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

April 2, 2018 updated by: Jie Li, Rush University Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830001
        • People's Hospital of Xinjiang Uygur Autonomous Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FEV1 change from initial
Time Frame: 30-60 mins
FEV1 abs Δ: post FEV 1 - pre FEV1 and FEV1 %Δinit: (post FEV1 - pre FEV1)/pre FEV1 × 100
30-60 mins

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breath sound
Time Frame: 30-60 mins
Wheezing
30-60 mins
Heart rate
Time Frame: 30-60 mins
The number of heart beats per minute
30-60 mins
Respiratory rate
Time Frame: 30-60 mins

About 4,630,000 results (0.68 seconds)

Search Results

The number of breaths per minute
30-60 mins
Side effects
Time Frame: 30-60 mins
Tremor
30-60 mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Collaborators

People's Hospital of Xinjiang Uygur Autonomous Region

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2017

Primary Completion (Actual)

March 31, 2018

Study Completion (Actual)

March 31, 2018

Study Registration Dates

First Submitted

March 15, 2017

First Submitted That Met QC Criteria

March 21, 2017

First Posted (Actual)

March 27, 2017

Study Record Updates

Last Update Posted (Actual)

April 4, 2018

Last Update Submitted That Met QC Criteria

April 2, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BDTHFNC01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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