Trial Outcomes & Findings for Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler® (NCT NCT01048333)
NCT ID: NCT01048333
Last Updated: 2012-10-25
Results Overview
FEV1(Forced Expiratory Volume in 1 second) measured by spirometry 5 minutes post dose, percentage change versus pre dose FEV1
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
109 participants
Primary outcome timeframe
Pre-dose and 5 minutes post-dose
Results posted on
2012-10-25
Participant Flow
Patients recruited at 14 clinics in 3 countries: Sweden (4 clinics); Italy (6 clinics); Spain (6 clinics)between January and May 2010
141 patients enrolled; 32 excluded: 28 due to eligibility criteria not fulfilled and 4 for subject decision
Participant milestones
| Measure |
Formoterol, Then Salmeterol, Then Placebo
Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler
|
Salmeterol, Then Palcebo, Then Formoterol
Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
|
Placebo, Then Formoterol, Then Salmeterol
Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
|
Formoterol, Then Placebo, Then Salmeterol
Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
|
Salmeterol, Then Formoterol, Then Placebo
Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler
|
Placebo, Then Salmeterol, Then Formoterol
Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
21
|
19
|
16
|
18
|
17
|
18
|
|
Treatment Period 1
COMPLETED
|
21
|
19
|
16
|
18
|
17
|
18
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Wash-Out Period 1 of 2 - 7 Days
STARTED
|
21
|
19
|
16
|
18
|
17
|
18
|
|
Wash-Out Period 1 of 2 - 7 Days
COMPLETED
|
21
|
19
|
16
|
18
|
17
|
18
|
|
Wash-Out Period 1 of 2 - 7 Days
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2
STARTED
|
21
|
19
|
16
|
18
|
17
|
18
|
|
Treatment Period 2
COMPLETED
|
21
|
19
|
16
|
18
|
17
|
18
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Wash-Out Period 2 of 2 - 7 Days
STARTED
|
21
|
19
|
16
|
18
|
17
|
18
|
|
Wash-Out Period 2 of 2 - 7 Days
COMPLETED
|
21
|
18
|
16
|
18
|
17
|
18
|
|
Wash-Out Period 2 of 2 - 7 Days
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period 3
STARTED
|
21
|
18
|
16
|
18
|
17
|
18
|
|
Treatment Period 3
COMPLETED
|
21
|
18
|
16
|
18
|
17
|
18
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Formoterol, Then Salmeterol, Then Placebo
Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler
|
Salmeterol, Then Palcebo, Then Formoterol
Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
|
Placebo, Then Formoterol, Then Salmeterol
Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
|
Formoterol, Then Placebo, Then Salmeterol
Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
|
Salmeterol, Then Formoterol, Then Placebo
Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler
|
Placebo, Then Salmeterol, Then Formoterol
Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
|
|---|---|---|---|---|---|---|
|
Wash-Out Period 2 of 2 - 7 Days
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler®
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=109 Participants
Includes all 3 arms : Formoterol, Salmeterol and Placebo.
