Trial Outcomes & Findings for The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01205269)
NCT ID: NCT01205269
Last Updated: 2014-03-19
Results Overview
Maximum FEV1 value
COMPLETED
PHASE2
28 participants
0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h
2014-03-19
Participant Flow
The study has been performed at four centers in Poland. The first subject entered the study on 10 October 2010 and the last subject completed the study on 17 December 2010. The randomised population consisted of 28 patients, 27 completed the study. All patients were included in the analysis of all variables.
Participant milestones
| Measure |
First 50 mcg, Then 200 mcg, Then Placebo
period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: placebo
|
First 50 mcg, Then Placebo, Then 200 mcg
period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg
|
First 200 mcg, Then Placebo, Then 50 mcg
period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg
|
First 200 mcg, Then 50 mcg, Then Placebo
period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo
|
First Placebo, Then 200 mcg, Then 50 mcg
period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg
|
First Placebo, Then 50 mcg, Then 200 mcg
period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg
|
|---|---|---|---|---|---|---|
|
Period 1 - First Intervention
STARTED
|
4
|
4
|
4
|
6
|
5
|
5
|
|
Period 1 - First Intervention
COMPLETED
|
4
|
4
|
4
|
6
|
5
|
5
|
|
Period 1 - First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 - Washout
STARTED
|
4
|
4
|
4
|
6
|
5
|
5
|
|
Period 2 - Washout
COMPLETED
|
4
|
4
|
4
|
6
|
5
|
5
|
|
Period 2 - Washout
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3 - Second Intervention
STARTED
|
4
|
4
|
4
|
6
|
5
|
5
|
|
Period 3 - Second Intervention
COMPLETED
|
4
|
4
|
4
|
6
|
5
|
5
|
|
Period 3 - Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 4 - Washout
STARTED
|
4
|
4
|
4
|
6
|
5
|
5
|
|
Period 4 - Washout
COMPLETED
|
4
|
4
|
4
|
5
|
5
|
5
|
|
Period 4 - Washout
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period 5 - Third Intervention
STARTED
|
4
|
4
|
4
|
5
|
5
|
5
|
|
Period 5 - Third Intervention
COMPLETED
|
4
|
4
|
4
|
5
|
5
|
5
|
|
Period 5 - Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
First 50 mcg, Then 200 mcg, Then Placebo
period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: placebo
|
First 50 mcg, Then Placebo, Then 200 mcg
period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg
|
First 200 mcg, Then Placebo, Then 50 mcg
period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg
|
First 200 mcg, Then 50 mcg, Then Placebo
period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo
|
First Placebo, Then 200 mcg, Then 50 mcg
period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg
|
First Placebo, Then 50 mcg, Then 200 mcg
period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg
|
|---|---|---|---|---|---|---|
|
Period 4 - Washout
Eligibility criteria not fulfilled
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=28 Participants
Includes all groups randomized to one of 6 sequences of drug or placebo.
|
|---|---|
|
Age, Continuous
|
63.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 hPopulation: Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables
Maximum FEV1 value
Outcome measures
| Measure |
AZD8683 50 mcg
n=28 Participants
1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
|
AZD8683 200 mcg
n=28 Participants
1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
|
Placebo
n=27 Participants
1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
|
|---|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose
|
1.67 L
Standard Deviation 0.48
|
1.73 L
Standard Deviation 0.47
|
1.64 L
Standard Deviation 0.47
|
PRIMARY outcome
Timeframe: 22 h, 24 h, 26 hPopulation: Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables
Trough FEV1 value
Outcome measures
| Measure |
AZD8683 50 mcg
n=28 Participants
1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
|
AZD8683 200 mcg
n=28 Participants
1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
|
Placebo
n=27 Participants
1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
|
|---|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose
|
1.53 L
Standard Deviation 0.46
|
1.60 L
Standard Deviation 0.46
|
1.49 L
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 hPopulation: Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables
Average FEV1 value
Outcome measures
| Measure |
AZD8683 50 mcg
n=28 Participants
1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
|
AZD8683 200 mcg
n=28 Participants
1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
|
Placebo
n=27 Participants
1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
|
|---|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post-dose
|
1.49 L
Standard Deviation 0.42
|
1.54 L
Standard Deviation 0.42
|
1.44 L
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 hPopulation: Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables
Maximum FVC value
Outcome measures
| Measure |
AZD8683 50 mcg
n=28 Participants
1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
|
AZD8683 200 mcg
n=28 Participants
1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
|
Placebo
n=27 Participants
1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
|
|---|---|---|---|
|
Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose
|
3.35 L
