Trial Outcomes & Findings for Symbicort Maintenance and Reliever Therapy - Experience in Real Life Setting in Malaysia (NCT NCT00576316)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

201 participants

Primary outcome timeframe

6 months after each patient was initially treated with Symbicort SMART

Results posted on

2010-12-16

Participant Flow

201 patients were recruited from 10 government hospital based outpatient clinics from Dec 2007 until May 2008

Participant milestones

Participant milestones
Measure	Symbicort 160/4.5 Turbuhaler Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
Overall Study STARTED	201
Overall Study COMPLETED	181
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Symbicort 160/4.5 Turbuhaler Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
Overall Study Adverse Event	9
Overall Study Withdrawal by Subject	2
Overall Study Protocol Violation	9

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Symbicort 160/4.5 Turbuhaler n=201 Participants Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
Age Continuous Mean Age	46.73 years STANDARD_DEVIATION 12.31 • n=5 Participants
Sex: Female, Male Female	155 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after each patient was initially treated with Symbicort SMART

Population: 201 participants were recruited but statistical analysis was completed for 195 participants

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

Outcome measures

Outcome measures
Measure	Symbicort 160/4.5 Turbuhaler n=195 Participants Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
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	0.37 Scores on a scale Standard Deviation 0.73

SECONDARY outcome

Timeframe: 6 months after each patient was initially treated with Symbicort SMART

Population: 201 participants were recruited but statistical analysis was completed for 195 participants

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

Outcome measures

Outcome measures
Measure	Symbicort 160/4.5 Turbuhaler n=195 Participants Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
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	-0.97 scores on a scale Standard Deviation 1.22

Adverse Events

Symbicort 160/4.5 Turbuhaler

Serious events: 17 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Symbicort 160/4.5 Turbuhaler Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
Cardiac disorders Congestive Cardiac Failure	0.51% 1/195
Ear and labyrinth disorders Vestibular Neuronitis	0.51% 1/195
General disorders Secretion And Pyrexia	1.5% 3/195
Infections and infestations Upper Respiratory Tract Infection	2.6% 5/195
Respiratory, thoracic and mediastinal disorders Asthma	7.7% 15/195

Other adverse events

Other adverse events
Measure	Symbicort 160/4.5 Turbuhaler Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	13.3% 26/195
General disorders General discomfort	5.6% 11/195
Respiratory, thoracic and mediastinal disorders Productive Cough	16.9% 33/195

Additional Information

Gerard Lynch

AstraZeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60