Trial Outcomes & Findings for A Single Inhalation Dose Study to Assess Efficacy, Pharmacokinetics (PK), Safety and Tolerability of AZD8871 in Patients With Long-term Lung Diseases. (NCT NCT03645434)
NCT ID: NCT03645434
Last Updated: 2020-12-17
Results Overview
To evaluate the efficacy of inhaled AZD8871 600 μg in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
73 participants
Primary outcome timeframe
Day 15
Results posted on
2020-12-17
Participant Flow
Subjects who met all the inclusion and none of the exclusion criteria were enrolled at 3 sites in Germany and 2 sites in the United Kingdom (UK).
Subjects attended Screening Visit within a 14 to 28-days Screening Period, before receiving their first dose of AZD8871. All subjects underwent inclusion exclusion criteria assessment and all eligible subjects signed the informed consent before undergoing any study related procedures.
Participant milestones
| Measure |
Treatment Sequence A
Randomized subjects received 14 repeated daily oral doses of inhalation powder via DPI as follows:
Treatment period 1: AZD8871 600 μg and Anoro® Ellipta® matching placebo. Treatment period 2: AZD8871 matching placebo and Anoro® Ellipta® 55 μg / 22 μg. Treatment period 3: Matching placebo of AZD8871 and Anoro® Ellipta®.
|
Treatment Sequence B
Randomized subjects received 14 repeated daily oral doses of inhalation powder via DPI as follows:
Treatment period 1: AZD8871 600 μg and Anoro® Ellipta® matching placebo. Treatment period 2: Matching placebo of AZD8871 and Anoro® Ellipta®. Treatment period 3: AZD8871 matching placebo and Anoro® Ellipta® 55 μg / 22 μg.
|
Treatment Sequence C
Randomized subjects received 14 repeated daily oral doses of inhalation powder via DPI as follows:
Treatment period 1: AZD8871 matching placebo and Anoro® Ellipta® 55 μg / 22 μg.
Treatment period 2: AZD8871 600 μg and Anoro® Ellipta® matching placebo. Treatment period 3: Matching placebo of AZD8871 and Anoro® Ellipta®.
|
Treament Sequence D
Randomized subjects received 14 repeated daily oral doses of inhalation powder via DPI as follows:
Treatment period 1: AZD8871 matching placebo and Anoro® Ellipta® 55 μg / 22 μg.
Treatment period 2: Matching placebo of AZD8871 and Anoro® Ellipta®. Treatment period 3: AZD8871 600 μg and Anoro® Ellipta® matching placebo.
|
Treatment Sequence E
Randomized subjects received 14 repeated daily oral doses of inhalation powder via DPI as follows:
Treatment period 1: Matching placebo of AZD8871 and Anoro® Ellipta®. Treatment period 2: AZD8871 600 μg and Anoro® Ellipta® matching placebo. Treatment period 3: AZD8871 matching placebo and Anoro® Ellipta® 55 μg / 22 μg.
|
Treatment Sequence F
Randomized subjects received 14 repeated daily oral doses of inhalation powder via DPI as follows:
Treatment period 1: Matching placebo of AZD8871 and Anoro® Ellipta®. Treatment period 2: AZD8871 matching placebo and Anoro® Ellipta® 55 μg / 22 μg. Treatment period 3: AZD8871 600 μg and Anoro® Ellipta® matching placebo.
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|---|---|---|---|---|---|---|
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Period 1
STARTED
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12
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13
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13
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11
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12
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12
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Period 1
COMPLETED
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12
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13
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13
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10
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11
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12
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Period 1
NOT COMPLETED
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0
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0
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0
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1
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1
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0
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Period 2
STARTED
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10
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13
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13
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10
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11
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11
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Period 2
COMPLETED
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10
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13
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13
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10
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11
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11
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Period 2
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Period 3
STARTED
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10
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13
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11
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10
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11
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11
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Period 3
COMPLETED
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10
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13
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11
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10
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11
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11
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Period 3
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
| Measure |
Treatment Sequence A
Randomized subjects received 14 repeated daily oral doses of inhalation powder via DPI as follows:
Treatment period 1: AZD8871 600 μg and Anoro® Ellipta® matching placebo. Treatment period 2: AZD8871 matching placebo and Anoro® Ellipta® 55 μg / 22 μg. Treatment period 3: Matching placebo of AZD8871 and Anoro® Ellipta®.
|
Treatment Sequence B
Randomized subjects received 14 repeated daily oral doses of inhalation powder via DPI as follows:
Treatment period 1: AZD8871 600 μg and Anoro® Ellipta® matching placebo. Treatment period 2: Matching placebo of AZD8871 and Anoro® Ellipta®. Treatment period 3: AZD8871 matching placebo and Anoro® Ellipta® 55 μg / 22 μg.
|
Treatment Sequence C
Randomized subjects received 14 repeated daily oral doses of inhalation powder via DPI as follows:
Treatment period 1: AZD8871 matching placebo and Anoro® Ellipta® 55 μg / 22 μg.
Treatment period 2: AZD8871 600 μg and Anoro® Ellipta® matching placebo. Treatment period 3: Matching placebo of AZD8871 and Anoro® Ellipta®.
|
Treament Sequence D
Randomized subjects received 14 repeated daily oral doses of inhalation powder via DPI as follows:
Treatment period 1: AZD8871 matching placebo and Anoro® Ellipta® 55 μg / 22 μg.
Treatment period 2: Matching placebo of AZD8871 and Anoro® Ellipta®. Treatment period 3: AZD8871 600 μg and Anoro® Ellipta® matching placebo.
|
Treatment Sequence E
Randomized subjects received 14 repeated daily oral doses of inhalation powder via DPI as follows:
Treatment period 1: Matching placebo of AZD8871 and Anoro® Ellipta®. Treatment period 2: AZD8871 600 μg and Anoro® Ellipta® matching placebo. Treatment period 3: AZD8871 matching placebo and Anoro® Ellipta® 55 μg / 22 μg.
|
Treatment Sequence F
Randomized subjects received 14 repeated daily oral doses of inhalation powder via DPI as follows:
Treatment period 1: Matching placebo of AZD8871 and Anoro® Ellipta®. Treatment period 2: AZD8871 matching placebo and Anoro® Ellipta® 55 μg / 22 μg. Treatment period 3: AZD8871 600 μg and Anoro® Ellipta® matching placebo.
|
|---|---|---|---|---|---|---|
|
Period 1
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period 1
COPD exacerbation
|
0
|
0
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0
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0
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1
|
0
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Baseline Characteristics
A Single Inhalation Dose Study to Assess Efficacy, Pharmacokinetics (PK), Safety and Tolerability of AZD8871 in Patients With Long-term Lung Diseases.
Baseline characteristics by cohort
| Measure |
All Participants
n=73 Participants
Subjects received AZD8871 inhalation powder 600 μg, 1 inhalation per day; umeclidinium 55 μg / vilanterol 22 μg. as oral inhalation once per day; Placebo to AZD8871 via oral inhalation, 1 inhalation per day.
|
|---|---|
|
Age, Continuous
|
66.0 Years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 15Population: The full analysis set (FAS): All participants randomised and receiving study treatment, irrespective of their protocol adherence and continued participation in the study.
To evaluate the efficacy of inhaled AZD8871 600 μg in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Outcome measures
| Measure |
AZD8871
n=70 Participants
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
n=69 Participants
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
n=68 Participants
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
Change From Baseline in Trough FEV1 at Day 15
|
0.1904 Liters
Standard Deviation 0.2052
|
0.2260 Liters
Standard Deviation 0.2275
|
-0.0222 Liters
Standard Deviation 0.1404
|
PRIMARY outcome
Timeframe: Day 1 to Day 8, Day 9 to Day 14, Day 1 to Day 14Population: The full analysis set (FAS): All participants randomised and receiving study treatment, irrespective of their protocol adherence and continued participation in the study.
To evaluate the efficacy of inhaled AZD8871 600 μg in patients with moderate to severe COPD. At each visit, patients are asked to evaluate the impact of COPD on their wellbeing and daily life on a 6-point Likert scale ranging from 0 to 5, with higher scores indicating a higher impact of COPD. The CAT is expressed as a total score, which is a sum of the 8 questions, ranging from 0 to 40.
