A Phase II Study to Evaluate the Efficacy, Safety and Tol... | NCT01704495

ID	Type	Description	Link
2012-001869-33

Official Title

A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study With an Optional Safety Extension Treatment Period up to 6 Months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients With Uncontrolled Persistent Asthma

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AZD5069 5 mg	Experimental	AZD5069 oral capsules self-administered twice daily	Drug: AZD5069
AZD5069 15 mg	Experimental	AZD5069 oral capsules self-administered twice daily	Drug: AZD5069
AZD5069 45 mg	Experimental	AZD5069 oral capsules self-administered twice daily	Drug: AZD5069
Placebo	Placebo Comparator	Placebo oral capsules self-administered twice daily	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
AZD5069	Drug	AZD5069 oral capsules self-administered twice daily.	AZD5069 15 mg AZD5069 45 mg AZD5069 5 mg

Outcomes Module

Measure	Description	Time Frame
Rate of Severe Asthma Exacerbations During 6 Months		From start of treatment up to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months		From start of treatment up to 6 months
Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions		From start of treatment up to 6 months

Eligibility Module

Name	Affiliation	Role
Bengt Larsson, MEDICAL SCIENCE DIRECTOR	AZ Mondal R&D, Sweden	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Gotse Delchev			Bulgaria
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27574788	Derived	O'Byrne PM, Metev H, Puu M, Richter K, Keen C, Uddin M, Larsson B, Cullberg M, Nair P. Efficacy and safety of a CXCR2 antagonist, AZD5069, in patients with uncontrolled persistent asthma: a randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2016 Oct;4(10):797-806. doi: 10.1016/S2213-2600(16)30227-2. Epub 2016 Aug 27.

Results Section

Participant Flow Module

ID	Title	Description
FG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
FG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
BG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
BG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
BG003	Placebo	Placebo oral capsules self-administred twice daily
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00051± 11.6 BG00152± 12.7 BG00253± 11.5 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000107 BG001113 BG002

FEV1 pre-bronchodilator

Median

Full Range

percentage of predicted normal

Title

Denominators

Categories

Title	Measurements
	BG00063.74(30.11 to 85.41) BG00166.35(29.92 to 113.57) BG002

FEV1 post-bronchodilator

Median

Full Range

percentage of predicted normal

Title

Denominators

Categories

Title	Measurements
	BG00074.34(32.33 to 105.44) BG00177.95(30.38 to 112.83) BG002

Reversibility

Mean

Standard Deviation

percentage change

Title

Denominators

Categories

Title	Measurements
	BG00018.73± 20.617 BG00116.05± 15.580 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Rate of Severe Asthma Exacerbations During 6 Months

Full analysis set

Posted

Least Squares Mean

90% Confidence Interval

Exacerbations per 6 month

From start of treatment up to 6 months

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants	OG000161 OG001153 OG002156 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.31(0.20 to 0.50) OG0010.31(0.19 to 0.49) OG0020.26(0.16 to 0.42) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003		Poisson regression	Correction for overdispersion made by Pearson chi-square	0.119	2-sided p-value	Risk Ratio (RR)	1.56			2-Sided	90	0.98	2.49			AZD5069 45 mg BID vs Placebo	No	Superiority or Other
OG001 OG003

Secondary

Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months

Posted

Least Squares Mean

90% Confidence Interval

Exacerbations per 6 month

From start of treatment up to 6 months

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions

Full analysis set

Posted

Least Squares Mean

90% Confidence Interval

Days

From start of treatment up to 6 months

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms

Full analysis set

Posted

Least Squares Mean

90% Confidence Interval

Days

From start of treatment up to 6 months

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis

Full analysis set

Posted

Least Squares Mean

90% Confidence Interval

Baseline (Day 0) and 2 weeks after Day 0

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts

Secondary

Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at one month are included in the analysis

Posted

Least Squares Mean

95% Confidence Interval

Baseline (Day 0) and 1 month after Day 0

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at two months are included in the analysis

Full analysis set

Posted

Least Squares Mean

90% Confidence Interval

Baseline (Day 0) and 2 months after Day 0

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts

Secondary

Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at three months are included in the analysis

Full analysis set

Posted

Least Squares Mean

90% Confidence Interval

Baseline (Day 0) and 3 months after Day 0

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts

Secondary

Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at four months are included in the analysis

Full analysis set

Posted

Least Squares Mean

90% Confidence Interval

Baseline (Day 0) and 4 months after Day 0

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts

Secondary

Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at six months are included in the analysis

Full Analysis set

Posted

Least Squares Mean

90% Confidence Interval

Baseline (Day 0) and 6 months after Day 0

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts

Secondary

Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis

Posted

Least Squares Mean

90% Confidence Interval

Baseline (Day 0) and 2 weeks after Day 0

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at one month are included in the analysis

