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A Safety and Efficacy Study of Symbicort Turbuhaler Compared With Standard Chronic Obstructive Pulmonary Disease (COPD) Treatment in Japan

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Symbicort Turbuhaler (Budesonide/formoterol) (Drug); Drug: any available COPD treatment; investigator to decide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Tomas Andersson, MD, Study Chair, Affiliation: AstraZeneca, R&D, Lund, Sweden

Summary

The purpose of this study is to evaluate the safety and efficacy of Symbicort Turbuhaler compared to standard COPD treatment during one year in Japanese patients with COPD.

Clinical Details

Official title: An Open-label Phase III, Multi-centre 52-week , Parallel-group Study Evaluating the Safety and Efficacy of Symbicort Turbuhaler 320/9 Twice Daily Compared With Standard Treatment in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Clinical Laboratory Test: Haematology -Erythrocytes

Clinical Laboratory Test: Haematology -Haemoglobin

Clinical Laboratory Test: Haematology -Leucocytes

Clinical Laboratory Test: Haematology -Platelet Count

Clinical Laboratory Test: Haematology -Eosinophils

Clinical Laboratory Test: Haematology -Basophils

Clinical Laboratory Test: Haematology -Lymphocytes

Clinical Laboratory Test: Haematology -Monocytes

Clinical Laboratory Test: Haematology -Neutrophils

Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase

Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase

Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP)

Clinical Laboratory Test: Clinical Chemistry- S-Creatinine

Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin

Clinical Laboratory Test: Clinical Chemistry- S-Sodium

Clinical Laboratory Test: Clinical Chemistry- S-Potassium

Clinical Laboratory Test: Clinical Chemistry- S- Calcium

Clinical Laboratory Test: Clinical Chemistry- S-Albumin

Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total

Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein

Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen

Vital Signs- Sitting Systolic Blood Pressure(SBP)

Vital Signs- Sitting Diastolic Blood Pressure(DBP)

Vital Signs- Pulse Rate

ECG Variables - Heart Rate

ECG Variables - QT Interval

ECG Variables - QTcB Interval

ECG Variables - QTcF Interval

ECG Variables - RR Interval

Secondary outcome:

Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening

Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness

Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough

Forced Expiratory Volume in 1 Second (FEV1) Measured With the Spirometer at the Clinic

Forced Vital Capacity (FVC) Measured With the Spirometer at the Clinic

Time to First COPD Exacerbation

Number of COPD Exacerbations Over the Study Treatment Period

Rescue Medication Use

Health Related Quality of Life (HRQL) Based on the St. George's Respiratory Questionnaire (SGRQ)

Morning Peak Expiratory Flow (PEF) Measured at Home

Evening Peak Expiratory Flow (PEF) Measured at Home

Morning FEV1 Measured by the Subjects at Home

Evening FEV1 Measured by the Subjects at Home

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- A current clinical diagnosis of COPD according to the guidelines (GOLD, JPS)

- Documented COPD symptoms for more than 2 years

- Pre-bronchodilator FEV1≦50% of predicted normal value, and post-bronchodilator

FEV1/FVC<70% Exclusion Criteria:

- History and/or current clinical diagnosis of asthma and atopic diseases such as

allergic rhinitis

- Subjects with significant or unstable ischemic heart disease, arrhythmia,

cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator

- COPD exacerbation during the run-in period or within 4 weeks prior to registration,

requiring hospitalization and/or treatment with systemic steroids.

Locations and Contacts

Research Site, Hiroshima, Japan

Research Site, Kyoto, Japan

Research Site, Nagoya, Aichi, Japan

Research Site, Toyota, Aichi, Japan

Research Site, Yanagawa, Fukuoka, Japan

Research Site, Asahikawa, Hokkaido, Japan

Research Site, Sapporo, Hokkaido, Japan

Research Site, Itami, Hyogo, Japan

Research Site, Hitachi, Ibaraki, Japan

Research Site, Tsukuba, Ibaraki, Japan

Research Site, Sakaide, Kagawa, Japan

Research Site, Fujisawa, Kanagawa, Japan

Research Site, Yokohama, Kanagawa, Japan

Research Site, Koshi, Kumamoto, Japan

Research Site, Shibata, Miyagi, Japan

Research Site, Chuo, Tokyo, Japan

Research Site, Setagaya, Tokyo, Japan

Additional Information

Starting date: January 2010
Last updated: April 14, 2014

Page last updated: August 23, 2015

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