Trial Outcomes & Findings for A Study to Look at Day to Day Changes in Lung Function in COPD Subjects Taking Albuterol/Salbutamol and Ipratropium (NCT NCT01691482)
NCT ID: NCT01691482
Last Updated: 2018-06-20
Results Overview
FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily FEV1 was measured as the fluctuation around the mean FEV1 data collected from Day 1 to Day 10. Variability was measured by the coefficient of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is the difference between the maximum and minimum FEV1 values.
COMPLETED
PHASE4
56 participants
up to 10 days
2018-06-20
Participant Flow
This was a randomized, open-label, two-period cross-over study to evaluate the daily bronchodilator response to albuterol/salbutamol and ipratropium individually and in combination in participants with chronic obstructive pulmonary disease.
Participant milestones
| Measure |
A/S Then Ipratropium in TP1; Ipratropium Then A/S in TP2
Participants received albuterol (4 puffs; 90 micrograms \[µg\] per puff)/salbutamol (A/S) (4 puffs; 100 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via a metered-dose inhaler (MDI) during treatment period 1 (TP1) then, ipratropium followed by A/S at the same doses via an MDI in treatment period 2 (TP2).
|
Ipratropium Then A/S in TP1; A/S Then Ipratropium in TP2
Participants received Ipratropium (4 puffs; 20 µg per puff) followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) (A/S) via a MDI in TP1, then A/S followed by ipratropium at the same doses via an MDI in TP2.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
28
|
28
|
|
Treatment Period 1
COMPLETED
|
28
|
28
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2
STARTED
|
28
|
28
|
|
Treatment Period 2
COMPLETED
|
27
|
26
|
|
Treatment Period 2
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
A/S Then Ipratropium in TP1; Ipratropium Then A/S in TP2
Participants received albuterol (4 puffs; 90 micrograms \[µg\] per puff)/salbutamol (A/S) (4 puffs; 100 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via a metered-dose inhaler (MDI) during treatment period 1 (TP1) then, ipratropium followed by A/S at the same doses via an MDI in treatment period 2 (TP2).
|
Ipratropium Then A/S in TP1; A/S Then Ipratropium in TP2
Participants received Ipratropium (4 puffs; 20 µg per puff) followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) (A/S) via a MDI in TP1, then A/S followed by ipratropium at the same doses via an MDI in TP2.
|
|---|---|---|
|
Treatment Period 2
Adverse Event
|
0
|
1
|
|
Treatment Period 2
Protocol Violation
|
1
|
1
|
Baseline Characteristics
A Study to Look at Day to Day Changes in Lung Function in COPD Subjects Taking Albuterol/Salbutamol and Ipratropium
Baseline characteristics by cohort
| Measure |
All Randomized Participants
n=56 Participants
All participants randomized to receive a sequence of either salbutamol (4 puffs; 100 µg per puff) via an MDI and albuterol (4 puffs; 90 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in TP1 and the same dose of each bronchodilator given in the opposite order in TP2, or ipratropium followed by albuterol/salbutamol in TP1 and the same dose of each bronchodilator given in the opposite order in TP2
|
|---|---|
|
Age, Continuous
|
60.3 Years
STANDARD_DEVIATION 7.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 10 daysPopulation: Efficacy Population: participants in the Intent-to-Treat Population (all participants who were randomized and received at least one bronchodilator in the treatment period) who completed pre- and post- bronchodilator assessments for at least 17 visits, with no more than 3 consecutive missing days
FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily FEV1 was measured as the fluctuation around the mean FEV1 data collected from Day 1 to Day 10. Variability was measured by the coefficient of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is the difference between the maximum and minimum FEV1 values.