Full Analysis set

Posted

Least Squares Mean

90% Confidence Interval

Baseline (Day 0) and 1 month after Day 0

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts

Secondary

Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at two months are included in the analysis

Full Analysis set

Posted

Least Squares Mean

90% Confidence Interval

Baseline (Day 0) and 2 months after Day 0

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts

Secondary

Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at three months are included in the analysis

Full Analysis set

Posted

Least Squares Mean

90% Confidence Interval

Baseline (Day 0) and 3 months after Day 0

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts

Secondary

Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at four months are included in the analysis

Full Analysis set

Posted

Least Squares Mean

90% Confidence Interval

Baseline (Day 0) and 4 months after Day 0

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts

Secondary

Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at six months are included in the analysis

Full Analysis set

Posted

Least Squares Mean

90% Confidence Interval

Baseline (Day 0) and 6 months after Day 0

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts

Secondary

Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score

The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).

Full Analysis set

Posted

Least Squares Mean

90% Confidence Interval

Units on a scale]

Baseline (Day 0), Treatment Period (1,2,3,4, and 6 months)

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo

Secondary

Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version)

Full Analysis set

Posted

Number

Participants with improvement

Baseline (Day 0) and 6 months after Day 0

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Secondary

Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score

The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.

Posted

Least Squares Mean

90% Confidence Interval

Overall Score

Baseline (Day 0), Treatment Period (1,3, and 6 months)

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo

Secondary

Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score

Full Analysis set

Posted

Number

Participants with improvement

Baseline (Day 0) and 6 months after Day 0

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily

Secondary

Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days

Full Analysis set

Posted

Least Squares Mean

90% Confidence Interval

Asthma symptom free days

Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Change From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days

Full Analysis set

Posted

Least Squares Mean

90% Confidence Interval

symptom free days

Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days

Full Analysis set

Posted

Least Squares Mean

90% Confidence Interval

symptom free days

Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days

Full Analysis set

Posted

Least Squares Mean

90% Confidence Interval

symptom free days

Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days

Full Analysis set

Posted

Least Squares Mean

90% Confidence Interval

asthma control days

Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Change From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days

Full Analysis set

Posted

Least Squares Mean

90% Confidence Interval

asthma control days

Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days

Full Analysis set

Posted

Least Squares Mean

90% Confidence Interval

asthma control days

Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days

Full Analysis set

Posted

Least Squares Mean

90% Confidence Interval

asthma control days

Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days

Full analysis set

Posted

Least Squares Mean

90% Confidence Interval

rescue medication free days

Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Change From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days

Full Analysis set

Posted

Least Squares Mean

90% Confidence Interval

rescue medication free days

Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Change From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days

Posted

Least Squares Mean

90% Confidence Interval

rescue medication free days

Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days

Full Analysis set

Posted

Least Squares Mean

90% Confidence Interval

rescue medication free days

Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months)

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms

Full analysis set

Posted

Least Squares Mean

90% Confidence Interval

night time awakenings

Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Change From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms

Full Analysis set

Posted

Least Squares Mean

90% Confidence Interval

night time awakenings

Baseline (last 14 days before randomization) and Treatment Period (Day 29 to Day 56)

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms

full analysis set

Posted

Least Squares Mean

90% Confidence Interval

night time awakenings

Baseline (last 14 days before randomization) and Treatment Period (Day 57 to Day 84)

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms

Full analysis set

Posted

Least Squares Mean

90% Confidence Interval

night time awakenings

Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Number of Participants With Well Controlled Asthma Weeks at Baseline

Posted

Number

participants

Last 2 weeks before randomization

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants	OG000

Secondary

Number of Well Controlled Asthma Weeks During Treatment

Full Analysis set

Posted

Mean

Standard Deviation

well controlled asthma weeks

Day 1to end of the 6 months treatment period

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline

Full analysis set

Posted

Number

participants

Last 2 weeks before randomization

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Number of Uncontrolled Persistent Asthma Weeks During Treatment

Full analysis set

Posted

Mean

Standard Deviation

uncontrolled persistent asthma weeks

Day 1 to end of the 6 months treatment period

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Mean Plasma Concentration of AZD5069 at Day 7

PK analysis set

Posted

Geometric Mean

Geometric Coefficient of Variation

(nmol/L)

Day 7

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Secondary

Mean Plasma Concentration of AZD5069 at 1 Month

PK analysis set

Posted

Geometric Mean

Geometric Coefficient of Variation

(nmol/L)

at 1 month

ID	Title	Description
OG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily
OG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily
OG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily
OG003	Placebo	Placebo oral capsules self-administred twice daily

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AZD5069 45 mg BID	AZD5069 oral capsules self-administered twice daily	14	161	86	161
EG001	AZD5069 15 mg BID	AZD5069 oral capsules self-administered twice daily	8	153	68	153
EG002	AZD5069 5 mg BID	AZD5069 oral capsules self-administered twice daily	7	156	74	156
EG003	Placebo	Placebo oral capsules self-administered twice daily	13	159	96	159

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
PNEUMONIA	Infections and infestations	Systematic Assessment	EG0003 affected161 at risk EG0011 affected153 at risk EG0020 affected156 at risk EG0032 affected159 at risk
RENAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected161 at risk EG0010 affected153 at risk EG0020 affected156 at risk EG003
LUNG NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected161 at risk EG0010 affected153 at risk EG0020 affected156 at risk EG003
UTERINE LEIOMYOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected161 at risk EG0010 affected153 at risk EG0020 affected156 at risk EG003
ABDOMINAL ABSCESS	Infections and infestations	Systematic Assessment	EG0001 affected161 at risk EG0010 affected153 at risk EG0020 affected156 at risk EG003
HELICOBACTER GASTRITIS	Infections and infestations	Systematic Assessment	EG0000 affected161 at risk EG0011 affected153 at risk EG0020 affected156 at risk EG003
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	Systematic Assessment	EG0001 affected161 at risk EG0010 affected153 at risk EG0020 affected156 at risk EG003
LOWER RESPIRATORY TRACT INFECTION BACTERIAL	Infections and infestations	Systematic Assessment	EG0000 affected161 at risk EG0010 affected153 at risk EG0021 affected156 at risk EG003
SALMONELLOSIS	Infections and infestations	Systematic Assessment	EG0000 affected161 at risk EG0011 affected153 at risk EG0020 affected156 at risk EG003
STREPTOCOCCAL SEPSIS	Infections and infestations	Systematic Assessment	EG0000 affected161 at risk EG0011 affected153 at risk EG0020 affected156 at risk EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	Systematic Assessment	EG0001 affected161 at risk EG0010 affected153 at risk EG0020 affected156 at risk EG003
ACUTE TONSILLITIS	Infections and infestations	Systematic Assessment	EG0000 affected161 at risk EG0010 affected153 at risk EG0020 affected156 at risk EG003
NEUTROPENIA	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected161 at risk EG0011 affected153 at risk EG0020 affected156 at risk EG003
CRITICAL ILLNESS POLYNEUROPATHY	Nervous system disorders	Systematic Assessment	EG0000 affected161 at risk EG0011 affected153 at risk EG0020 affected156 at risk EG003
ISCHAEMIC STROKE	Nervous system disorders	Systematic Assessment	EG0000 affected161 at risk EG0010 affected153 at risk EG0020 affected156 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	Systematic Assessment	EG0001 affected161 at risk EG0010 affected153 at risk EG0020 affected156 at risk EG003
CORONARY ARTERY DISEASE	Cardiac disorders	Systematic Assessment	EG0000 affected161 at risk EG0010 affected153 at risk EG0020 affected156 at risk EG003
PERIPHERAL EMBOLISM	Vascular disorders	Systematic Assessment	EG0000 affected161 at risk EG0010 affected153 at risk EG0021 affected156 at risk EG003
HYPERTENSION	Vascular disorders	Systematic Assessment	EG0000 affected161 at risk EG0010 affected153 at risk EG0020 affected156 at risk EG003
ASTHMA	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 affected161 at risk EG0013 affected153 at risk EG0024 affected156 at risk EG003
ASTHMATIC CRISIS	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected161 at risk EG0011 affected153 at risk EG0020 affected156 at risk EG003
BARRETTS OESOPHAGUS	Gastrointestinal disorders	Systematic Assessment	EG0000 affected161 at risk EG0011 affected153 at risk EG0020 affected156 at risk EG003
GASTRITIS	Gastrointestinal disorders	Systematic Assessment	EG0001 affected161 at risk EG0010 affected153 at risk EG0020 affected156 at risk EG003
HIATUS HERNIA	Gastrointestinal disorders	Systematic Assessment	EG0000 affected161 at risk EG0011 affected153 at risk EG0020 affected156 at risk EG003
ABDOMINAL HERNIA	Gastrointestinal disorders	Systematic Assessment	EG0000 affected161 at risk EG0010 affected153 at risk EG0020 affected156 at risk EG003
INGUINAL HERNIA	Gastrointestinal disorders	Systematic Assessment	EG0000 affected161 at risk EG0010 affected153 at risk EG0020 affected156 at risk EG003
CHOLECYSTITIS CHRONIC	Hepatobiliary disorders	Systematic Assessment	EG0000 affected161 at risk EG0010 affected153 at risk EG0021 affected156 at risk EG003
CHOLELITHIASIS	Hepatobiliary disorders	Systematic Assessment	EG0000 affected161 at risk EG0011 affected153 at risk EG0020 affected156 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected161 at risk EG0011 affected153 at risk EG0020 affected156 at risk EG003
