Study to Assess the Efficacy and Safety of AZD1981 in Pat... | NCT00690482

NCT00690482

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
AZD1981	Experimental	AZD1981 Oral tablet, twice daily	Drug: AZD1981
Placebo	Placebo Comparator	Placebo Oral tablet, twice daily	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
AZD1981	Drug	Oral tablet, twice daily	AZD1981
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
FEV1	Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing)	Baseline and Week 4
Clinical COPD Questionnaire	Mean change in Total CCQ from baseline to Week 4 (last measurement post dose used, if data missing). Scores for total CCQ range from 0 (low symptoms) to 6 (high symptoms).	Baseline and Week 4

Secondary Outcomes

Measure	Description	Time Frame
Forced Vital Capacity	Mean change in FVC from baseline to Week 4 (last measurement post dose used, if data missing)	Baseline and Week 4
Slow Vital Capacity	Mean change in SVC from baseline to Week 4 (last measurement post dose used, if data missing)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Jörgen Vestbo	Professor in Respiratory Medicine, Hvidovre, Denmark	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Pleven			Bulgaria
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23827726	Derived	Snell N, Foster M, Vestbo J. Efficacy and safety of AZD1981, a CRTH2 receptor antagonist, in patients with moderate to severe COPD. Respir Med. 2013 Nov;107(11):1722-30. doi: 10.1016/j.rmed.2013.06.006. Epub 2013 Jul 1.

Label	URL
Related Info	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

ID	Title	Description
FG000	AZD1981	AZD1981 Oral tablet, twice daily
FG001	Placebo	Placebo Oral tablet, twice daily

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

One patient randomised to placebo withdrew consent immediately after the first dose of investigational product on the day of randomisation. No clinical measurements were performed and no reports of AEs were received for this patient. Since the patient is non-informative both in terms of efficacy and safety, he has been excluded from the analyses.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

Years

Title

Denominators

Categories

Title	Measurements
	OG0000.007± -0.810(-0.810 to 0.740) OG0010.011± -0.550(-0.550 to 0.550)

Primary

Clinical COPD Questionnaire

Mean change in Total CCQ from baseline to Week 4 (last measurement post dose used, if data missing). Scores for total CCQ range from 0 (low symptoms) to 6 (high symptoms).

The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Posted

Mean

Full Range

Scores on a scale

Baseline and Week 4

ID	Title	Description
OG000	AZD1981	AZD1981 Oral tablet, twice daily
OG001	Placebo	Placebo Oral tablet, twice daily

Units	Counts
Participants	OG000

Secondary

Forced Vital Capacity

Mean change in FVC from baseline to Week 4 (last measurement post dose used, if data missing)

The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Posted

Mean

Full Range

Baseline and Week 4

ID	Title	Description
OG000	AZD1981	AZD1981 Oral tablet, twice daily
OG001	Placebo	Placebo Oral tablet, twice daily

Units	Counts
Participants	OG000

Secondary

Slow Vital Capacity

Mean change in SVC from baseline to Week 4 (last measurement post dose used, if data missing)

The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Posted

Mean

Full Range

Baseline and Week 4

ID	Title	Description
OG000	AZD1981	AZD1981 Oral tablet, twice daily
OG001	Placebo	Placebo Oral tablet, twice daily

Units	Counts
Participants	OG000

Secondary

Inspiratory Capacity

Mean change in IC from baseline to Week 4 (last measurement post dose used, if data missing)

The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Posted

Mean

Full Range

Baseline and Week 4

ID	Title	Description
OG000	AZD1981	AZD1981 Oral tablet, twice daily
OG001	Placebo	Placebo Oral tablet, twice daily

Units	Counts
Participants	OG000

Secondary

FEF25%-75%

Mean change in FEF25%-75% (forced expiratory flow between 25% and 75% of the FVC) from baseline to Week 4 (last measurement post dose used, if data missing)

The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Posted

Mean

Full Range

L/s

Baseline and Week 4

ID	Title	Description
OG000	AZD1981	AZD1981 Oral tablet, twice daily
OG001	Placebo	Placebo Oral tablet, twice daily

Units	Counts
Participants	OG000

Secondary

COPD Symptom Sleep Score

Mean change in COPD symptom sleep score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom sleep score range from 0 (no symptoms) to 4 (no sleep).

The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Posted

Mean

Full Range

Scores on a scale

Baseline and 4-week treatment period average

ID	Title	Description
OG000	AZD1981	AZD1981 Oral tablet, twice daily
OG001	Placebo	Placebo Oral tablet, twice daily

Units	Counts
Participants	OG000

Secondary

COPD Symptom Breathing Score

Mean change in COPD symptom breathing score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom breathing score range from 0 (none) to 4 (severe).

The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Posted

Mean

Full Range

Scores on a scale

Baseline and 4-week treatment period average

ID	Title	Description
OG000	AZD1981	AZD1981 Oral tablet, twice daily
OG001	Placebo	Placebo Oral tablet, twice daily

Units	Counts
Participants	OG000

Secondary

COPD Symptom Cough Score

Mean change in COPD symptom cough score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom cough score range from 0 (none) to 4 (almost constant).

The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Posted

Mean

Full Range

Scores on a scale

Baseline and 4-week treatment period average

ID	Title	Description
OG000	AZD1981	AZD1981 Oral tablet, twice daily
OG001	Placebo	Placebo Oral tablet, twice daily

Units	Counts
Participants	OG000

Secondary

COPD Symptom Sputum Score

Mean change in COPD symptom sputum score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom sputum score range from 0 (none) to 4 (severe).

The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Posted

Mean

Full Range

Scores on a scale

Baseline and 4-week treatment period average

ID	Title	Description
OG000	AZD1981	AZD1981 Oral tablet, twice daily
OG001	Placebo	Placebo Oral tablet, twice daily

Units	Counts
Participants	OG000

Secondary

PEF (Peak Expiratory Flow) Morning

Mean change in PEF morning from baseline to treatment period average (calculated using all available data after randomisation for each patient).

The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Posted

Mean

Full Range

L/min

Baseline and 4-week treatment period average

ID	Title	Description
OG000	AZD1981	AZD1981 Oral tablet, twice daily
OG001	Placebo	Placebo Oral tablet, twice daily

Units	Counts
Participants	OG000

Secondary

PEF (Peak Expiratory Flow) Evening

Mean change in PEF evening from baseline to treatment period average (calculated using all available data after randomisation for each patient).

The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Posted

Mean

Full Range

L/min

Baseline and 4-week treatment period average

ID	Title	Description
OG000	AZD1981	AZD1981 Oral tablet, twice daily
OG001	Placebo	Placebo Oral tablet, twice daily

Units	Counts
Participants	OG000

Secondary

Total Use of Reliever

Mean change in Total use of reliever from baseline to treatment period average (calculated using all available data after randomisation for each patient).

The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Posted

Mean

Full Range

Number of inhalations per day

Baseline and 4-week treatment period average

ID	Title	Description
OG000	AZD1981	AZD1981 Oral tablet, twice daily
OG001	Placebo	Placebo Oral tablet, twice daily

Units	Counts
Participants	OG000

Secondary

Adverse Event

The number of participants that experienced at least one adverse event.

The safety analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo.

Posted

Number

Participants

Up to 4 Weeks

ID	Title	Description
OG000	AZD1981	AZD1981 Oral tablet, twice daily
OG001	Placebo	Placebo Oral tablet, twice daily

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AZD1981	AZD1981 Oral tablet, twice daily			0	61	8	61
EG001	Placebo	Placebo Oral tablet, twice daily			1	56	6	56

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Non-systematic Assessment		EG0000 affected61 at risk EG0011 affected56 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
NASOPHARYNGITIS	Infections and infestations	MedDRA 10.0	Non-systematic Assessment		EG0006 affected61 at risk EG0013 affected56 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Non-systematic Assessment		EG0004 affected61 at risk EG0013 affected56 at risk

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C569518	AZD1981

ID	Title	Description
BG000	AZD1981	AZD1981 Oral tablet, twice daily
BG001	Placebo	Placebo Oral tablet, twice daily
BG002	Total	Total of all reporting groups