Phase 4
Completed N=862
Study to Investigate Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma Patients Across Asia
Source: ClinicalTrials.gov NCT00939341 ↗Enrolled (actual)
862
Serious AEs
1.4%
Results posted
Nov 2011
Primary outcomePrimary: Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level — -0.58 Units on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level |
-0.58 | — |
| SECONDARY Change in ACQ(5) Score From Baseline at Country Level (China) |
-0.58 | — |
| SECONDARY Change in Overall ACQ(5) Score From Baseline at Country Level (India) |
-0.74 | — |
| SECONDARY Change in Overall ACQ(5) Score From Baseline at Country Level (Indonesia) |
-1.18 | — |
| SECONDARY Change in Overall ACQ(5) Score From Baseline at Country Level (Taiwan) |
-0.22 | — |
| SECONDARY Change in Overall ACQ(5) Score From Baseline at Country Level (Thailand) |
-0.36 | — |
| SECONDARY Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ (S)) Overall Scores From Baseline |
0.70 | — |
| SECONDARY Change in AQLQ (S) Domain (Symptom) Scores From Baseline |
0.77 | — |
| SECONDARY Change in AQLQ (S) Domain (Activity Limitation) Scores From Baseline |
0.59 | — |
| SECONDARY Change in AQLQ (S) Domain (Emotion Function) Scores From Baseline |
0.77 | — |
| SECONDARY Change in AQLQ (S) Domain (Environmental Stimuli) Scores From Baseline |
0.67 | — |
| SECONDARY Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Day-time Reliever Medication From run-in Period |
-0.30 | — |
| SECONDARY Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Night-time Reliever Medication From run-in Period |
-0.30 | — |
| SECONDARY Study Medication Use (Maintenance and Reliever) in Diary Cards - Total Number of Inhalations of Symbicort® 160µg/4.5µg Per Day During Treatment Period |
2.51 | — |
| SECONDARY 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 |
28.25 | — |
| SECONDARY 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 |
6.21 | — |
| SECONDARY 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 |
0.19 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00939341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.