CALCULUS URETERIC	Renal and urinary disorders	Systematic Assessment	EG0000 affected161 at risk EG0010 affected153 at risk EG0020 affected156 at risk EG003
OVARIAN CYST	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected161 at risk EG0010 affected153 at risk EG0020 affected156 at risk EG003
PSEUDOHYPOPARATHYROIDISM	Congenital, familial and genetic disorders	Systematic Assessment	EG0000 affected161 at risk EG0010 affected153 at risk EG0021 affected156 at risk EG003
ALANINE AMINOTRANSFERASE INCREASED	Investigations	Systematic Assessment	EG0000 affected161 at risk EG0011 affected153 at risk EG0020 affected156 at risk EG003
PATELLA FRACTURE	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected161 at risk EG0010 affected153 at risk EG0020 affected156 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
NASOPHARYNGITIS	Infections and infestations	Systematic Assessment	EG00018 affected161 at risk EG00113 affected153 at risk EG00218 affected156 at risk EG00331 affected159 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 affected161 at risk EG0014 affected153 at risk EG0021 affected156 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected161 at risk EG0012 affected153 at risk EG0022 affected156 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	Systematic Assessment	EG0002 affected161 at risk EG0014 affected153 at risk EG0024 affected156 at risk EG003
NAUSEA	Gastrointestinal disorders	Systematic Assessment	EG0003 affected161 at risk EG0013 affected153 at risk EG0022 affected156 at risk EG003
DIARRHOEA	Gastrointestinal disorders	Systematic Assessment	EG0004 affected161 at risk EG0010 affected153 at risk EG0022 affected156 at risk EG003
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	Systematic Assessment	EG0004 affected161 at risk EG0010 affected153 at risk EG0021 affected156 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected161 at risk EG0012 affected153 at risk EG0023 affected156 at risk EG003
HEADACHE	Nervous system disorders	Systematic Assessment	EG00012 affected161 at risk EG00112 affected153 at risk EG0026 affected156 at risk EG003
BRONCHITIS	Infections and infestations	Systematic Assessment	EG0007 affected161 at risk EG0016 affected153 at risk EG0021 affected156 at risk EG003
PHARYNGITIS	Infections and infestations	Systematic Assessment	EG0003 affected161 at risk EG0014 affected153 at risk EG0025 affected156 at risk EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	Systematic Assessment	EG0006 affected161 at risk EG0013 affected153 at risk EG0023 affected156 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	Systematic Assessment	EG0003 affected161 at risk EG0012 affected153 at risk EG0026 affected156 at risk EG003
INFLUENZA	Infections and infestations	Systematic Assessment	EG0003 affected161 at risk EG0013 affected153 at risk EG0024 affected156 at risk EG003
PNEUMONIA	Infections and infestations	Systematic Assessment	EG0004 affected161 at risk EG0012 affected153 at risk EG0021 affected156 at risk EG003
RHINITIS	Infections and infestations	Systematic Assessment	EG0002 affected161 at risk EG0014 affected153 at risk EG0021 affected156 at risk EG003
SINUSITIS	Infections and infestations	Systematic Assessment	EG0003 affected161 at risk EG0011 affected153 at risk EG0023 affected156 at risk EG003
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	Systematic Assessment	EG0004 affected161 at risk EG0011 affected153 at risk EG0021 affected156 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	Systematic Assessment	EG0003 affected161 at risk EG0013 affected153 at risk EG0020 affected156 at risk EG003
GASTROENTERITIS	Infections and infestations	Systematic Assessment	EG0001 affected161 at risk EG0012 affected153 at risk EG0021 affected156 at risk EG003
Other	Infections and infestations	Systematic Assessment	EG0000 affected161 at risk EG0011 affected153 at risk EG0024 affected156 at risk EG003
Other	Nervous system disorders	Systematic Assessment	EG0005 affected161 at risk EG0012 affected153 at risk EG0023 affected156 at risk EG003
Other	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0005 affected161 at risk EG0015 affected153 at risk EG0021 affected156 at risk EG003
Other	Gastrointestinal disorders	Systematic Assessment	EG0008 affected161 at risk EG0014 affected153 at risk EG0021 affected156 at risk EG003
Other	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0005 affected161 at risk EG0012 affected153 at risk EG0025 affected156 at risk EG003
ASTHMA	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 affected161 at risk EG0013 affected153 at risk EG0024 affected156 at risk EG003

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases