A Phase IIa Study Assessing the Effects of AZD1236 on Bio... | NCT00758706

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

Label	Type	Description	Intervention Names
AZD1236	Experimental	oral tablet, 75 mg, twice daily during 6 weeks	Drug: AZD1236
Placebo	Placebo Comparator	Dosing to match AZD1236	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
AZD1236	Drug	oral tablet, 75 mg, twice daily during 6 weeks	AZD1236

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ratio of TNF Alpha at Week 6 to Baseline	Ratio reflects Sputum Tumor Necrosis Factor alpha (TNF alpha) at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).	Baseline and Week 6
Ratio of Sputum Total Cells at Week 6 to Baseline	Ratio reflects Sputum Total Cells at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).	Baseline and Week 6
Ratio of Total Urine Desmosine at Week 6 to Baseline	Ratio reflects Total Urine Desmosine at week 6 value divide by baseline value. Baseline is visit 3(Randomization) value.	Baseline and Week 6

Secondary Outcomes

Measure	Description	Time Frame
Incidence of Adverse Events	Number of patients who had an AE	all study visits
Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6	Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Ronald Dahl, MD, Professor	Arhus Kommune HospitalMedicinsk	Principal Investigator
Andrew Lockton, MD	AstraZeneca R&D Charnwood	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Aalborg			Denmark
Research Site

Label	URL
Related Info	View source
D4260C00007	View source

Results Section

Participant Flow Module

ID	Title	Description
FG000	AZD1236	AZD1236 75mg oral tablet twice daily(bid)
FG001	Placebo	Placebo to AZD1236 twice daily(bid)

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

Intervention Browse Module

ID	Title	Description
BG000	AZD1236	AZD1236 75mg oral tablet twice daily(bid)
BG001	Placebo	Placebo to AZD1236 twice daily(bid)
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00026 BG00129 BG00255

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

Year

Title

Denominators

Categories

Title	Measurements
	OG0001.37± 0.532(0.532 to 18.7) OG0011.21± 0.270(0.270 to 20.4)

Primary

Ratio of Sputum Total Cells at Week 6 to Baseline

Ratio reflects Sputum Total Cells at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).

Full analysis set excluded participants without baseline or post-baseline data.

Posted

Mean

Full Range

ratio

Baseline and Week 6

ID	Title	Description
OG000	AZD1236	AZD1236 75mg oral tablet twice daily(bid)
OG001	Placebo	Placebo to AZD1236 twice daily(bid)

Units	Counts
Participants	OG000

Primary

Ratio of Total Urine Desmosine at Week 6 to Baseline

Ratio reflects Total Urine Desmosine at week 6 value divide by baseline value. Baseline is visit 3(Randomization) value.

Full analysis set excluded participants without baseline or post-baseline data.

Posted

Mean

Full Range

ratio

Baseline and Week 6

ID	Title	Description
OG000	AZD1236	AZD1236 75mg oral tablet twice daily(bid)
OG001	Placebo	Placebo to AZD1236 twice daily(bid)

Units	Counts
Participants	OG000

Secondary

Incidence of Adverse Events

Number of patients who had an AE

Posted

Number

Participants

all study visits

ID	Title	Description
OG000	AZD1236	AZD1236 75mg oral tablet twice daily(bid)
OG001	Placebo	Placebo to AZD1236 twice daily(bid)

Units	Counts
Participants	OG00026 OG001

Secondary

Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6

Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.

Full analysis set completed at week 6

Posted

Mean

Full Range

Baseline and Week 6

ID	Title	Description
OG000	AZD1236	AZD1236 75mg oral tablet twice daily(bid)
OG001	Placebo	Placebo to AZD1236 twice daily(bid)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Forced Vital Capacity (FVC) at Week 6

Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.

Full analysis set completed at week 6

Posted

Mean

Full Range

Baseline and Week 6

ID	Title	Description
OG000	AZD1236	AZD1236 75mg oral tablet twice daily(bid)
OG001	Placebo	Placebo to AZD1236 twice daily(bid)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Vital Capacity (VC) at Week 6

Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.

