Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00837967
• Other study ID #: D589LC00003
• Status: Completed
• Phase: Phase 3
• First received: February 5, 2009
• Last updated: August 27, 2012
• Start date: January 2009
• Est. completion date: July 2009

Study information

• Verified date: August 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Symbicort Turbuhaler
160/4.5µg for 3 days
• Terbutaline Turbuhaler
0.4 mg for 3 days

Locations

Country	Name	City	State
Japan	Research Site	Ibaragi
Japan	Research Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Total number of adverse events	3 days	No
Primary	Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC)	The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.	up to 740 min after start dosing for each treatment day	No
Primary	Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC)	The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.	up to 140 min after start dosing for each treatment day	No
Primary	Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC)	The mean AUC of QTcF (ECG interval measured from the beginning of the Q wave to the end of the T wave, corrected for heart rate using Fridericia's formula)was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.	up to 740 min after start dosing for each treatment day	No
Primary	Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC)	The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.	up to 740 min after start dosing for each treatment day	No
Primary	Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC)	The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.	up to 740 min after start dosing for each treatment day	No