Trial Outcomes & Findings for Efficacy Safety Study of Arformoterol QD Dosing Versus BID Dosing in COPD (NCT NCT00571428)
NCT ID: NCT00571428
Last Updated: 2012-02-22
Results Overview
Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken within 24 hours of dosing.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
33 participants
Primary outcome timeframe
0-24 hours post dose
Results posted on
2012-02-22
Participant Flow
Participant milestones
| Measure |
15 Mcg BID / 30 Mcg QD
Arformoterol 15 mcg twice a day (morning and evening) for one visit followed by Arformoterol 30 mcg once a day (morning) and placebo (evening) for the next visit.
|
30 Mcg QD / 15 Mcg BID
Arformoterol 30 mcg once a day (morning) and placebo (evening) for one visit followed by Arformoterol 15 mcg twice a day (morning and evening) for the next visit.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
18
|
|
Overall Study
COMPLETED
|
15
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy Safety Study of Arformoterol QD Dosing Versus BID Dosing in COPD
Baseline characteristics by cohort
| Measure |
15 Mcg BID / 30 Mcg QD
n=15 Participants
Arformoterol 15 mcg twice a day (morning and evening) for one visit followed by Arformoterol 30 mcg once a day (morning) and placebo (evening) for the next visit.
|
30 Mcg QD / 15 Mcg BID
n=18 Participants
Arformoterol 30 mcg once a day (morning) and placebo (evening) for one visit followed by Arformoterol 15 mcg twice a day (morning and evening) for the next visit.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14.0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19.0 Participants
n=5 Participants
|
|
Age Continuous
|
63.9 Years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
64.9 Years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
64.5 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13.0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20.0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4.0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29.0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Inhaled Corticosteroid Use at Baseline
Yes
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5.0 participants
n=5 Participants
|
|
Inhaled Corticosteroid Use at Baseline
No
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28.0 participants
n=5 Participants
|
|
Participants Categorized by the Number of Pack Years Smoked
>=15 years - <25 years
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3.0 participants
n=5 Participants
|
|
Participants Categorized by the Number of Pack Years Smoked
>=25 years - < 30 years
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3.0 participants
n=5 Participants
|
|
Participants Categorized by the Number of Pack Years Smoked
>=30 years
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27.0 participants
n=5 Participants
|
|
Participants Categorized by the Number of Packs Currently Smoked per Day
>0 -1 pack
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9.0 participants
n=5 Participants
|
|
Participants Categorized by the Number of Packs Currently Smoked per Day
>1 -2 packs
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6.0 participants
n=5 Participants
|
|
Participants Categorized by the Number of Packs Currently Smoked per Day
>2 - 4 packs
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0.0 participants
n=5 Participants
|
|
Participants Categorized by the Number of Packs Currently Smoked per Day
> 4 packs
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0.0 participants
n=5 Participants
|
|
Participants Categorized by the Number of Packs Currently Smoked per Day
Currently does not smoke
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
18.0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-24 hours post dosePopulation: Intent to treat population
Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken within 24 hours of dosing.
Outcome measures
| Measure |
15 Mcg BID
n=32 Participants
Arformoterol 15 mcg twice a day (morning and evening)
|
30 Mcg QD
n=32 Participants
Arformoterol 30 mcg once a day (morning) and placebo (evening)
|
|---|---|---|
|
Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 24 Hours
|
0.156 liters
Standard Deviation 0.156
|
0.173 liters
Standard Deviation 0.183
|
SECONDARY outcome
Timeframe: 0-12 hoursPopulation: Intent to treat population
Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken within 12 hours of dosing.
Outcome measures
| Measure |
15 Mcg BID
n=32 Participants
Arformoterol 15 mcg twice a day (morning and evening)
|
30 Mcg QD
n=32 Participants
Arformoterol 30 mcg once a day (morning) and placebo (evening)
|
|---|---|---|
|
Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 12 Hours
|
0.148 liters
Standard Deviation 0.152
|
0.214 liters
Standard Deviation 0.163
|
SECONDARY outcome
Timeframe: 12-24 hoursPopulation: Intent to treat population
Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken between 12 and 24 hours of dosing.
