NCT00939341

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
862

participants targeted

Target at P75+ for phase_4 asthma

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_4 asthma

Geographic Reach
5 countries

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 28, 2011

Completed
Last Updated

January 16, 2012

Status Verified

January 1, 2012

Enrollment Period

1.1 years

First QC Date

July 13, 2009

Results QC Date

August 11, 2011

Last Update Submit

January 12, 2012

Conditions

Asthma

Keywords

Symbicort SMART

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (16)

  • Change in ACQ(5) Score From Baseline at Country Level (China)

    Baseline and 12 weeks

  • Change in Overall ACQ(5) Score From Baseline at Country Level (India)

    Baseline and 12 weeks

  • Change in Overall ACQ(5) Score From Baseline at Country Level (Indonesia)

    Baseline and 12 weeks

  • Change in Overall ACQ(5) Score From Baseline at Country Level (Taiwan)

    Baseline and 12 weeks

  • Change in Overall ACQ(5) Score From Baseline at Country Level (Thailand)

    Baseline and 12 weeks

  • +11 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL

Symbicort Turbuhaler 160/4.5 µg delivered dose

Drug: Symbicort (Budesonide/Formoterol)

Interventions

Symbicort (Budesonide/Formoterol)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

Also known as: Symbicort
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Research Site

Guangzhou, Guangdong, China

Location

Research Site

Zheng Ahou, Henan, China

Location

Research Site

Wuhan, Hubei, China

Location

Research Site

Changsha, Hunan, China

Location

Research Site

Qingdao, Shandong, China

Location

Research Site

Shanghai, Shanghai Municipality, China

Location

Research Site

Beijing, China

Location

Research Site

Chengdu, China

Location

Research Site

Fuzhou, China

Location

Research Site

Hangzhou, China

Location

Research Site

Nanjing, China

Location

Research Site

Shenyang, China

Location

Research Site

Zhengzhou, China

Location

Research Site

Hyderabad, Andhra Pradesh, India

Location

Research Site

Ahmedabad, Gujarat, India

Location

Research Site

Bangalore, Karnataka, India

Location

Research Site

Bengaluru, Karnataka, India

Location

Research Site

Indore, Madhya Pradesh, India

Location

Research Site

Mumbai, Maharashtra, India

Location

Research Site

Chennai, Tamil Nadu, India

Location

Research Site

Coimbatore, Tamil Nadu, India

Location

Research Site

Lucknow, Uttar Pradesh, India

Location

Research Site

Noida, Uttar Pradesh, India

Location

Research Site

Jakarta, DKI Jakarta, Indonesia

Location

Research Site

Surabaya, East Java, Indonesia

Location

Research Site

Chiayi City, Taiwan

Location

Research Site

Kaohsiung City, Taiwan

Location

Research Site

Taichung, Taiwan

Location

Research Site

Taipei, Taiwan

Location

Research Site

Taoyuan, Taiwan

Location

Research Site

Taoyuan District, Taiwan

Location

Research Site

Bangkok, Bangkok, Thailand

Location

Research Site

Pathumwan, Bangkok, Thailand

Location

Research Site

Pathum Thani, Changwat Pathum Thani, Thailand

Location

Research Site

Nakhonratchasima, Naimuang, Thailand

Location

Related Publications (2)

  • 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.

    PMID: 26831844DERIVED

  • 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.

    PMID: 23557023DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Budesonide, Formoterol Fumarate Drug CombinationBudesonideFormoterol Fumarate

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Limitations and Caveats

The design of the study does not allow for any conclusion regarding the effect of Symbicort SMART, it being a within-group comparison

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com
+44 1625 518062

Study Officials

  • Guy Yeoman, MD

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2009

First Posted

July 15, 2009

Study Start

July 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

January 16, 2012

Results First Posted

November 28, 2011

Record last verified: 2012-01

Locations

IN(10)TW(6)ID(2)TH(4)CN(13)