Outcome measures
| Measure |
Albuterol/Salbutamol Followed by Ipratropium
n=55 Participants
All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
|
Ipratropium Followed by Albuterol/Salbutamol
n=55 Participants
All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
|
|---|---|---|
|
Variability in Daily FEV1, Estimated by Coefficient of Variation
Pre-dose/non-bronchodilator
|
0.081 Liters
Standard Error 0.0394
|
0.079 Liters
Standard Error 0.0372
|
|
Variability in Daily FEV1, Estimated by Coefficient of Variation
Albuterol/Salbutamol (A/S) alone, 1 hour
|
0.059 Liters
Standard Error 0.0276
|
NA Liters
Standard Error NA
Participants in this treatment arm received ipratropium as the first bronchodilator; thus, data were not collected for albuterol/salbutamol (A/S) at this time point.
|
|
Variability in Daily FEV1, Estimated by Coefficient of Variation
A/S followed by ipratropium, 2 hours
|
0.054 Liters
Standard Error 0.0232
|
NA Liters
Standard Error NA
Participants in this treatment arm received ipratropium followed by A/S; thus, data were not collected for A/S followed by ipratropium.
|
|
Variability in Daily FEV1, Estimated by Coefficient of Variation
Ipratropium alone, 1 hour
|
NA Liters
Standard Error NA
Participants in this treatment arm received A/S as the first bronchodilator; thus, data were not collected for ipratropium at this time point.
|
0.072 Liters
Standard Error 0.0406
|
|
Variability in Daily FEV1, Estimated by Coefficient of Variation
Ipratropium followed by A/S, 2 hours
|
NA Liters
Standard Error NA
Participants in this treatment arm received A/S followed by ipratropium; thus, data were not collected for ipratropium followed by A/S.
|
0.063 Liters
Standard Error 0.0327
|
PRIMARY outcome
Timeframe: up to 10 daysPopulation: Efficacy Population
FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily FEV1 was measured as the fluctuation around the mean FEV1 data collected from Day 1 to Day 10. Variability was measured by the coefficient of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is half the difference between the maximum and minimum FEV1 values.
Outcome measures
| Measure |
Albuterol/Salbutamol Followed by Ipratropium
n=55 Participants
All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
|
Ipratropium Followed by Albuterol/Salbutamol
n=55 Participants
All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
|
|---|---|---|
|
Variability in Daily FEV1, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum Values)
Pre-dose/non-bronchodilator
|
0.136 Liters
Standard Error 0.0627
|
0.135 Liters
Standard Error 0.0780
|
|
Variability in Daily FEV1, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum Values)
Albuterol/Salbutamol (A/S) alone, 1 hour
|
0.125 Liters
Standard Error 0.0525
|
NA Liters
Standard Error NA
Participants in this treatment arm received ipratropium as the first bronchodilator; thus, data were not collected for albuterol/salbutamol (A/S) at this time point.
|
|
Variability in Daily FEV1, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum Values)
A/S followed by ipratropium, 2 hours
|
0.122 Liters
Standard Error 0.0542
|
NA Liters
Standard Error NA
Participants in this treatment arm received ipratropium followed by A/S; thus, data were not collected for A/S followed by ipratropium.
|
|
Variability in Daily FEV1, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum Values)
Ipratropium alone, 1 hour
|
NA Liters
Standard Error NA
Participants in this treatment arm received A/S as the first bronchodilator; thus, data were not collected for ipratropium at this time point.
|
0.145 Liters
Standard Error 0.0805
|
|
Variability in Daily FEV1, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum Values)
Ipratropium followed by A/S, 2 hours
|
NA Liters
Standard Error NA
Participants in this treatment arm received A/S followed by ipratropium; thus, data were not collected for ipratropium followed by A/S.
|
0.137 Liters
Standard Error 0.0726
|
SECONDARY outcome
Timeframe: up to 10 daysPopulation: Efficacy Population
The maximal bronchodilator response for the first administered agent is defined as the FEV1 (the maximal amount of air that can be forcefully exhaled in one second) 1 hour post-dose of the first bronchodilator minus the pre-dose. The maximal bronchodilator response for the second agent is defined as the FEV1 1 hour post-dose of the second bronchodilator minus the FEV1 at 1 hour post-dose of the first bronchodilator. The maximal bronchodilator response for the combination is defined as the FEV1 (the maximal amount of air that can be forcefully exhaled in one second) at 1 hour post-administration of the second bronchodilator minus the corresponding pre-dose FEV1. Derived FEV1 response is FEV1 change from 0 hours (0H) for the first agent assessment (at 1 hour \[1H\]); change from 1H for the second agent assessment (at 2 hours \[2H\]); and change from 0H for the combination assessment (at 2H). Data were adjusted for FEV1, smoking status, and center.
Outcome measures
| Measure |
Albuterol/Salbutamol Followed by Ipratropium
n=55 Participants
All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
|
Ipratropium Followed by Albuterol/Salbutamol
All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
|
|---|---|---|
|
The Maximal Bronchodilator Response for the First Administered Agent
First agent, albuterol/salbutamol (A/S)
|
0.269 Liters
Standard Error 0.0174
|
—
|
|
The Maximal Bronchodilator Response for the First Administered Agent
First agent, ipratropium
|
0.243 Liters
Standard Error 0.0174
|
—
|
|
The Maximal Bronchodilator Response for the First Administered Agent
Second agent, A/S
|
0.094 Liters
Standard Error 0.0123
|
—
|
|
The Maximal Bronchodilator Response for the First Administered Agent
Second agent, ipratropium
|
0.094 Liters
Standard Error 0.0123
|
—
|
|
The Maximal Bronchodilator Response for the First Administered Agent
A/S followed by ipratropium
|
0.363 Liters
Standard Error 0.0200
|
—
|
|
The Maximal Bronchodilator Response for the First Administered Agent
Ipratropium followed by A/S
|
0.337 Liters
Standard Error 0.0200
|
—
|
SECONDARY outcome
Timeframe: up to 35 daysPopulation: Efficacy Population
FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours).
Outcome measures
| Measure |
Albuterol/Salbutamol Followed by Ipratropium
n=55 Participants
All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
|
Ipratropium Followed by Albuterol/Salbutamol
n=55 Participants
All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
|
|---|---|---|
|
Percentage of Days for Which Participants Achieved a >=12% and 200 Milliliter (mL) Increase From Baseline in FEV1
Ipratropium alone, 1 hour
|
NA percentage of days
Standard Deviation NA
Participants in this treatment arm received A/S as the first bronchodilator; thus, data were not collected for ipratropium at this time point.
|
55.4 percentage of days
Standard Deviation 39.34
|
|
Percentage of Days for Which Participants Achieved a >=12% and 200 Milliliter (mL) Increase From Baseline in FEV1
Albuterol/Salbutamol (A/S) alone, 1 hour
|
58.4 percentage of days
Standard Deviation 38.26
|
NA percentage of days
Standard Deviation NA
Participants in this treatment arm received ipratropium as the first bronchodilator; thus, data were not collected for albuterol/salbutamol (A/S) at this time point.
|
|
Percentage of Days for Which Participants Achieved a >=12% and 200 Milliliter (mL) Increase From Baseline in FEV1
A/S followed by ipratropium, 2 hours
|
71.7 percentage of days
Standard Deviation 35.51
|
NA percentage of days
Standard Deviation NA
Participants in this treatment arm received ipratropium followed by A/S; thus, data were not collected for A/S followed by ipratropium.
|
|
Percentage of Days for Which Participants Achieved a >=12% and 200 Milliliter (mL) Increase From Baseline in FEV1
Ipratropium followed by A/S, 2 hours
|
NA percentage of days
Standard Deviation NA
Participants in this treatment arm received A/S followed by ipratropium; thus, data were not collected for ipratropium followed by A/S.
|
69.1 percentage of days
Standard Deviation 36.82
|
SECONDARY outcome
Timeframe: up to 35 daysPopulation: Efficacy Population
FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours).
