal Cannula With Heliox and Oxygen. Respir Care. 2017 Sep;62(9):1186-1192. doi: 10.4187/respcare.05127. Epub 2017 Jun 6.

Reference Type BACKGROUND
PMID: 28588117 (View on PubMed)

Reminiac F, Vecellio L, Heuze-Vourc'h N, Petitcollin A, Respaud R, Cabrera M, Pennec DL, Diot P, Ehrmann S. Aerosol Therapy in Adults Receiving High Flow Nasal Cannula Oxygen Therapy. J Aerosol Med Pulm Drug Deliv. 2016 Apr;29(2):134-41. doi: 10.1089/jamp.2015.1219. Epub 2015 Jul 21.

Reference Type BACKGROUND
PMID: 26196740 (View on PubMed)

Dugernier 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.

Reference Type BACKGROUND
PMID: 28463044 (View on PubMed)

Reminiac F, Vecellio L, Loughlin RM, Le Pennec D, Cabrera M, Vourc'h NH, Fink JB, Ehrmann S. Nasal high flow nebulization in infants and toddlers: An in vitro and in vivo scintigraphic study. Pediatr Pulmonol. 2017 Mar;52(3):337-344. doi: 10.1002/ppul.23509. Epub 2016 Jul 8.

Reference Type BACKGROUND
PMID: 27392199 (View on PubMed)

Morgan SE, Mosakowski S, Solano P, Hall JB, Tung A. High-Flow Nasal Cannula and Aerosolized beta Agonists for Rescue Therapy in Children With Bronchiolitis: A Case Series. Respir Care. 2015 Sep;60(9):e161-5. doi: 10.4187/respcare.03996. Epub 2015 Jun 23.

Reference Type BACKGROUND
PMID: 26106204 (View on PubMed)

Baudin F, Buisson A, Vanel B, Massenavette B, Pouyau R, Javouhey E. Nasal high flow in management of children with status asthmaticus: a retrospective observational study. Ann Intensive Care. 2017 Dec;7(1):55. doi: 10.1186/s13613-017-0278-1. Epub 2017 May 22.

Reference Type BACKGROUND
PMID: 28534235 (View on PubMed)

Other Identifiers

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BDTHFNC01

Identifier Type: -

Identifier Source: org_study_id

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