Phase 3
Completed N=25
Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients
Source: ClinicalTrials.gov NCT00837967 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcomePrimary: Adverse Events — 14; 24 adverse events
Summary
The primary objective of the study is to compare the tolerability of Symbicort® Turbuhaler® 160/4.5 μg 10 inhalations with terbutaline Turbuhaler® 0.4 mg 10 inhalations for 3 days on top of Symbicort® Turbuhaler® 160/4.5 μg 1 inhalation twice a day (bid) in adult asthma patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
14; 24 | — |
| PRIMARY Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC) |
4.01; 3.88 | — |
| PRIMARY Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC) |
121.1; 129.5 | — |
| PRIMARY Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC) |
411.71; 414.33 | — |
| PRIMARY Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC) |
115.3; 114.9 | — |
| PRIMARY Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC) |
70.0; 74.1 | — |
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent prior to any study specific procedures
- A minimum of 6 months documented history of asthma according to the JGL2006/GINA2006 definition
- FEV1> 70% of predicted normal value pre-bronchodilator
Exclusion Criteria
- Having a known or suspected allergy to study therapy (active drugs or additive)
- Having a known clinical history of hypertension, relevant arrhythmias or other heart disease, eg, ischemic heart disease, cardiomyopathy, valvular heart disease, or heart failure
- Having been treated with oral, parenteral or rectal glucocorticoids within 4 weeks, or with depot parenteral glucocorticoids within 3 months
- Respiratory infection significantly affecting the asthma, as judged by the investigator within 4 weeks
Data sourced from ClinicalTrials.gov (NCT00837967). 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.