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

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.
ClinicalTrials.gov Identifier: NCT00837967
Recruitment Status : Completed
First Posted : February 6, 2009
Results First Posted : August 29, 2012
Last Update Posted : August 29, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Symbicort Turbuhaler Drug: Terbutaline Turbuhaler Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2009
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: First Symbicort, then Terbutaline
Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days
Drug: Symbicort Turbuhaler
160/4.5μg for 3 days
Drug: Terbutaline Turbuhaler
0.4 mg for 3 days
Experimental: First Turbuhaler, then Symbicort
Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,
Drug: Symbicort Turbuhaler
160/4.5μg for 3 days
Drug: Terbutaline Turbuhaler
0.4 mg for 3 days


Outcome Measures

Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 3 days ]
    Total number of adverse events

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837967


Locations
Japan
Research Site
Ibaragi, Japan
Research Site
Tokyo, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Tomas Andersson, MD AstraZeneca R&D Lund
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00837967     History of Changes
Other Study ID Numbers: D589LC00003
First Posted: February 6, 2009    Key Record Dates
Results First Posted: August 29, 2012
Last Update Posted: August 29, 2012
Last Verified: August 2012

Keywords provided by AstraZeneca:
Asthma
Symbicort Turbuhaler

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide, Formoterol Fumarate Drug Combination
Terbutaline
Anti-Asthmatic Agents
Respiratory System Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action