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

NCT01070784 | Completed Phase 3 Results

• 1 other identifier: D589DC00008
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Symbicort; Safety; Efficacy; COPD; Japanese

Outcome Measures

Primary Outcomes (29)

• Clinical Laboratory Test: Haematology -Erythrocytes

  Mean change from Baseline

  Baseline and 52 week after

• Clinical Laboratory Test: Haematology -Haemoglobin

  Change from baseline

  Baseline and 52 week after

• Clinical Laboratory Test: Haematology -Leucocytes

  Change from baseline

  Baseline and 52 week after

• Clinical Laboratory Test: Haematology -Platelet Count

  Change from baseline

  Baseline and 52 week after

• Clinical Laboratory Test: Haematology -Eosinophils

  Change from baseline

  Baseline and 52 week after

• Clinical Laboratory Test: Haematology -Basophils

  Change from baseline

  Baseline and 52 week after

• Clinical Laboratory Test: Haematology -Lymphocytes

  Change from baseline

  Baseline and 52 week after

• Clinical Laboratory Test: Haematology -Monocytes

  Change from baseline

  Baseline and 52 week after

• Clinical Laboratory Test: Haematology -Neutrophils

  Change from baseline

  Baseline and 52 week after

• Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase

  Change from baseline

  Baseline and 52 week after

• Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase

  Change from baseline

  Baseline and 52 week after

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

  Change from baseline

  Baseline and 52 week after

• Clinical Laboratory Test: Clinical Chemistry- S-Creatinine

  Change from baseline

  Baseline and 52 week after

• Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin

  Change from baseline

  Baseline and 52 week after

• Clinical Laboratory Test: Clinical Chemistry- S-Sodium

  Change from baseline

  Baseline and 52 week after

• Clinical Laboratory Test: Clinical Chemistry- S-Potassium

  Change from baseline

  Baseline and 52 week after

• Clinical Laboratory Test: Clinical Chemistry- S- Calcium

  Change from baseline

  Baseline and 52 week after

• Clinical Laboratory Test: Clinical Chemistry- S-Albumin

  Change from baseline

  Baseline and 52 week after

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

  Change from baseline

  Baseline and 52 week after

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

  Change from baseline

  Baseline and 52 week after

• Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen

  Change from baseline

  Baseline and 52 week after

• Vital Signs- Sitting Systolic Blood Pressure(SBP)

  Change from baseline

  Baseline and 52 week after

• Vital Signs- Sitting Diastolic Blood Pressure(DBP)

  Change from baseline

  Baseline and 52 week after

• Vital Signs- Pulse Rate

  Change from baseline

  Baseline and 52 week after

• ECG Variables - Heart Rate

  Change from baseline

  Baseline and 52 week after

• ECG Variables - QT Interval

  Change from baseline

  Baseline and 52 week after

• ECG Variables - QTcB Interval

  Change from baseline

  Baseline and 52 week after

• ECG Variables - QTcF Interval

  Change from baseline

  Baseline and 52 week after

• ECG Variables - RR Interval

  Change from baseline

  Baseline and 52 week after

Secondary Outcomes (13)

• Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening

  Daily during run-in period and daily during 52-week randomization treatment

• Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness

  Daily during run-in period and daily during 52-week randomization treatment

• Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough

  Daily during run-in period and daily during 52-week randomization treatment

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

  Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization

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

  Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization

Study Arms (2)

1

EXPERIMENTAL

Drug: Symbicort Turbuhaler (Budesonide/formoterol)

2

ACTIVE COMPARATOR

Drug: Drug: any available COPD treatment; investigator to decide

Interventions

Symbicort Turbuhaler (Budesonide/formoterol) DRUG

2 x 160/4.5 microgram, inhalation, bid, 52 weeks

Also known as: Symbicort Turbuhaler

1

Drug: any available COPD treatment; investigator to decide DRUG

According to investigator decision, 52 weeks, Standard COPD treatment according to investigator decision

2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (17)

Research Site

Nagoya, Aichi-ken, Japan

Location

Research Site

Toyota, Aichi-ken, Japan

Location

Research Site

Yanagawa, Fukuoka, Japan

Location

Research Site

Hiroshima, Hiroshima, Japan

Location

Research Site

Asahikawa, Hokkaido, Japan

Location

Research Site

Sapporo, Hokkaido, Japan

Location

Research Site

Itami, Hyōgo, Japan

Location

Research Site

Hitachi, Ibaraki, Japan

Location

Research Site

Tsukuba, Ibaraki, Japan

Location

Research Site

Sakaidechō, Kagawa-ken, Japan

Location

Research Site

Fujisawa, Kanagawa, Japan

Location

Research Site

Yokohama, Kanagawa, Japan

Location

Research Site

Kōshi, Kumamoto, Japan

Location

Research Site

Kyoto, Kyoto, Japan

Location

Research Site

Murata, Miyagi, Japan

Location

Research Site

Chūō, Tokyo, Japan

Location

Research Site

Setagaya City, Tokyo, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide, Formoterol Fumarate Drug Combination; Budesonide; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Goran Eckerwall, MSD
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Tomas Andersson, MD

  AstraZeneca, R&D, Lund, Sweden

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2010
• First Posted: February 18, 2010
• Study Start: January 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 29, 2014
• Results First Posted: December 5, 2013

Record last verified: 2014-04

Locations

JP (17)