Trial Outcomes & Findings for Efficacy of Aclidinium Bromide Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients (NCT NCT00868231)
NCT ID: NCT00868231
Last Updated: 2017-01-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Day 15
Results posted on
2017-01-04
Participant Flow
This study was conducted at 2 sites in Germany. The first patient was screened in Mar 2009 and the last patient visit was in Jul 2009.
Eligible patients had at least a 5-day run-in period (and a maximum of 9 days) to assess patient's clinical stability.
Participant milestones
| Measure |
Aclidinium 400 μg BID - Placebo - Tiotropium 18 μg
The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.
In treatment period 1, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
|
Aclidinium 400 μg BID - Tiotropium 18 μg - Placebo
The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.
In treatment period 1, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
|
Tiotropium 18 μg - Aclidinium 400 μg BID - Placebo
The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.
In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 2, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
|
Tiotropium 18 μg - Placebo - Aclidinium 400 μg BID
The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.
In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the evening and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 3, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
|
Placebo - Aclidinium 400 μg BID - Tiotropium 18 μg
The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.
In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 2, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
|
Placebo - Tiotropium 18 μg - Aclidinium 400 μg BID
The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.
In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 3, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler at in the evening for 15 consecutive days.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Treatment Period 1
COMPLETED
|
5
|
5
|
5
|
5
|
4
|
5
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period 2
STARTED
|
5
|
5
|
5
|
5
|
4
|
5
|
|
Treatment Period 2
COMPLETED
|
4
|
5
|
5
|
5
|
4
|
5
|
|
Treatment Period 2
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3
STARTED
|
4
|
5
|
5
|
5
|
4
|
5
|
|
Treatment Period 3
COMPLETED
|
4
|
5
|
4
|
5
|
4
|
5
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Aclidinium 400 μg BID - Placebo - Tiotropium 18 μg
The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.
In treatment period 1, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
|
Aclidinium 400 μg BID - Tiotropium 18 μg - Placebo
The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.
In treatment period 1, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
|
Tiotropium 18 μg - Aclidinium 400 μg BID - Placebo
The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.
In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 2, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
|
Tiotropium 18 μg - Placebo - Aclidinium 400 μg BID
The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.
In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the evening and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 3, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
|
Placebo - Aclidinium 400 μg BID - Tiotropium 18 μg
The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.
In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 2, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
|
Placebo - Tiotropium 18 μg - Aclidinium 400 μg BID
The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.
In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 3, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler at in the evening for 15 consecutive days.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period 2
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy of Aclidinium Bromide Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
Baseline characteristics by cohort
| Measure |
Overall Study Population
n=30 Participants
All patients randomized into the crossover study
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Gender
Female
|
11 Participants
n=5 Participants
|
|
Gender
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 15Population: Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1
Outcome measures
| Measure |
Aclidininum Bromide 400 μg Bid
n=29 Participants
Aclidinium bromide 400 μg twice-daily via inhalation
|
Tiotropium 18 μg Once-daily
n=28 Participants
Tiotropium 18 μg once-daily by inhalation
|
Placebo
n=27 Participants
Placebo via inhalation
|
|---|---|---|---|
|
Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment.
|
0.236 Liters
Standard Error 0.069
|
0.260 Liters
Standard Error 0.070
|
0.015 Liters
Standard Error 0.070
|
SECONDARY outcome
Timeframe: Day 15Population: Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1
Outcome measures
| Measure |
Aclidininum Bromide 400 μg Bid
n=28 Participants
Aclidinium bromide 400 μg twice-daily via inhalation
|
Tiotropium 18 μg Once-daily
n=28 Participants
Tiotropium 18 μg once-daily by inhalation
|
Placebo
n=27 Participants
Placebo via inhalation
|
|---|---|---|---|
|
Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24hr at Day 15 on Treatment
|
0.174 Liters
Standard Error 0.070
|
0.096 Liters
Standard Error 0.070
|
-0.032 Liters
Standard Error 0.071
|
SECONDARY outcome
Timeframe: Day 15Population: Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1
Outcome measures
| Measure |
Aclidininum Bromide 400 μg Bid
n=28 Participants
Aclidinium bromide 400 μg twice-daily via inhalation
|
Tiotropium 18 μg Once-daily
n=28 Participants
Tiotropium 18 μg once-daily by inhalation
|
Placebo
n=27 Participants
Placebo via inhalation
|
|---|---|---|---|
|
Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment
|
0.226 Liters
Standard Error 0.063
|
0.178 Liters
Standard Error 0.063
|
-0.006 Liters
Standard Error 0.063
|
SECONDARY outcome
Timeframe: Day 1Population: Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1
Outcome measures
| Measure |
Aclidininum Bromide 400 μg Bid
n=29 Participants
Aclidinium bromide 400 μg twice-daily via inhalation
|
Tiotropium 18 μg Once-daily
n=28 Participants
Tiotropium 18 μg once-daily by inhalation
|
Placebo
n=30 Participants
Placebo via inhalation
|
|---|---|---|---|
|
Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC0-12) in Liters at Day 1 on Treatment
|
0.230 Liters
Standard Error 0.040
|
0.178 Liters
Standard Error 0.040
|
0.016 Liters
Standard Error 0.040
|
SECONDARY outcome
Timeframe: Day 1Population: Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1
Outcome measures
| Measure |
Aclidininum Bromide 400 μg Bid
n=28 Participants
Aclidinium bromide 400 μg twice-daily via inhalation
|
Tiotropium 18 μg Once-daily
n=27 Participants
Tiotropium 18 μg once-daily by inhalation
|
Placebo
n=29 Participants
Placebo via inhalation
|
|---|---|---|---|
|
Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment
|
0.202 Liters
Standard Error 0.051
|
0.101 Liters
Standard Error 0.051
|
-0.060 Liters
Standard Error 0.050
|
SECONDARY outcome
Timeframe: Day 1Population: Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1
Outcome measures
| Measure |
Aclidininum Bromide 400 μg Bid
n=29 Participants
Aclidinium bromide 400 μg twice-daily via inhalation
|
Tiotropium 18 μg Once-daily
n=28 Participants
Tiotropium 18 μg once-daily by inhalation
|
Placebo
n=29 Participants
Placebo via inhalation
|
|---|---|---|---|
|
Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment
|
0.211 Liters
Standard Error 0.044
|
0.138 Liters
Standard Error 0.044
|
-0.024 Liters
Standard Error 0.044
|
SECONDARY outcome
Timeframe: Day 15Population: Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1
Outcome measures
| Measure |
Aclidininum Bromide 400 μg Bid
n=29 Participants
Aclidinium bromide 400 μg twice-daily via inhalation
|
Tiotropium 18 μg Once-daily
n=28 Participants
Tiotropium 18 μg once-daily by inhalation
|
Placebo
n=27 Participants
Placebo via inhalation
|
|---|---|---|---|
|
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment
|
0.297 Liters
Standard Error 0.083
|
0.345 Liters
Standard Error 0.083
|
0.009 Liters
Standard Error 0.084
|
SECONDARY outcome
Timeframe: Day 15Population: Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1
Outcome measures
| Measure |
Aclidininum Bromide 400 μg Bid
n=28 Participants
Aclidinium bromide 400 μg twice-daily via inhalation
|
Tiotropium 18 μg Once-daily
n=28 Participants
Tiotropium 18 μg once-daily by inhalation
|
Placebo
n=27 Participants
Placebo via inhalation
|
|---|---|---|---|
|
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 15 on Treatment
|
0.224 Liters
Standard Error 0.074
|
0.087 Liters
Standard Error 0.074
|
-0.095 Liters
Standard Error 0.075
|
SECONDARY outcome
Timeframe: Day 15Population: Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1
Outcome measures
| Measure |
Aclidininum Bromide 400 μg Bid
n=28 Participants
Aclidinium bromide 400 μg twice-daily via inhalation
|
Tiotropium 18 μg Once-daily
n=28 Participants
Tiotropium 18 μg once-daily by inhalation
|
Placebo
n=27 Participants
Placebo via inhalation
|
|---|---|---|---|
|
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment
|
0.281 Liters
Standard Error 0.078
|
0.219 Liters
Standard Error 0.078
|
-0.039 Liters
Standard Error 0.078
|
SECONDARY outcome
Timeframe: Day 1Population: Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1
Outcome measures
| Measure |
Aclidininum Bromide 400 μg Bid
n=29 Participants
Aclidinium bromide 400 μg twice-daily via inhalation
|
Tiotropium 18 μg Once-daily
n=28 Participants
Tiotropium 18 μg once-daily by inhalation
|
Placebo
n=30 Participants
Placebo via inhalation
|
|---|---|---|---|
|
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 1 on Treatment
|
0.331 Liters
Standard Error 0.064
|
0.289 Liters
Standard Error 0.064
|
0.005 Liters
Standard Error 0.063
|
SECONDARY outcome
Timeframe: Day 1Population: Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1
Outcome measures
| Measure |
Aclidininum Bromide 400 μg Bid
n=28 Participants
Aclidinium bromide 400 μg twice-daily via inhalation
|
Tiotropium 18 μg Once-daily
n=27 Participants
Tiotropium 18 μg once-daily by inhalation
|
Placebo
n=29 Participants
Placebo via inhalation
|
|---|---|---|---|
|
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment
|
0.293 Liters
Standard Error 0.072
|
0.150 Liters
Standard Error 0.073
|
-0.127 Liters
Standard Error 0.072
|
SECONDARY outcome
Timeframe: Day 1Population: Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1
Outcome measures
| Measure |
Aclidininum Bromide 400 μg Bid
n=29 Participants
Aclidinium bromide 400 μg twice-daily via inhalation
|
Tiotropium 18 μg Once-daily
n=28 Participants
Tiotropium 18 μg once-daily by inhalation
|
Placebo
n=29 Participants
Placebo via inhalation
|
|---|---|---|---|
|
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment
|
0.310 Liters
Standard Error 0.067
|
0.215 Liters
Standard Error 0.067
|
-0.051 Liters
Standard Error 0.066
|
Adverse Events
Aclidininum Bromide 400 μg Bid
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Tiotropium 18 μg Once-daily
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aclidininum Bromide 400 μg Bid
n=29 participants at risk
Aclidinium bromide 400 μg twice-daily via inhalation
|
Tiotropium 18 μg Once-daily
n=28 participants at risk
Tiotropium 18 μg once-daily by inhalation
|
Placebo
n=30 participants at risk
Placebo via inhalation
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/29
|
0.00%
0/28
|
3.3%
1/30 • Number of events 1
|
Other adverse events
| Measure |
Aclidininum Bromide 400 μg Bid
n=29 participants at risk
Aclidinium bromide 400 μg twice-daily via inhalation
|
Tiotropium 18 μg Once-daily
n=28 participants at risk
Tiotropium 18 μg once-daily by inhalation
|
Placebo
n=30 participants at risk
Placebo via inhalation
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.9%
2/29
|
0.00%
0/28
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/29
|
0.00%
0/28
|
10.0%
3/30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All the information related to this clinical trial is considered strictly confidential and is the property of Almirall. This information will not be given to a third party without the written consent of Almirall. 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 Almirall.
- Publication restrictions are in place
Restriction type: OTHER