Investigation of Efficacy, Safety and Tolerability of Onc... | NCT01197794

ID	Type	Description	Link
2010-020407-73	EudraCT Number

Official Title

A Double-blind, Placebo-controlled, Randomised, Parallel-group, Phase II, Multi-centre Study to Assess the Efficacy, Safety and Tolerability of 4 Twice Daily Doses and 2 Once Daily Doses of AZD1981 Given as Tablets During 12 Weeks in Asthmatic Patients

Status Module

Oversight 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
AZD1981 10 mg	Experimental	AZD1981 10 mg	Drug: AZD1981
AZD1981 40 mg	Experimental	AZD1981 40 mg	Drug: AZD1981
AZD1981 100 mg	Experimental	AZD1981 100 mg	Drug: AZD1981
AZD1981 400 mg	Experimental	AZD1981 400 mg	Drug: AZD1981
AZD1981 80 mg	Experimental	AZD1981 80 mg	Drug: AZD1981
AZD1981 200 mg	Experimental	AZD1981 200 mg	Drug: AZD1981
Placebo	Placebo Comparator

Name	Type	Description	Arm Group Labels	Other Names
AZD1981	Drug	AZD1981 twice daily	AZD1981 10 mg AZD1981 100 mg AZD1981 40 mg AZD1981 400 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pre-bronchodilator FEV1 at the Clinic	Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.	Twelve week treatment period

Secondary Outcomes

Measure	Description	Time Frame
Morning and Evening PEF	Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available morning (evening) PEF during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.	Twelve week treatment period

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Chris O'Brien, MD	AstraZeneca	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Fullerton	California		United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29765200	Derived	Bateman ED, O'Brien C, Rugman P, Luke S, Ivanov S, Uddin M. Efficacy and safety of the CRTh2 antagonist AZD1981 as add-on therapy to inhaled corticosteroids and long-acting beta2-agonists in patients with atopic asthma. Drug Des Devel Ther. 2018 May 4;12:1093-1106. doi: 10.2147/DDDT.S147389. eCollection 2018.

Results Section

Participant Flow Module

ID	Title	Description
FG000	AZD1981 400 mg	AZD1981 400 mg twice daily
FG001	AZD1981 200 mg	AZD1981 200 mg once daily

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Three patients (1 in the AZD1981 40 mg bid group and 2 in the placebo group) randomized at a Japanese centre were excluded from the analyses due to Good Clinical Practice violations identified after study completion.

Arm/Group Information

ID	Title	Description
BG000	AZD1981 400 mg	AZD1981 400 mg twice daily
BG001	AZD1981 200 mg	AZD1981 200 mg once daily
BG002	AZD1981 100 mg	AZD1981 100 mg twice daily
BG003	AZD1981 80 mg	AZD1981 80 mg once daily
BG004	AZD1981 40 mg	AZD1981 40 mg twice daily
BG005	AZD1981 10 mg	AZD1981 10 mg twice daily
BG006	Placebo	Placebo
BG007	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
	BG00046.6± 13.98 BG00146.7± 12.84 BG00246.4± 14.65 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00076 BG00182 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000117 BG001115 BG002

Time since asthma diagnosis

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00018.6± 13.87 BG00118.5± 14.25 BG002

Smoking status

Number

Participants

Title

Denominators

Categories

Former smoker

Title	Measurements
	BG00025 BG00124 BG002

Pre-bronchodilator FEV1 percentage of predicted normal (PN) at randomization

Mean

Standard Deviation

Percentage of predicted normal

Title

Denominators

Categories

Title	Measurements
	BG00070.03± 10.544 BG00168.86± 11.580 BG002

Total daily dose of inhaled glucocorticosteroids (ICS)

Mean

Full Range

µg

Title

Denominators

Categories

Title	Measurements
	BG000406.31(125.0 to 1000.0) BG001399.75(100.0 to 1000.0) 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

Pre-bronchodilator FEV1 at the Clinic

Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.

The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint

Posted

Feb 2013

Least Squares Mean

95% Confidence Interval

Liters

Twelve week treatment period

ID	Title	Description
OG000	Arm 1 - AZD1981 400 mg	AZD1981 400 mg twice daily
OG001	Arm 2 - AZD1981 200 mg	AZD1981 200 mg once daily
OG002	Arm 3 - AZD1981 100 mg	AZD1981 100 mg twice daily
OG003	Arm 4 - AZD1981 80 mg	AZD1981 80 mg once daily
OG004	Arm 5 - AZD1981 40 mg	AZD1981 40 mg twice daily
OG005	Arm 6 - AZD1981 10 mg	AZD1981 10 mg twice daily
OG006	Arm7-Placebo	Placebo

Units	Counts
Participants	OG000160 OG001156 OG002162 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.16(0.10 to 0.21) OG0010.19(0.14 to 0.25) OG0020.19(0.13 to 0.24) OG003

Secondary

Morning and Evening PEF

Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available morning (evening) PEF during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.

