Efficacy of AZD3199 in Chronic Obstructive Pulmonary Dise... | NCT00929708

Status Module

Oversight 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
1	Experimental	AZD3199 low dose	Drug: AZD3199
2	Experimental	AZD3199 intermediate dose	Drug: AZD3199
3	Experimental	AZD3199 high dose	Drug: AZD3199
4	Active Comparator	Formoterol 2x4.5 microgram bid	Drug: formoterol
5	Placebo Comparator	Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
AZD3199	Drug	Dry powder for inhalation, o.d., 4 weeks	1 2 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
FEV1, E0-4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect)	change from baseline	0,5 min, 15 min, 60 min, 2 h, 4 h
FEV1, E24-26; the Average Value at Visit 5 Between 24 and 26 Hours Following the Morning Dose (Trough Effect)	change from baseline	24h, 26h

Secondary Outcomes

Measure	Description	Time Frame
Cmax; the Highest Plasma Concentration of AZD3199 Measured	PK is only measured for AZD3199	0,15 min, 1, 4 and 24 hours post dose
AUC0-24; Area Under the Plasma Concentration Curve From Zero to 24 Hours After Dose

Eligibility Module

Name	Affiliation	Role
Piotr Kuna, Professor	University Hospital, Lodz, Poland	Principal Investigator

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23731768	Derived	Kuna P, Ivanov Y, Trofimov VI, Saito T, Beckman O, Bengtsson T, Jorup C, Maltais F. Efficacy and safety of AZD3199 vs formoterol in COPD: a randomized, double-blind study. Respir Res. 2013 Jun 3;14(1):64. doi: 10.1186/1465-9921-14-64.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	AZD3199 200 Mcg od	2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
FG001	AZD3199 400 Mcg od	2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	AZD3199 200 Mcg od	2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
BG001	AZD3199 400 Mcg od	2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
BG002	AZD3199 800 Mcg od	2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
BG003	Formoterol 9 Mcg Bid	2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
BG004	Placebo	2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
BG005	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

Full Range

Years

Title

Denominators

Categories

Title	Measurements
	OG0000.21± 0.33 OG0010.17± 0.31 OG0020.14± 0.27 OG003

Primary

FEV1, E24-26; the Average Value at Visit 5 Between 24 and 26 Hours Following the Morning Dose (Trough Effect)

change from baseline

Posted

Mean

Standard Deviation

Litre

24h, 26h

ID	Title	Description
OG000	AZD3199 200 Mcg od	2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG001	AZD3199 400 Mcg od	2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG002	AZD3199 800 Mcg od	2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG003	Formoterol 9 Mcg Bid	2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
OG004	Placebo	2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)

Secondary

Cmax; the Highest Plasma Concentration of AZD3199 Measured

PK is only measured for AZD3199

AZD3199 plasma data were available for 178 of the 199 randomized patients, but data from 2 patients in AZD3199 200 mcg group were excluded from analysis because most of the values were below LOQ.

Posted

Geometric Mean

Full Range

nmol/L

0,15 min, 1, 4 and 24 hours post dose

ID	Title	Description
OG000	AZD3199 200 Mcg od	2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG001	AZD3199 400 Mcg od	2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG002	AZD3199 800 Mcg od	2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG003	Formoterol 9 Mcg Bid	2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
OG004

Secondary

AUC0-24; Area Under the Plasma Concentration Curve From Zero to 24 Hours After Dose

PK is only measured for AZD3199

AZD3199 plasma data were available for 178 of the 199 randomized patients, but data from 2 patients in AZD3199 200 mcg group were excluded from analysis because most of the values were below LOQ.

Posted

Geometric Mean

Full Range

nmol*h/L

0,15 min, 1, 4 and 24 hours post dose

ID	Title	Description
OG000	AZD3199 200 Mcg od	2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG001	AZD3199 400 Mcg od	2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG002	AZD3199 800 Mcg od	2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG003	Formoterol 9 Mcg Bid	2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
OG004

Secondary

FEV1 Post Salbutamol Inhalation

Mean value of FEV1 pre and post salbutamol at visit 2 and visit 5

Posted

Mean

Standard Deviation

Litre

Baseline (visit 2) and 26 h after the last morning dose (visit 5).

ID	Title	Description
OG000	AZD3199 200 Mcg od	2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG001	AZD3199 400 Mcg od	2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG002	AZD3199 800 Mcg od	2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG003	Formoterol 9 Mcg Bid	2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
OG004	Placebo	2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)

Secondary

Total Number of Reliever Medication Inhalations Per 24h

Change from run-in

Posted

Mean

Standard Deviation

Number of reliver inh.

