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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00837967
First Posted: February 6, 2009
Last Update Posted: August 29, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
February 5, 2009
February 6, 2009
July 5, 2010
August 29, 2012
August 29, 2012
January 2009
July 2009   (Final data collection date for primary outcome measure)
  • Adverse Events [ Time Frame: 3 days ]
    Total number of adverse events
  • Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC) [ Time Frame: up to 740 min after start dosing for each treatment day ]
    The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
  • Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC) [ Time Frame: up to 140 min after start dosing for each treatment day ]
    The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
  • Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC) [ Time Frame: up to 740 min after start dosing for each treatment day ]
    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.
  • Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC) [ Time Frame: up to 740 min after start dosing for each treatment day ]
    The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
  • Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC) [ Time Frame: up to 740 min after start dosing for each treatment day ]
    The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Adverse events, Clinical laboratory tests, ECG, Vital signs (blood pressure, pulse rate, body temperature) [ Time Frame: daily ]
Complete list of historical versions of study NCT00837967 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: Symbicort Turbuhaler
    160/4.5μg for 3 days
  • Drug: Terbutaline Turbuhaler
    0.4 mg for 3 days
  • Experimental: First Symbicort, then Terbutaline
    Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days
    Interventions:
    • Drug: Symbicort Turbuhaler
    • Drug: Terbutaline Turbuhaler
  • Experimental: First Turbuhaler, then Symbicort
    Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,
    Interventions:
    • Drug: Symbicort Turbuhaler
    • Drug: Terbutaline Turbuhaler
Saito T, Hasunuma T. Safety and tolerability of high-dose budesonide/formoterol via Turbuhaler® 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
July 2009
July 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years to 65 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00837967
D589LC00003
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Tomas Andersson, MD AstraZeneca R&D Lund
AstraZeneca
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP