Trial Outcomes & Findings for Single Dose Study to Assess Efficacy, Safety and Tolerability of LAS100977 in Asthmatic Patients. (NCT NCT01425801)
NCT ID: NCT01425801
Last Updated: 2018-05-08
Results Overview
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
COMPLETED
PHASE2
62 participants
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
2018-05-08
Participant Flow
The study was conducted in 10 sites in Germany and United Kingdom, 9 of which randomized patients
Screening took place 12-16 days before randomization. After screening, eligible patients entered a run-in period to assess clinical stability. A total of 115 patients were screened; 62 patients were assessed as eligible and randomized; 53 were not randomized due to screening failure (primarily non-fulfillment of inclusion/exclusion criteria)
Participant milestones
| Measure |
Sequence A
Salbutamol 400 μg - LAS100977 0.313 μg - Placebo - LAS100977 0.625 μg - LAS100977 2.5 μg - LAS100977 1.25 μg
|
Sequence B
LAS100977 0.313 μg - LAS100977 0.625 μg - Salbutamol 400 μg - LAS100977 1.25 μg - Placebo - LAS100977 2.5 μg
|
Sequence C
LAS100977 0.625 μg - LAS100977 1.25 μg - LAS100977 0.313 μg - LAS100977 2.5 μg - Salbutamol 400 μg - Placebo
|
Sequence D
LAS100977 1.25 μg - LAS100977 2.5 μg - LAS100977 0.625 μg - Placebo - LAS100977 0.313 μg - Salbutamol 400 μg
|
Sequence E
LAS100977 2.5 μg - Placebo - LAS100977 1.25 μg - Salbutamol 400 μg - LAS100977 0.625 μg - LAS100977 0.313 μg
|
Sequence F
Placebo - Salbutamol 400 μg - LAS100977 2.5 μg - LAS100977 0.313 μg - LAS100977 1.25 μg - LAS100977 0.625 μg
|
|---|---|---|---|---|---|---|
|
Period 1
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Reasons for withdrawal
| Measure |
Sequence A
Salbutamol 400 μg - LAS100977 0.313 μg - Placebo - LAS100977 0.625 μg - LAS100977 2.5 μg - LAS100977 1.25 μg
|
Sequence B
LAS100977 0.313 μg - LAS100977 0.625 μg - Salbutamol 400 μg - LAS100977 1.25 μg - Placebo - LAS100977 2.5 μg
|
Sequence C
LAS100977 0.625 μg - LAS100977 1.25 μg - LAS100977 0.313 μg - LAS100977 2.5 μg - Salbutamol 400 μg - Placebo
|
Sequence D
LAS100977 1.25 μg - LAS100977 2.5 μg - LAS100977 0.625 μg - Placebo - LAS100977 0.313 μg - Salbutamol 400 μg
|
Sequence E
LAS100977 2.5 μg - Placebo - LAS100977 1.25 μg - Salbutamol 400 μg - LAS100977 0.625 μg - LAS100977 0.313 μg
|
Sequence F
Placebo - Salbutamol 400 μg - LAS100977 2.5 μg - LAS100977 0.313 μg - LAS100977 1.25 μg - LAS100977 0.625 μg
|
|---|---|---|---|---|---|---|
|
Period 1
Withdrawal by Subject
|
0
|
0
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0
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0
|
1
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0
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Period 2
Withdrawal by Subject
|
0
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0
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0
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0
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1
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0
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Period 3
Stability criteria not fullfilled
|
0
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0
|
1
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0
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0
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0
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|
Period 4
Not able to maintain visit schedule
|
0
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0
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1
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0
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0
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0
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Baseline Characteristics
Single Dose Study to Assess Efficacy, Safety and Tolerability of LAS100977 in Asthmatic Patients.
