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Completed

NCT Number: NCT03091504

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

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.

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Key information

Conditions

High Flow Nasal Cannula

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Flow Nasal Cannula

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.

Other names: Optiflow, Fisher Paykel

Albuterol sulfate

Drug

Albuterol is a short acting inhaled bronchodilator

Other names: Ventolin

Primary outcomes

  1. 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

Secondary outcomes

  1. Breath sound

    Time frame: 30-60 mins

    Wheezing

  2. Heart rate

    Time frame: 30-60 mins

    The number of heart beats per minute

  3. Respiratory rate

    Time frame: 30-60 mins

    About 4,630,000 results (0.68 seconds)

    Search Results

    The number of breaths per minute

  4. Side effects

    Time frame: 30-60 mins

    Tremor

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • People's Hospital of Xinjiang Uygur Autonomous Region

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 27, 2017
Registry last updated
Apr 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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