Standard Deviation 0.87
|
3.39 L
Standard Deviation 0.81
|
3.28 L
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: 0, 30 min, 2 h, 4 hPopulation: Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables
Average systolic blood pressure value
Outcome measures
| Measure |
AZD8683 50 mcg
n=28 Participants
1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
|
AZD8683 200 mcg
n=28 Participants
1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
|
Placebo
n=27 Participants
1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
|
|---|---|---|---|
|
Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose
|
130.7 mmHg
Standard Deviation 14.1
|
131.2 mmHg
Standard Deviation 12.0
|
132.2 mmHg
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: 0, 30 min, 2 h, 4 hPopulation: Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables
Average diastolic blood pressure value
Outcome measures
| Measure |
AZD8683 50 mcg
n=28 Participants
1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
|
AZD8683 200 mcg
n=28 Participants
1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
|
Placebo
n=27 Participants
1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
|
|---|---|---|---|
|
Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose
|
77.9 mmHg
Standard Deviation 7.6
|
77.5 mmHg
Standard Deviation 6.5
|
77.7 mmHg
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: 0, 30 min, 2 h, 4 hPopulation: Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables
Average pulse value
Outcome measures
| Measure |
AZD8683 50 mcg
n=28 Participants
1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
|
AZD8683 200 mcg
n=28 Participants
1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
|
Placebo
n=27 Participants
1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
|
|---|---|---|---|
|
Pulse, Average Effect Over 0 - 4 Hours Post-dose
|
77.3 bpm
Standard Deviation 10.5
|
76.0 bpm
Standard Deviation 11.9
|
74.9 bpm
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: 0, 30 min, 2 h, 4 hPopulation: Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables
Average heart rate value
Outcome measures
| Measure |
AZD8683 50 mcg
n=28 Participants
1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
|
AZD8683 200 mcg
n=28 Participants
1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
|
Placebo
n=27 Participants
1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
|
|---|---|---|---|
|
Heart Rate, Average Effect Over 0 - 4 Hours Post-dose
|
76.2 bpm
Standard Deviation 12.1
|
75.0 bpm
Standard Deviation 13.4
|
72.8 bpm
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: 0, 30 min, 2 h, 4 hPopulation: Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables
Average QTcF value. QTcF = QT interval corrected for heart rate using Fridericia's formula
Outcome measures
| Measure |
AZD8683 50 mcg
n=28 Participants
1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
|
AZD8683 200 mcg
n=28 Participants
1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
|
Placebo
n=27 Participants
1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
|
|---|---|---|---|
|
QTcF, Average Effect Over 0 - 4 Hours Post-dose
|
412.8 ms
Standard Deviation 22.4
|
409.1 ms
Standard Deviation 23.7
|
411.9 ms
Standard Deviation 22.0
|
SECONDARY outcome
Timeframe: 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 hPopulation: Plasma concentrations were below the LLOQ for all post-dose samples for some patients and treatments. PK parameters for these 3 treatments have been set to missing and are not included in the descriptive statistics.
Maximum plasma concentration of AZD8683
Outcome measures
| Measure |
AZD8683 50 mcg
n=26 Participants
1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
|
AZD8683 200 mcg
n=27 Participants
1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
|
Placebo
1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
|
|---|---|---|---|
|
Plasma AZD8683 Cmax
|
0.0578 nmol/L
Interval 0.008 to 0.262
|
0.2791 nmol/L
Interval 0.03 to 1.25
|
—
|
SECONDARY outcome
Timeframe: 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 hPopulation: Plasma concentrations were below the LLOQ for all post-dose samples for some patients and treatments. PK parameters for these 3 treatments have been set to missing and are not included in the descriptive statistics.
Area under the AZD8683 plasma concentration curve from 0 to 24 hours
Outcome measures
| Measure |
AZD8683 50 mcg
n=26 Participants
1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
|
AZD8683 200 mcg
n=27 Participants
1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
|
Placebo
1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
|
|---|---|---|---|
|
Plasma AZD8683 AUC0-24
|
0.1872 nmol*h/L
Interval 0.013 to 0.836
|
0.8427 nmol*h/L
Interval 0.104 to 2.764
|
—
|
Adverse Events
AZD8683 50 mcg
AZD8683 200 mcg
Placebo
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 An Investigator agrees to provide a copy of the publication to AZ for review at least 60 days in advance of submission for publication. Investigators in multicenter (MC) studies agree to postpone MC publications until the earlier of the date of the first AZ-authorized MC publication or a period up to 18 months from study completion at all sites. AZ has the right to request delays: up to 60 days for confidential information, and an additional 90 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER