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

Sponsor
Rush University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03091504
Collaborator
People's Hospital of Xinjiang Uygur Autonomous Region (Other)
42
Enrollment
1
Location
1
Arm
6.8
Actual Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: High flow nasal cannula
  • Drug: Albuterol Sulfate
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation on the Efficacy of Bronchodilator Nebulization Via High Flow Nasal Cannula
Actual Study Start Date :
Sep 4, 2017
Actual Primary Completion Date :
Mar 31, 2018
Actual Study Completion Date :
Mar 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Device: 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.
Other Names:
  • Optiflow, Fisher Paykel

    • Drug: Albuterol Sulfate
    Albuterol is a short acting inhaled bronchodilator
    Other Names:
  • Ventolin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. FEV1 change from initial [30-60 mins]

      FEV1 abs Δ: post FEV 1 - pre FEV1 and FEV1 %Δinit: (post FEV1 - pre FEV1)/pre FEV1 × 100

    Secondary Outcome Measures

    1. Breath sound [30-60 mins]

      Wheezing

    2. Heart rate [30-60 mins]

      The number of heart beats per minute

    3. Respiratory rate [30-60 mins]

      About 4,630,000 results (0.68 seconds) Search Results The number of breaths per minute

    4. Side effects [30-60 mins]

      Tremor

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 People's Hospital of Xinjiang Uygur Autonomous Region Ürümqi Xinjiang China 830001

    Sponsors and Collaborators

    • Rush University Medical Center
    • People's Hospital of Xinjiang Uygur Autonomous Region

    Investigators

    • Principal Investigator: Minghua Zhao, MD, People's Hospital of Xinjiang Uygur Autonomous Region

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jie Li, Principal Investigator, Rush University Medical Center
    ClinicalTrials.gov Identifier:
    NCT03091504
    Other Study ID Numbers:
    • BDTHFNC01
    First Posted:
    Mar 27, 2017
    Last Update Posted:
    Apr 4, 2018
    Last Verified:
    Apr 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Albuterol

    Study Results

    No Results Posted as of Apr 4, 2018