Baseline characteristics by cohort
| Measure |
Overall Population
n=62 Participants
Safety population defined as all patients who were randomized and received at least one dose of investigational medicinal product
|
|---|---|
|
Age, Continuous
|
40.9 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dosePopulation: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
Outcome measures
| Measure |
Placebo
n=59 Participants
Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
|
LAS100977 0.313 μg
n=60 Participants
Dry powder administered via the Genuair® inhaler
|
LAS100977 0.625 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 1.25 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 2.5 μg
n=61 Participants
Dry powder for inhalation administered via Genuair®
|
Salbutamol 400 μg
n=58 Participants
Pressurised inhalation suspension administered via Ventolin Evohaler®
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
|
0.202 Liters
Standard Error 0.045
|
0.477 Liters
Standard Error 0.045
|
0.524 Liters
Standard Error 0.045
|
0.573 Liters
Standard Error 0.045
|
0.608 Liters
Standard Error 0.045
|
0.555 Liters
Standard Error 0.045
|
SECONDARY outcome
Timeframe: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dosePopulation: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
Outcome measures
| Measure |
Placebo
n=59 Participants
Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
|
LAS100977 0.313 μg
n=60 Participants
Dry powder administered via the Genuair® inhaler
|
LAS100977 0.625 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 1.25 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 2.5 μg
n=61 Participants
Dry powder for inhalation administered via Genuair®
|
Salbutamol 400 μg
n=58 Participants
Pressurised inhalation suspension administered via Ventolin Evohaler®
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
|
7.555 Percent change
Standard Error 1.655
|
18.282 Percent change
Standard Error 1.651
|
20.212 Percent change
Standard Error 1.651
|
21.809 Percent change
Standard Error 1.651
|
23.077 Percent change
Standard Error 1.650
|
21.374 Percent change
Standard Error 1.658
|
SECONDARY outcome
Timeframe: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dosePopulation: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning on Day 1. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
Outcome measures
| Measure |
Placebo
n=59 Participants
Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
|
LAS100977 0.313 μg
n=60 Participants
Dry powder administered via the Genuair® inhaler
|
LAS100977 0.625 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 1.25 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 2.5 μg
n=61 Participants
Dry powder for inhalation administered via Genuair®
|
Salbutamol 400 μg
n=58 Participants
Pressurised inhalation suspension administered via Ventolin Evohaler®
|
|---|---|---|---|---|---|---|
|
Peak Forced Expiratory Volume in One Second (FEV1)
|
2.855 Liters
Standard Error 0.045
|
3.129 Liters
Standard Error 0.045
|
3.177 Liters
Standard Error 0.045
|
3.225 Liters
Standard Error 0.045
|
3.260 Liters
Standard Error 0.045
|
3.207 Liters
Standard Error 0.045
|
SECONDARY outcome
Timeframe: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dosePopulation: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
Outcome measures
| Measure |
Placebo
n=59 Participants
Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
|
LAS100977 0.313 μg
n=60 Participants
Dry powder administered via the Genuair® inhaler
|
LAS100977 0.625 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 1.25 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 2.5 μg
n=61 Participants
Dry powder for inhalation administered via Genuair®
|
Salbutamol 400 μg
n=58 Participants
Pressurised inhalation suspension administered via Ventolin Evohaler®
|
|---|---|---|---|---|---|---|
|
Time to Peak Forced Expiratory Volume in One Second (FEV1)
|
2.3 Hours
Standard Deviation 1.3
|
2.6 Hours
Standard Deviation 1.3
|
3.0 Hours
Standard Deviation 1.1
|
3.1 Hours
Standard Deviation 0.9
|
3.0 Hours
Standard Deviation 1.1
|
1.1 Hours
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline and +23 h and +24 h post-dosePopulation: Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
Outcome measures
| Measure |
Placebo
n=58 Participants
Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
|
LAS100977 0.313 μg
n=60 Participants
Dry powder administered via the Genuair® inhaler
|
LAS100977 0.625 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 1.25 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 2.5 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
Salbutamol 400 μg
n=58 Participants
Pressurised inhalation suspension administered via Ventolin Evohaler®
|
|---|---|---|---|---|---|---|
|
Change From Baseline to Trough Forced Expiratory Volume in One Second (FEV1)
|
-0.054 Liters
Standard Error 0.039
|
0.166 Liters
Standard Error 0.039
|
0.205 Liters
Standard Error 0.039
|
0.278 Liters
Standard Error 0.039
|
0.346 Liters
Standard Error 0.039
|
-0.076 Liters
Standard Error 0.039
|
SECONDARY outcome
Timeframe: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 hPopulation: Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
FEV1 was normalized to baseline. Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
Outcome measures
| Measure |
Placebo
n=57 Participants
Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
|
LAS100977 0.313 μg
n=59 Participants
Dry powder administered via the Genuair® inhaler
|
