Trial Outcomes & Findings for Individualized Dosing Schedule of Inhaled Bronchodilator for Endotracheally Intubated COPD Patients (NCT NCT01933984)
NCT ID: NCT01933984
Last Updated: 2020-07-21
Results Overview
The value can be expressed as relative deviation from target =(measured Raw - target Raw)/target Raw X100
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
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.
Results posted on
2020-07-21
Participant Flow
Participant milestones
| Measure |
Individualized Dosing
* Ventilator support
* Determining personal target airway resistance
* Salmeterol/fluticasone 4 puffs inhalation q12h until ventilator discontinuation or the 28th day if ventilator-dependent
* Ipatropium/salbutamol 1 vial inhalation q6h for the first 3 days
* Methylprednisolone 40 mg intravenous injection q8h for the first 3 days
* Additional Salmeterol/fluticasone (Seretide) 4 puffs plus fenoterol (Berotec) 4 puffs inhalation if personal target airway resistance (measured every 8 hours) not met
|
Fixed Dosing
Ventilator support
* Determining personal target airway resistance
* Salmeterol/fluticasone 4 puffs inhalation q12h until ventilator discontinuation or the 28th day if ventilator-dependent
* Ipatropium/salbutamol 1 vial inhalation q6h for the first 3 days
* Methylprednisolone 40 mg intravenous injection q8h for the first 3 days
* No additional bronchodilator given if personal target airway resistance (measured every 8 hours) not met
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
|
Overall Study
COMPLETED
|
26
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Individualized Dosing Schedule of Inhaled Bronchodilator for Endotracheally Intubated COPD Patients
Baseline characteristics by cohort
| Measure |
Individualized Dosing
n=26 Participants
* 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)
|
Fixed Dosing
n=25 Participants
* 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
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.6 years
STANDARD_DEVIATION 13.3 • n=113 Participants
|
77.9 years
STANDARD_DEVIATION 8.7 • n=163 Participants
|
75.7 years
STANDARD_DEVIATION 11.3 • n=160 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
7 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=113 Participants
|
23 Participants
n=163 Participants
|
44 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Asian
|
26 participants
n=113 Participants
|
25 participants
n=163 Participants
|
51 participants
n=160 Participants
|
|
Body Mass Index
|
25.6 kg/m^2
STANDARD_DEVIATION 11.6 • n=113 Participants
|
23.4 kg/m^2
STANDARD_DEVIATION 4.9 • n=163 Participants
|
24.5 kg/m^2
STANDARD_DEVIATION 8.9 • n=160 Participants
|
PRIMARY outcome
Timeframe: 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.Population: The deviation of Raw from the personal target, which was calculated as (measured Raw-target Raw)/target Raw.
The value can be expressed as relative deviation from target =(measured Raw - target Raw)/target Raw X100
Outcome measures
| Measure |
Individualized Dosing
n=26 Participants
* 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) salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Additional broncho-dilators inhalation: Salmeterol/fluticasone (Seretide Evohaler) 4 puffs plus fenoterol (Berotec)(0
|
Fixed Dosing
n=25 Participants
* 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 salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Determining personal target airway resistance: Three consecutive doses of 4, 8 and 16 puffs of fenoterol MDI (100 mcg/puff, Berotec;Boehringer Ingelheim, Ingelheim, Germany) inhalation with each dose 15 minutes apart. The airway resistance measured 15 minutes later is assigned as th
|
|---|---|---|
|
∆Raw (the Difference Between Measured and Target Airway Resistance)
|
9 percentage of relative Raw deviation
Standard Deviation 10
|
44 percentage of relative Raw deviation
Standard Deviation 11
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Individualized Dosing
n=26 Participants
* 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) salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Additional broncho-dilators inhalation: Salmeterol/fluticasone (Seretide Evohaler) 4 puffs plus fenoterol (Berotec)(0
|
Fixed Dosing
n=25 Participants
* 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 salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Determining personal target airway resistance: Three consecutive doses of 4, 8 and 16 puffs of fenoterol MDI (100 mcg/puff, Berotec;Boehringer Ingelheim, Ingelheim, Germany) inhalation with each dose 15 minutes apart. The airway resistance measured 15 minutes later is assigned as th
|
|---|---|---|
|
Rapidity of ∆Raw Change
|
-3 percentage of relative Raw deviation
Standard Deviation 9.7
|
0.4 percentage of relative Raw deviation
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: From day 1 to day 28 after enrollmentVentilator-free days from day 1 to 28 after enrollment
Outcome measures
| Measure |
Individualized Dosing
n=26 Participants
* 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) salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Additional broncho-dilators inhalation: Salmeterol/fluticasone (Seretide Evohaler) 4 puffs plus fenoterol (Berotec)(0
|
Fixed Dosing
n=25 Participants
* 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 salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Determining personal target airway resistance: Three consecutive doses of 4, 8 and 16 puffs of fenoterol MDI (100 mcg/puff, Berotec;Boehringer Ingelheim, Ingelheim, Germany) inhalation with each dose 15 minutes apart. The airway resistance measured 15 minutes later is assigned as th
|
|---|---|---|
|
Ventilator-free Days From Day 1 to 28
|
19 day
|
22 day
|
SECONDARY outcome
Timeframe: the 28th day after enrollmentThe number of participants who breath without ventilator by day 28
Outcome measures
| Measure |
Individualized Dosing
n=26 Participants
* 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) salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Additional broncho-dilators inhalation: Salmeterol/fluticasone (Seretide Evohaler) 4 puffs plus fenoterol (Berotec)(0
|
Fixed Dosing
n=25 Participants
* 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 salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Determining personal target airway resistance: Three consecutive doses of 4, 8 and 16 puffs of fenoterol MDI (100 mcg/puff, Berotec;Boehringer Ingelheim, Ingelheim, Germany) inhalation with each dose 15 minutes apart. The airway resistance measured 15 minutes later is assigned as th
|
|---|---|---|
|
The Participants of Breathing Without Assistance by Day 28
|
19 the number of participants
|
22 the number of participants
|
SECONDARY outcome
Timeframe: the 28th day after enrollmentThe 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.
