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

NCT ID: NCT00939341

Last Updated: 2012-01-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

862 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Symbicort Turbuhaler 160/4.5 µg delivered dose

Group Type EXPERIMENTAL

Symbicort (Budesonide/Formoterol)

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Symbicort

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guy Yeoman, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Guangzhou, Guangdong, China

Site Status

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Zheng Ahou, Henan, China

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Wuhan, Hubei, China

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Changsha, Hunan, China

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Qingdao, Shandong, China

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Shanghai, Shanghai Municipality, China

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Beijing, , China

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Chengdu, , China

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Fuzhou, , China

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Hangzhou, , China

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Nanjing, , China

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Shenyang, , China

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Zhengzhou, , China

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Hyderabad, Andhra Pradesh, India

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Ahmedabad, Gujarat, India

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Bangalore, Karnataka, India

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Bengaluru, Karnataka, India

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Indore, Madhya Pradesh, India

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Mumbai, Maharashtra, India

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Chennai, Tamil Nadu, India

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Coimbatore, Tamil Nadu, India

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Lucknow, Uttar Pradesh, India

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Noida, Uttar Pradesh, India

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Jakarta, DKI Jakarta, Indonesia

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Surabaya, East Java, Indonesia

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Chiayi City, , Taiwan

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Kaohsiung City, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Taoyuan, , Taiwan

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Taoyuan District, , Taiwan

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Bangkok, Bangkok, Thailand

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Pathumwan, Bangkok, Thailand

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Pathum Thani, Changwat Pathum Thani, Thailand

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Nakhonratchasima, Naimuang, Thailand

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Countries

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China India Indonesia Taiwan Thailand

References

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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.

Reference Type DERIVED
PMID: 26831844 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23557023 (View on PubMed)

Other Identifiers

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D5890L00035

Identifier Type: -

Identifier Source: org_study_id

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