Outcome measures
| Measure |
15 Mcg BID
n=30 Participants
Arformoterol 15 mcg twice a day (morning and evening)
|
30 Mcg QD
n=32 Participants
Arformoterol 30 mcg once a day (morning) and placebo (evening)
|
|---|---|---|
|
Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Between 12-24 Hours
|
0.179 liters
Standard Deviation 0.154
|
0.132 liters
Standard Deviation 0.211
|
SECONDARY outcome
Timeframe: pre-dose and 24 hours post-dosePopulation: Intent to treat population
Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change in FEV1 from pre-dose to the readings taken 24 hours post-dose, which represents the trough in dose level.
Outcome measures
| Measure |
15 Mcg BID
n=31 Participants
Arformoterol 15 mcg twice a day (morning and evening)
|
30 Mcg QD
n=31 Participants
Arformoterol 30 mcg once a day (morning) and placebo (evening)
|
|---|---|---|
|
Change in Forced Expiratory Volume in One Second From Pre-dose to the 24 Hour Time Point
|
0.144 liters
Standard Deviation 0.161
|
0.120 liters
Standard Deviation 0.195
|
SECONDARY outcome
Timeframe: pre-dose, immediately post-dose, 30 min, 1,2,4,6,8,10,12, 12.5,13,14,16,23,24 hours post first dosePopulation: Intent to treat population
Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome offers the FEV1 readings taken pre-dose and at various time points within 24 hours post-dose.
Outcome measures
| Measure |
15 Mcg BID
n=33 Participants
Arformoterol 15 mcg twice a day (morning and evening)
|
30 Mcg QD
n=33 Participants
Arformoterol 30 mcg once a day (morning) and placebo (evening)
|
|---|---|---|
|
Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose
Pre-dose (n=32,32)
|
1.184 liters
Standard Deviation 0.366
|
1.179 liters
Standard Deviation 0.342
|
|
Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose
Immediately post first dose (n=32,33)
|
1.332 liters
Standard Deviation 0.418
|
1.358 liters
Standard Deviation 0.386
|
|
Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose
30 minutes (n=33,33)
|
1.349 liters
Standard Deviation 0.392
|
1.384 liters
Standard Deviation 0.374
|
|
Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose
1 hour post first dose (n=33,33)
|
1.362 liters
Standard Deviation 0.387
|
1.401 liters
Standard Deviation 0.394
|
|
Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose
2 hours post first dose (n=33,33)
|
1.378 liters
Standard Deviation 0.375
|
1.419 liters
Standard Deviation 0.378
|
|
Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose
4 hours post first dose (n=33,33)
|
1.342 liters
Standard Deviation 0.374
|
1.429 liters
Standard Deviation 0.375
|
|
Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose
6 hours post first dose (n=32,30)
|
1.359 liters
Standard Deviation 0.426
|
1.414 liters
Standard Deviation 0.384
|
|
Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose
8 hours post first dose (n=32,30)
|
1.303 liters
Standard Deviation 0.402
|
1.373 liters
Standard Deviation 0.397
|
|
Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose
10 hours post first dose (n=31,30)
|
1.308 liters
Standard Deviation 0.371
|
1.371 liters
Standard Deviation 0.411
|
|
Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose
12 hours post first dose (n=30,32)
|
1.270 liters
Standard Deviation 0.365
|
1.327 liters
Standard Deviation 0.400
|
|
Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose
12.5 hours post first dose (n=30,32)
|
1.359 liters
Standard Deviation 0.359
|
1.332 liters
Standard Deviation 0.409
|
|
Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose
13 hours post first dose (n=30,32)
|
1.389 liters
Standard Deviation 0.375
|
1.330 liters
Standard Deviation 0.378
|
|
Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose
14 hours post first dose (n=30,32)
|
1.397 liters
Standard Deviation 0.389
|
1.337 liters
Standard Deviation 0.411
|
|
Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose
16 hours post first dose (n=32,33)
|
1.368 liters
Standard Deviation 0.357
|
1.344 liters
Standard Deviation 0.420
|
|
Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose
23 hours post first dose (n=30,32)
|
1.297 liters
Standard Deviation 0.373
|
1.252 liters
Standard Deviation 0.412
|
|
Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose
24 hours post first dose (n=31,32)
|
1.296 liters
Standard Deviation 0.363
|
1.279 liters
Standard Deviation 0.417
|
SECONDARY outcome
Timeframe: Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dosePopulation: Intent to treat population
Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome offers the change in FEV1 readings between pre-dose and various time points within 24 hours post-dose.
Outcome measures
| Measure |
15 Mcg BID
n=33 Participants
Arformoterol 15 mcg twice a day (morning and evening)
|
30 Mcg QD
n=33 Participants
Arformoterol 30 mcg once a day (morning) and placebo (evening)
|
|---|---|---|
|
Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose
Immediately post first dose (n=32,32)
|
0.148 liters
Standard Deviation 0.109
|
0.187 liters
Standard Deviation 0.137
|
|
Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose
30 minutes post first dose (n=32,32)
|
0.168 liters
Standard Deviation 0.128
|
0.211 liters
Standard Deviation 0.157
|
|
Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose
1 hour post first dose (n=32,32)
|
0.179 liters
Standard Deviation 0.131
|
0.229 liters
Standard Deviation 0.156
|
|
Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose
2 hours post first dose (n=32,32)
|
0.193 liters
Standard Deviation 0.141
|
0.243 liters
Standard Deviation 0.160
|
|
Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose
4 hours post first dose (n=32,32)
|
0.161 liters
Standard Deviation 0.155
|
0.248 liters
Standard Deviation 0.172
|
|
Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose
6 hours post first dose (n=32,30)
|
0.175 liters
Standard Deviation 0.182
|
0.243 liters
Standard Deviation 0.181
|
|
Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose
8 hours post first dose (n=32,30)
|
0.119 liters
Standard Deviation 0.199
|
0.202 liters
Standard Deviation 0.191
|
|
Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose
10 hours post first dose (n=30,30)
|
0.145 liters
Standard Deviation 0.165
|
0.200 liters
Standard Deviation 0.203
|
|
Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose
12 hours post first dose (n=30,32)
|
0.105 liters
Standard Deviation 0.167
|
0.148 liters
Standard Deviation 0.197
|
|
Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose
12.5 hours post first dose (n=30,32)
|
0.193 liters
Standard Deviation 0.152
|
0.153 liters
Standard Deviation 0.211
|
|
Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose
13 hours post first dose (n=30,32)
|
0.223 liters
Standard Deviation 0.148
|
0.151 liters
Standard Deviation 0.198
|
|
Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose
14 hours post first dose (n=30,32)
|
0.232 liters
Standard Deviation 0.175
|
0.158 liters
Standard Deviation 0.229
|
|
Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose
16 hours post first dose (32,32)
|
0.184 liters
Standard Deviation 0.178
|
0.163 liters
Standard Deviation 0.237
|
|
Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose
23 hours post first dose (n=30,31)
|
0.132 liters
Standard Deviation 0.189
|
0.088 liters
Standard Deviation 0.211
|
|
Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose
24 hours post first dose (n=31,31)
|
0.144 liters
Standard Deviation 0.161
|
0.120 liters
Standard Deviation 0.195
|
SECONDARY outcome
Timeframe: Pre-dose, Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dosePopulation: Intent to treat population
Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the percent of the estimated healthy lung function at specified time points.
Outcome measures
| Measure |
15 Mcg BID
n=33 Participants
Arformoterol 15 mcg twice a day (morning and evening)
|
30 Mcg QD
n=33 Participants
Arformoterol 30 mcg once a day (morning) and placebo (evening)
|
|---|---|---|
|
Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose
Pre-dose (n=32,32)
|
40.717 Percent of Predicted FEV1
Standard Deviation 10.522
|
40.784 Percent of Predicted FEV1
Standard Deviation 10.554
|
|
Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose
Immediately post first dose (n=32,33)
|
45.504 Percent of Predicted FEV1
Standard Deviation 10.938
|
46.396 Percent of Predicted FEV1
Standard Deviation 10.617
|
|
Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose
30 min post first dose (n=33,33)
|
45.990 Percent of Predicted FEV1
Standard Deviation 10.407
|
47.303 Percent of Predicted FEV1
Standard Deviation 10.250
|
|
Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose
1 hour post first dose (n=33,33)
|
46.456 Percent of Predicted FEV1
Standard Deviation 10.638
|
47.816 Percent of Predicted FEV1
Standard Deviation 10.469
|
|
Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose
2 hours post first dose (n=33,33)
|
47.136 Percent of Predicted FEV1
Standard Deviation 10.393
|
48.559 Percent of Predicted FEV1
Standard Deviation 10.352
|
|
Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose
4 hours post first dose (n=33,33)
|
45.839 Percent of Predicted FEV1