|
|---|---|
|
Age Continuous
|
66.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 5 minutes post-doseFEV1(Forced Expiratory Volume in 1 second) measured by spirometry 5 minutes post dose, percentage change versus pre dose FEV1
Outcome measures
| Measure |
Formoterol
n=108 Participants
Formoterol Turbuhaler 9 mcg
|
Salmeterol
n=109 Participants
Serevent Diskus (salmeterol) 50 mcg
|
Placebo
n=109 Participants
Placebo salmeterol Diskus and Placebo Turbuhaler
|
|---|---|---|---|
|
FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose
|
1.072 percentage change
Interval 1.055 to 1.088
|
1.041 percentage change
Interval 1.025 to 1.057
|
1.007 percentage change
Interval 0.992 to 1.023
|
SECONDARY outcome
Timeframe: Pre dose and 15 minutes post doseAverage FEV1 during the first 15 minutes post dose, change versus pre dose FEV1
Outcome measures
| Measure |
Formoterol
n=108 Participants
Formoterol Turbuhaler 9 mcg
|
Salmeterol
n=109 Participants
Serevent Diskus (salmeterol) 50 mcg
|
Placebo
n=109 Participants
Placebo salmeterol Diskus and Placebo Turbuhaler
|
|---|---|---|---|
|
Average FEV1 During the First 15 Minutes Post Dose
|
1.064 percentage change
Interval 1.052 to 1.077
|
1.041 percentage change
Interval 1.03 to 1.053
|
1.012 percentage change
Interval 1.001 to 1.024
|
SECONDARY outcome
Timeframe: Pre dose and 120 minutes post doseAverage FEV1 during 120 minutes post dose, change versus pre dose FEV1
Outcome measures
| Measure |
Formoterol
n=108 Participants
Formoterol Turbuhaler 9 mcg
|
Salmeterol
n=109 Participants
Serevent Diskus (salmeterol) 50 mcg
|
Placebo
n=109 Participants
Placebo salmeterol Diskus and Placebo Turbuhaler
|
|---|---|---|---|
|
Average FEV1 During 120 Minutes Post Dose
|
1.096 percentage change
Interval 1.079 to 1.112
|
1.082 percentage change
Interval 1.066 to 1.098
|
1.014 percentage change
Interval 0.999 to 1.029
|
SECONDARY outcome
Timeframe: Pre dose, 5, 10, 15, 20, 30, 40, 50, 60 and 120 minutes post dosePercentage of patients who has achieved at least 12 % increase in FEV1 at each time point between 5 to 120 minutes post dose, change versus pre dose FEV1
Outcome measures
| Measure |
Formoterol
n=108 Participants
Formoterol Turbuhaler 9 mcg
|
Salmeterol
n=109 Participants
Serevent Diskus (salmeterol) 50 mcg
|
Placebo
n=109 Participants
Placebo salmeterol Diskus and Placebo Turbuhaler
|
|---|---|---|---|
|
Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1
5 min
|
23.1 Percentage of Participants
|
9.2 Percentage of Participants
|
6.4 Percentage of Participants
|
|
Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1
10 min
|
38.0 Percentage of Participants
|
17.6 Percentage of Participants
|
7.3 Percentage of Participants
|
|
Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1
15 min
|
39.8 Percentage of Participants
|
23.9 Percentage of Participants
|
9.2 Percentage of Participants
|
|
Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1
20 min
|
44.4 Percentage of Participants
|
27.5 Percentage of Participants
|
10.1 Percentage of Participants
|
|
Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1
30 min
|
45.4 Percentage of Participants
|
32.1 Percentage of Participants
|
13.8 Percentage of Participants
|
|
Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1
40 min
|
49.1 Percentage of Participants
|
36.7 Percentage of Participants
|
15.6 Percentage of Participants
|
|
Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1
50 min
|
53.7 Percentage of Participants
|
40.4 Percentage of Participants
|
16.5 Percentage of Participants
|
|
Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1
60 min
|
54.6 Percentage of Participants
|
43.1 Percentage of Participants
|
18.3 Percentage of Participants
|
|
Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1
120 min
|
55.6 Percentage of Participants
|
48.6 Percentage of Participants
|
20.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: At baseline and at each day of treatmentNumber of participants with at least 1 AE.
Outcome measures
| Measure |
Formoterol
n=108 Participants
Formoterol Turbuhaler 9 mcg
|
Salmeterol
n=109 Participants
Serevent Diskus (salmeterol) 50 mcg
|
Placebo
n=109 Participants
Placebo salmeterol Diskus and Placebo Turbuhaler
|
|---|---|---|---|
|
Adverse Events
|
6 Participants
|
6 Participants
|
2 Participants
|
Adverse Events
Formoterol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Salmeterol
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
Restriction type: LTE60