The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint

Posted

Feb 2013

Least Squares Mean

95% Confidence Interval

Liters/minute

Twelve week treatment period

ID	Title	Description
OG000	Arm 1 - AZD1981 400 mg	AZD1981 400 mg twice daily
OG001	Arm 2 - AZD1981 200 mg	AZD1981 200 mg once daily
OG002	Arm 3 - AZD1981 100 mg	AZD1981 100 mg twice daily
OG003	Arm 4 - AZD1981 80 mg	AZD1981 80 mg once daily

Secondary

Asthma Control Questionnaire 5-item (ACQ5)

The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. The minimal important difference is defined as a change in score of 0.5. Change from baseline: treatment period average minus baseline.

The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint

Posted

Feb 2013

Least Squares Mean

95% Confidence Interval

Scores on scale

Twelve week treatment period

ID	Title	Description
OG000	Arm 1 - AZD1981 400 mg	AZD1981 400 mg twice daily
OG001	Arm 2 - AZD1981 200 mg	AZD1981 200 mg once daily
OG002	Arm 3 - AZD1981 100 mg	AZD1981 100 mg twice daily
OG003	Arm 4 - AZD1981 80 mg	AZD1981 80 mg once daily

Secondary

Adverse Events

Number of participants who had at least one adverse event during the randomized treatment period

All randomized participants who received at least one dose of study medication and from whom any data after randomization was available

Posted

Feb 2013

Number

Participants

Twelve week treatment period

ID	Title	Description
OG000	Arm 1 - AZD1981 400 mg	AZD1981 400 mg twice daily
OG001	Arm 2 - AZD1981 200 mg	AZD1981 200 mg once daily
OG002	Arm 3 - AZD1981 100 mg	AZD1981 100 mg twice daily
OG003	Arm 4 - AZD1981 80 mg	AZD1981 80 mg once daily
OG004	Arm 5 - AZD1981 40 mg	AZD1981 40 mg twice daily

Secondary

Number of Participants With at Least One Severe Asthma Exacerbation

Severe asthma exacerbation defined as deterioration in asthma leading to either hospitalization/emergency room treatment or oral glucocorticosteroid treatment for at least 3 days

The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint

Posted

Feb 2013

Number

Participants

Twelve week treatment period

ID	Title	Description
OG000	Arm 1 - AZD1981 400 mg	AZD1981 400 mg twice daily
OG001	Arm 2 - AZD1981 200 mg	AZD1981 200 mg once daily
OG002	Arm 3 - AZD1981 100 mg	AZD1981 100 mg twice daily
OG003	Arm 4 - AZD1981 80 mg	AZD1981 80 mg once daily
OG004	Arm 5 - AZD1981 40 mg

Secondary

Number of Participants With at Least One Treatment Failure

Treatment failure is defined as a clinical need for additional inhaled corticosteroid use as judged by the investigator based on evaluations at the clinic.

The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint

Posted

Feb 2013

Number

Participants

Twelve week treatment period

ID	Title	Description
OG000	Arm 1 - AZD1981 400 mg	AZD1981 400 mg twice daily
OG001	Arm 2 - AZD1981 200 mg	AZD1981 200 mg once daily
OG002	Arm 3 - AZD1981 100 mg	AZD1981 100 mg twice daily
OG003	Arm 4 - AZD1981 80 mg	AZD1981 80 mg once daily
OG004	Arm 5 - AZD1981 40 mg

Secondary

Number of Participants With Well-controlled Asthma (ACQ5<=0.75)

The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. Well-controlled asthma is defined as ACQ5<=0.75 at the end of the 12-week treatment period.

The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint

Posted

Feb 2013

Number

Participants

Twelve week treatment period

ID	Title	Description
OG000	Arm 1 - AZD1981 400 mg	AZD1981 400 mg twice daily
OG001	Arm 2 - AZD1981 200 mg	AZD1981 200 mg once daily
OG002	Arm 3 - AZD1981 100 mg	AZD1981 100 mg twice daily
OG003	Arm 4 - AZD1981 80 mg	AZD1981 80 mg once daily

Secondary

Asthma Quality of Life Questionnaire (AQLQ(S))

The AQLQ(S) consists of 32 questions, each assessed on a scale from 1-7, with higher values indicating better health-related quality of life. Overall scores are calculated from the means of the individual scores. The minimal important difference is a change in score of 0.5. Change from baseline: treatment period average minus baseline.

The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint

Posted

Feb 2013

Least Squares Mean

95% Confidence Interval

Score on scale

Twelve week treatment period

ID	Title	Description
OG000	Arm 1 - AZD1981 400 mg	AZD1981 400 mg twice daily
OG001	Arm 2 - AZD1981 200 mg	AZD1981 200 mg once daily
OG002	Arm 3 - AZD1981 100 mg	AZD1981 100 mg twice daily
OG003	Arm 4 - AZD1981 80 mg	AZD1981 80 mg once daily

Secondary

Asthma Symptom Score

Asthma symptoms, measured in the morning and evening, based on a scale from 0-3 with higher scores indicating more severe asthma symptoms. Total asthma symptom score (0-6) is calculated by taking the sum of the morning and evening scores. Change from baseline: treatment period average minus baseline.

The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint

Posted

Feb 2013

Least Squares Mean

95% Confidence Interval

Score on scale

Twelve week treatment period

ID	Title	Description
OG000	Arm 1 - AZD1981 400 mg	AZD1981 400 mg twice daily
OG001	Arm 2 - AZD1981 200 mg	AZD1981 200 mg once daily
OG002	Arm 3 - AZD1981 100 mg	AZD1981 100 mg twice daily
OG003	Arm 4 - AZD1981 80 mg	AZD1981 80 mg once daily

Secondary

Total Reliever Medication Use

Reliever medication use (number of inhalations), measured in the morning and evening. Total reliever medication use is calculated by taking the sum of the number of daytime and evening inhalations of reliever medication. Change from baseline: treatment period average minus baseline.

The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint

Posted

Feb 2013

Least Squares Mean

95% Confidence Interval

Number of inhalations

Twelve week treatment period

ID	Title	Description
OG000	Arm 1 - AZD1981 400 mg	AZD1981 400 mg twice daily
OG001	Arm 2 - AZD1981 200 mg	AZD1981 200 mg once daily
OG002	Arm 3 - AZD1981 100 mg	AZD1981 100 mg twice daily
OG003	Arm 4 - AZD1981 80 mg	AZD1981 80 mg once daily

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AZD1981 400 mg	AZD1981 400 mg twice daily	0	164	12	164
EG001	AZD1981 200 mg	AZD1981 200 mg once daily	1	159	23	159
EG002	AZD1981 100 mg	AZD1981 100 mg twice daily	3	164	22	164
EG003	AZD1981 80 mg	AZD1981 80 mg once daily	1	164	21	164
EG004	AZD1981 40 mg	AZD1981 40 mg twice daily	0	163	20	163
EG005	AZD1981 10 mg	AZD1981 10 mg twice daily	0	163	32	163
EG006	Placebo	Placebo	1	163	21	163

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Epilepsy	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected164 at risk EG0010 affected159 at risk EG0021 affected164 at risk EG0030 affected164 at risk EG0040 affected163 at risk EG0050 affected163 at risk EG0060 affected163 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected164 at risk EG0011 affected159 at risk EG0020 affected164 at risk EG003
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected164 at risk EG0010 affected159 at risk EG0021 affected164 at risk EG003
Inguinal Hernia	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected164 at risk EG0010 affected159 at risk EG0020 affected164 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected164 at risk EG0010 affected159 at risk EG0020 affected164 at risk EG003
Syncope	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected164 at risk EG0010 affected159 at risk EG0021 affected164 at risk EG003
Vasculitis	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected164 at risk EG0011 affected159 at risk EG0020 affected164 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0004 affected164 at risk EG00110 affected159 at risk EG0027 affected164 at risk EG0039 affected164 at risk EG0045 affected163 at risk EG00510 affected163 at risk EG0066 affected163 at risk
Bronchitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected164 at risk EG0014 affected159 at risk EG0022 affected164 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected164 at risk EG0012 affected159 at risk EG0024 affected164 at risk EG003
Influenza	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected164 at risk EG0010 affected159 at risk EG0020 affected164 at risk EG003
Respiratory Tract Infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected164 at risk EG0011 affected159 at risk EG0021 affected164 at risk EG003
Headache	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected164 at risk EG0017 affected159 at risk EG0027 affected164 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected164 at risk EG0010 affected159 at risk EG0024 affected164 at risk EG003
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected164 at risk EG0010 affected159 at risk EG0021 affected164 at risk EG003