Phase 3
Completed N=742
Symbicort Rapihaler Therapeutic Equivalence Study
Source: ClinicalTrials.gov NCT00536731 ↗Enrolled (actual)
742
Serious AEs
0.3%
Results posted
Aug 2012
Primary outcomePrimary: Morning Peak Expiratory Flow (PEF) — 12.88; 13.78; 4.59 Liters/min
Summary
The purpose of the this study is to evaluate the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Morning Peak Expiratory Flow (PEF) |
12.88; 13.78; 4.59 | — |
| SECONDARY Evening Peak Expiratory Flow (PEF) |
12.34; 10.80; 1.43 | — |
| SECONDARY Asthma Symptom Score, Night |
-0.24; -0.27; -0.15 | — |
| SECONDARY Asthma Symptom Score, Day |
-0.21; -0.24; -0.15 | — |
| SECONDARY Asthma Symptom Score, Total |
-0.45; -0.51; -0.30 | — |
| SECONDARY Percentage of Nights With Awakenings Due to Asthma |
-14.0; -14.0; -8.3 | — |
| SECONDARY Use of Rescue Medication, Night |
-0.41; -0.39; -0.19 | — |
| SECONDARY Use of Rescue Medication, Day |
-0.21; -0.20; -0.13 | — |
| SECONDARY Use of Rescue Medication, Total |
-0.62; -0.58; -0.32 | — |
| SECONDARY Percentage of Symptom-free Days |
12.5; 15.3; 9.1 | — |
| SECONDARY Percentage of Asthma Control Days |
12.7; 15.1; 9.1 | — |
| SECONDARY Percentage of Rescue Free Days |
24.0; 26.2; 17.2 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) |
0.095; 0.147; 0.112 | — |
Eligibility Criteria
Inclusion Criteria
- Asthma clinically diagnosed since at least 6 months.
- Lung function values measured ≥ 50% and ≤ 90% of predicted normal.
- Patients with reversible airway obstruction Daily use of inhaled steroids (any brand) for >3 months.
Exclusion Criteria
- Use of oral, rectal or parenteral steroids within 30 days prior to start of study.
- Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to start of randomised treatment.
- Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study or the patient's ability to participate in the study.
Data sourced from ClinicalTrials.gov (NCT00536731). 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.