Clinical trial NCT00837967: Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients
Official title: A Comparison of Tolerability of 10 Inhalations of Symbicort® Turbuhaler® 160/4.5 μg and 10 Inhalations of Terbutaline Turbuhaler® 0.4 mg on Top of Symbicort® Turbuhaler® 160/4.5 μg 1 Inhalation Bid, Randomized, Double-blind, Cross Over, Phase III Study in Japanese Adults Asthma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Symbicort Turbuhaler
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-02-06
Enrollment: 25
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Adverse Events
timeFrame: 3 days
measure: Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC)
timeFrame: up to 740 min after start dosing for each treatment day
measure: Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC)
timeFrame: up to 140 min after start dosing for each treatment day
measure: Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC)
timeFrame: up to 740 min after start dosing for each treatment day
measure: Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC)
timeFrame: up to 740 min after start dosing for each treatment day
measure: Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC)
timeFrame: up to 740 min after start dosing for each treatment day
Secondary outcomes:
Other outcomes:
Locations:
city: Ibaragi
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Lund
name: Tomas Andersson, MD
role: STUDY_DIRECTOR
References:
citation: Saito T, Hasunuma T. Safety and tolerability of high-dose budesonide/formoterol via Turbuhaler(R) in Japanese patients with asthma: a randomized, double-blind, crossover, active comparator-controlled, phase III study. Clin Drug Investig. 2012 Jan 1;32(1):51-61. doi: 10.2165/11595440-000000000-00000.