Full analysis set completed at week 6

Posted

Mean

Full Range

Baseline and Week 6

ID	Title	Description
OG000	AZD1236	AZD1236 75mg oral tablet twice daily(bid)
OG001	Placebo	Placebo to AZD1236 twice daily(bid)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Inspiratory Capacity (IC) at Week 6

Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.

Full analysis set completed at week 6

Posted

Mean

Full Range

Baseline and Week 6

ID	Title	Description
OG000	AZD1236	AZD1236 75mg oral tablet twice daily(bid)
OG001	Placebo	Placebo to AZD1236 twice daily(bid)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Week 6

Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.

Full analysis set completed at week 6

Posted

Mean

Full Range

L/s

Baseline and Week 6

ID	Title	Description
OG000	AZD1236	AZD1236 75mg oral tablet twice daily(bid)
OG001	Placebo	Placebo to AZD1236 twice daily(bid)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Peak Expiratory Flow (PEF) Morning at Average of Last 4 Week Treatment

Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.

Full analysis set

Posted

Mean

Full Range

L/min

Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)

ID	Title	Description
OG000	AZD1236	AZD1236 75mg oral tablet twice daily(bid)
OG001	Placebo	Placebo to AZD1236 twice daily(bid)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Peak Expiratory Flow (PEF) Evening at Average of Last 4 Week Treatment

Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.

Full analysis set

Posted

Mean

Full Range

L/min

Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)

ID	Title	Description
OG000	AZD1236	AZD1236 75mg oral tablet twice daily(bid)
OG001	Placebo	Placebo to AZD1236 twice daily(bid)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Clinical COPD Questionnaire(CCQ) Total

Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)

Full analysis set

Posted

Mean

Full Range

Score on scale

Baseline and Week 6

ID	Title	Description
OG000	AZD1236	AZD1236 75mg oral tablet twice daily(bid)
OG001	Placebo	Placebo to AZD1236 twice daily(bid)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in COPD Symptoms, Breathlessness at Average of Last 4 Week Treatment

Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).

Full analysis set

Posted

Mean

Full Range

Score on scale

Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)

ID	Title	Description
OG000	AZD1236	AZD1236 75mg oral tablet twice daily(bid)
OG001	Placebo	Placebo to AZD1236 twice daily(bid)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in COPD Symptoms, Chest Tightness at Average of Last 4 Week Treatment

Full analysis set

Posted

Mean

Full Range

Score on scale

Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)

ID	Title	Description
OG000	AZD1236	AZD1236 75mg oral tablet twice daily(bid)
OG001	Placebo	Placebo to AZD1236 twice daily(bid)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in COPD Symptoms, Cough Score at Average of Last 4 Week Treatment

Full analysis set

Posted

Mean

Full Range

Score on scale

Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)

ID	Title	Description
OG000	AZD1236	AZD1236 75mg oral tablet twice daily(bid)
OG001	Placebo	Placebo to AZD1236 twice daily(bid)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in COPD Symptoms, Night Time Awakenings at Average of Last 4 Week Treatment

Full analysis set

Posted

Mean

Full Range

Score on scale

Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)

ID	Title	Description
OG000	AZD1236	AZD1236 75mg oral tablet twice daily(bid)
OG001	Placebo	Placebo to AZD1236 twice daily(bid)

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	AZD1236	AZD1236 75mg oral tablet twice daily(bid)			4	26	7	26
EG001	Placebo	Placebo to AZD1236 twice daily(bid)			0	29	10	29

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Exacerbation COPD	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected26 at risk EG0010 affected29 at risk
Increased Dyspnoe After Stopping Normal Treatment	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected26 at risk EG0010 affected29 at risk
Decompensation Cordis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected26 at risk EG0010 affected29 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COPD	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected26 at risk EG0013 affected29 at risk
influenza	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected26 at risk EG0013 affected29 at risk
nasopharyngitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected26 at risk EG0013 affected29 at risk
oedema peripheral	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected26 at risk EG0011 affected29 at risk

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