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Individualized Dosing Schedule of Inhaled Bronchodilator for Endotracheally Intubated COPD Patients

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ClinicalTrials.gov Identifier: NCT01933984
Recruitment Status : Completed
First Posted : September 4, 2013
Results First Posted : February 21, 2020
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Shin-hwar Wu, Changhua Christian Hospital

Brief Summary:
This study evaluates whether individualized dosing schedule of inhaled bronchodilator is more effective than fixed dosing in reducing airway resistance of intubated COPD patients.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Bronchodilators inhalation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Individualized Dosing Schedule of Inhaled Bronchodilator for Endotracheally Intubated Chronic Obstructive Pulmonary Disease Patients
Study Start Date : August 2013
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Individualized dosing
  • Ventilator support
  • Determining personal target airway resistance
  • Bronchodilator:Salmeterol/fluticasone 4 puffs inhalation every 12 hours until ventilator discontinuation or the 28th day if ventilator-dependent
  • Bronchodilator:Ipatropium/salbutamol 1 vial inhalation every 6 hours for the first 3 days
  • Steroid:Methylprednisolone 40 mg intravenous injection every 8 hours for the first 3 days
  • Additional broncho-dilators inhalation: Salmeterol/fluticasone (Seretide) 4 puffs plus fenoterol (Berotec) 4 puffs inhalation if personal target airway resistance (measured every 8 hours) not met (until ventilator discontinuation or the 28th day if ventilator-dependent)
Drug: Bronchodilators inhalation
Salmeterol/fluticasone (Seretide Evohaler) 4 puffs plus fenoterol (Berotec)(0.1mg/puff) 4 puffs inhalation when target airway resistance, measured every 8 hours, not met
Other Names:
  • Salmeterol/fluticasone (Seretide Evohaler)
  • fenoterol (Berotec)(0.1mg/puff)

Active Comparator: Fixed dosing
  • Ventilator support
  • Determining personal target airway resistance
  • Bronchodilator:Salmeterol/fluticasone 4 puffs inhalation every 12 hours until ventilator discontinuation or the 28th day if ventilator-dependent
  • Bronchodilator:Ipatropium/salbutamol 1 vial inhalation every 6 hours for the first 3 days
  • Steroid:Methylprednisolone 40 mg intravenous injection every 8 hours for the first 3 days
  • No additional bronchodilator given if personal target airway resistance (measured every 8 hours) not met
Drug: Bronchodilators inhalation
Salmeterol/fluticasone (Seretide Evohaler) 4 puffs plus fenoterol (Berotec)(0.1mg/puff) 4 puffs inhalation when target airway resistance, measured every 8 hours, not met
Other Names:
  • Salmeterol/fluticasone (Seretide Evohaler)
  • fenoterol (Berotec)(0.1mg/puff)




Primary Outcome Measures :
  1. ∆Raw (the Difference Between Measured and Target Airway Resistance) [ Time Frame: Airway resistance will be recorded everyday. If a patient's ventilator was liberated less than 28 days, the day of liberation was the reported time frame. If the day of ventilator liberation was over 28 days, the 28th day was the reported time frame. ]
    The value can be expressed as relative deviation from target =(measured Raw - target Raw)/target Raw X100

  2. Rapidity of ∆Raw Change [ Time Frame: Airway resistance will be recorded everyday. If a patient's ventilator was liberated less than 28 days, the day of liberation was the reported time frame. If the day of ventilator liberation was over 28 days, the 28th day was the reported time frame. ]
    The deviation of ∆Raw from the personal target, which was calculated as (measured Raw-target Raw)/target Raw multiplied by 100.


Secondary Outcome Measures :
  1. Ventilator-free Days From Day 1 to 28 [ Time Frame: From day 1 to day 28 after enrollment ]
    Ventilator-free days from day 1 to 28 after enrollment

  2. The Participants of Breathing Without Assistance by Day 28 [ Time Frame: the 28th day after enrollment ]
    The number of participants who breath without ventilator by day 28

  3. Number of Episode of Nosocomial Pneumonia [ Time Frame: the 28th day after enrollment ]
    The number of episodes of nosocomial pneumonia happened by day 28. And nosocomial pneumonia is a lower respiratory infection that was not incubating at the time of hospital admission and that presents clinically 2 or more days after hospitalization.

  4. Number of Total Puff of Rescue Short-acting Bronchodilator [ Time Frame: the 28th day after enrollment ]
    The number of total puff of rescue short-acting bronchodilator.

  5. Numbers of Episode of Drug-related Adverse Effect [ Time Frame: From day 1 to day 28 after enrollment ]
    The numbers of episode of drug-related adverse effect. Naranjo score should be over 4 to be considered drug-related adverse effect. Naranjo score range form 0 to 9, and the higher scores means a higher relationship with drug-related adverse effect.

  6. Mortality Rate [ Time Frame: the 180th day after enrollment ]
    The percentage of participants died at day 180.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic obstructive pulmonary disease
  • acute respiratory failure under ventilator support for less than 72 hours
  • endotracheal tube inserted

Exclusion Criteria:

  • confirmed asthma
  • Acute Physiology and Chronic Health Evaluation II score over 35
  • a co-morbidity of septic shock

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): NCT01933984


Locations
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China, Taiwan
Changhua Christian Hospital
Changhua, Taiwan, China, 50006
Sponsors and Collaborators
Shin-hwar Wu
Investigators
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Principal Investigator: Shin-hwar Wu Changhua Christian Hospital
  Study Documents (Full-Text)

Documents provided by Shin-hwar Wu, Changhua Christian Hospital:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shin-hwar Wu, Attending physician, Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT01933984    
Other Study ID Numbers: 102-CCH-IRP-017
First Posted: September 4, 2013    Key Record Dates
Results First Posted: February 21, 2020
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We have no plan to share IPD.
Keywords provided by Shin-hwar Wu, Changhua Christian Hospital:
Bronchodilator agents,
chronic obstructive pulmonary disease,
endotracheal intubation,
mechanical ventilator
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Fluticasone
Fenoterol
Salmeterol Xinafoate
Bronchodilator Agents
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents