Individualized Dosing Schedule of Inhaled Bronchodilator for Endotracheally Intubated COPD Patients

NCT01933984 | Completed Results DMC

• 1 other identifier: 102-CCH-IRP-017
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Bronchodilator agents,; chronic obstructive pulmonary disease,; endotracheal intubation,; mechanical ventilator

Outcome Measures

Primary Outcomes (2)

• ∆Raw (the Difference Between Measured and Target Airway Resistance)

  The value can be expressed as relative deviation from target =(measured Raw - target Raw)/target Raw X100

  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.

• Rapidity of ∆Raw Change

  The deviation of ∆Raw from the personal target, which was calculated as (measured Raw-target Raw)/target Raw multiplied by 100.

  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.

Secondary Outcomes (6)

• Ventilator-free Days From Day 1 to 28

  From day 1 to day 28 after enrollment

• The Participants of Breathing Without Assistance by Day 28

  the 28th day after enrollment

• Number of Episode of Nosocomial Pneumonia

  the 28th day after enrollment

• Number of Total Puff of Rescue Short-acting Bronchodilator

  the 28th day after enrollment

• Numbers of Episode of Drug-related Adverse Effect

  From day 1 to day 28 after enrollment

Study Arms (2)

Individualized dosing

EXPERIMENTAL

* 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

Fixed dosing

ACTIVE COMPARATOR

* 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

Interventions

Bronchodilators inhalation DRUG

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

Also known as: Salmeterol/fluticasone (Seretide Evohaler), fenoterol (Berotec)(0.1mg/puff)

Fixed dosing; Individualized dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shin-hwar Wu: lead

Study Sites (1)

Changhua Christian Hospital

Changhua, Taiwan, 50006, China

Location

Related Publications (6)

• Fuller HD, Dolovich MB, Posmituck G, Pack WW, Newhouse MT. Pressurized aerosol versus jet aerosol delivery to mechanically ventilated patients. Comparison of dose to the lungs. Am Rev Respir Dis. 1990 Feb;141(2):440-4. doi: 10.1164/ajrccm/141.2.440.

  PMID: 2154154 BACKGROUND

• Aerosol consensus statement. Consensus Conference on Aerosol Delivery. Chest. 1991 Oct;100(4):1106-9. No abstract available.

  PMID: 1914568 BACKGROUND

• Dhand R, Duarte AG, Jubran A, Jenne JW, Fink JB, Fahey PJ, Tobin MJ. Dose-response to bronchodilator delivered by metered-dose inhaler in ventilator-supported patients. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):388-93. doi: 10.1164/ajrccm.154.2.8756811.

  PMID: 8756811 BACKGROUND

• Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981 Aug;30(2):239-45. doi: 10.1038/clpt.1981.154. No abstract available.

  PMID: 7249508 BACKGROUND

• Malliotakis P, Linardakis M, Gavriilidis G, Georgopoulos D. Duration of salmeterol-induced bronchodilation in mechanically ventilated chronic obstructive pulmonary disease patients: a prospective clinical study. Crit Care. 2008;12(6):R140. doi: 10.1186/cc7117. Epub 2008 Nov 14.

  PMID: 19014570 BACKGROUND

• Wu SH, Shyu LJ, Li CH, Yu CH, Chen HC, Kor CT, Wang CH, Lin KH. Better airway resistance reduction profile in intubated COPD patients by personalized bronchodilator dosing: A pilot randomized control trial. Pulm Pharmacol Ther. 2018 Apr;49:134-139. doi: 10.1016/j.pupt.2018.02.004. Epub 2018 Feb 21.

  PMID: 29474893 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Salmeterol Xinafoate; Fluticasone; Fenoterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Metaproterenol; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Dr. Shin-Hwar Wu
• Organization: Division of Critical Care Medicine, Department of Medicine, Changhua Christian Hospital

126366@cch.org.tw

886-4-7238595

Study Officials

• Shin-hwar Wu

  Changhua Christian Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 4, 2013
• Study Start: August 1, 2013
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: July 21, 2020
• Results First Posted: February 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)