Study to Investigate Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma Patients Across Asia

Asthma Clinical Trial

— SMARTASIA  

Official title:

Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy (SMART) in Asthma Patients Across Asia: SMARTASIA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00939341
• Other study ID #: D5890L00035
• Status: Completed
• Phase: Phase 4
• First received: July 13, 2009
• Last updated: January 12, 2012
• Start date: July 2009
• Est. completion date: August 2010

Study information

• Verified date: January 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeIndia: Ministry of HealthIndonesia: Departement Kesehatan (Department of Health)Taiwan: Institutional Review BoardThailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare whether Symbicort Maintenance & Reliever Therapy (SMART) is more effective in uncontrolled asthmatic patients than their current therapy in a real life situation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 862
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provision of signed informed consent

• Asthma diagnosis at least 6 months before visit 1 of study

• Patients who have reversible airway obstruction continuous asthma treatment except Symbicort at least within 4 weeks before visit 1 of study

Exclusion Criteria:

• Known or suspected allergy to active ingredients of study medication or excipients

• Use of oral, rectal or parenteral glucocorticosteroids 30 days before visit 1 of study

• Smoking, current or previous with a smoking history of = 10 pack years

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Symbicort (Budesonide/Formoterol)
Turbuhaler 160/4.5 µg delivered dose, twice daily (one inhalation in the morning and one inhalation in the evening) and as need (prn) in response to symptoms

Locations

Country	Name	City	State
China	Research Site	Beijing
China	Research Site	Changsha	Hunan
China	Research Site	Chengdu
China	Research Site	Fuzhou
China	Research Site	Guangzhou	Guangdong
China	Research Site	Hangzhou
China	Research Site	Nanjing
China	Research Site	Qingdao	Shandong
China	Research Site	Shanghai	Shanghai
China	Research Site	Shenyang
China	Research Site	Wuhan	Hubei
China	Research Site	Zheng Ahou	He Nan
China	Research Site	Zhengzhou
India	Research Site	Ahmedabad	Gujarat
India	Research Site	Bangalore	Karnataka
India	Research Site	Bengaluru	Karnataka
India	Research Site	Chennai	Tamil Nadu
India	Research Site	Coimbatore	Tamil Nadu
India	Research Site	Hyderabad	Andhra Pradesh
India	Research Site	Indore	Madhya Pradesh
India	Research Site	Lucknow	Uttar Pradesh
India	Research Site	Mumbai	Maharashtra
India	Research Site	Noida	Uttar Pradesh
Indonesia	Research Site	Jakarta	DKI Jakarta
Indonesia	Research Site	Surabaya	East Java
Taiwan	Research Site	Chia-Yi
Taiwan	Research Site	Hsin Chu
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taoyuan City
Thailand	Research Site	Bangkok
Thailand	Research Site	Nakhonratchasima	Naimuang
Thailand	Research Site	Pathumthani
Thailand	Research Site	Pathumwan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

China,  India,  Indonesia,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level	Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).	Baseline and 12 weeks	No
Secondary	Change in ACQ(5) Score From Baseline at Country Level (China)	Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).	Baseline and 12 weeks	No
Secondary	Change in Overall ACQ(5) Score From Baseline at Country Level (India)	Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).	Baseline and 12 weeks	No
Secondary	Change in Overall ACQ(5) Score From Baseline at Country Level (Indonesia)	Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).	Baseline and 12 weeks	No
Secondary	Change in Overall ACQ(5) Score From Baseline at Country Level (Taiwan)	Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).	Baseline and 12 weeks	No
Secondary	Change in Overall ACQ(5) Score From Baseline at Country Level (Thailand)	Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).	Baseline and 12 weeks	No
Secondary	Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ (S)) Overall Scores From Baseline	Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) score from baseline were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)	Baseline and 12 weeks	No
Secondary	Change in AQLQ (S) Domain (Symptom) Scores From Baseline	Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) symptom score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).	Baseline and 12 weeks	No
Secondary	Change in AQLQ (S) Domain (Activity Limitation) Scores From Baseline	Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) symptom score from baseline were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)	Baseline and 12 weeks	No
Secondary	Change in AQLQ (S) Domain (Emotion Function) Scores From Baseline	Participants' emotional functions were scored on a scale of decreasing impairment to emotional function from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) emotion function score were calculated as change from baseline (Week 0) to the treatment period (mean of the scores at Week 4, Week 8, Week 12)	Baseline and 12 weeks	No
Secondary	Change in AQLQ (S) Domain (Environmental Stimuli) Scores From Baseline	Participants ' responses to environmental stimuli were scored on a scale of decreasing response to environmental stimuli from 1 to 7, in which 1 = maximum response. The change in overall mean AQLQ(S) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)	Baseline and 12 weeks	No
Secondary	Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Day-time Reliever Medication From run-in Period	Change in the number of as-needed day-time inhalations of medication, defined as the difference in mean value of all available data obtained during treatment period and mean value in run-in period.	Baseline and 12 weeks	No
Secondary	Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Night-time Reliever Medication From run-in Period	Change in the number of as-needed night-time inhalations of medication, calculated as difference in mean value of all available data obtained during treatment period and mean value in run-in period.	Baseline and 12 weeks	No
Secondary	Study Medication Use (Maintenance and Reliever) in Diary Cards - Total Number of Inhalations of Symbicort® 160µg/4.5µg Per Day During Treatment Period	Total number of inhalations of Symbicort® 160µg/4.5µg per day during treatment period, defined as the sum of maintenance medication and as-needed medication during night and day time	Baseline and 12 weeks	No
Secondary	Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used = 3 Inhalations of Symbicort® 160µg/4.5µg in a Day	The mean percentage of days during treatment period participants used = 3 inhalations of Symbicort® 160µg/4.5µg in a day	Baseline and 12 weeks	No
Secondary	Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used = 5 Inhalations of of Symbicort® 160µg/4.5µg in a Day	The mean percentage of days during treatment period participants used = 5 inhalations of Symbicort® 160µg/4.5µg in a day	Baseline and 12 weeks	No
Secondary	Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used = 9 Inhalations of Symbicort® 160µg/4.5µg in a Day	The mean percentage of days during treatment period participants used = 9 inhalations of Symbicort® 160µg/4.5µg in a day	Baseline and 12 weeks	No