Symbicort Maintenance and Reliever Therapy - Experience in Real Life Setting in Malaysia - SMARTER

Study identifier:D5890L00027

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Symbicort Maintenance And Reliever Therapy - Experience in Real Life Setting in Malaysia - SMARTER Study

Medical condition

asthma

Phase

Phase 4

Healthy volunteers

Study drug

Symbicort Turbuhaler 160/4.5

Sex

All

Actual Enrollment

201

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Jan 2008

Primary Completion Date: -

Study Completion Date: 01 Nov 2008

Study design

Allocation: Non-randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2010 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Kuala Lumpur, Malaysia

Arms	Assigned Interventions

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
201 patients were recruited from 10 government hospital based outpatient clinics from Dec 2007 until May 2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Symbicort 160/4.5 Turbuhaler	Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever

Participant Flow: Overall Study

	Symbicort 160/4.5 Turbuhaler
STARTED	201^[1]
COMPLETED	181^[2]
NOT COMPLETED	20
Adverse Event	9
Withdrawal by Subject	2
Protocol Violation	9

[1]	Number of patients recruited
[2]	Number of patients who completed study

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Symbicort 160/4.5 Turbuhaler	Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever

Baseline Measures

	Symbicort 160/4.5 Turbuhaler
Number of Participants [units: Participants]	201
Age Continuous [units: years] Mean ± Standard Deviation	46.73 ± 12.31
Gender, Male/Female [units: Participants]
Female	155
Male	46

Outcome Measures

1. Primary Outcome Measure: Change in Satisfaction with Asthma Treatment Questionnaire (SATQ) scores from baseline to the mean of 3 months and 6 months after patient was initially treated with SMART [ Time Frame: 6 months after each patient was initially treated with Symbicort SMART ]

Measure Type	Primary
Measure Name	Change in Satisfaction with Asthma Treatment Questionnaire (SATQ) scores from baseline to the mean of 3 months and 6 months after patient was initially treated with SMART
Measure Description	Difference/change in SATQ score between baseline and mean of 3 months and 6 months after SMART treatment as analysed by paired t-test. SATQ is a patient reported questionnaire which consists of 26 questions and scored to a scale of 1-7, the higher score indicating a greater level of satisfaction
Time Frame	6 months after each patient was initially treated with Symbicort SMART
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
201 participants were recruited but statistical analysis was completed for 195 participants

Reporting Groups

	Description
Symbicort 160/4.5 Turbuhaler	Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever

Measured Values

	Symbicort 160/4.5 Turbuhaler
Number of Participants Analyzed [units:participants]	195
Change in Satisfaction with Asthma Treatment Questionnaire (SATQ) scores from baseline to the mean of 3 months and 6 months after patient was initially treated with SMART [units: Scores on a scale] Mean (Standard Deviation)	0.37 (0.73)

No statistical analysis provided for Change in Satisfaction with Asthma Treatment Questionnaire (SATQ) scores from baseline to the mean of 3 months and 6 months after patient was initially treated with SMART

2. Secondary Outcome Measure: Changes in Asthma Control Questionnaire (ACQ-5) score from baseline to the mean of 3 months and 6 months after patient was initially treated with SMART [ Time Frame: 6 months after each patient was initially treated with Symbicort SMART ]

Measure Type	Secondary
Measure Name	Changes in Asthma Control Questionnaire (ACQ-5) score from baseline to the mean of 3 months and 6 months after patient was initially treated with SMART
Measure Description	Difference/change in ACQ-5 scores between baseline and mean of 3 months and 6 months after SMART treatment. ACQ-5 is a 5 question patient reported outcome measuring level of asthma control during the past 7 days and it is scored on scale of 0-6. 0 indicates no symptoms and 6 represents severe symptoms
Time Frame	6 months after each patient was initially treated with Symbicort SMART
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
201 participants were recruited but statistical analysis was completed for 195 participants

Reporting Groups

	Description
Symbicort 160/4.5 Turbuhaler	Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever

Measured Values

	Symbicort 160/4.5 Turbuhaler
Number of Participants Analyzed [units:participants]	195
Changes in Asthma Control Questionnaire (ACQ-5) score from baseline to the mean of 3 months and 6 months after patient was initially treated with SMART [units: scores on a scale] Mean (Standard Deviation)	-0.97 (1.22)

No statistical analysis provided for Changes in Asthma Control Questionnaire (ACQ-5) score from baseline to the mean of 3 months and 6 months after patient was initially treated with SMART

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
Symbicort 160/4.5 Turbuhaler	Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever

Serious Adverse Events

Symbicort 160/4.5 Turbuhaler

Total, serious adverse events

# participants affected / at risk

17/---

Cardiac disorders

Congestive Cardiac Failure¹,^†

# participants affected / at risk

1/---

Ear and labyrinth disorders

Vestibular Neuronitis¹,^†

# participants affected / at risk

1/---

General disorders

Secretion And Pyrexia¹,^†

# participants affected / at risk

3/---

Infections and infestations

Upper Respiratory Tract Infection¹,^†

# participants affected / at risk

5/---

Respiratory, thoracic and mediastinal disorders

Asthma¹,^†

# participants affected / at risk

15/---

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 10.0
2	Term from vocabulary,

Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Symbicort 160/4.5 Turbuhaler	Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever

Other Adverse Events

Symbicort 160/4.5 Turbuhaler

Total, other (not including serious) adverse events

# participants affected / at risk

70/---

Respiratory, thoracic and mediastinal disorders

Upper respiratory tract infection¹,^†

# participants affected / at risk

26/---

General disorders

General discomfort¹,^†

# participants affected / at risk

11/---

Respiratory, thoracic and mediastinal disorders

Productive Cough¹,^†

# participants affected / at risk

33/---

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 10.0
2	Term from vocabulary,

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description:

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Gerard Lynch
Organization:	AstraZeneca
E-mail:	[email protected]

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=385&filename=CSR-D5890L00027.pdf
Download
CSR-D5890L00027.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Sdn Malaysia Clinical Study

+603 20892288

Investigators

Principal Investigator

Akhmal Yusof

AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=385&filename=CSR-D5890L00027.pdf

CSR-D5890L00027.pdf

Trial Results Summaries