LAS100977 0.625 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 1.25 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 2.5 μg
n=59 Participants
Dry powder for inhalation administered via Genuair®
|
Salbutamol 400 μg
n=53 Participants
Pressurised inhalation suspension administered via Ventolin Evohaler®
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24h at Day 1
|
0.007 Liters
Standard Error 0.039
|
0.282 Liters
Standard Error 0.039
|
0.321 Liters
Standard Error 0.038
|
0.390 Liters
Standard Error 0.038
|
0.446 Liters
Standard Error 0.039
|
0.100 Liters
Standard Error 0.039
|
SECONDARY outcome
Timeframe: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 hPopulation: Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
Outcome measures
| Measure |
Placebo
n=59 Participants
Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
|
LAS100977 0.313 μg
n=60 Participants
Dry powder administered via the Genuair® inhaler
|
LAS100977 0.625 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 1.25 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 2.5 μg
n=61 Participants
Dry powder for inhalation administered via Genuair®
|
Salbutamol 400 μg
n=58 Participants
Pressurised inhalation suspension administered via Ventolin Evohaler®
|
|---|---|---|---|---|---|---|
|
Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
3 hr
|
2.771 Liters
Standard Error 0.041
|
3.069 Liters
Standard Error 0.041
|
3.102 Liters
Standard Error 0.041
|
3.190 Liters
Standard Error 0.041
|
3.196 Liters
Standard Error 0.041
|
3.040 Liters
Standard Error 0.041
|
|
Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
4 hr
|
2.774 Liters
Standard Error 0.044
|
3.058 Liters
Standard Error 0.044
|
3.124 Liters
Standard Error 0.044
|
3.167 Liters
Standard Error 0.044
|
3.211 Liters
Standard Error 0.044
|
2.937 Liters
Standard Error 0.044
|
|
Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
0.25 hr
|
2.696 Liters
Standard Error 0.030
|
2.863 Liters
Standard Error 0.030
|
2.886 Liters
Standard Error 0.030
|
2.934 Liters
Standard Error 0.030
|
3.007 Liters
Standard Error 0.030
|
3.106 Liters
Standard Error 0.030
|
|
Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
1 hr
|
2.719 Liters
Standard Error 0.037
|
3.000 Liters
Standard Error 0.037
|
3.025 Liters
Standard Error 0.037
|
3.098 Liters
Standard Error 0.037
|
3.133 Liters
Standard Error 0.037
|
3.147 Liters
Standard Error 0.037
|
|
Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
2 hr
|
2.746 Liters
Standard Error 0.039
|
3.034 Liters
Standard Error 0.038
|
3.081 Liters
Standard Error 0.038
|
3.136 Liters
Standard Error 0.038
|
3.188 Liters
Standard Error 0.039
|
3.123 Liters
Standard Error 0.039
|
|
Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
6 hr
|
2.722 Liters
Standard Error 0.038
|
3.008 Liters
Standard Error 0.038
|
3.087 Liters
Standard Error 0.038
|
3.157 Liters
Standard Error 0.038
|
3.194 Liters
Standard Error 0.038
|
2.812 Liters
Standard Error 0.038
|
|
Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
8 hr
|
2.715 Liters
Standard Error 0.040
|
3.033 Liters
Standard Error 0.039
|
3.062 Liters
Standard Error 0.039
|
3.139 Liters
Standard Error 0.039
|
3.180 Liters
Standard Error 0.039
|
2.772 Liters
Standard Error 0.039
|
|
Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
12 hr
|
2.659 Liters
Standard Error 0.044
|
2.943 Liters
Standard Error 0.043
|
2.980 Liters
Standard Error 0.043
|
3.035 Liters
Standard Error 0.043
|
3.111 Liters
Standard Error 0.043
|
2.669 Liters
Standard Error 0.044
|
|
Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
14 hr
|
2.597 Liters
Standard Error 0.042
|
2.903 Liters
Standard Error 0.041
|
2.941 Liters
Standard Error 0.041
|
3.018 Liters
Standard Error 0.041
|
3.094 Liters
Standard Error 0.042
|
2.683 Liters
Standard Error 0.043
|
|
Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
23 hr
|
2.588 Liters
Standard Error 0.040
|
2.804 Liters
Standard Error 0.039
|
2.836 Liters
Standard Error 0.040
|
2.923 Liters
Standard Error 0.040
|
2.985 Liters
Standard Error 0.040
|
2.562 Liters
Standard Error 0.040
|
|
Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
24 hr
|
2.618 Liters
Standard Error 0.040
|
2.840 Liters
Standard Error 0.039
|
2.890 Liters
Standard Error 0.040
|
2.948 Liters
Standard Error 0.040
|
3.019 Liters
Standard Error 0.040
|
2.605 Liters
Standard Error 0.040
|
|
Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
36 hr
|
2.689 Liters
Standard Error 0.042
|
2.823 Liters
Standard Error 0.041
|
2.798 Liters
Standard Error 0.041
|
2.892 Liters
Standard Error 0.041
|
2.929 Liters
Standard Error 0.041
|
2.690 Liters
Standard Error 0.041
|
|
Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
0.5 hr
|
2.723 Liters
Standard Error 0.034
|
2.956 Liters
Standard Error 0.033
|
2.972 Liters
Standard Error 0.033
|
3.033 Liters
Standard Error 0.033
|
3.089 Liters
Standard Error 0.033
|
3.142 Liters
Standard Error 0.034
|
SECONDARY outcome
Timeframe: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 hPopulation: Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.
Outcome measures
| Measure |
Placebo
n=59 Participants
Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
|
LAS100977 0.313 μg
n=60 Participants
Dry powder administered via the Genuair® inhaler
|
LAS100977 0.625 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 1.25 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 2.5 μg
n=61 Participants
Dry powder for inhalation administered via Genuair®
|
Salbutamol 400 μg
n=58 Participants
Pressurised inhalation suspension administered via Ventolin Evohaler®
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
0.25 hr
|
0.048 Liters
Standard Error 0.030
|
0.214 Liters
Standard Error 0.030
|
0.237 Liters
Standard Error 0.030
|
0.285 Liters
Standard Error 0.030
|
0.358 Liters
Standard Error 0.030
|
0.457 Liters
Standard Error 0.030
|
|
Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
0.5 hr
|
0.071 Liters
Standard Error 0.034
|
0.304 Liters
Standard Error 0.033
|
0.319 Liters
Standard Error 0.033
|
0.381 Liters
Standard Error 0.033
|
0.437 Liters
Standard Error 0.033
|
0.490 Liters
Standard Error 0.034
|
|
Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
1 hr
|
0.067 Liters
Standard Error 0.037
|
0.348 Liters
Standard Error 0.037
|
0.373 Liters
Standard Error 0.037
|
0.446 Liters
Standard Error 0.037
|
0.481 Liters
Standard Error 0.037
|
0.495 Liters
Standard Error 0.037
|
|
Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
2 hr
|
0.094 Liters
Standard Error 0.039
|
0.382 Liters
Standard Error 0.038
|
0.429 Liters
Standard Error 0.038
|
0.484 Liters
Standard Error 0.038
|
0.536 Liters
Standard Error 0.039
|
0.471 Liters
Standard Error 0.039
|
|
Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
3 hr
|
0.119 Liters
Standard Error 0.041
|
0.416 Liters
Standard Error 0.041
|
0.450 Liters
Standard Error 0.041
|
0.537 Liters
Standard Error 0.041
|
0.543 Liters
Standard Error 0.041
|
0.388 Liters
Standard Error 0.041
|
|
Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
4 hr
|
0.121 Liters
Standard Error 0.044
|
0.406 Liters
Standard Error 0.044
|
0.471 Liters
Standard Error 0.044
|
0.515 Liters
Standard Error 0.044
|
0.558 Liters
Standard Error 0.044
|
0.284 Liters
Standard Error 0.044
|
|
Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
6 hr
|
0.067 Liters
Standard Error 0.038
|
0.353 Liters
Standard Error 0.038
|
0.432 Liters
Standard Error 0.038
|
0.501 Liters
Standard Error 0.038
|
0.539 Liters
Standard Error 0.038
|
0.157 Liters
Standard Error 0.038
|
|
Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
8 hr
|
0.056 Liters
Standard Error 0.040
|
0.374 Liters
Standard Error 0.039
|
0.403 Liters
Standard Error 0.039
|
0.480 Liters
Standard Error 0.039
|
0.521 Liters
Standard Error 0.039
|
0.113 Liters
Standard Error 0.039
|
|
Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
12 hr
|
0.005 Liters
Standard Error 0.044
|
0.288 Liters
Standard Error 0.043
|
0.326 Liters
Standard Error 0.043
|
0.380 Liters
Standard Error 0.043
|
0.456 Liters
Standard Error 0.043
|
0.014 Liters
Standard Error 0.044
|
|
Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
14 hr
|
-0.053 Liters
Standard Error 0.042
|
0.253 Liters
Standard Error 0.041
|
0.291 Liters
Standard Error 0.041
|
0.367 Liters
Standard Error 0.041
|
0.443 Liters
Standard Error 0.042
|
0.032 Liters
Standard Error 0.043
|
|
Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
23 hr
|
-0.067 Liters
Standard Error 0.040
|
0.148 Liters
Standard Error 0.039
|
0.181 Liters
Standard Error 0.040
|
0.268 Liters
Standard Error 0.040
|
0.330 Liters
Standard Error 0.040
|
-0.093 Liters
Standard Error 0.040
|
|
Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
24 hr
|
-0.040 Liters
Standard Error 0.040
|
0.183 Liters
Standard Error 0.039
|
0.233 Liters
Standard Error 0.040
|
0.291 Liters
Standard Error 0.040
|
0.362 Liters
Standard Error 0.040
|
-0.052 Liters
Standard Error 0.040
|
|
Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
36 hr
|
0.035 Liters
Standard Error 0.042
|
0.169 Liters
Standard Error 0.041
|
0.144 Liters
Standard Error 0.041
|
0.238 Liters
Standard Error 0.041
|
0.275 Liters
Standard Error 0.041
|
0.036 Liters
Standard Error 0.041
|
SECONDARY outcome
Timeframe: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 hPopulation: Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.
Outcome measures
| Measure |
Placebo
n=59 Participants
Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
|
LAS100977 0.313 μg
n=60 Participants
Dry powder administered via the Genuair® inhaler
|
LAS100977 0.625 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 1.25 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 2.5 μg
n=61 Participants
Dry powder for inhalation administered via Genuair®
|
Salbutamol 400 μg
n=58 Participants
Pressurised inhalation suspension administered via Ventolin Evohaler®
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
0.25 hr
|
1.519 Percent change
Standard Error 1.090
|
8.325 Percent change
Standard Error 1.084
|
8.846 Percent change
Standard Error 1.084
|
10.789 Percent change
Standard Error 1.084
|
13.511 Percent change
Standard Error 1.081
|
17.744 Percent change
Standard Error 1.098
|
|
Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
0.5 hr
|
2.449 Percent change
Standard Error 1.205
|
11.757 Percent change
Standard Error 1.199
|
12.006 Percent change
Standard Error 1.199
|
14.362 Percent change
Standard Error 1.199
|
16.715 Percent change
Standard Error 1.196
|
18.806 Percent change
Standard Error 12.209
|
|
Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
1 hr
|
2.407 Percent change
Standard Error 1.356
|
13.452 Percent change
Standard Error 1.350
|
14.307 Percent change
Standard Error 1.350
|
16.927 Percent change
Standard Error 1.350
|
18.336 Percent change
Standard Error 1.352
|
19.085 Percent change
Standard Error 1.360
|
|
Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
2 hr
|
3.520 Percent change
Standard Error 1.434
|
14.741 Percent change
Standard Error 1.427
|
16.371 Percent change
Standard Error 1.428
|
18.509 Percent change
Standard Error 1.428
|
20.226 Percent change
Standard Error 1.430
|
17.755 Percent change
Standard Error 1.438
|
|
Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
3 hr
|
4.435 Percent change
Standard Error 1.479
|
15.965 Percent change
Standard Error 1.472
|
17.190 Percent change
Standard Error 1.472
|
20.357 Percent change
Standard Error 1.477
|
20.550 Percent change
Standard Error 1.470
|
14.537 Percent change
Standard Error 1.484
|
|
Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
4 hr
|
4.288 Percent change
Standard Error 1.596
|
15.400 Percent change
Standard Error 1.589
|
17.960 Percent change
Standard Error 1.590
|
19.454 Percent change
Standard Error 1.590
|
21.155 Percent change
Standard Error 1.587
|
10.608 Percent change
Standard Error 1.600
|
|
Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
6 hr
|
2.682 Percent change
Standard Error 1.439
|
13.661 Percent change
Standard Error 1.424
|
16.490 Percent change
Standard Error 1.425
|
19.080 Percent change
Standard Error 1.425
|
20.612 Percent change
Standard Error 1.421
|
5.796 Percent change
Standard Error 1.438
|
|
Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
8 hr
|
2.752 Percent change
Standard Error 1.505
|
14.118 Percent change
Standard Error 1.482
|
15.128 Percent change
Standard Error 1.482
|
18.199 Percent change
Standard Error 1.482
|
19.733 Percent change
Standard Error 1.478
|
4.493 Percent change
Standard Error 1.497
|
|
Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
12 hr
|
0.402 Percent change
Standard Error 1.627
|
10.847 Percent change
Standard Error 1.614
|
12.388 Percent change
Standard Error 1.614
|
14.251 Percent change
Standard Error 1.614
|
17.170 Percent change
Standard Error 1.616
|
0.997 Percent change
Standard Error 1.639
|
|
Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
14 hr
|
-1.903 Percent change
Standard Error 1.559
|
9.427 Percent change
Standard Error 1.551
|
11.008 Percent change
Standard Error 1.544
|
11.771 Percent change
Standard Error 1.544
|
16.716 Percent change
Standard Error 1.555
|
1.892 Percent change
Standard Error 1.594
|
|
Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
23 hr
|
-2.117 Percent change
Standard Error 1.464
|
5.451 Percent change
Standard Error 1.444
|
6.955 Percent change
Standard Error 1.445
|
9.893 Percent change
Standard Error 1.445
|
12.375 Percent change
Standard Error 1.449
|
-3.649 Percent change
Standard Error 1.464
|
|
Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
24 hr
|
-0.611 Percent change
Standard Error 1.473
|
7.084 Percent change
Standard Error 1.453
|
8.918 Percent change
Standard Error 1.461
|
10.975 Percent change
Standard Error 1.461
|
13.716 Percent change
Standard Error 1.458
|
-1.736 Percent change
Standard Error 1.482
|
|
Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
36 hr
|
1.904 Percent change
Standard Error 1.574
|
6.396 Percent change
Standard Error 1.554
|
5.589 Percent change
Standard Error 1.555
|
8.742 Percent change
Standard Error 1.555
|
10.370 Percent change
Standard Error 1.558
|
2.098 Percent change
Standard Error 1.572
|
SECONDARY outcome
Timeframe: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dosePopulation: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
Outcome measures
| Measure |
Placebo
n=59 Participants
Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
|
LAS100977 0.313 μg
n=60 Participants
Dry powder administered via the Genuair® inhaler
|
LAS100977 0.625 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 1.25 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 2.5 μg
n=61 Participants
Dry powder for inhalation administered via Genuair®
|
Salbutamol 400 μg
n=58 Participants
Pressurised inhalation suspension administered via Ventolin Evohaler®
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Peak Forced Vital Capacity (FVC)
|
0.222 Liters
Standard Error 0.034
|
0.317 Liters
Standard Error 0.034
|
0.329 Liters
Standard Error 0.034
|
0.361 Liters
Standard Error 0.034
|
0.380 Liters
Standard Error 0.034
|
0.361 Liters
Standard Error 0.034
|
SECONDARY outcome
Timeframe: +15 min, +30 min, +1 h, +2 h, +3 h, +4 hPopulation: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
Outcome measures
| Measure |
Placebo
n=59 Participants
Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
|
LAS100977 0.313 μg
n=60 Participants
Dry powder administered via the Genuair® inhaler
|
LAS100977 0.625 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 1.25 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 2.5 μg
n=61 Participants
Dry powder for inhalation administered via Genuair®
|
Salbutamol 400 μg
n=58 Participants
Pressurised inhalation suspension administered via Ventolin Evohaler®
|
|---|---|---|---|---|---|---|
|
Peak Forced Vital Capacity (FVC)
|
4.483 Liters
Standard Error 0.034
|
4.578 Liters
Standard Error 0.034
|
4.590 Liters
Standard Error 0.034
|
4.622 Liters
Standard Error 0.034
|
4.641 Liters
Standard Error 0.034
|
4.622 Liters
Standard Error 0.034
|
SECONDARY outcome
Timeframe: +15 min, +30 min, +1 h, +2 h, +3 h, +4 hPopulation: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
Outcome measures
| Measure |
Placebo
n=59 Participants
Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
|
LAS100977 0.313 μg
n=60 Participants
Dry powder administered via the Genuair® inhaler
|
LAS100977 0.625 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 1.25 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 2.5 μg
n=61 Participants
Dry powder for inhalation administered via Genuair®
|
Salbutamol 400 μg
n=58 Participants
Pressurised inhalation suspension administered via Ventolin Evohaler®
|
|---|---|---|---|---|---|---|
|
Time to Peak Forced Vital Capacity (FVC)
|
2.1 Hours
Standard Deviation 1.4
|
1.8 Hours
Standard Deviation 1.4
|
2.3 Hours
Standard Deviation 1.4
|
2.1 Hours
Standard Deviation 1.2
|
2.2 Hours
Standard Deviation 1.4
|
1.5 Hours
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline and +23 h +24 h post-dosePopulation: Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
Outcome measures
| Measure |
Placebo
n=58 Participants
Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
|
LAS100977 0.313 μg
n=60 Participants
Dry powder administered via the Genuair® inhaler
|
LAS100977 0.625 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 1.25 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 2.5 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
Salbutamol 400 μg
n=58 Participants
Pressurised inhalation suspension administered via Ventolin Evohaler®
|
|---|---|---|---|---|---|---|
|
Change From Baseline to Trough Forced Vital Capacity (FVC)
|
-0.028 Liters
Standard Error 0.035
|
0.094 Liters
Standard Error 0.035
|
0.050 Liters
Standard Error 0.035
|
0.111 Liters
Standard Error 0.035
|
0.120 Liters
Standard Error 0.035
|
-0.065 Liters
Standard Error 0.035
|
SECONDARY outcome
Timeframe: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 hPopulation: Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
FVC was normalized to baseline. Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
Outcome measures
| Measure |
Placebo
n=57 Participants
Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
|
LAS100977 0.313 μg
n=59 Participants
Dry powder administered via the Genuair® inhaler
|
LAS100977 0.625 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 1.25 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 2.5 μg
n=59 Participants
Dry powder for inhalation administered via Genuair®
|
Salbutamol 400 μg
n=53 Participants
Pressurised inhalation suspension administered via Ventolin Evohaler®
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Normalized Forced Vital Capacity (FVC) Area Under the Curve (AUC)
|
0.017 Liters
Standard Error 0.031
|
0.135 Liters
Standard Error 0.031
|
0.109 Liters
Standard Error 0.030
|
0.169 Liters
Standard Error 0.030
|
0.192 Liters
Standard Error 0.031
|
0.054 Liters
Standard Error 0.031
|
SECONDARY outcome
Timeframe: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 hPopulation: Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.
Outcome measures
| Measure |
Placebo
n=59 Participants
Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
|
LAS100977 0.313 μg
n=60 Participants
Dry powder administered via the Genuair® inhaler
|
LAS100977 0.625 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 1.25 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 2.5 μg
n=61 Participants
Dry powder for inhalation administered via Genuair®
|
Salbutamol 400 μg
n=58 Participants
Pressurised inhalation suspension administered via Ventolin Evohaler®
|
|---|---|---|---|---|---|---|
|
Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint
1 hr
|
4.295 Liters
Standard Error 0.034
|
4.442 Liters
Standard Error 0.034
|
4.429 Liters
Standard Error 0.034
|
4.480 Liters
Standard Error 0.034
|
4.498 Liters
Standard Error 0.034
|
4.502 Liters
Standard Error 0.034
|
|
Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint
2 hr
|
4.321 Liters
Standard Error 0.034
|
4.445 Liters
Standard Error 0.034
|
4.444 Liters
Standard Error 0.034
|
4.495 Liters
Standard Error 0.034
|
4.512 Liters
Standard Error 0.034
|
4.477 Liters
Standard Error 0.034
|
|
Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint
3 hr
|
4.352 Liters
Standard Error 0.036
|
4.462 Liters
Standard Error 0.035
|
4.472 Liters
Standard Error 0.035
|
4.505 Liters
Standard Error 0.035
|
4.505 Liters
Standard Error 0.035
|
4.454 Liters
Standard Error 0.036
|
|
Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint
0.25h
|
4.295 Liters
Standard Error 0.030
|
4.420 Liters
Standard Error 0.030
|
4.368 Liters
Standard Error 0.030
|
4.383 Liters
Standard Error 0.030
|
4.417 Liters
Standard Error 0.030
|
4.471 Liters
Standard Error 0.030
|
|
Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint
0.5 hr
|
4.320 Liters
Standard Error 0.032
|
4.458 Liters
Standard Error 0.032
|
4.405 Liters
Standard Error 0.032
|
4.438 Liters
Standard Error 0.032
|
4.443 Liters
Standard Error 0.032
|
4.502 Liters
Standard Error 0.032
|
|
Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint
4 hr
|
4.316 Liters
Standard Error 0.035
|
4.459 Liters
Standard Error 0.035
|
4.462 Liters
Standard Error 0.035
|
4.463 Liters
Standard Error 0.035
|
4.517 Liters
Standard Error 0.034
|
4.398 Liters
Standard Error 0.035
|
|
Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint
6 hr
|
4.322 Liters
Standard Error 0.033
|
4.413 Liters
Standard Error 0.033
|
1.411 Liters
Standard Error 0.033
|
4.464 Liters
Standard Error 0.033
|
4.513 Liters
Standard Error 0.033
|
4.360 Liters
Standard Error 0.033
|
|
Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint
8 hr
|
4.325 Liters
Standard Error 0.035
|
4.456 Liters
Standard Error 0.035
|
4.412 Liters
Standard Error 0.035
|
4.487 Liters
Standard Error 0.035
|
4.499 Liters
Standard Error 0.035
|
4.335 Liters
Standard Error 0.035
|
|
Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint
12 hr
|
4.310 Liters
Standard Error 0.036
|
4.409 Liters
Standard Error 0.036
|
4.349 Liters
