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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:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00837967
First received: February 5, 2009
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Asthma
Drug: Symbicort Turbuhaler
Drug: Terbutaline Turbuhaler
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.


Enrollment: 25
Study Start Date: January 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by AstraZeneca

Additional 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
Study First Received: February 5, 2009
Results First Received: July 5, 2010
Last Updated: August 27, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:
Asthma
Symbicort Turbuhaler

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Budesonide
Symbicort
Terbutaline
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on November 23, 2014