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

July 13, 2009
January 12, 2012
July 2009
August 2010   (final data collection date for primary outcome measure)
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).
Change in Asthma Control Questionnaire (ACQ(5)) score from baseline at a regional level [ Time Frame: At initiate study treatment visit with 3 further visits at 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00939341 on ClinicalTrials.gov Archive Site
  • 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
  • Change in ACQ (5) score from baseline at country level [ Time Frame: At initiate study treatment visit with 3 further visits at 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Change in Asthma Quality of Life Questionnaire, standardized version (AQLQ (S)) domain and overall scores from baseline [ Time Frame: At initiate study treatment visit with 3 further visits at 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Study medication use (maintenance and reliever) in Diary Cards [ Time Frame: At initiate study treatment visit with 2 further visits at 4 and 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study to Investigate Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma Patients Across Asia
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.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
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
Experimental: 1
Symbicort Turbuhaler 160/4.5 µg delivered dose
Intervention: Drug: Symbicort (Budesonide/Formoterol)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
862
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   India,   Indonesia,   Taiwan,   Thailand
 
NCT00939341
D5890L00035
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Guy Yeoman, MD AstraZeneca
AstraZeneca
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP