Trial Outcomes & Findings for To Investigate the Relative Efficacy of Terbutaline Turbuhaler® and Salbutamol Pressurized Metered Dose Inhaler (pMDI) a Single Blind Study (NCT NCT01096017)
NCT ID: NCT01096017
Last Updated: 2012-08-31
Results Overview
FEV1 (Forced Expiratory Volume in 1 second) AUC 0-4 hours after drug inhalation
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
24 participants
Primary outcome timeframe
At two visits during a maximum of 15 days. FEV1 timepoints: all time points t=5, 15, 30, 60, 120, 180 and 240 minutes.
Results posted on
2012-08-31
Participant Flow
Participants recruited at one clinic in Tokyo, Japan, between March and April 2010
37 participants enrolled; 13 excluded (9 due to eligibility criteria not fulfilled and 4 for other reasons)
Participant milestones
| Measure |
Salbutamol First, Then Terbutaline
Salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI
|
Terbutaline First, Then Salbutamol
Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒Salbutamol pMDI 200 μg +placebo Turbuhaler®
|
|---|---|---|
|
Treatment Period 1
STARTED
|
12
|
12
|
|
Treatment Period 1
COMPLETED
|
12
|
12
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout 1 - 14 Days
STARTED
|
12
|
12
|
|
Washout 1 - 14 Days
COMPLETED
|
12
|
12
|
|
Washout 1 - 14 Days
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2
STARTED
|
12
|
12
|
|
Treatment Period 2
COMPLETED
|
11
|
11
|
|
Treatment Period 2
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Salbutamol First, Then Terbutaline
Salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI
|
Terbutaline First, Then Salbutamol
Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒Salbutamol pMDI 200 μg +placebo Turbuhaler®
|
|---|---|---|
|
Treatment Period 2
Eligibility criteria not fulfilled
|
1
|
1
|
Baseline Characteristics
To Investigate the Relative Efficacy of Terbutaline Turbuhaler® and Salbutamol Pressurized Metered Dose Inhaler (pMDI) a Single Blind Study
Baseline characteristics by cohort
| Measure |
All Study Participants
n=24 Participants
|
|---|---|
|
Age Continuous
|
41.7 Years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At two visits during a maximum of 15 days. FEV1 timepoints: all time points t=5, 15, 30, 60, 120, 180 and 240 minutes.FEV1 (Forced Expiratory Volume in 1 second) AUC 0-4 hours after drug inhalation
Outcome measures
| Measure |
Salbutamol pMDI
n=22 Participants
200 μg, inhalation, single dose
|
Terbutaline Turbuhaler®
n=22 Participants
0.4 mg, inhalation, single dose
|
|---|---|---|
|
FEV1 (Forced Expiratory Volume in 1 Second) Area Under Curve (AUC) 0-4 Hours After Drug Inhalation
|
617.56 milliLiters x minutes
Interval 352.57 to 974.45
|
634.64 milliLiters x minutes
Interval 356.68 to 1016.46
|
SECONDARY outcome
Timeframe: At two visits during a maximum of 15 dayspercent of pre-dose (ratio)
Outcome measures
| Measure |
Salbutamol pMDI
n=22 Participants
200 μg, inhalation, single dose
|
Terbutaline Turbuhaler®
n=22 Participants
0.4 mg, inhalation, single dose
|
|---|---|---|
|
FEV1 (Forced Expiratory Volume in 1 Second) at 5 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
|
115.58 Percentage of Pre-Dose FEV1
Interval 102.8 to 137.95
|
112.80 Percentage of Pre-Dose FEV1
Interval 100.0 to 134.85
|
SECONDARY outcome
Timeframe: At two visits during a maximum of 15 dayspercent of pre-dose (ratio)
Outcome measures
| Measure |
Salbutamol pMDI
n=22 Participants
200 μg, inhalation, single dose
|
Terbutaline Turbuhaler®
n=22 Participants
0.4 mg, inhalation, single dose
|
|---|---|---|
|
FEV1 (Forced Expiratory Volume in 1 Second) at 15 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
|
118.15 Percentage of Pre-Dose FEV1
Interval 105.11 to 142.16
|
115.69 Percentage of Pre-Dose FEV1
Interval 103.27 to 138.59
|
SECONDARY outcome
Timeframe: At two visits during a maximum of 15 dayspercent of pre-dose (ratio)
Outcome measures
| Measure |
Salbutamol pMDI
n=22 Participants
200 μg, inhalation, single dose
|
Terbutaline Turbuhaler®
n=22 Participants
0.4 mg, inhalation, single dose
|
|---|---|---|
|
FEV1 (Forced Expiratory Volume in 1 Second) at 30 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
|
119.42 Percentage of Pre-Dose FEV1
Interval 103.28 to 147.32
|