Outcome measures
| Measure |
Individualized Dosing
n=26 Participants
* 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) salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Additional broncho-dilators inhalation: Salmeterol/fluticasone (Seretide Evohaler) 4 puffs plus fenoterol (Berotec)(0
|
Fixed Dosing
n=25 Participants
* 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 salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Determining personal target airway resistance: Three consecutive doses of 4, 8 and 16 puffs of fenoterol MDI (100 mcg/puff, Berotec;Boehringer Ingelheim, Ingelheim, Germany) inhalation with each dose 15 minutes apart. The airway resistance measured 15 minutes later is assigned as th
|
|---|---|---|
|
Number of Episode of Nosocomial Pneumonia
|
0 episodes of nosocomial pneumonia
Standard Deviation 0
|
0 episodes of nosocomial pneumonia
Standard Deviation 0
|
SECONDARY outcome
Timeframe: the 28th day after enrollmentThe number of total puff of rescue short-acting bronchodilator.
Outcome measures
| Measure |
Individualized Dosing
n=26 Participants
* 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) salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Additional broncho-dilators inhalation: Salmeterol/fluticasone (Seretide Evohaler) 4 puffs plus fenoterol (Berotec)(0
|
Fixed Dosing
n=25 Participants
* 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 salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Determining personal target airway resistance: Three consecutive doses of 4, 8 and 16 puffs of fenoterol MDI (100 mcg/puff, Berotec;Boehringer Ingelheim, Ingelheim, Germany) inhalation with each dose 15 minutes apart. The airway resistance measured 15 minutes later is assigned as th
|
|---|---|---|
|
Number of Total Puff of Rescue Short-acting Bronchodilator
|
0 puffs
|
0 puffs
|
SECONDARY outcome
Timeframe: From day 1 to day 28 after enrollmentThe 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.
Outcome measures
| Measure |
Individualized Dosing
n=26 Participants
* 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) salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Additional broncho-dilators inhalation: Salmeterol/fluticasone (Seretide Evohaler) 4 puffs plus fenoterol (Berotec)(0
|
Fixed Dosing
n=25 Participants
* 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 salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Determining personal target airway resistance: Three consecutive doses of 4, 8 and 16 puffs of fenoterol MDI (100 mcg/puff, Berotec;Boehringer Ingelheim, Ingelheim, Germany) inhalation with each dose 15 minutes apart. The airway resistance measured 15 minutes later is assigned as th
|
|---|---|---|
|
Numbers of Episode of Drug-related Adverse Effect
|
0 episodes
Standard Deviation 0
|
0 episodes
Standard Deviation 0
|
SECONDARY outcome
Timeframe: the 180th day after enrollmentThe percentage of participants died at day 180.
Outcome measures
| Measure |
Individualized Dosing
n=26 Participants
* 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) salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Additional broncho-dilators inhalation: Salmeterol/fluticasone (Seretide Evohaler) 4 puffs plus fenoterol (Berotec)(0
|
Fixed Dosing
n=25 Participants
* 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 salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Determining personal target airway resistance: Three consecutive doses of 4, 8 and 16 puffs of fenoterol MDI (100 mcg/puff, Berotec;Boehringer Ingelheim, Ingelheim, Germany) inhalation with each dose 15 minutes apart. The airway resistance measured 15 minutes later is assigned as th
|
|---|---|---|
|
Mortality Rate
|
35 percentage of participants
|
40 percentage of participants
|
Adverse Events
Individualized Dosing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 9 deaths
Fixed Dosing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 10 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Shin-Hwar Wu
Division of Critical Care Medicine, Department of Medicine, Changhua Christian Hospital
Phone: 886-4-7238595
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place