Outcome measures
| Measure |
AZD8871
n=70 Participants
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
n=69 Participants
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
n=68 Participants
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) at Day 1 to Day 8, Day 9 to Day 14, Day 1 to Day 14
Day 1 to Day 8
|
-2.11 Score on a scale
Standard Deviation 4.34
|
-2.78 Score on a scale
Standard Deviation 4.34
|
-0.57 Score on a scale
Standard Deviation 4.69
|
|
Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) at Day 1 to Day 8, Day 9 to Day 14, Day 1 to Day 14
Day 9 to Day 14
|
-2.87 Score on a scale
Standard Deviation 5.01
|
-3.29 Score on a scale
Standard Deviation 4.94
|
-0.52 Score on a scale
Standard Deviation 5.06
|
|
Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) at Day 1 to Day 8, Day 9 to Day 14, Day 1 to Day 14
Day 1 to Day 14
|
-2.42 Score on a scale
Standard Deviation 4.49
|
-3.01 Score on a scale
Standard Deviation 4.51
|
-0.59 Score on a scale
Standard Deviation 4.81
|
SECONDARY outcome
Timeframe: At Day 1, Day 8, and Day 14Population: The full analysis set (FAS): All participants randomised and receiving study treatment, irrespective of their protocol adherence and continued participation in the study.
To evaluate the efficacy of inhaled AZD8871 600 μg in patients with moderate to severe COPD
Outcome measures
| Measure |
AZD8871
n=70 Participants
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
n=69 Participants
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
n=68 Participants
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
FEV1 AUC(0-4)/4h (Area Under the Curve for the Change in FEV1 From Baseline to 4h, Normalised by the Time Window)
Day 1
|
0.3604 Liters
Standard Deviation 0.1753
|
0.2912 Liters
Standard Deviation 0.1677
|
0.0430 Liters
Standard Deviation 0.0783
|
|
FEV1 AUC(0-4)/4h (Area Under the Curve for the Change in FEV1 From Baseline to 4h, Normalised by the Time Window)
Day 8
|
0.4296 Liters
Standard Deviation 0.2197
|
0.3796 Liters
Standard Deviation 0.2133
|
0.0808 Liters
Standard Deviation 0.2117
|
|
FEV1 AUC(0-4)/4h (Area Under the Curve for the Change in FEV1 From Baseline to 4h, Normalised by the Time Window)
Day 14
|
0.4060 Liters
Standard Deviation 0.2448
|
0.3358 Liters
Standard Deviation 0.2011
|
0.0209 Liters
Standard Deviation 0.1210
|
SECONDARY outcome
Timeframe: Day 1 and Day 14Population: The full analysis set (FAS): All participants randomised and receiving study treatment, irrespective of their protocol adherence and continued participation in the study.
To evaluate the efficacy of inhaled AZD8871 600 μg in patients with moderate to severe COPD
Outcome measures
| Measure |
AZD8871
n=70 Participants
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
n=69 Participants
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
n=68 Participants
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
FEV1 AUC(0-8)/8h (Area Under the Curve for the Change in FEV1 From Baseline to 8h, Normalised by the Time Window)
Day 1
|
0.3072 Liters
Standard Deviation 0.1565
|
0.2798 Liters
Standard Deviation 0.1695
|
0.0230 Liters
Standard Deviation 0.0923
|
|
FEV1 AUC(0-8)/8h (Area Under the Curve for the Change in FEV1 From Baseline to 8h, Normalised by the Time Window)
Day 14
|
0.3394 Liters
Standard Deviation 0.2462
|
0.3102 Liters
Standard Deviation 0.1998
|
0.0021 Liters
Standard Deviation 0.1204
|
SECONDARY outcome
Timeframe: Day 1 and Day 14Population: The full analysis set (FAS): All participants randomised and receiving study treatment, irrespective of their protocol adherence and continued participation in the study.
