Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00837967
First received: February 5, 2009
Last updated: August 27, 2012
Last verified: August 2012
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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 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 Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Terbutaline Budesonide Symbicort Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses 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 Glucocorticoids |
ClinicalTrials.gov processed this record on May 23, 2013