An Efficacy Study Comparing SYMBICORT® Pressurised Metere... | NCT00419757

NCT00419757

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions 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
Symbicort	Active Comparator	SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily	Drug: Budesonide/formoterol (SYMBICORT) pMDI
Budesonide	Active Comparator	budesonide HFA pMDI 160 μg x 2 actuations twice daily	Drug: Budesonide HFA pMDI

Name	Type	Description	Arm Group Labels	Other Names
Budesonide/formoterol (SYMBICORT) pMDI	Drug	SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily	Symbicort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Morning Peak Expiratory Flow (AM PEF)	Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks, with baseline value as covariate.	Baseline (run-in) and throughout 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Pre-defined Asthma Events	Asthma Events, defined as any of: decrease in lung function (FEV1 or AM PEF), use of rescue medication over maximum allowed per day, night awakening requiring use of rescue medication, exacerbation of asthma requiring medical assistance, use of not allowed asthma medication	12 weeks

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Christer Hultquist, MD	AstraZeneca	Study Director

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22329608	Derived	Murphy KR, Uryniak T, Martin UJ, Zangrilli J. The effect of budesonide/formoterol pressurized metered-dose inhaler on predefined criteria for worsening asthma in four different patient populations with asthma. Drugs R D. 2012 Mar 1;12(1):9-14. doi: 10.2165/11630600-000000000-00000.
21875546	Derived	Zangrilli J, Mansfield LE, Uryniak T, O'Brien CD. Efficacy of budesonide/formoterol pressurized metered-dose inhaler versus budesonide pressurized metered-dose inhaler alone in Hispanic adults and adolescents with asthma: a randomized, controlled trial. Ann Allergy Asthma Immunol. 2011 Sep;107(3):258-65.e2. doi: 10.1016/j.anai.2011.05.024. Epub 2011 Jul 14.

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

Arm/Group Information

ID	Title	Description
FG000	Symbicort	SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
FG001	Budesonide	Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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No data is available for this block.

Document Section

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Derived Section

Miscellaneous Info Module

Submission Tracking

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No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

FG000127 subjectsRandomized patients

FG001123 subjectsRandomized patients

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Symbicort	SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
BG001	Budesonide	Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
BG002	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
	OG00025.40± 6.0(+/-6.0 to ) OG00119.90± 6.5(+/-6.5 to )

Secondary

Percentage of Participants With Pre-defined Asthma Events

Asthma Events, defined as any of: decrease in lung function (FEV1 or AM PEF), use of rescue medication over maximum allowed per day, night awakening requiring use of rescue medication, exacerbation of asthma requiring medical assistance, use of not allowed asthma medication

Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Posted

Number

Percentage of Participants

12 weeks

ID	Title	Description
OG000	Symbicort	SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
OG001	Budesonide	Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With "Withdrawals Due to Pre-defined Asthma Events"

Percentage of participants with "Withdrawals Due to Pre-defined Asthma Events" as recorded in CRF. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Posted

Number

Percentage of Participants

12 weeks

ID	Title	Description
OG000	Symbicort	SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
OG001	Budesonide	Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

Units	Counts
Participants	OG000

Secondary

Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1)

Changes in pre-dose FEV1 from baseline to the average value over the treatment period, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Posted

Least Squares Mean

Standard Error

Liters

Baseline, 2, 6 and 12 weeks

ID	Title	Description
OG000	Symbicort	SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
OG001	Budesonide	Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

Units	Counts
Participants	OG000

Secondary

Change From Baseline in a Evening Peak Expiratory Flow (PM PEF)

Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks with baseline as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Posted

Least Squares Mean

Standard Error

Liters/minutes

Baseline (run-in) and throughout 12 weeks

ID	Title	Description
OG000	Symbicort	SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
OG001	Budesonide	Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

Units	Counts
Participants	OG000

Secondary

Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks

Change from baseline in average of daily scores for nighttime asthma over 12 weeks of treatment, with baseline value as covariate.

Daily scale:

0 = No symptoms
1 = Mild symptoms
2 = Moderate symptoms
3 = Severe symptoms

Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Posted

Least Squares Mean

Standard Error

Units on a scale

Baseline (run-in) and throughout 12 weeks

ID	Title	Description
OG000	Symbicort	SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
OG001	Budesonide	Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

Units	Counts
Participants	OG000

Secondary

Change in Daytime Asthma Symptom Score From Baseline Through 12 Weeks

Change from baseline in average of daily scores for daytime asthma over 12 weeks of treatment, with baseline value as covariate.

Daily scale:

0 = No symptoms
1 = Mild symptoms
2 = Moderate symptoms
3 = Severe symptoms

Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Posted

Least Squares Mean

Standard Error

Units on a scale

Baseline (run-in) and throughout 12 weeks

ID	Title	Description
OG000	Symbicort	SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
OG001	Budesonide	Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

Units	Counts
Participants	OG000

Secondary

Change in Asthma Related Awakenings Free Nights, From Baseline Through 12 Weeks

Change from baseline in percentage of nights with awakenings due to asthma over 12 weeks of treatment, with baseline value as covariate.

Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Posted

Least Squares Mean

Standard Error

Percentage of nights

Baseline (run-in) and throughout 12 weeks

ID	Title	Description
OG000	Symbicort	SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
OG001	Budesonide	Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Rescue Medication Use Over 12 Weeks of Treatment

Change from baseline in rescue medication use over 12 weeks of treatment with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Posted

Least Squares Mean

Standard Error

puffs/day

Baseline (run-in) and throughout 12 weeks

ID	Title	Description
OG000	Symbicort	SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
OG001	Budesonide	Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Rescue-free Days Over 12 Weeks of Treatment

Change from baseline in percentage of rescue-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Posted

Least Squares Mean

Standard Error

Percentage of days

Baseline (run-in) and throughout 12 weeks

ID	Title	Description
OG000	Symbicort	SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
OG001	Budesonide	Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Symptom-free Days Over 12 Weeks of Treatment

Change from baseline in percentage of symptom-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Posted

Least Squares Mean

Standard Error

Percentage of days

Baseline (run-in) and throughout 12 weeks

ID	Title	Description
OG000	Symbicort	SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
OG001	Budesonide	Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

Units	Counts
Participants	OG000

Secondary

Subject Global Assessment

The assessment was made using a 5-point Likert scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1 and 2 combined as "Yes" and points 3, 4, 5 as "No". Percent of Participants that gave positive responses.

Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Posted

Number

Percent of Participants

Baseline and week 12

ID	Title	Description
OG000	Symbicort	SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
OG001	Budesonide	Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

Units	Counts
Participants	OG000

Secondary

Physician Global Assessment

The assessment was made using a 5-point scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1and 2 combined as "Yes" and points 3, 4, 5 as "No". Percent of Participants that gave positive responses.

Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Posted

Number

Perscentage of Participants

Baseline and week 12

ID	Title	Description
OG000	Symbicort	SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
OG001	Budesonide	Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

Units	Counts
Participants	OG000

Secondary

Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Control Relief Index

Mean scores (6-points scale, where 1-means the most positive opinion and 6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.

Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 12

ID	Title	Description
OG000	Symbicort	SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
OG001	Budesonide	Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

Units	Counts
Participants	OG000

Secondary

Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Overall Perception of Medication

Mean scores (6 or 5-points scale, where 1-means the most positive opinion and 5/6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.

Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 12

ID	Title	Description
OG000	Symbicort	SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
OG001	Budesonide	budesonide HFA pMDI 160 μg x 2 actuations twice daily

Units	Counts
Participants	OG000

Secondary

Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Comparison With Other Medications

Mean scores (5-points scale, where 1-means the most positive opinion and 5-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.

Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 12

ID	Title	Description
OG000	Symbicort	SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
OG001	Budesonide	budesonide HFA pMDI 160 μg x 2 actuations 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	Symbicort	SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily			4	127	69	127
EG001	Budesonide	budesonide HFA pMDI 160 μg x 2 actuations twice daily			0	123	48	123

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Gastrointestinal Hemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected127 at risk EG0010 affected123 at risk
Cellulitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected127 at risk EG0010 affected123 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected127 at risk EG0010 affected123 at risk
Status Asthmaticus	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected127 at risk EG0010 affected123 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected127 at risk EG0015 affected123 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected127 at risk EG0013 affected123 at risk
Bronchitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected127 at risk EG0010 affected123 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected127 at risk EG0017 affected123 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected127 at risk EG0010 affected123 at risk
Ear Pain	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected127 at risk EG0010 affected123 at risk
Headache	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00019 affected127 at risk EG00114 affected123 at risk
Influenza	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected127 at risk EG0010 affected123 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected127 at risk EG0010 affected123 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0007 affected127 at risk EG0010 affected123 at risk
Pain	General disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected127 at risk EG0010 affected123 at risk
Pharyngitis Streptococcal	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected127 at risk EG0010 affected123 at risk
Pharyngolaryngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected127 at risk EG0013 affected123 at risk
Pyrexia	General disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected127 at risk EG0010 affected123 at risk
Sinusitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected127 at risk EG0013 affected123 at risk
Toothache	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected127 at risk EG0013 affected123 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected127 at risk EG0014 affected123 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0007 affected127 at risk EG0016 affected123 at risk

ID	Term
D001249	Asthma

Ancestor Terms

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

ID	Term
D019819	Budesonide
D000068759	Formoterol Fumarate
D000069502	Budesonide, Formoterol Fumarate Drug Combination

Ancestor Terms

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines
D004338	Drug Combinations
D004364	Pharmaceutical Preparations