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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Symbicort Turbuhaler 160/4.5 µg delivered dose

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 to investigate real life effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma patients across Asia

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

Research Site

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

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).

Age Continuous

Gender, Male/Female

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

Change in Asthma Control Questionnaire (ACQ(5)) score from baseline at a regional level

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.

Change in ACQ(5) score from baseline at country level (China)

Change in overall ACQ(5) score from baseline at country level (India)

Change in overall ACQ(5) score from baseline at country level (Indonesia)

Change in overall ACQ(5) score from baseline at country level (Taiwan)

Change in overall ACQ(5) score from baseline at country level (Thailand)

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 Asthma Quality of Life Questionnaire, standardized version (AQLQ (S)) overall scores from baseline

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 (symptom) scores from baseline

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 (activity limitation) scores from baseline

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 (emotion function) scores from baseline

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)

Change in AQLQ (S) domain (environmental stimuli) scores from baseline

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 day-time reliever medication from run-in period

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 – change in as-needed night-time reliever medication from run-in period

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 – total number of inhalations of Symbicort® 160µg/4.5µg per day during treatment period

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 ≥ 3 inhalations of Symbicort® 160µg/4.5µg in a day

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 ≥ 5 inhalations of of Symbicort® 160µg/4.5µg in a day

The mean percentage of days during treatment period participants used ≥ 9 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

Overall Study

The study consisted of an initial screening visit followed by a 2-week run-in period before a 12-week treatment with investigational drug.

Study to investigate real life effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma patients across Asia - SMARTASIA

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=387&filename=CSR-D5890L00035.pdf

CSR-D5890L00035.pdf

CSR-D5890L00035.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator