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

January 12, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

862

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Symbicort Turbuhaler 160/4.5 µg delivered dose
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
Other Names:
  • Symbicort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level
Time Frame: Baseline and 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ACQ(5) Score From Baseline at Country Level (China)
Time Frame: Baseline and 12 weeks
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
Change in Overall ACQ(5) Score From Baseline at Country Level (India)
Time Frame: Baseline and 12 weeks
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
Change in Overall ACQ(5) Score From Baseline at Country Level (Indonesia)
Time Frame: Baseline and 12 weeks
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
Change in Overall ACQ(5) Score From Baseline at Country Level (Taiwan)
Time Frame: Baseline and 12 weeks
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
Change in Overall ACQ(5) Score From Baseline at Country Level (Thailand)
Time Frame: Baseline and 12 weeks
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
Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ (S)) Overall Scores From Baseline
Time Frame: Baseline and 12 weeks
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
Change in AQLQ (S) Domain (Symptom) Scores From Baseline
Time Frame: Baseline and 12 weeks
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
Change in AQLQ (S) Domain (Activity Limitation) Scores From Baseline
Time Frame: Baseline and 12 weeks
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
Change in AQLQ (S) Domain (Emotion Function) Scores From Baseline
Time Frame: Baseline and 12 weeks
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
Change in AQLQ (S) Domain (Environmental Stimuli) Scores From Baseline
Time Frame: Baseline and 12 weeks
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
Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Day-time Reliever Medication From run-in Period
Time Frame: Baseline and 12 weeks
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
Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Night-time Reliever Medication From run-in Period
Time Frame: Baseline and 12 weeks
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
Study Medication Use (Maintenance and Reliever) in Diary Cards - Total Number of Inhalations of Symbicort® 160µg/4.5µg Per Day During Treatment Period
Time Frame: Baseline and 12 weeks
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
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
Time Frame: Baseline and 12 weeks
The mean percentage of days during treatment period participants used ≥ 3 inhalations of Symbicort® 160µg/4.5µg in a day
Baseline and 12 weeks
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
Time Frame: Baseline and 12 weeks
The mean percentage of days during treatment period participants used ≥ 5 inhalations of Symbicort® 160µg/4.5µg in a day
Baseline and 12 weeks
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
Time Frame: Baseline and 12 weeks
The mean percentage of days during treatment period participants used ≥ 9 inhalations of Symbicort® 160µg/4.5µg in a day
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Guy Yeoman, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

July 13, 2009

First Submitted That Met QC Criteria

July 14, 2009

First Posted (ESTIMATE)

July 15, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 16, 2012

Last Update Submitted That Met QC Criteria

January 12, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5890L00035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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