Standard Deviation 10.366
|
48.832 Percent of Predicted FEV1
Standard Deviation 9.868
|
|
Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose
6 hours post first dose (n=32,30)
|
46.294 Percent of Predicted FEV1
Standard Deviation 10.678
|
48.133 Percent of Predicted FEV1
Standard Deviation 10.958
|
|
Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose
8 hours post first dose (n=32,30)
|
44.534 Percent of Predicted FEV1
Standard Deviation 10.892
|
46.491 Percent of Predicted FEV1
Standard Deviation 10.507
|
|
Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose
10 hours post first dose (n=31,30)
|
44.913 Percent of Predicted FEV1
Standard Deviation 10.947
|
46.360 Percent of Predicted FEV1
Standard Deviation 10.932
|
|
Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose
12 hours post first dose (n=30,32)
|
43.885 Percent of Predicted FEV1
Standard Deviation 10.726
|
45.446 Percent of Predicted FEV1
Standard Deviation 10.821
|
|
Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose
12.5 hours post dose (n=30,32)
|
46.935 Percent of Predicted FEV1
Standard Deviation 10.728
|
45.560 Percent of Predicted FEV1
Standard Deviation 11.216
|
|
Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose
13 hours post first dose (n=30,32)
|
47.848 Percent of Predicted FEV1
Standard Deviation 10.703
|
45.723 Percent of Predicted FEV1
Standard Deviation 11.043
|
|
Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose
14 hours post first dose (n=30,32)
|
48.051 Percent of Predicted FEV1
Standard Deviation 10.730
|
45.711 Percent of Predicted FEV1
Standard Deviation 11.116
|
|
Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose
16 hours post first dose (n=32,33)
|
46.977 Percent of Predicted FEV1
Standard Deviation 10.236
|
45.599 Percent of Predicted FEV1
Standard Deviation 11.074
|
|
Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose
23 hours post first dose (n=30,32)
|
44.876 Percent of Predicted FEV1
Standard Deviation 11.561
|
42.793 Percent of Predicted FEV1
Standard Deviation 11.537
|
|
Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose
24 hours post first dose (n=31,32)
|
44.844 Percent of Predicted FEV1
Standard Deviation 10.730
|
43.729 Percent of Predicted FEV1
Standard Deviation 11.178
|
SECONDARY outcome
Timeframe: Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dosePopulation: Intent to treat population
Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the change in percent of the estimated healthy lung function at specified time points compared to the pre-dose value.
Outcome measures
| Measure |
15 Mcg BID
n=33 Participants
Arformoterol 15 mcg twice a day (morning and evening)
|
30 Mcg QD
n=33 Participants
Arformoterol 30 mcg once a day (morning) and placebo (evening)
|
|---|---|---|
|
Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose
Immediately post first dose (n=32,32)
|
4.787 percent of predicted FEV1
Standard Deviation 3.274
|
6.028 percent of predicted FEV1
Standard Deviation 4.296
|
|
Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose
30 minutes post first dose (n=32,32)
|
5.574 percent of predicted FEV1
Standard Deviation 3.880
|
6.917 percent of predicted FEV1
Standard Deviation 4.911
|
|
Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose
1 hour post first dose (n=32,32)
|
5.980 percent of predicted FEV1
Standard Deviation 4.124
|
7.437 percent of predicted FEV1
Standard Deviation 4.578
|
|
Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose
2 hours post first dose (n=32,32)
|
6.570 percent of predicted FEV1
Standard Deviation 4.607
|
8.055 percent of predicted FEV1
Standard Deviation 4.761
|
|
Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose
4 hours post first dose (n=32,32)
|
5.399 percent of predicted FEV1
Standard Deviation 4.820
|
8.189 percent of predicted FEV1
Standard Deviation 5.103
|
|
Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose
6 hours post first dose (n=32,30)
|
5.576 percent of predicted FEV1
Standard Deviation 5.237
|
7.904 percent of predicted FEV1
Standard Deviation 5.786
|
|
Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose
8 hours post first dose (n=32,30)
|
3.816 percent of predicted FEV1
Standard Deviation 6.276
|
6.261 percent of predicted FEV1
Standard Deviation 6.101
|
|
Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose
10 hours post first dose (n=30,30)
|
4.810 percent of predicted FEV1
Standard Deviation 5.710
|
6.130 percent of predicted FEV1
Standard Deviation 6.679
|
|
Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose
12 hours post first dose (n=30,32)
|
3.507 percent of predicted FEV1
Standard Deviation 5.382
|
4.662 percent of predicted FEV1
Standard Deviation 6.733
|
|
Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose
12.5 hours post first dose (n=30,32)
|
6.557 percent of predicted FEV1
Standard Deviation 5.216
|
4.776 percent of predicted FEV1
Standard Deviation 7.496
|
|
Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose
13 hours post first dose (n=30,32)
|
7.470 percent of predicted FEV1
Standard Deviation 4.903
|
4.939 percent of predicted FEV1
Standard Deviation 6.978
|
|
Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose
14 hours post first dose (n=30,32)
|
7.672 percent of predicted FEV1
Standard Deviation 5.398
|
4.927 percent of predicted FEV1
Standard Deviation 7.734
|
|
Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose
16 hours post first dose (n=32,32)
|
6.259 percent of predicted FEV1
Standard Deviation 5.767
|
4.937 percent of predicted FEV1
Standard Deviation 8.080
|
|
Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose
23 hours post first dose (n=30,31)
|
4.498 percent of predicted FEV1
Standard Deviation 6.276
|
2.457 percent of predicted FEV1
Standard Deviation 7.732
|
|
Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose
24 hours post first dose (n=31,31)
|
4.875 percent of predicted FEV1
Standard Deviation 4.925
|
3.528 percent of predicted FEV1
Standard Deviation 6.540
|
SECONDARY outcome
Timeframe: 12 hoursPopulation: Intent to treat population
Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the percent of the estimated healthy lung function and reports the highest percent found within 12 hours of dosing.
Outcome measures
| Measure |
15 Mcg BID
n=33 Participants
Arformoterol 15 mcg twice a day (morning and evening)
|
30 Mcg QD
n=33 Participants
Arformoterol 30 mcg once a day (morning) and placebo (evening)
|
|---|---|---|
|
Peak Percent of Predicted Forced Expiratory Volume at One Second (FEV1) Over 12 Hours Post-Dose.
|
49.399 percent of predicted FEV1
Standard Deviation 10.738
|
51.251 percent of predicted FEV1
Standard Deviation 10.606
|
SECONDARY outcome
Timeframe: 12 hoursForced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change in FEV1 from pre-dose to the readings taken 12 hours post-dose, and reports the largest change during that time.
Outcome measures
| Measure |
15 Mcg BID
n=32 Participants
Arformoterol 15 mcg twice a day (morning and evening)
|
30 Mcg QD
n=32 Participants
Arformoterol 30 mcg once a day (morning) and placebo (evening)
|
|---|---|---|
|
Peak Change in Forced Expiratory Volume at One Second (FEV1) Within 12 Hours Post Dose Compared to Pre-dose
|
0.269 liters
Standard Deviation 0.154
|
0.324 liters
Standard Deviation 0.166
|
SECONDARY outcome
Timeframe: 12 hours post first dosePopulation: Intent to treat population. Limited to those patients who had a 15% response.
Time to a 15 percent improvement in forced expiratory volume in one second (FEV1) within 12 hours of dosing. Only patients who achieved at least a 15 percent improvement are included.
Outcome measures
| Measure |
15 Mcg BID
n=20 Participants
Arformoterol 15 mcg twice a day (morning and evening)
|
30 Mcg QD
n=25 Participants
Arformoterol 30 mcg once a day (morning) and placebo (evening)
|
|---|---|---|
|
Time to Onset of 15 Percent Response Within 12 Hours of Dosing
|
7.75 minutes
Interval 1.26 to 111.28
|
2.43 minutes
Interval 1.13 to 692.29
|
SECONDARY outcome
Timeframe: up to 12 hours post dosePopulation: Intent to treat population. Limited to patients who met both criteria: a 12 percent increase in FEV1 and a 200 milliliter increase in FEV1
Time to a 12 percent improvement in forced expiratory volume in one second (FEV1) AND a 200 milliliter increase in FEV1 within 12 hours of dosing. Only patients who met both conditions are included
Outcome measures
| Measure |
15 Mcg BID
n=20 Participants
Arformoterol 15 mcg twice a day (morning and evening)
|
30 Mcg QD
n=25 Participants
Arformoterol 30 mcg once a day (morning) and placebo (evening)
|
|---|---|---|
|
Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase Within 12 Hours of Dosing
|
12.62 minutes
Interval 1.22 to 343.91
|
2.86 minutes
Interval 1.22 to 595.6
|
SECONDARY outcome
Timeframe: pre-dose, immediately post first dose, 30 min, 1,2,4,6,8,10,12, 12.5, 13, 14, 16, 23,24 hours post first dosePopulation: Intent to treat population
Forced vital capacity is the total amount of air that can forcibly be blown out after full inspiration.
Outcome measures
| Measure |
15 Mcg BID
n=33 Participants
Arformoterol 15 mcg twice a day (morning and evening)
|
30 Mcg QD
n=33 Participants
Arformoterol 30 mcg once a day (morning) and placebo (evening)
|
|---|---|---|
|
Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing
Pre-dose (n=32,32)
|
2.545 minutes
Standard Deviation 0.718
|
2.601 minutes
Standard Deviation 0.746
|
|
Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing
Immediately post first dose (n=32,33)
|
2.838 minutes
Standard Deviation 0.790
|
2.905 minutes
Standard Deviation 0.796
|
|
Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing
30 minutes post first dose (n=33,33)
|
2.903 minutes
Standard Deviation 0.814
|
2.953 minutes
Standard Deviation 0.808
|
|
Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing
1 hour post first dose (n=33,33)
|
2.918 minutes
Standard Deviation 0.771
|
3.003 minutes
Standard Deviation 0.846
|
|
Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing
2 hours post first dose (n=33,33)
|
2.931 minutes
Standard Deviation 0.804
|
3.030 minutes
Standard Deviation 0.800
|
|
Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing
4 hours post first dose (n=33,33)
|
2.871 minutes
Standard Deviation 0.783
|
3.028 minutes
Standard Deviation 0.849
|
|
Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing
6 hours post first dose (n=32,30)
|
2.849 minutes
Standard Deviation 0.822
|
2.993 minutes
Standard Deviation 0.844
|
|
Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing
8 hours post first dose (n=32,30)
|
2.776 minutes
Standard Deviation 0.828
|
2.940 minutes
Standard Deviation 0.850
|
|
Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing
10 hours post first dose (n=31,30)
|
2.796 minutes
Standard Deviation 0.852
|
2.906 minutes
Standard Deviation 0.910
|
|
Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing
12 hours post first dose (n=30,32)
|
2.702 minutes
Standard Deviation 0.832
|
2.797 minutes
Standard Deviation 0.862
|
|
Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing
12.5 hours post first dose (n=30,32)
|
2.852 minutes
Standard Deviation 0.832
|
2.796 minutes
Standard Deviation 0.852
|
|
Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing
13 hours post first dose (n=30,32)
|
2.905 minutes
Standard Deviation 0.876
|
2.815 minutes
Standard Deviation 0.829
|
|
Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing
14 hours post first dose (n=30,32)
|
2.878 minutes
Standard Deviation 0.839
|
2.813 minutes
Standard Deviation 0.862
|
|
Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing
16 hours post first dose (n=32,33)
|
2.854 minutes
Standard Deviation 0.824
|
2.812 minutes
Standard Deviation 0.869
|
|
Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing
23 hours post first dose (n=30,32)
|
2.733 minutes
Standard Deviation 0.834
|
2.700 minutes
Standard Deviation 0.866
|
|
Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing
24 hours post first dose (n=31,32)
|
2.774 minutes
Standard Deviation 0.809
|
2.763 minutes
Standard Deviation 0.875
|
SECONDARY outcome
Timeframe: immediately post first dose, 30 min, 1,2,4,6,8,10,12, 12.5, 13, 14, 16, 23,24 hours post first dosePopulation: Intent to treat population
Forced vital capacity is the total amount of air that can forcibly be blown out after full inspiration. The measure compares the change from pre-dose reading to each post-dose time point.
