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OpenTrials
Completed

NCT Number: NCT00837967

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Ibaraki, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Symbicort Turbuhaler

Drug

160/4.5μg for 3 days

Terbutaline Turbuhaler

Drug

0.4 mg for 3 days

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 6, 2009
Registry last updated
Aug 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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