Standard Error 0.036
|
4.414 Liters
Standard Error 0.036
|
4.453 Liters
Standard Error 0.036
|
4.277 Liters
Standard Error 0.037
|
|
Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint
14 hr
|
4.235 Liters
Standard Error 0.036
|
4.357 Liters
Standard Error 0.036
|
4.360 Liters
Standard Error 0.036
|
4.436 Liters
Standard Error 0.036
|
4.458 Liters
Standard Error 0.036
|
4.269 Liters
Standard Error 0.037
|
|
Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint
23 hr
|
4.244 Liters
Standard Error 0.037
|
4.366 Liters
Standard Error 0.036
|
4.303 Liters
Standard Error 0.036
|
4.375 Liters
Standard Error 0.036
|
4.367 Liters
Standard Error 0.036
|
4.223 Liters
Standard Error 0.037
|
|
Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint
24 hr
|
4.238 Liters
Standard Error 0.038
|
4.359 Liters
Standard Error 0.037
|
4.335 Liters
Standard Error 0.038
|
4.384 Liters
Standard Error 0.038
|
4.410 Liters
Standard Error 0.038
|
4.193 Liters
Standard Error 0.038
|
|
Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint
36 hr
|
4.252 Liters
Standard Error 0.040
|
4.390 Liters
Standard Error 0.039
|
4.280 Liters
Standard Error 0.039
|
4.352 Liters
Standard Error 0.039
|
4.381 Liters
Standard Error 0.039
|
4.284 Liters
Standard Error 0.040
|
SECONDARY outcome
Timeframe: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 hPopulation: Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.
Outcome measures
| Measure |
Placebo
n=59 Participants
Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
|
LAS100977 0.313 μg
n=60 Participants
Dry powder administered via the Genuair® inhaler
|
LAS100977 0.625 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 1.25 μg
n=60 Participants
Dry powder for inhalation administered via Genuair®
|
LAS100977 2.5 μg
n=61 Participants
Dry powder for inhalation administered via Genuair®
|
Salbutamol 400 μg
n=58 Participants
Pressurised inhalation suspension administered via Ventolin Evohaler®
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint
0.25 hr
|
0.038 Liters
Standard Error 0.030
|
0.162 Liters
Standard Error 0.030
|
0.111 Liters
Standard Error 0.030
|
0.125 Liters
Standard Error 0.030
|
0.159 Liters
Standard Error 0.030
|
0.213 Liters
Standard Error 0.030
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint
0.5 hr
|
0.059 Liters
Standard Error 0.032
|
0.197 Liters
Standard Error 0.032
|
0.144 Liters
Standard Error 0.032
|
0.177 Liters
Standard Error 0.032
|
0.182 Liters
Standard Error 0.032
|
0.241 Liters
Standard Error 0.032
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint
1 hr
|
0.034 Liters
Standard Error 0.034
|
0.182 Liters
Standard Error 0.034
|
0.169 Liters
Standard Error 0.034
|
0.219 Liters
Standard Error 0.034
|
0.237 Liters
Standard Error 0.034
|
0.242 Liters
Standard Error 0.034
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint
2 hr
|
0.060 Liters
Standard Error 0.034
|
0.184 Liters
Standard Error 0.034
|
0.183 Liters
Standard Error 0.034
|
0.234 Liters
Standard Error 0.034
|
0.252 Liters
Standard Error 0.034
|
0.217 Liters
Standard Error 0.034
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint
3 hr
|
0.089 Liters
Standard Error 0.036
|
0.199 Liters
Standard Error 0.035
|
0.209 Liters
Standard Error 0.035
|
0.241 Liters
Standard Error 0.035
|
0.242 Liters
Standard Error 0.035
|
0.191 Liters
Standard Error 0.036
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint
4 hr
|
0.055 Liters
Standard Error 0.035
|
0.198 Liters
Standard Error 0.035
|
0.201 Liters
Standard Error 0.035
|
0.202 Liters
Standard Error 0.035
|
0.256 Liters
Standard Error 0.034
|
0.137 Liters
Standard Error 0.035
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint
6 hr
|
0.057 Liters
Standard Error 0.033
|
0.149 Liters
Standard Error 0.033
|
0.147 Liters
Standard Error 0.033
|
0.200 Liters
Standard Error 0.033
|
0.249 Liters
Standard Error 0.033
|
0.096 Liters
Standard Error 0.033
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint
8 hr
|
0.054 Liters
Standard Error 0.035
|
0.185 Liters
Standard Error 0.035
|
0.141 Liters
Standard Error 0.035
|
0.216 Liters
Standard Error 0.035
|
0.228 Liters
Standard Error 0.035
|
0.064 Liters
Standard Error 0.035
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint
12 hr
|
0.042 Liters
Standard Error 0.036
|
0.141 Liters
Standard Error 0.036
|
0.081 Liters
Standard Error 0.036
|
0.146 Liters
Standard Error 0.036
|
0.185 Liters
Standard Error 0.036
|
0.001 Liters
Standard Error 0.037
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint
14 hr
|
-0.027 Liters
Standard Error 0.036
|
0.095 Liters
Standard Error 0.036
|
0.097 Liters
Standard Error 0.036
|
0.173 Liters
Standard Error 0.036
|
0.195 Liters
Standard Error 0.036
|
0.006 Liters
Standard Error 0.037
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint
23 hr
|
-0.022 Liters
Standard Error 0.037
|
0.101 Liters
Standard Error 0.036
|
0.038 Liters
Standard Error 0.036
|
0.110 Liters
Standard Error 0.036
|
0.102 Liters
Standard Error 0.036
|
-0.043 Liters
Standard Error 0.037
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint
24 hr
|
-0.034 Liters
Standard Error 0.038
|
0.086 Liters
Standard Error 0.037
|
0.063 Liters
Standard Error 0.038
|
0.111 Liters
Standard Error 0.038
|
0.137 Liters
Standard Error 0.038
|
-0.079 Liters
Standard Error 0.038
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint
36 hr
|
-0.011 Liters
Standard Error 0.040
|
0.128 Liters
Standard Error 0.039
|
0.018 Liters
Standard Error 0.039
|
0.089 Liters
Standard Error 0.039
|
0.118 Liters
Standard Error 0.039
|
0.022 Liters
Standard Error 0.040
|
Adverse Events
Placebo
LAS100977 0.313 μg
LAS100977 0.625 μg
LAS100977 1.25 μg
LAS100977 2.5 μg
Salbutamol 400 μg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=59 participants at risk
Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
|
LAS100977 0.313 μg
n=60 participants at risk
Dry powder administered via the Genuair® inhaler
|
LAS100977 0.625 μg
n=60 participants at risk
Dry powder for inhalation administered via Genuair®
|
LAS100977 1.25 μg
n=60 participants at risk
Dry powder for inhalation administered via Genuair®
|
LAS100977 2.5 μg
n=61 participants at risk
Dry powder for inhalation administered via Genuair®
|
Salbutamol 400 μg
n=62 participants at risk
Pressurised inhalation suspension administered via Ventolin Evohaler®
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
11.9%
7/59 • Up to 14 (±2) days after last intake of investigational medicinal product
Safety population defined as all randomized patients who took at least 1 dose of investigational medicinal product The total number of patients in the safety population was 62; due to study drop-out and the crossover study design, not all patients received all treatments
|
6.7%
4/60 • Up to 14 (±2) days after last intake of investigational medicinal product
Safety population defined as all randomized patients who took at least 1 dose of investigational medicinal product The total number of patients in the safety population was 62; due to study drop-out and the crossover study design, not all patients received all treatments
|
11.7%
7/60 • Up to 14 (±2) days after last intake of investigational medicinal product
Safety population defined as all randomized patients who took at least 1 dose of investigational medicinal product The total number of patients in the safety population was 62; due to study drop-out and the crossover study design, not all patients received all treatments
|
13.3%
8/60 • Up to 14 (±2) days after last intake of investigational medicinal product
Safety population defined as all randomized patients who took at least 1 dose of investigational medicinal product The total number of patients in the safety population was 62; due to study drop-out and the crossover study design, not all patients received all treatments
|
11.5%
7/61 • Up to 14 (±2) days after last intake of investigational medicinal product
Safety population defined as all randomized patients who took at least 1 dose of investigational medicinal product The total number of patients in the safety population was 62; due to study drop-out and the crossover study design, not all patients received all treatments
|
9.7%
6/62 • Up to 14 (±2) days after last intake of investigational medicinal product
Safety population defined as all randomized patients who took at least 1 dose of investigational medicinal product The total number of patients in the safety population was 62; due to study drop-out and the crossover study design, not all patients received all treatments
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
1/59 • Up to 14 (±2) days after last intake of investigational medicinal product
Safety population defined as all randomized patients who took at least 1 dose of investigational medicinal product The total number of patients in the safety population was 62; due to study drop-out and the crossover study design, not all patients received all treatments
|
13.3%
8/60 • Up to 14 (±2) days after last intake of investigational medicinal product
Safety population defined as all randomized patients who took at least 1 dose of investigational medicinal product The total number of patients in the safety population was 62; due to study drop-out and the crossover study design, not all patients received all treatments
|
5.0%
3/60 • Up to 14 (±2) days after last intake of investigational medicinal product
Safety population defined as all randomized patients who took at least 1 dose of investigational medicinal product The total number of patients in the safety population was 62; due to study drop-out and the crossover study design, not all patients received all treatments
|
6.7%
4/60 • Up to 14 (±2) days after last intake of investigational medicinal product
Safety population defined as all randomized patients who took at least 1 dose of investigational medicinal product The total number of patients in the safety population was 62; due to study drop-out and the crossover study design, not all patients received all treatments
|
3.3%
2/61 • Up to 14 (±2) days after last intake of investigational medicinal product
Safety population defined as all randomized patients who took at least 1 dose of investigational medicinal product The total number of patients in the safety population was 62; due to study drop-out and the crossover study design, not all patients received all treatments
|
0.00%
0/62 • Up to 14 (±2) days after last intake of investigational medicinal product
Safety population defined as all randomized patients who took at least 1 dose of investigational medicinal product The total number of patients in the safety population was 62; due to study drop-out and the crossover study design, not all patients received all treatments
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication and/or presentation whether complete or partial, of any part of the data or results of this trial will be subject to revision and written agreement between the investigator and sponsor
- Publication restrictions are in place
Restriction type: OTHER