Outcome measures
| Measure |
15 Mcg BID
n=33 Participants
Arformoterol 15 mcg twice a day (morning and evening)
|
30 Mcg QD
n=33 Participants
Arformoterol 30 mcg once a day (morning) and placebo (evening)
|
|---|---|---|
|
Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point
Immediately post first dose (n=32,32)
|
0.293 liters
Standard Deviation 0.240
|
0.290 liters
Standard Deviation 0.274
|
|
Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point
30 minutes post first dose (n=32,32)
|
0.334 liters
Standard Deviation 0.264
|
0.340 liters
Standard Deviation 0.274
|
|
Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point
1 hour post first dose (n=32,32)
|
0.352 liters
Standard Deviation 0.270
|
0.390 liters
Standard Deviation 0.310
|
|
Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point
2 hours post first dose (n=32,32)
|
0.355 liters
Standard Deviation 0.277
|
0.411 liters
Standard Deviation 0.335
|
|
Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point
4 hours post first dose (n=32,32)
|
0.296 liters
Standard Deviation 0.308
|
0.398 liters
Standard Deviation 0.369
|
|
Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point
6 hours post first dose (n=32,30)
|
0.304 liters
Standard Deviation 0.331
|
0.384 liters
Standard Deviation 0.364
|
|
Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point
8 hours post first dose (n=32,30)
|
0.231 liters
Standard Deviation 0.352
|
0.331 liters
Standard Deviation 0.393
|
|
Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point
10 hours post first dose (n=30,30)
|
0.246 liters
Standard Deviation 0.345
|
0.297 liters
Standard Deviation 0.386
|
|
Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point
12 hours post first dose (n=30,32)
|
0.175 liters
Standard Deviation 0.319
|
0.196 liters
Standard Deviation 0.359
|
|
Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point
12.5 hours post first dose (n=30,32)
|
0.325 liters
Standard Deviation 0.348
|
0.195 liters
Standard Deviation 0.355
|
|
Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point
13 hours post first dose (n=30,32)
|
0.378 liters
Standard Deviation 0.326
|
0.214 liters
Standard Deviation 0.359
|
|
Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point
14 hours post first dose (n=30,32)
|
0.351 liters
Standard Deviation 0.374
|
0.213 liters
Standard Deviation 0.383
|
|
Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point
16 hours post first dose (n=32,32)
|
0.308 liters
Standard Deviation 0.378
|
0.183 liters
Standard Deviation 0.414
|
|
Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point
23 hours post first dose (n=30,31)
|
0.206 liters
Standard Deviation 0.348
|
0.088 liters
Standard Deviation 0.380
|
|
Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point
24 hours post first dose (n=31,31)
|
0.257 liters
Standard Deviation 0.337
|
0.148 liters
Standard Deviation 0.344
|
Adverse Events
15 Mcg BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
30 Mcg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
15 Mcg BID
n=33 participants at risk
Arformoterol 15 mcg twice a day (morning and evening)
|
30 Mcg QD
n=33 participants at risk
Arformoterol 30 mcg once a day (morning) and placebo (evening)
|
|---|---|---|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/33
Total number of participants in study is 33. 33 particpants at risk in each treatment arm due to cross over study design.
|
3.0%
1/33 • Number of events 1
Total number of participants in study is 33. 33 particpants at risk in each treatment arm due to cross over study design.
|
|
Musculoskeletal and connective tissue disorders
Arthraglia
|
0.00%
0/33
Total number of participants in study is 33. 33 particpants at risk in each treatment arm due to cross over study design.
|
3.0%
1/33 • Number of events 1
Total number of participants in study is 33. 33 particpants at risk in each treatment arm due to cross over study design.
|
|
Psychiatric disorders
Anxiety
|
3.0%
1/33 • Number of events 1
Total number of participants in study is 33. 33 particpants at risk in each treatment arm due to cross over study design.
|
3.0%
1/33 • Number of events 1
Total number of participants in study is 33. 33 particpants at risk in each treatment arm due to cross over study design.
|
|
Psychiatric disorders
Insomnia
|
3.0%
1/33 • Number of events 1
Total number of participants in study is 33. 33 particpants at risk in each treatment arm due to cross over study design.
|
0.00%
0/33
Total number of participants in study is 33. 33 particpants at risk in each treatment arm due to cross over study design.
|
Additional Information
Brovana Medical Director
Sunovion
Phone: 1-866-503-6351
Results disclosure agreements
- Principal investigator is a sponsor employee In addition to the 60 to 180 day restriction above, since this is a multicenter study, first publication of study results shall be made with other participating study sites as a multicenter publication; provided, if a multicenter publication is not forthcoming within 24 months following completion of study at all sites, the PI shall be free to publish
- Publication restrictions are in place
Restriction type: OTHER