Study to Evaluate the Safety and Efficacy of Formoterol in a Daily Dose of 18 µg (9 µg Twice Daily) in Japanese Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT01047553 | Completed Phase 3 Results DMC

• 1 other identifier: D5122C00002
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 27

Brief Summary

This study is a multicentre, open, randomised, parallel-group study with formoterol 9 μg one inhalation b.i.d, or standard COPD therapy. Standard (reference) COPD treatment arm should be the group to refer to when safety results of formoterol arm will be evaluated. 240 patients with moderate-to-severe COPD will be randomised (120 patients in the formoterol-arm and 120 patients on standard COPD therapy).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; COPD; Japanese; Phase 3; Safety; OT; Oxis

Outcome Measures

Primary Outcomes (28)

• Clinical Laboratory Test: Haematology -Erythrocytes

  Mean change from Baseline

  Baseline and week 52

• Clinical Laboratory Test: Haematology -Haemoglobin

  Change from baseline

  Baseline and week 52

• Clinical Laboratory Test: Haematology-Leucocytes

  Change from baseline

  Baseline and week 52

• Clinical Laboratory Test: Haematology-Platelet Count

  Change from baseline

  Baseline and week 52

• Clinical Laboratory Test: Haematology Eosinophils

  Change from baseline

  baseline and week 52

• Clinical Laboratory Test: Haematology Basophil

  Change from baseline

  Baseline and week 52

• Clinical Laboratory Test: Haematology-Lymphocytes

  Change from baseline

  Baseline and week 52

• Clinical Laboratory Test: Haematology-Monocytes

  Change from baseline

  Baseline and week 52

• Clinical Laboratory Test: Haematology -Neutrophils

  Change from baseline

  Baseline and week 52

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

  Change from baseline

  Baseline and week 52

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

  Change from baseline

  Baseline and week 52

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

  Change from baseline

  Baseline and week 52

• Clinical Laboratory Test: Clinical Chemistry-S-Creatinine

  Change from Baseline

  Baseline and week 52

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

  Change from baseline

  Baseline and week 52

• Clinical Laboratory Test: Clinical Chemistry-S-Sodium

  Change from baseline

  Baseline and week 52

• Clinical Laboratory Test: Clinical Chemistry-S-Potassium

  Change from baseline

  Baseline and week 52

• Clinical Laboratory Test: Clinical Chemistry-S- Calcium

  Change from baseline

  Baseline and week 52

• Clinical Laboratory Test: Clinical Chemistry-S-Albumin

  Change from baseline

  Baseline and week 52

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

  Change from baseline

  Baseline and week 52

• Clinical Laboratory Test: Clinical Chemistry - S-Blood Urea Nitrogen (BUN)

  Change from baseline

  Baseline and week 52

• Vital Signs- Sitting SBP

  Change from baseline

  Baseline and week 52

• Vital Signs- Sitting DBP

  Change from baseline

  Baseline and week 52

• Vital Signs - Pulse Rate

  Change from baseline

  Baseline and week 52

• ECG Variables - Heart Rate

  Change from baseline

  Baseline and week 52

• ECG Variables - QT Interval

  Change from baseline

  Baseline and week 52

• ECG Variables - QTcB Interval

  Change from baseline

  Baseline and week 52

• ECG Variables QTcF Interval

  Change from baseline

  Baseline and week 52

• ECG Variables RR Interval

  Change from baseline

  Baseline and week 52

Secondary Outcomes (11)

• Forced Expiratory Volume in One Second (FEV1)

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

• Forced Vital Capacity (FVC)

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

• Morning Peak Expiratory Flow(PEF)

  Daily during run-in period (14 - 18 days before Randomisation visit)and daily during 52-week randomization treatment

• Evening Peak Expiratory Flow (PEF)

  Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment

• Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms

  Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment

Study Arms (1)

1

EXPERIMENTAL

Formoterol 9 μg/dose

Drug: Formoterol (OT)

Interventions

Formoterol (OT) DRUG

9 μg/dose, Inhaled, twice daily for 52 weeks

Also known as: Oxis Turbuhaler®

1

Eligibility Criteria

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

You may qualify if:

• Outpatients, men or women ≥ 40 years
• A clinical diagnosis of COPD according to guidelines, and current COPD symptoms.
• Post-bronchodilator FEV1 \< 80% of predicted normal value and FEV1/FVC \< 70%, post-bronchodilator

You may not qualify if:

• A history and/or current clinical diagnosis of asthma and atopic diseases such as Allergic rhinitis
• Patients who have experienced COPD exacerbation requiring at least one of the following treatment, hospitalisation and/or a course of systemic steroid within 4 weeks prior to the study start.
• Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (27)

Research Site

Nagoya, Aichi-ken, Japan

Location

Research Site

Akita, Akita, Japan

Location

Research Site

Fukuoka, Fukuoka, Japan

Location

Research Site

Chitose, Hokkaido, Japan

Location

Research Site

Obihiro, Hokkaido, Japan

Location

Research Site

Sapporo, Hokkaido, Japan

Location

Research Site

Ako, Hyōgo, Japan

Location

Research Site

Kobe, Hyōgo, Japan

Location

Research Site

Hitachi, Ibaraki, Japan

Location

Research Site

Tsukuba, Ibaraki, Japan

Location

Research Site

Kanazawa, Ishikawa-ken, Japan

Location

Research Site

Sakaidechō, Kagawa-ken, Japan

Location

Research Site

Fujisawa, Kanagawa, Japan

Location

Research Site

Kawasaki-shi, Kanagawa, Japan

Location

Research Site

Yokohama, Kanagawa, Japan

Location

Research Site

Kōshi, Kumamoto, Japan

Location

Research Site

Kyoto, Kyoto, Japan

Location

Research Site

Nagaoka, Niigata, Japan

Location

Research Site

Saiki-shi, Oita Prefecture, Japan

Location

Research Site

Moriguchi, Osaka, Japan

Location

Research Site

Matsue, Shimane, Japan

Location

Research Site

Bunkyo, Tokyo, Japan

Location

Research Site

Chūō, Tokyo, Japan

Location

Research Site

Katsushika-ku, Tokyo, Japan

Location

Research Site

Kodaira, Tokyo, Japan

Location

Research Site

Setagaya City, Tokyo, Japan

Location

Research Site

Tosima-ku, Tokyo, Japan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

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

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

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: January 12, 2010
• First Posted: January 13, 2010
• Study Start: December 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 4, 2013
• Results First Posted: January 4, 2013

Record last verified: 2012-12

Locations

JP (27)