117.02 Percentage of Pre-Dose FEV1
Interval 99.59 to 139.83
|
SECONDARY outcome
Timeframe: At two visits during a maximum of 15 dayspercent of pre-dose (ratio)
Outcome measures
| Measure |
Salbutamol pMDI
n=22 Participants
200 μg, inhalation, single dose
|
Terbutaline Turbuhaler®
n=22 Participants
0.4 mg, inhalation, single dose
|
|---|---|---|
|
FEV1 (Forced Expiratory Volume in 1 Second) at 60 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
|
120.28 Percentage of Pre-Dose FEV1
Interval 102.19 to 149.19
|
118.11 Percentage of Pre-Dose FEV1
Interval 102.86 to 144.4
|
SECONDARY outcome
Timeframe: At two visits during a maximum of 15 dayspercent of pre-dose (ratio)
Outcome measures
| Measure |
Salbutamol pMDI
n=22 Participants
200 μg, inhalation, single dose
|
Terbutaline Turbuhaler®
n=22 Participants
0.4 mg, inhalation, single dose
|
|---|---|---|
|
FEV1 (Forced Expiratory Volume in 1 Second) at 120 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
|
119.54 Percentage of Pre-Dose FEV1
Interval 97.45 to 149.73
|
119.79 Percentage of Pre-Dose FEV1
Interval 103.27 to 150.21
|
SECONDARY outcome
Timeframe: At two visits during a maximum of 15 dayspercent of pre-dose (ratio)
Outcome measures
| Measure |
Salbutamol pMDI
n=22 Participants
200 μg, inhalation, single dose
|
Terbutaline Turbuhaler®
n=22 Participants
0.4 mg, inhalation, single dose
|
|---|---|---|
|
FEV1 (Forced Expiratory Volume in 1 Second) at 180 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
|
116.68 Percentage of Pre-Dose FEV1
Interval 92.7 to 142.7
|
118.48 Percentage of Pre-Dose FEV1
Interval 100.68 to 146.06
|
SECONDARY outcome
Timeframe: At two visits during a maximum of 15 dayspercent of pre-dose (ratio)
Outcome measures
| Measure |
Salbutamol pMDI
n=22 Participants
200 μg, inhalation, single dose
|
Terbutaline Turbuhaler®
n=22 Participants
0.4 mg, inhalation, single dose
|
|---|---|---|
|
FEV1 (Forced Expiratory Volume in 1 Second) at 240 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
|
113.59 Percentage of Pre-Dose FEV1
Interval 87.96 to 132.67
|
117.05 Percentage of Pre-Dose FEV1
Interval 97.96 to 139.0
|
SECONDARY outcome
Timeframe: At two visits during a maximum of 15 dayspercent of pre-dose (ratio)
Outcome measures
| Measure |
Salbutamol pMDI
n=22 Participants
200 μg, inhalation, single dose
|
Terbutaline Turbuhaler®
n=22 Participants
0.4 mg, inhalation, single dose
|
|---|---|---|
|
Maximum % Change in FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation
|
122.62 Percent change
Interval 105.11 to 149.73
|
121.43 Percent change
Interval 105.31 to 150.21
|
SECONDARY outcome
Timeframe: At two visits during a maximum of 15 daysTime to peak measurement of FEV1 (min)
Outcome measures
| Measure |
Salbutamol pMDI
n=22 Participants
200 μg, inhalation, single dose
|
Terbutaline Turbuhaler®
n=22 Participants
0.4 mg, inhalation, single dose
|
|---|---|---|
|
Time to Peak FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation
|
60.00 Minutes
Interval 5.0 to 180.0
|
120.00 Minutes
Interval 5.0 to 240.0
|
SECONDARY outcome
Timeframe: At two visits during a maximum of 15 daysNumber of patients with % change in FEV1 \>15% within 4 hours after drug inhalation.
Outcome measures
| Measure |
Salbutamol pMDI
n=22 Participants
200 μg, inhalation, single dose
|
Terbutaline Turbuhaler®
n=22 Participants
0.4 mg, inhalation, single dose
|
|---|---|---|
|
Number of Patients With % Change in FEV1 (Forced Expiratory Volume in 1 Second) >15% Within 4 Hours After Drug Inhalation
|
17 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: At two visits during a maximum of 15 daysTime to change more than or equal to 15% (time to onset response) within 4 hours after drug inhalation
Outcome measures
| Measure |
Salbutamol pMDI
n=22 Participants
200 μg, inhalation, single dose
|
Terbutaline Turbuhaler®
n=22 Participants
0.4 mg, inhalation, single dose
|
|---|---|---|
|
Time to Change More Than or Equal to 15% (Time to Onset Response) Within 4 Hours After Drug Inhalation
|
31.36 Minutes
Standard Deviation 37.49
|
34.32 Minutes
Standard Deviation 40.31
|
Adverse Events
Salbutamol pMDI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Terbutaline Turbuhaler®
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