Clinical trial NCT03091504: Evaluation on the Efficacy of Bronchodilator Nebulization Via High Flow Nasal Cannula
Official title: Evaluation on the Efficacy of Bronchodilator Nebulization Via High Flow Nasal Cannula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Flow Nasal Cannula
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: People's Hospital of Xinjiang Uygur Autonomous Region
First posted: 2017-03-27
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: FEV1 change from initial
timeFrame: 30-60 mins
Secondary outcomes:
measure: Breath sound
timeFrame: 30-60 mins
measure: Heart rate
timeFrame: 30-60 mins
measure: Respiratory rate
timeFrame: 30-60 mins
measure: Side effects
timeFrame: 30-60 mins
Other outcomes:
Locations:
city: Ürümqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
Study officials:
affiliation: People's Hospital of Xinjiang Uygur Autonomous Region
name: Minghua Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.