During day (from rising from bed until going to bed) and night (from going to bed until rising from bed) at visit 1 to visit 5 (24h), up to 4 weeks.

ID	Title	Description
OG000	AZD3199 200 Mcg od	2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG001	AZD3199 400 Mcg od	2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG002	AZD3199 800 Mcg od	2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG003	Formoterol 9 Mcg Bid	2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
OG004	Placebo	2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)

Secondary

Total AstraZeneca COPD Symptoms Scores (Included Breathlessness, Chest Tightness, Cough and Night-time Awakenings)

Score on a scale 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) for each symptom, total score is the sum of each symptom ranged from 0 to 16. Change from run-in.

Posted

Mean

Standard Deviation

total score

Daily, during run-in and treatment

ID	Title	Description
OG000	AZD3199 200 Mcg od	2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG001	AZD3199 400 Mcg od	2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG002	AZD3199 800 Mcg od	2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG003	Formoterol 9 Mcg Bid	2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
OG004	Placebo

Secondary

Overall Mean CCQ (Clinical COPD Questionnaire)

Change from baseline to treatment in score. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited). The data below represent the average of week 1,2,4 minus week 0.

Posted

Mean

Standard Deviation

score on scale

Mean over week 0, mean over week 1, mean over week 2, and mean over week 4

ID	Title	Description
OG000	AZD3199 200 Mcg od	2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG001	AZD3199 400 Mcg od	2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG002	AZD3199 800 Mcg od	2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG003	Formoterol 9 Mcg Bid	2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
OG004	Placebo

Secondary

Total Score SGRQ-C (St George's Respiratory Questionnaire for COPD)

The total score is calculated using all questions including their weights and scores range from 0 (perfect health) to 100 (worst possible state)

Posted

Mean

Standard Deviation

Score

At baseline (visit 2) and after 4 weeks of treatment (visit 5).

ID	Title	Description
OG000	AZD3199 200 Mcg od	2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG001	AZD3199 400 Mcg od	2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG002	AZD3199 800 Mcg od	2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
OG003	Formoterol 9 Mcg Bid	2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
OG004	Placebo

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AZD3199 200 Mcg od	2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)	1	65	1	65
EG001	AZD3199 400 Mcg od	2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)	4	69	8	69
EG002	AZD3199 800 Mcg od	2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)	0	65	7	65
EG003	Formoterol 9 Mcg Bid	2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)	3	67	4	67
EG004	Placebo	2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)	2	63	3	63

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Chroniv obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected65 at risk EG0010 affected69 at risk EG0020 affected65 at risk EG0030 affected67 at risk EG004
Clavicle fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected65 at risk EG0011 affected69 at risk EG0020 affected65 at risk EG003
Colitis ishaemic	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected65 at risk EG0010 affected69 at risk EG0020 affected65 at risk EG003
Head injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected65 at risk EG0011 affected69 at risk EG0020 affected65 at risk EG003
Hypertensive crisis	Vascular disorders	Non-systematic Assessment	EG0000 affected65 at risk EG0010 affected69 at risk EG0020 affected65 at risk EG003
Macular degeneration	Eye disorders	Non-systematic Assessment	EG0000 affected65 at risk EG0010 affected69 at risk EG0020 affected65 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected65 at risk EG0011 affected69 at risk EG0020 affected65 at risk EG003
Pneumonia bacterial	Infections and infestations	Non-systematic Assessment	EG0000 affected65 at risk EG0010 affected69 at risk EG0020 affected65 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected65 at risk EG0011 affected69 at risk EG0020 affected65 at risk EG003
Circulatory collapse	Vascular disorders	Non-systematic Assessment	EG0000 affected65 at risk EG0010 affected69 at risk EG0020 affected65 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nasopharyngitis	Infections and infestations		Non-systematic Assessment		EG0001 affected65 at risk EG0014 affected69 at risk EG0023 affected65 at risk EG0032 affected67 at risk EG0043 affected63 at risk
Cough	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment		EG0000 affected65 at risk EG0014 affected69 at risk EG0024 affected65 at risk EG003

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D053120	Respiratory Aspiration

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
D012120	Respiration Disorders

ID	Term
C544523	AZD-3199
D000068759	Formoterol Fumarate

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines