Phase 3
Completed N=2,091
Study to Investigate the Efficacy of Symbicort® SMART.
Source: ClinicalTrials.gov NCT00839800 ↗Enrolled (actual)
2,091
Serious AEs
5.5%
Results posted
Nov 2012
Primary outcomePrimary: The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study — 16; 22 percentage of participants
Summary
The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus as needed) with Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg as needed, as asthma therapy
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study |
16; 22 | — |
| SECONDARY Number of Asthma Exacerbations |
259; 363 | — |
| SECONDARY Morning Peak Expiratory Flow (PEF) |
331.8; 324.7 | — |
| SECONDARY Evening PEF |
334.2; 327.8 | — |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) |
2.258; 2.222 | — |
| SECONDARY Use of As-needed Medication |
1.21; 1.46 | — |
| SECONDARY Asthma Symptom Score |
1.12; 1.22 | — |
| SECONDARY Nights With Awakening(s) Due to Asthma Symptoms |
15.7; 17.5 | — |
| SECONDARY The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations |
71; 80 | — |
| SECONDARY Symptom-free Days (no Symptoms and no Awakenings) |
45.5; 41.6 | — |
| SECONDARY Percentage of As-needed-free Days |
51.4; 47.2 | — |
| SECONDARY Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use) |
41.7; 37.9 | — |
| SECONDARY Asthma Control Questionnaire (ACQ) |
1.162; 1.289 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of asthma according to the Global Initiative for Asthma guidelines (GINA) 2007 with a documented history of at least 6 months duration.
- Reversible airway obstruction, defined as an increase in FEV1 ≥12% relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline Turbuhaler
- Prescribed use of inhaled glucocorticoid steroid (GCS) (any brand) for at least 12 weeks.
Exclusion Criteria
- Respiratory infection affecting the asthma, as judged by the investigator, within 4 weeks.
- Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 weeks.
Data sourced from ClinicalTrials.gov (NCT00839800). 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.