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Trial record 2 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

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

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ClinicalTrials.gov Identifier: NCT00939341
Recruitment Status : Completed
First Posted : July 15, 2009
Results First Posted : November 28, 2011
Last Update Posted : January 16, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Asthma
Intervention Drug: Symbicort (Budesonide/Formoterol)
Enrollment 862
Recruitment Details A total of 1022 asthma patients were enrolled at 51 sites in 5 Asian countries: China (21 sites), India (12 sites), Indonesia (3 sites), Thailand (6 sites) and Taiwan (9 sites) during the period July 2009 to August 2010. Of the 1022 enrolled, 862 participants entered into a 12-week treatment with the investigational drug.
Pre-assignment Details The study consisted of an initial screening visit followed by a 2-week run-in period before a 12-week treatment with investigational drug.
Arm/Group Title Symbicort Turbuhaler
Hide Arm/Group Description 160/4.5 µg delivered dose
Period Title: Overall Study
Started 862 [1]
Completed 796 [2]
Not Completed 66
Reason Not Completed
Adverse Event             15
Pregnancy             1
Lost to Follow-up             23
Withdrawal by Subject             13
Protocol Violation             6
Incorrect enrolment             8
[1]
1022 participants were enrolled. There were 160 screen failures, 862 proceeded to treatment period.
[2]
862 participants entered into the 12-week treatment,66 discontinued, 796 completed the treatment.
Arm/Group Title Symbicort Turbuhaler
Hide Arm/Group Description 160/4.5 µg delivered dose
Overall Number of Baseline Participants 862
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
All Participants Number Analyzed 862 participants
13.7  (44.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 862 participants
Female
455
  52.8%
Male
407
  47.2%
1.Primary Outcome
Title Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level
Hide Description 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).
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Turbuhaler
Hide Arm/Group Description:
160/4.5 µg delivered dose
Overall Number of Participants Analyzed 841
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-0.58
(-0.64 to -0.51)
2.Secondary Outcome
Title Change in ACQ(5) Score From Baseline at Country Level (China)
Hide Description 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).
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.
Arm/Group Title Symbicort Turbuhaler
Hide Arm/Group Description:
160/4.5 µg delivered dose
Overall Number of Participants Analyzed 386
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-0.58
(-0.67 to -0.49)
3.Secondary Outcome
Title Change in Overall ACQ(5) Score From Baseline at Country Level (India)
Hide Description 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).
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.
Arm/Group Title Symbicort Turbuhaler
Hide Arm/Group Description:
160/4.5 µg delivered dose
Overall Number of Participants Analyzed 159
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-0.74
(-0.92 to -0.57)
4.Secondary Outcome
Title Change in Overall ACQ(5) Score From Baseline at Country Level (Indonesia)
Hide Description 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).
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.
Arm/Group Title Symbicort Turbuhaler
Hide Arm/Group Description:
160/4.5 µg delivered dose
Overall Number of Participants Analyzed 61
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-1.18
(-1.40 to -0.95)
5.Secondary Outcome
Title Change in Overall ACQ(5) Score From Baseline at Country Level (Taiwan)
Hide Description 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).
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.
Arm/Group Title Symbicort Turbuhaler
Hide Arm/Group Description:
160/4.5 µg delivered dose
Overall Number of Participants Analyzed 100
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-0.22
(-0.38 to -0.06)
6.Secondary Outcome
Title Change in Overall ACQ(5) Score From Baseline at Country Level (Thailand)
Hide Description 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).
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.
Arm/Group Title Symbicort Turbuhaler
Hide Arm/Group Description:
160/4.5 µg delivered dose
Overall Number of Participants Analyzed 128
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-0.36
(-0.48 to -0.23)
7.Secondary Outcome
Title Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ (S)) Overall Scores From Baseline
Hide Description 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)
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Turbuhaler
Hide Arm/Group Description:
160/4.5 µg delivered dose
Overall Number of Participants Analyzed 842
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
0.70
(0.64 to 0.76)
8.Secondary Outcome
Title Change in AQLQ (S) Domain (Symptom) Scores From Baseline
Hide Description 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).
