Clinical trial NCT00939341: Study to Investigate Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma Patients Across Asia
Official title: Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy (SMART) in Asthma Patients Across Asia: SMARTASIA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Symbicort SMART
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-07-15
Enrollment: 862
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in ACQ(5) Score From Baseline at Country Level (China)
timeFrame: Baseline and 12 weeks
measure: Change in Overall ACQ(5) Score From Baseline at Country Level (India)
timeFrame: Baseline and 12 weeks
measure: Change in Overall ACQ(5) Score From Baseline at Country Level (Indonesia)
timeFrame: Baseline and 12 weeks
measure: Change in Overall ACQ(5) Score From Baseline at Country Level (Taiwan)
timeFrame: Baseline and 12 weeks
measure: Change in Overall ACQ(5) Score From Baseline at Country Level (Thailand)
timeFrame: Baseline and 12 weeks
measure: Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ (S)) Overall Scores From Baseline
timeFrame: Baseline and 12 weeks
measure: Change in AQLQ (S) Domain (Symptom) Scores From Baseline
timeFrame: Baseline and 12 weeks
measure: Change in AQLQ (S) Domain (Activity Limitation) Scores From Baseline
timeFrame: Baseline and 12 weeks
measure: Change in AQLQ (S) Domain (Emotion Function) Scores From Baseline
timeFrame: Baseline and 12 weeks
measure: Change in AQLQ (S) Domain (Environmental Stimuli) Scores From Baseline
timeFrame: Baseline and 12 weeks
measure: Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Day-time Reliever Medication From run-in Period
timeFrame: Baseline and 12 weeks
measure: Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Night-time Reliever Medication From run-in Period
timeFrame: Baseline and 12 weeks
measure: Study Medication Use (Maintenance and Reliever) in Diary Cards - Total Number of Inhalations of Symbicort® 160µg/4.5µg Per Day During Treatment Period
timeFrame: Baseline and 12 weeks
measure: 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
timeFrame: Baseline and 12 weeks
measure: 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
timeFrame: Baseline and 12 weeks
measure: 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
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Zheng Ahou
country: China
facility: Research Site
state: He Nan
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Qingdao
country: China
facility: Research Site
state: Shandong
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Beijing
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Fuzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Research Site
state: Gujarat
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Bengaluru
country: India
facility: Research Site
state: Karnataka
city: Indore
country: India
facility: Research Site
state: Madhya Pradesh
city: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Chennai
country: India
facility: Research Site
state: Tamil Nadu
city: Coimbatore
country: India
facility: Research Site
state: Tamil Nadu
city: Lucknow
country: India
facility: Research Site
state: Uttar Pradesh
city: Noida
country: India
facility: Research Site
state: Uttar Pradesh
city: Jakarta
country: Indonesia
facility: Research Site
state: DKI Jakarta
city: Surabaya
country: Indonesia
facility: Research Site
state: East Java
city: Chia-Yi
country: Taiwan
facility: Research Site
city: Hsin Chu
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoyuan City
country: Taiwan
facility: Research Site
city: Pathumwan
country: Thailand
facility: Research Site
state: Bangkok
city: Nakhonratchasima
country: Thailand
facility: Research Site
state: Naimuang
city: Bangkok
country: Thailand
facility: Research Site
city: Pathumthani
country: Thailand
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Guy Yeoman, MD
role: STUDY_DIRECTOR
References:
citation: Lin J, Tang Y, Xiu Q, Kang J, Cai S, Huang K, Itoh Y, Ling X, Zhong N. Real-life effectiveness of budesonide/formoterol therapy in asthma: A subanalysis of the SMARTASIA study. Allergy Asthma Proc. 2016 Jan-Feb;37(1):27-34. doi: 10.2500/aap.2016.37.3910.
citation: Zhong N, Lin J, Mehta P, Ngamjanyaporn P, Wu TC, Yunus F. Real-life effectiveness of budesonide/formoterol maintenance and reliever therapy in asthma patients across Asia: SMARTASIA study. BMC Pulm Med. 2013 Apr 4;13:22. doi: 10.1186/1471-2466-13-22.