Trial Outcomes & Findings for Effect of Brovana and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00773786)
NCT ID: NCT00773786
Last Updated: 2019-08-06
Results Overview
Change from baseline in Forced Expiratory Volume in 1 second (FEV1) after 1 week on Brovana or Placebo (measured 2 hours post dose). (Change = 1 week - baseline)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
baseline and 1 week
Results posted on
2019-08-06
Participant Flow
Participant milestones
| Measure |
Tiotropium + Arformoterol (Brovana), Then Tiotropium + Placebo
Participants first received Tiotropium + Brovana twice daily for 1 week via nebulizer. After a 1 week washout period, they received Tiotropium + placebo twice daily for 1 week.
|
Placebo, Then Arformoterol (Brovana)
Participants first received Tiotropium + Placebo twice daily for 1 week . After a 1 week washout period, they received Tiotropium + Brovana twice daily for 1 week via nebulizer.
|
|---|---|---|
|
First Intervention (1 Week)
STARTED
|
10
|
10
|
|
First Intervention (1 Week)
COMPLETED
|
10
|
10
|
|
First Intervention (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Washout (1 Week)
STARTED
|
10
|
10
|
|
Washout (1 Week)
COMPLETED
|
10
|
10
|
|
Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Week)
STARTED
|
10
|
10
|
|
Second Intervention (1 Week)
COMPLETED
|
10
|
10
|
|
Second Intervention (1 Week)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Brovana and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
All Study Participants
n=20 Participants
Participants randomized and received either Tiotropium + Brovana twice daily for 1 week or Tiotropium + placebo twice daily for 1 week.
|
|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
26 Kg/m2
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Forced Expiratory Volume in 1 second (FEV1)
|
53 percent-predicted
STANDARD_DEVIATION 9 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 1 weekChange from baseline in Forced Expiratory Volume in 1 second (FEV1) after 1 week on Brovana or Placebo (measured 2 hours post dose). (Change = 1 week - baseline)
Outcome measures
| Measure |
Brovana (Arformoterol)
n=20 Participants
Participants who received Tiotropium + Brovana twice daily for 1 week via nebulizer
|
Placebo
n=20 Participants
Participants who received Tiotropium + Placebo twice daily for 1 week.
|
|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 1 Week
Trough to trough
|
0.069 Liters
Standard Error 0.048
|
0.010 Liters
Standard Error 0.040
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 1 Week
Peak to peak
|
0.121 Liters
Standard Error 0.037
|
0.023 Liters
Standard Error 0.036
|
SECONDARY outcome
Timeframe: baseline and 1 weekChange from baseline in Forced Vital Capacity (FVC) after 1 week on Brovana or Placebo. (Change = 1 week - baseline)
Outcome measures
| Measure |
Brovana (Arformoterol)
n=10 Participants
Participants who received Tiotropium + Brovana twice daily for 1 week via nebulizer
|
Placebo
n=10 Participants
Participants who received Tiotropium + Placebo twice daily for 1 week.
|
|---|---|---|
|
Change From Baseline in Forced Vital Capacity (FVC) at 1 Week
Trough to trough
|
0120 Liters
Standard Error 0.072
|
0.000 Liters
Standard Error 0.091
|
|
Change From Baseline in Forced Vital Capacity (FVC) at 1 Week
Peak to peak
|
0.080 Liters
Standard Error 0.062
|
-0.062 Liters
Standard Error 0.064
|
SECONDARY outcome
Timeframe: baseline and 2 hours after dosingChange from baseline in Inspiratory Capacity (IC) after 1 week on Brovana or Placebo (measured 2 hours post dose). (Change = 1 week - baseline).
Outcome measures
| Measure |
Brovana (Arformoterol)
n=20 Participants
Participants who received Tiotropium + Brovana twice daily for 1 week via nebulizer
|
Placebo
n=20 Participants
Participants who received Tiotropium + Placebo twice daily for 1 week.
|
|---|---|---|
|
Change From Baseline in Inspiratory Capacity at 1 Week
Trough to trough
|
0.001 Liters
Standard Error 0.898
|
-0.019 Liters
Standard Error 0.647
|
|
Change From Baseline in Inspiratory Capacity at 1 Week
Peak to peak
|
0.113 Liters
Standard Error 0.063
|
-0.004 Liters
Standard Error 0.042
|
Adverse Events
Arformoterol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place