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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00939341
First received: July 13, 2009
Last updated: January 12, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Symbicort (Budesonide/Formoterol)
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy (SMART) in Asthma Patients Across Asia: SMARTASIA

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Change in ACQ(5) Score From Baseline at Country Level (China) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Change in Overall ACQ(5) Score From Baseline at Country Level (India) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Change in Overall ACQ(5) Score From Baseline at Country Level (Indonesia) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Change in Overall ACQ(5) Score From Baseline at Country Level (Taiwan) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Change in Overall ACQ(5) Score From Baseline at Country Level (Thailand) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ (S)) Overall Scores From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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)

  • Change in AQLQ (S) Domain (Symptom) Scores From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Change in AQLQ (S) Domain (Activity Limitation) Scores From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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)

  • Change in AQLQ (S) Domain (Emotion Function) Scores From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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)

  • Change in AQLQ (S) Domain (Environmental Stimuli) Scores From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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)

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    The mean percentage of days during treatment period participants used ≥ 3 inhalations of Symbicort® 160µg/4.5µg in a day

  • 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 ] [ Designated as safety issue: No ]
    The mean percentage of days during treatment period participants used ≥ 5 inhalations of Symbicort® 160µg/4.5µg in a day

  • 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 ] [ Designated as safety issue: No ]
    The mean percentage of days during treatment period participants used ≥ 9 inhalations of Symbicort® 160µg/4.5µg in a day


Enrollment: 862
Study Start Date: July 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Symbicort

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939341

  Show 35 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Guy Yeoman, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00939341     History of Changes
Other Study ID Numbers: D5890L00035
Study First Received: July 13, 2009
Results First Received: August 11, 2011
Last Updated: January 12, 2012
Health Authority: China: Ethics Committee
India: Ministry of Health
Indonesia: Departement Kesehatan (Department of Health)
Taiwan: Institutional Review Board
Thailand: Ethical Committee

Keywords provided by AstraZeneca:
Symbicort SMART

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Symbicort
Anti-Asthmatic Agents
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014