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

Condition(s) targeted: Asthma

Intervention: Symbicort (Budesonide/Formoterol) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Joher Raniwalla, MD, Study Director, Affiliation: AstraZeneca

Overall contact:
AstraZeneca Thailand Clinical Study Information, Phone: +66 2 739 7400, Email: nongluk.yimsuan@astrazeneca.com

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.

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

Study design: Treatment, Open Label, Single Group Assignment

Primary outcome: Change in Asthma Control Questionnaire (ACQ(5)) score from baseline at a regional level

Secondary outcome:

Change in ACQ (5) score from baseline at country level

Change in Asthma Quality of Life Questionnaire, standardized version (AQLQ (S)) domain and overall scores from baseline

Study medication use (maintenance and reliever) in Diary Cards

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

AstraZeneca Thailand Clinical Study Information, Phone: +66 2 739 7400, Email: nongluk.yimsuan@astrazeneca.com

Research Site, BEIJING, China; Recruiting

Research Site, CHENGDU, China; Not yet recruiting

Research Site, FUZHOU, China; Not yet recruiting

Research Site, HANGZHOU, China; Not yet recruiting

Research Site, NANJING, China; Not yet recruiting

Research Site, SHENYANG, China; Not yet recruiting

Research Site, SHANGHAI, China; Not yet recruiting

Research Site, Ahmedabad, India; Not yet recruiting

Research Site, Bengaluru, India; Not yet recruiting

Research Site, Chennai, India; Not yet recruiting

Research Site, Delhi, India; Not yet recruiting

Research Site, Hyderabad, India; Not yet recruiting

Research Site, Lucknow, India; Not yet recruiting

Research Site, Mumbai, India; Not yet recruiting

Research Site, Auckland, New Zealand; Not yet recruiting

Research Site, Christchurch, New Zealand; Not yet recruiting

Research Site, Wellington, New Zealand; Not yet recruiting

Research Site, Chiayi, Taiwan; Not yet recruiting

Research Site, Kaohsiung, Taiwan; Not yet recruiting

Research Site, Taichung, Taiwan; Not yet recruiting

Research Site, Taipei, Taiwan; Not yet recruiting

Research Site, BANGKOK, Thailand; Not yet recruiting

Research Site, PATHUMWAN, BANGKOK, Thailand; Not yet recruiting

Research Site, Rotorua, Bay of Plenty, New Zealand; Not yet recruiting

Research Site, Surakarta, Central Java, Indonesia; Not yet recruiting

Research Site, Jakarta, DKI Jakarta, Indonesia; Not yet recruiting

Research Site, Surabaya, East Java, Indonesia; Not yet recruiting

Research Site, GUANGZHOU, GUANGDONG, China; Not yet recruiting

Research Site, ZHENGZHOU, HENAN, China; Not yet recruiting

Research Site, WUHAN, HUBEI, China; Not yet recruiting

Research Site, CHANGSHA, HUNAN, China; Not yet recruiting

Research Site, Medan, North Sumatra, Indonesia; Not yet recruiting

Research Site, PATHUMTHANI, Pathumathani, Thailand; Not yet recruiting

Starting date: July 2009
Ending date: April 2010
Last updated: July 23, 2009