To evaluate the efficacy of inhaled AZD8871 600 μg in patients with moderate to severe COPD
Outcome measures
| Measure |
AZD8871
n=70 Participants
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
n=69 Participants
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
n=68 Participants
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
FEV1 AUC(0-12)/12h (Area Under the Curve for the Change in FEV1 From Baseline to 12h, Normalised by the Time Window)
Day 1
|
0.2668 Liters
Standard Deviation 0.1494
|
0.2720 Liters
Standard Deviation 0.1697
|
0.0096 Liters
Standard Deviation 0.0946
|
|
FEV1 AUC(0-12)/12h (Area Under the Curve for the Change in FEV1 From Baseline to 12h, Normalised by the Time Window)
Day 14
|
0.3024 Liters
Standard Deviation 0.2141
|
0.2919 Liters
Standard Deviation 0.2027
|
-0.0032 Liters
Standard Deviation 0.1150
|
SECONDARY outcome
Timeframe: Day 1 and Day 14Population: The full analysis set (FAS): All participants randomised and receiving study treatment, irrespective of their protocol adherence and continued participation in the study.
To evaluate the efficacy of inhaled AZD8871 600 μg in patients with moderate to severe COPD
Outcome measures
| Measure |
AZD8871
n=70 Participants
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
n=69 Participants
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
n=68 Participants
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
FEV1 AUC(0-24)/24h (Area Under the Curve for the Change in FEV1 From Baseline to 24h, Normalised by the Time Window)
Day 1
|
0.1832 Liters
Standard Deviation 0.1399
|
0.2333 Liters
Standard Deviation 0.1742
|
-0.0132 Liters
Standard Deviation 0.0920
|
|
FEV1 AUC(0-24)/24h (Area Under the Curve for the Change in FEV1 From Baseline to 24h, Normalised by the Time Window)
Day 14
|
0.2223 Liters
Standard Deviation 0.2154
|
0.2417 Liters
Standard Deviation 0.2012
|
-0.0324 Liters
Standard Deviation 0.1104
|
SECONDARY outcome
Timeframe: Day 2 and Day 8.Population: The full analysis set (FAS): All participants randomised and receiving study treatment, irrespective of their protocol adherence and continued participation in the study.
To evaluate the efficacy of inhaled AZD8871 600 μg in patients with moderate to severe COPD
Outcome measures
| Measure |
AZD8871
n=70 Participants
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
n=69 Participants
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
n=68 Participants
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
Change From Baseline in Trough FEV1 on Day 2 and Day 8.
Day 2
|
0.1359 Liters
Standard Deviation 0.1672
|
0.2249 Liters
Standard Deviation 0.1897
|
0.0339 Liters
Standard Deviation 0.1139
|
|
Change From Baseline in Trough FEV1 on Day 2 and Day 8.
Day 8
|
0.2161 Liters
Standard Deviation 0.1613
|
0.2748 Liters
Standard Deviation 0.1894
|
0.0121 Liters
Standard Deviation 0.1240
|
SECONDARY outcome
Timeframe: At Day 1, Day 8, and Day 14.Population: The full analysis set (FAS): All participants randomised and receiving study treatment, irrespective of their protocol adherence and continued participation in the study.
To evaluate the efficacy of inhaled AZD8871 600 μg in patients with moderate to severe COPD
Outcome measures
| Measure |
AZD8871
n=70 Participants
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
n=69 Participants
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
n=68 Participants
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
Change From Baseline in Peak FEV1 on Day 1, Day 8 and Day 14.
Day 1
|
0.403 Liters
Standard Deviation 0.182
|
0.333 Liters
Standard Deviation 0.176
|
0.092 Liters
Standard Deviation 0.086
|
|
Change From Baseline in Peak FEV1 on Day 1, Day 8 and Day 14.
Day 8
|
0.511 Liters
Standard Deviation 0.240
|
0.454 Liters
Standard Deviation 0.227
|
0.120 Liters
Standard Deviation 0.130
|
|
Change From Baseline in Peak FEV1 on Day 1, Day 8 and Day 14.
Day 14
|
0.464 Liters
Standard Deviation 0.255
|
0.391 Liters
Standard Deviation 0.215
|
0.066 Liters
Standard Deviation 0.131
|
SECONDARY outcome
Timeframe: Day 1 to Day 8, Day 9 to Day 14, Day 1 to Day 14Population: The full analysis set (FAS): All participants randomised and receiving study treatment, irrespective of their protocol adherence and continued participation in the study.
To evaluate the efficacy of inhaled AZD8871 600 μg in patients with moderate to severe COPD. The BCSS questionnaire is a 3-item, patient-reported outcome (PRO) measure. On a daily basis, patients are asked to evaluate each of their 3 symptoms (breathlessness, cough, and sputum) on a 5-point Likert scale ranging from 0 to 4, with higher scores indicating a higher severity of the symptom. The BCSS questionnaire is expressed as a daily total score, which is the sum of the 3 symptom scores, ranging from 0 to 12.
Outcome measures
| Measure |
AZD8871
n=70 Participants
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
n=69 Participants
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
n=68 Participants
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
Change From Baseline in Breathlessness, Cough and Sputum Scale (BCSS) Total Score at Day 1 to Day 8, Day 9 to Day 14, Day 1 to Day 14
Day 1 to Day 8
|
-0.37 Score on a scale
Standard Deviation 1.27
|
-0.61 Score on a scale
Standard Deviation 1.31
|
0.16 Score on a scale
Standard Deviation 1.11
|
|
Change From Baseline in Breathlessness, Cough and Sputum Scale (BCSS) Total Score at Day 1 to Day 8, Day 9 to Day 14, Day 1 to Day 14
Day 9 to Day 14
|
-0.35 Score on a scale
Standard Deviation 1.58
|
-0.63 Score on a scale
Standard Deviation 1.49
|
0.53 Score on a scale
Standard Deviation 1.43
|
|
Change From Baseline in Breathlessness, Cough and Sputum Scale (BCSS) Total Score at Day 1 to Day 8, Day 9 to Day 14, Day 1 to Day 14
Day 1 to Day 14
|
-0.36 Score on a scale
Standard Deviation 1.33
|
-0.63 Score on a scale
Standard Deviation 1.32
|
0.36 Score on a scale
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: From Screening to folow-up or discontinuation (42 days after last study drug)To evaluate the safety and tolerability of inhaled AZD8871 600 μg in patients with moderate to severe COPD
Outcome measures
| Measure |
AZD8871
n=70 Participants
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
n=69 Participants
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
n=68 Participants
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
Number of Participants With Adverse Events.
Any AE
|
39 Participants
|
38 Participants
|
35 Participants
|
|
Number of Participants With Adverse Events.
Any AE with outcome=death
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events.
Any SAE (including events with outcome=death)
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events.
Any AE leading to discontinuation of treatment
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events.
Any AE leading to withdrawal from study
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 1 and Day 14 (at pre-dose and at 30 minutes (min), 1, 2, 4, 6, 8, 12, and 24 hours post-dose)Population: PK analysis set (PKS): All participants participating in the subset of the PK participants, who received at least 1 dose of AZD8871 600 μg.
To investigate the Cmax of AZD8871 600 μg and its primary metabolite after multiple dose administration of inhaled AZD8871 in patients with moderate to severe COPD
Outcome measures
| Measure |
AZD8871
n=70 Participants
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
AZD8871 - Day 1
|
310.4 pg/mL
Geometric Coefficient of Variation 61.30
|
—
|
—
|
|
Maximum Plasma Concentration (Cmax)
AZD8871 - Day 14
|
532.9 pg/mL
Geometric Coefficient of Variation 46.58
|
—
|
—
|
|
Maximum Plasma Concentration (Cmax)
LAS191861- Day 1
|
26.64 pg/mL
Geometric Coefficient of Variation 53.33
|
—
|
—
|
|
Maximum Plasma Concentration (Cmax)
LAS191861- Day 14
|
63.29 pg/mL
Geometric Coefficient of Variation 52.12
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 1 and Day 14 (at pre-dose and at 30 minutes (min), 1, 2, 4, 6, 8, 12, and 24 hours post-dose)Population: PK analysis set (PKS): All participants participating in the subset of the PK participants, who received at least 1 dose of AZD8871 600 μg.
To investigate the Tmax of AZD8871 600 μg and its primary metabolite after multiple dose administration of inhaled AZD8871 in patients with moderate to severe COPD
Outcome measures
| Measure |
AZD8871
n=70 Participants
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax)
AZD8871- Day 1
|
0.99 Hours
Interval 0.38 to 2.02
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax)
AZD8871- Day 14
|
0.98 Hours
Interval 0.45 to 2.05
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax)
LAS191861 - Day 1
|
2.00 Hours
Interval 0.98 to 4.0
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax)
LAS191861 - Day 14
|
2.00 Hours
Interval 0.98 to 4.03
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 1 and Day 14 (at pre-dose and at 30 minutes (min), 1, 2, 4, 6, 8, 12, and 24 hours post-dose)Population: PK analysis set (PKS): All participants participating in the subset of the PK participants, who received at least 1 dose of AZD8871 600 μg.
To investigate the Tlast of AZD8871 600 μg and its primary metabolite after multiple dose administration of inhaled AZD8871 in patients with moderate to severe COPD
Outcome measures
| Measure |
AZD8871
n=70 Participants
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
Time to Reach Last Quantifiable Plasma Concentration (Tlast)
AZD8871 -Day 1
|
23.93 Hours
Interval 7.98 to 24.05
|
—
|
—
|
|
Time to Reach Last Quantifiable Plasma Concentration (Tlast)
AZD8871-Day 14
|
24.03 Hours
Interval 23.9 to 24.37
|
—
|
—
|
|
Time to Reach Last Quantifiable Plasma Concentration (Tlast)
LAS191861 - Day 1
|
23.92 Hours
Interval 1.97 to 24.05
|
—
|
—
|
|
Time to Reach Last Quantifiable Plasma Concentration (Tlast)
LAS191861 - Day 14
|
24.03 Hours
Interval 23.9 to 24.37
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 1 and Day 14 (at pre-dose and at 30 minutes (min), 1, 2, 4, 6, 8, 12, and 24 hours post-dose)Population: PK analysis set (PKS): All participants participating in the subset of the PK participants, who received at least 1 dose of AZD8871 600 μg.
To investigate the AUClast of AZD8871 600 μg and its primary metabolite after multiple dose administration of inhaled AZD8871 in patients with moderate to severe COPD
Outcome measures
| Measure |
AZD8871
n=70 Participants
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast)
AZD8871- Day 1
|
1655 h*pg/mL
Geometric Coefficient of Variation 85.24
|
—
|
—
|
|
Area Under the Plasma Concentration-curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast)
AZD8871-Day 14
|
4001 h*pg/mL
Geometric Coefficient of Variation 55.64
|
—
|
—
|
|
Area Under the Plasma Concentration-curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast)
LAS191861 -Day 1
|
251.9 h*pg/mL
Geometric Coefficient of Variation 97.81
|
—
|
—
|
|
Area Under the Plasma Concentration-curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast)
LAS191861 -Day 14
|
943.3 h*pg/mL
Geometric Coefficient of Variation 63.08
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 1 and Day 14 (at pre-dose and at 30 minutes (min), 1, 2, 4, 6, 8, 12, and 24 hours post-dose)Population: PK analysis set (PKS): All participants participating in the subset of the PK participants, who received at least 1 dose of AZD8871 600 μg.
To investigate the AUC(0-24) of AZD8871 600 μg and its primary metabolite after multiple dose administration of inhaled AZD8871 in patients with moderate to severe COPD
Outcome measures
| Measure |
AZD8871
n=70 Participants
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-curve From Time 0 to 24 Hours Post-dose [AUC(0-24)]
AZD8871- Day 1
|
1661 h*pg/mL
Geometric Coefficient of Variation 83.55
|
—
|
—
|
|
Area Under the Plasma Concentration-curve From Time 0 to 24 Hours Post-dose [AUC(0-24)]
AZD8871- Day 14
|
3996 h*pg/mL
Geometric Coefficient of Variation 55.66
|
—
|
—
|
|
Area Under the Plasma Concentration-curve From Time 0 to 24 Hours Post-dose [AUC(0-24)]
LAS191861 - Day 1
|
289.5 h*pg/mL
Geometric Coefficient of Variation 57.83
|
—
|
—
|
|
Area Under the Plasma Concentration-curve From Time 0 to 24 Hours Post-dose [AUC(0-24)]
LAS191861 - Day 14
|
941.7 h*pg/mL
Geometric Coefficient of Variation 63.11
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 14 (at pre-dose and at 30 minutes (min), 1, 2, 4, 6, 8, 12, and 24 hours post-dose)Population: PK analysis set (PKS): All participants participating in the subset of the PK participants, who received at least 1 dose of AZD8871 600 μg.
To investigate the Cavg of AZD8871 600 μg and its primary metabolite after multiple dose administration of inhaled AZD8871 in patients with moderate to severe COPD
Outcome measures
| Measure |
AZD8871
n=70 Participants
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
Average Plasma Concentration During a Dosing Interval (Cavg)
AZD8871 -Day 14
|
166.5 pg/mL
Geometric Coefficient of Variation 55.63
|
—
|
—
|
|
Average Plasma Concentration During a Dosing Interval (Cavg)
LAS191861 - Day 14
|
39.23 pg/mL
Geometric Coefficient of Variation 63.06
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 14 (at pre-dose and at 30 minutes (min), 1, 2, 4, 6, 8, 12, and 24 hours post-dose)Population: PK analysis set (PKS): All participants participating in the subset of the PK participants, who received at least 1 dose of AZD8871 600 μg.
To investigate the %Fluctuation of AZD8871 600 μg and its primary metabolite after multiple dose administration of inhaled AZD8871 in patients with moderate to severe COPD. Fluctuation index during a dosing interval is estimated as 100\*(Cmax - Cmin)/Cavg (%), where Cmin is the minimum concentration at the end of the dosing interval.
Outcome measures
| Measure |
AZD8871
n=70 Participants
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
Fluctuation Index During a Dosing Interval (%Fluctuation)
AZD8871- Day 14
|
273.1 percentage of fluctuation
Interval 128.0 to 514.0
|
—
|
—
|
|
Fluctuation Index During a Dosing Interval (%Fluctuation)
LAS191861 - Day 14
|
91.03 percentage of fluctuation
Interval 39.3 to 174.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 14Population: PK analysis set (PKS): All participants participating in the subset of the PK participants, who received at least 1 dose of AZD8871 600 μg.
To investigate the Rac (Cmax) of AZD8871 600 μg and its primary metabolite after multiple dose administration of inhaled AZD8871 in patients with moderate to severe COPD. Accumulation ratio for Cmax estimated as (Cmax on Day 14/Cmax on Day 1).
Outcome measures
| Measure |
AZD8871
n=70 Participants
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
Accumulation Ratio for Cmax (Rac(Cmax))
AZD8871 -Day 14
|
1.725 Ratio
Geometric Coefficient of Variation 44.77
|
—
|
—
|
|
Accumulation Ratio for Cmax (Rac(Cmax))
LAS191861 - Day 14
|
2.377 Ratio
Geometric Coefficient of Variation 40.02
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 14Population: PK analysis set (PKS): All participants participating in the subset of the PK participants, who received at least 1 dose of AZD8871 600 μg.
To investigate the Rac(AUC(0-24) of AZD8871 600 μg and its primary metabolite after multiple dose administration of inhaled AZD8871 in patients with moderate to severe COPD. Accumulation ratio for AUC0-24 estimated as (AUC0-24 on Day 14/AUC0-24 on Day 1).
Outcome measures
| Measure |
AZD8871
n=70 Participants
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
Accumulation Ratio for AUC(0-24) Rac(AUC(0-24))
AZD8871 - Day 14
|
2.406 Ratio
Geometric Coefficient of Variation 50.37
|
—
|
—
|
|
Accumulation Ratio for AUC(0-24) Rac(AUC(0-24))
LAS191861 -Day 14
|
3.443 Ratio
Geometric Coefficient of Variation 47.15
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 8 and Day 9 to Day 14Population: The full analysis set (FAS): All participants randomised and receiving study treatment, irrespective of their protocol adherence and continued participation in the study.
To evaluate the efficacy of inhaled AZD8871 600 μg in patients with moderate to severe COPD
Outcome measures
| Measure |
AZD8871
n=70 Participants
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
n=69 Participants
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
n=68 Participants
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
Change From Baseline in Use of Rescue Medication
Day 1 to Day 8
|
-1.00 Percentage of use
Standard Deviation 1.83
|
-0.95 Percentage of use
Standard Deviation 2.03
|
0.18 Percentage of use
Standard Deviation 2.13
|
|
Change From Baseline in Use of Rescue Medication
Day 9 to Day 14
|
-0.78 Percentage of use
Standard Deviation 1.97
|
-0.87 Percentage of use
Standard Deviation 1.96
|
0.52 Percentage of use
Standard Deviation 1.80
|
Adverse Events
AZD8871
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Anoro® Ellipta®
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD8871
n=70 participants at risk
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
n=69 participants at risk
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
n=68 participants at risk
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
Infections and infestations
Tooth abscess
|
0.00%
0/70 • AEs starting on or after the first administration of study treatment, up to and including 42 days after the last dose of study treatment.
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomized patients who took at least one dose of IMP.
|
1.4%
1/69 • AEs starting on or after the first administration of study treatment, up to and including 42 days after the last dose of study treatment.
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomized patients who took at least one dose of IMP.
|
0.00%
0/68 • AEs starting on or after the first administration of study treatment, up to and including 42 days after the last dose of study treatment.
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomized patients who took at least one dose of IMP.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/70 • AEs starting on or after the first administration of study treatment, up to and including 42 days after the last dose of study treatment.
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomized patients who took at least one dose of IMP.
|
0.00%
0/69 • AEs starting on or after the first administration of study treatment, up to and including 42 days after the last dose of study treatment.
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomized patients who took at least one dose of IMP.
|
1.5%
1/68 • AEs starting on or after the first administration of study treatment, up to and including 42 days after the last dose of study treatment.
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomized patients who took at least one dose of IMP.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/70 • AEs starting on or after the first administration of study treatment, up to and including 42 days after the last dose of study treatment.
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomized patients who took at least one dose of IMP.
|
1.4%
1/69 • AEs starting on or after the first administration of study treatment, up to and including 42 days after the last dose of study treatment.
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomized patients who took at least one dose of IMP.
|
0.00%
0/68 • AEs starting on or after the first administration of study treatment, up to and including 42 days after the last dose of study treatment.
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomized patients who took at least one dose of IMP.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/70 • AEs starting on or after the first administration of study treatment, up to and including 42 days after the last dose of study treatment.
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomized patients who took at least one dose of IMP.
|
0.00%
0/69 • AEs starting on or after the first administration of study treatment, up to and including 42 days after the last dose of study treatment.
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomized patients who took at least one dose of IMP.
|
1.5%
1/68 • AEs starting on or after the first administration of study treatment, up to and including 42 days after the last dose of study treatment.
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomized patients who took at least one dose of IMP.
|
Other adverse events
| Measure |
AZD8871
n=70 participants at risk
Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
|
Anoro® Ellipta®
n=69 participants at risk
Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
|
Placebo
n=68 participants at risk
Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
20.0%
14/70 • AEs starting on or after the first administration of study treatment, up to and including 42 days after the last dose of study treatment.
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomized patients who took at least one dose of IMP.
|
18.8%
13/69 • AEs starting on or after the first administration of study treatment, up to and including 42 days after the last dose of study treatment.
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomized patients who took at least one dose of IMP.
|
20.6%
14/68 • AEs starting on or after the first administration of study treatment, up to and including 42 days after the last dose of study treatment.
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomized patients who took at least one dose of IMP.
|
|
Infections and infestations
Nasopharyngitis
|
8.6%
6/70 • AEs starting on or after the first administration of study treatment, up to and including 42 days after the last dose of study treatment.
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomized patients who took at least one dose of IMP.
|
11.6%
8/69 • AEs starting on or after the first administration of study treatment, up to and including 42 days after the last dose of study treatment.
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomized patients who took at least one dose of IMP.
|
4.4%
3/68 • AEs starting on or after the first administration of study treatment, up to and including 42 days after the last dose of study treatment.
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomized patients who took at least one dose of IMP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place