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Turbuhaler
Hide Arm/Group Description:
160/4.5 µg delivered dose
Overall Number of Participants Analyzed 842
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
0.77
(0.70 to 0.84)
9.Secondary Outcome
Title Change in AQLQ (S) Domain (Activity Limitation) Scores From Baseline
Hide Description 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)
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Turbuhaler
Hide Arm/Group Description:
160/4.5 µg delivered dose
Overall Number of Participants Analyzed 842
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
0.59
(0.53 to 0.65)
10.Secondary Outcome
Title Change in AQLQ (S) Domain (Emotion Function) Scores From Baseline
Hide Description 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)
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Turbuhaler
Hide Arm/Group Description:
160/4.5 µg delivered dose
Overall Number of Participants Analyzed 842
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
0.77
(0.70 to 0.84)
11.Secondary Outcome
Title Change in AQLQ (S) Domain (Environmental Stimuli) Scores From Baseline
Hide Description 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)
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Turbuhaler
Hide Arm/Group Description:
160/4.5 µg delivered dose
Overall Number of Participants Analyzed 842
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
0.67
(0.60 to 0.74)
12.Secondary Outcome
Title Study Medication Use (Maintenance and Reliever) in Diary Cards – Change in As-needed Day-time Reliever Medication From run-in Period
Hide Description 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.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Turbuhaler
Hide Arm/Group Description:
160/4.5 µg delivered dose
Overall Number of Participants Analyzed 841
Mean (95% Confidence Interval)
Unit of Measure: Number of inhalations
-0.30
(-0.36 to -0.23)
13.Secondary Outcome
Title Study Medication Use (Maintenance and Reliever) in Diary Cards – Change in As-needed Night-time Reliever Medication From run-in Period
Hide Description 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.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Turbuhaler
Hide Arm/Group Description:
160/4.5 µg delivered dose
Overall Number of Participants Analyzed 852
Mean (95% Confidence Interval)
Unit of Measure: Number of inhalations
-0.30
(-0.35 to -0.24)
14.Secondary Outcome
Title Study Medication Use (Maintenance and Reliever) in Diary Cards – Total Number of Inhalations of Symbicort® 160µg/4.5µg Per Day During Treatment Period
Hide Description 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
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Turbuhaler
Hide Arm/Group Description:
160/4.5 µg delivered dose
Overall Number of Participants Analyzed 858
Mean (Standard Deviation)
Unit of Measure: Number of inhalations
2.51  (0.93)
15.Secondary Outcome
Title 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
Hide Description The mean percentage of days during treatment period participants used ≥ 3 inhalations of Symbicort® 160µg/4.5µg in a day
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Turbuhaler
Hide Arm/Group Description:
160/4.5 µg delivered dose
Overall Number of Participants Analyzed 858
Mean (Standard Deviation)
Unit of Measure: Percentage of days
28.25  (33.03)
16.Secondary Outcome
Title 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
Hide Description The mean percentage of days during treatment period participants used ≥ 5 inhalations of Symbicort® 160µg/4.5µg in a day
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Turbuhaler
Hide Arm/Group Description:
160/4.5 µg delivered dose
Overall Number of Participants Analyzed 858
Mean (Standard Deviation)
Unit of Measure: Percentage of days
6.21  (16.17)
17.Secondary Outcome
Title 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
Hide Description The mean percentage of days during treatment period participants used ≥ 9 inhalations of Symbicort® 160µg/4.5µg in a day
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Turbuhaler
Hide Arm/Group Description:
160/4.5 µg delivered dose
Overall Number of Participants Analyzed 858
Mean (Standard Deviation)
Unit of Measure: Percentage of days
0.19  (1.92)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Symbicort Turbuhaler
Hide Arm/Group Description 160/4.5 µg delivered dose
All-Cause Mortality
Symbicort Turbuhaler
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Symbicort Turbuhaler
Affected / at Risk (%)
Total   12/862 (1.39%) 
Cardiac disorders   
Myocardial Infarction  1  1/862 (0.12%) 
Gastrointestinal disorders   
Inguinal hernia  1  1/862 (0.12%) 
Ileus  1  1/862 (0.12%) 
Infections and infestations   
Pneumonia  1  1/862 (0.12%) 
Appendicitis  1  1/862 (0.12%) 
Musculoskeletal and connective tissue disorders   
Spinal Osteoarthritis  1  1/862 (0.12%) 
Nervous system disorders   
Headache  1  1/862 (0.12%) 
Cerebral Infarction  1  1/862 (0.12%) 
Renal and urinary disorders   
Renal Cysts  1  1/862 (0.12%) 
Reproductive system and breast disorders   
Breast Cancer  1  1/862 (0.12%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1  2/862 (0.23%) 
Nasal Polyps  1  1/862 (0.12%) 
Surgical and medical procedures   
Post procedural haemorrhage  1  1/862 (0.12%) 
Vascular disorders   
Atrioventricular block complete  1  1/862 (0.12%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Symbicort Turbuhaler
Affected / at Risk (%)
Total   0/862 (0.00%) 
The design of the study does not allow for any conclusion regarding the effect of Symbicort SMART, it being a within-group comparison
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
Phone: +44 1625 518062 ext 28062
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00939341     History of Changes
Other Study ID Numbers: D5890L00035
First Submitted: July 13, 2009
First Posted: July 15, 2009
Results First Submitted: August 11, 2011
Results First Posted: November 28, 2011
Last Update Posted: January 16, 2012