Outcome measures
| Measure |
Albuterol/Salbutamol Followed by Ipratropium
n=55 Participants
All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
|
Ipratropium Followed by Albuterol/Salbutamol
n=55 Participants
All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
|
|---|---|---|
|
Percentage of Days for Which Participants Achieved a Threshold Increase From Baseline in FEV1 of 100 mL, 200 mL, and 250 mL
A/S alone, 1 hour, 250 mL
|
45.9 percentage of days
Standard Deviation 38.85
|
NA percentage of days
Standard Deviation NA
Participants in this treatment arm received ipratropium as the first bronchodilator; thus, data were not collected for albuterol/salbutamol (A/S) at this time point.
|
|
Percentage of Days for Which Participants Achieved a Threshold Increase From Baseline in FEV1 of 100 mL, 200 mL, and 250 mL
A/S alone, 1 hour, 100 mL
|
81.6 percentage of days
Standard Deviation 31.35
|
NA percentage of days
Standard Deviation NA
Participants in this treatment arm received ipratropium as the first bronchodilator; thus, data were not collected for albuterol/salbutamol (A/S) at this time point.
|
|
Percentage of Days for Which Participants Achieved a Threshold Increase From Baseline in FEV1 of 100 mL, 200 mL, and 250 mL
A/S followed by ipratropium, 2 hours, 100 mL
|
85.2 percentage of days
Standard Deviation 29.92
|
NA percentage of days
Standard Deviation NA
Participants in this treatment arm received ipratropium followed by A/S; thus, data were not collected for A/S followed by ipratropium.
|
|
Percentage of Days for Which Participants Achieved a Threshold Increase From Baseline in FEV1 of 100 mL, 200 mL, and 250 mL
Ipratropium alone, 1 hour, 100 mL
|
NA percentage of days
Standard Deviation NA
Participants in this treatment arm received A/S as the first bronchodilator; thus, data were not collected for ipratropium at this time point.
|
72.9 percentage of days
Standard Deviation 38.06
|
|
Percentage of Days for Which Participants Achieved a Threshold Increase From Baseline in FEV1 of 100 mL, 200 mL, and 250 mL
Ipratropium followed by A/S, 2 hours, 100 mL
|
NA percentage of days
Standard Deviation NA
Participants in this treatment arm received A/S followed by ipratropium; thus, data were not collected for ipratropium followed by A/S.
|
81.2 percentage of days
Standard Deviation 33.46
|
|
Percentage of Days for Which Participants Achieved a Threshold Increase From Baseline in FEV1 of 100 mL, 200 mL, and 250 mL
A/S alone, 1 hour, 200 mL
|
59.2 percentage of days
Standard Deviation 38.20
|
NA percentage of days
Standard Deviation NA
Participants in this treatment arm received ipratropium as the first bronchodilator; thus, data were not collected for albuterol/salbutamol (A/S) at this time point.
|
|
Percentage of Days for Which Participants Achieved a Threshold Increase From Baseline in FEV1 of 100 mL, 200 mL, and 250 mL
A/S followed by ipratropium, 2 hours, 200 mL
|
72.7 percentage of days
Standard Deviation 35.25
|
NA percentage of days
Standard Deviation NA
Participants in this treatment arm received ipratropium followed by A/S; thus, data were not collected for A/S followed by ipratropium.
|
|
Percentage of Days for Which Participants Achieved a Threshold Increase From Baseline in FEV1 of 100 mL, 200 mL, and 250 mL
Ipratropium alone, 1 hour, 200 mL
|
NA percentage of days
Standard Deviation NA
Participants in this treatment arm received A/S as the first bronchodilator; thus, data were not collected for ipratropium at this time point.
|
56.0 percentage of days
Standard Deviation 39.54
|
|
Percentage of Days for Which Participants Achieved a Threshold Increase From Baseline in FEV1 of 100 mL, 200 mL, and 250 mL
Ipratropium followed by A/S, 2 hours, 200 mL
|
NA percentage of days
Standard Deviation NA
Participants in this treatment arm received A/S followed by ipratropium; thus, data were not collected for ipratropium followed by A/S.
|
70.5 percentage of days
Standard Deviation 36.23
|
|
Percentage of Days for Which Participants Achieved a Threshold Increase From Baseline in FEV1 of 100 mL, 200 mL, and 250 mL
A/S followed by ipratropium, 2 hours, 250 mL
|
64.0 percentage of days
Standard Deviation 39.08
|
NA percentage of days
Standard Deviation NA
Participants in this treatment arm received ipratropium followed by A/S; thus, data were not collected for A/S followed by ipratropium.
|
|
Percentage of Days for Which Participants Achieved a Threshold Increase From Baseline in FEV1 of 100 mL, 200 mL, and 250 mL
Ipratropium alone, 1 hour, 250 mL
|
NA percentage of days
Standard Deviation NA
Participants in this treatment arm received A/S as the first bronchodilator; thus, data were not collected for ipratropium at this time point.
|
45.8 percentage of days
Standard Deviation 36.94
|
|
Percentage of Days for Which Participants Achieved a Threshold Increase From Baseline in FEV1 of 100 mL, 200 mL, and 250 mL
Ipratropium followed by A/S, 2 hours, 250 mL
|
NA percentage of days
Standard Deviation NA
Participants in this treatment arm received A/S followed by ipratropium; thus, data were not collected for ipratropium followed by A/S.
|
59.6 percentage of days
Standard Deviation 38.19
|
SECONDARY outcome
Timeframe: up to 10 daysPopulation: Efficacy Population
IC is the the total amount of air that can be drawn into the lungs after normal expiration. During each study period, pre- and post-bronchodilator spirometry for evaluation of IC was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily IC was measured as the fluctuation around the mean IC data collected from Day 1 to Day 10. Variability was measured by the coefficent of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is the difference between the maximum and minimum IC values.
Outcome measures
| Measure |
Albuterol/Salbutamol Followed by Ipratropium
n=55 Participants
All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
|
Ipratropium Followed by Albuterol/Salbutamol
n=55 Participants
All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
|
|---|---|---|
|
Variability in Daily Inspiratory Capacity (IC), Estimated by Coefficient of Variation
Pre-dose/non-bronchodilator
|
0.078 Liters
Standard Deviation 0.0305
|
0.083 Liters
Standard Deviation 0.0374
|
|
Variability in Daily Inspiratory Capacity (IC), Estimated by Coefficient of Variation
Albuterol/Salbutamol (A/S) alone, 1 hour
|
0.069 Liters
Standard Deviation 0.0310
|
NA Liters
Standard Deviation NA
Participants in this treatment arm received ipratropium as the first bronchodilator; thus, data were not collected for albuterol/salbutamol (A/S) at this time point.
|
|
Variability in Daily Inspiratory Capacity (IC), Estimated by Coefficient of Variation
A/S followed by ipratropium (A+I), 2 hours
|
0.070 Liters
Standard Deviation 0.0373
|
NA Liters
Standard Deviation NA
Participants in this treatment arm received ipratropium followed by A/S; thus, data were not collected for A/S followed by ipratropium.
|
|
Variability in Daily Inspiratory Capacity (IC), Estimated by Coefficient of Variation
Ipratropium alone, 1 hour
|
NA Liters
Standard Deviation NA
Participants in this treatment arm received A/S as the first bronchodilator; thus, data were not collected for ipratropium at this time point.
|
0.072 Liters
Standard Deviation 0.0353
|
|
Variability in Daily Inspiratory Capacity (IC), Estimated by Coefficient of Variation
Ipratropium followed by A/S (I+A), 2 hours
|
NA Liters
Standard Deviation NA
Participants in this treatment arm received A/S followed by ipratropium; thus, data were not collected for ipratropium followed by A/S.
|
0.066 Liters
Standard Deviation 0.0307
|
SECONDARY outcome
Timeframe: up to 10 daysPopulation: Efficacy Population
IC is the the total amount of air that can be drawn into the lungs after normal expiration. During each study period, pre- and post-bronchodilator spirometry for evaluation of IC was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily IC was measured as the fluctuation around the mean IC data collected from Day 1 to Day 10. Variability was measured by the coefficent of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is half the difference between the maximum and minimum IC values.
Outcome measures
| Measure |
Albuterol/Salbutamol Followed by Ipratropium
n=55 Participants
All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
|
Ipratropium Followed by Albuterol/Salbutamol
n=55 Participants
All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
|
|---|---|---|
|
Variability in Daily IC, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum)
Pre-dose/non-bronchodilator
|
0.225 Liters
Standard Deviation 0.1017
|
0.236 Liters
Standard Deviation 0.1166
|
|
Variability in Daily IC, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum)
Albuterol/Salbutamol (A/S) alone, 1 hour
|
0.229 Liters
Standard Deviation 0.1004
|
NA Liters
Standard Deviation NA
Participants in this treatment arm received ipratropium as the first bronchodilator; thus, data were not collected for albuterol/salbutamol (A/S) at this time point.
|
|
Variability in Daily IC, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum)
A/S followed by ipratropium, 2 hours
|
0.233 Liters
Standard Deviation 0.1132
|
NA Liters
Standard Deviation NA
Participants in this treatment arm received ipratropium followed by A/S; thus, data were not collected for A/S followed by ipratropium.
|
|
Variability in Daily IC, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum)
Ipratropium alone, 1 hour
|
NA Liters
Standard Deviation NA
Participants in this treatment arm received A/S as the first bronchodilator; thus, data were not collected for ipratropium at this time point.
|
0.235 Liters
Standard Deviation 0.1026
|
|
Variability in Daily IC, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum)
Ipratropium followed by A/S, 2 hours
|
NA Liters
Standard Deviation NA
Participants in this treatment arm received A/S followed by ipratropium; thus, data were not collected for ipratropium followed by A/S.
|
0.221 Liters
Standard Deviation 0.1066
|
Adverse Events
All Randomized Participants
Serious adverse events
| Measure |
All Randomized Participants
n=56 participants at risk
All participants randomized to receive a sequence of either salbutamol (4 puffs; 100 µg per puff) via an MDI and albuterol (4 puffs; 90 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in TP1 and the same dose of each bronchodilator given in the opposite order in TP2, or ipratropium followed by albuterol/salbutamol in TP1 and the same dose of each bronchodilator given in the opposite order in TP2
|
|---|---|
|
General disorders
Death
|
1.8%
1/56
|
Other adverse events
| Measure |
All Randomized Participants
n=56 participants at risk
All participants randomized to receive a sequence of either salbutamol (4 puffs; 100 µg per puff) via an MDI and albuterol (4 puffs; 90 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in TP1 and the same dose of each bronchodilator given in the opposite order in TP2, or ipratropium followed by albuterol/salbutamol in TP1 and the same dose of each bronchodilator given in the opposite order in TP2
|
|---|---|
|
Nervous system disorders
Headache
|
7.1%
4/56
|
|
Nervous system disorders
Dizziness
|
1.8%
1/56
|
|
Nervous system disorders
Dysgeusia
|
1.8%
1/56
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
1/56
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.8%
1/56
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
1.8%
1/56
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
1.8%
1/56
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.8%
1/56
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.8%
1/56
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/56
|
|
Gastrointestinal disorders
Toothache
|
1.8%
1/56
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/56
|
|
General disorders
Chest discomfort
|
1.8%
1/56
|
|
General disorders
Influenza like illness
|
1.8%
1/56
|
|
General disorders
Oedema peripheral
|
1.8%
1/56
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.8%
1/56
|
|
Injury, poisoning and procedural complications
Fall
|
1.8%
1/56
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.8%
1/56
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.8%
1/56
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
1.8%
1/56
|
|
Infections and infestations
Bacterial infection
|
1.8%
1/56
|
|
Infections and infestations
Herpes zoster
|
1.8%
1/56
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
1/56
|
|
Infections and infestations
Rhinitis
|
1.8%
1/56
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
1/56
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.8%
1/56
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.8%
1/56
|
|
Renal and urinary disorders
Haematuria
|
1.8%
1/56
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER