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

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ClinicalTrials.gov Identifier: NCT03091504
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
People's Hospital of Xinjiang Uygur Autonomous Region
Information provided by (Responsible Party):
Jie Li, Rush University Medical Center

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
High Flow Nasal Cannula Device: High flow nasal cannula Drug: Albuterol Sulfate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
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 : September 4, 2017
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine


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 Name: Optiflow, Fisher Paykel

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091504


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

Publications:

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Responsible Party: Jie Li, Principal Investigator, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03091504     History of Changes
Other Study ID Numbers: BDTHFNC01
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action