Evaluation of Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU - Full Text View

Purpose

The purpose of this study is to show the efficacy and safety of formoterol for the maintenance treatment of patients with COPD compared with placebo in patients in Japan and in European countries during 12 weeks.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Formoterol Turbuhaler® 4.5mg Drug: Formoterol Turbuhaler® 9 mg Drug: Turbuhaler® placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A 12-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-national, Phase III, Efficacy and Safety Study of Inhaled Formoterol 4.5 μg and 9 μg Twice Daily in Japanese and European Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:

MedlinePlus related topics: COPD Cough

Drug Information available for: Formoterol fumarate Formoterol Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose [ Time Frame: from baseline up to 12 weeks ] [ Designated as safety issue: No ]
FEV1 (expressed as litres [L]) is a spirometric measure of lung function. FEV1 was measured 60 minutes after administration of study drug. The results are expressed as a percentage in relation to the baseline value.

Secondary Outcome Measures:

Forced Vital Capacity (FVC) 60 Minutes Post-dose [ Time Frame: from baseline up to 12 weeks ] [ Designated as safety issue: No ]
Forced Vital Capacity (FVC) is a spirometric measure of lung function. FVC was measured 60 minutes after administration of study drug. The results are expressed as a percentage in relation to the baseline value
FEV1 Pre-dose [ Time Frame: baseline at week 0 and pre-dose at weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
Lung function (FEV1) was measured before administrations of the study drug (pre-dose). The results are expressed as a percentage of mean FEV1 over visists 4-6 in relation to the baseline (visit 3) value
FVC Pre-dose [ Time Frame: baseline at week 0 and pre-dose at weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
Lung function (FVC) was measured before administrations of the study drug (pre-dose). The results are expressed as a percentage of mean FEV1 over visists 4-6 in relation to the baseline (visit 3) value
FEV1 5 Minutes Post-dose [ Time Frame: baseline and 5 minutes anter first dose ] [ Designated as safety issue: No ]
Lung function (FEV1) was measured 5 minutes after the first dose of study drug. The results are expressed as a percentage in relation to the baseline value
FVC 5 Minutes Post-dose [ Time Frame: baseline and 5 minutes anter first dose ] [ Designated as safety issue: No ]
Lung function (FVC) was measured 5 minutes after the first dose of study drug, The results are expressed as a percentage in relation to the baseline value
Change in Peak Expiratory Flow (PEF), Morning [ Time Frame: run-in period and 12 week ] [ Designated as safety issue: No ]
Patients were asked to measure and record lung function (peak expiratory flow [PEF] measured in the morning). Average values over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value
Change in Peak Expiratory Flow (PEF), Evening [ Time Frame: run-in period and 12 week ] [ Designated as safety issue: No ]
Patients were asked to measure and record lung function (peak expiratory flow [PEF] measured in the evening). Average values over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value
Change in Night-time Awakenings Due to Symptoms [ Time Frame: run-in period up to 12 weeks ] [ Designated as safety issue: No ]
Patients were asked to record the night-time awakenings due to symptoms (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value
Breathlessness [ Time Frame: run-in period up to 12 weeks ] [ Designated as safety issue: No ]
Patients were asked to record breathlessness (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value
Cough [ Time Frame: run-in period up to 12 weeks ] [ Designated as safety issue: No ]
Patients were asked to record cough (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value
Use of Reliever Medication [ Time Frame: 12 weeks (end of run-in to last visit) ] [ Designated as safety issue: No ]
Patients were asked to record reliever medication use. Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value
St George's Respiratory Questionnaire (SGRQ) [ Time Frame: 12 weeks (end of run-in to last visit) ] [ Designated as safety issue: No ]
Patients were asked to complete the St George's Respiratory Questionnaire (SGRQ). Subscale symptom score ranges from 0 to 100% and measures the effect of respiratory symptoms, frequency, and severity on quality of life. A score of 0 indicates the best possible status. Results are expressed as the change from baseline score with a decrease in score indicating improvement.


Enrollment:	613
Study Start Date:	December 2007
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: F 4.5 bid Formoterol 4.5 ug twice daily (bid)	Drug: Formoterol Turbuhaler® 4.5mg 4.5 mg inhaled twice daily Other Name: Oxis
Experimental: F 9.0 bid Formoterol 9.0 ug bid	Drug: Formoterol Turbuhaler® 9 mg 9 mg inhaled twice daily Other Name: Oxis
Placebo Comparator: PBO Placebo	Drug: Turbuhaler® placebo placebo inhaled twice daily

Eligibility


Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females aged above 40 with a clinical diagnosis of COPD and current COPD symptoms
Current or previous smoker with a smoking history of 10 or more pack years
Lung function parameters: FEV1/FVC < 70%, post-bronchodilator and post-bronchodilator FEV1 < 80% of predicted normal value

Exclusion Criteria:

History and/or current clinical diagnosis of asthma or atopic diseases such as allergic rhinitis
Use of inhaled glucocorticosteroids within 4 weeks prior to Visit 2
Any relevant cardiovascular disorder as judged by the investigator or any current respiratory tract disorder other than COPD.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628862

Show 48 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	Lars-Goran Carlsson, MD	AstraZeneca R&D Lund, Sweden
Principal Investigator:	Miron A Bogdan, MD	Clinica Medic Or, Calea

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bogdan MA, Aizawa H, Fukuchi Y, Mishima M, Nishimura M, Ichinose M. Efficacy and safety of inhaled formoterol 4.5 and 9 μg twice daily in Japanese and European COPD patients: phase III study results. BMC Pulm Med. 2011 Nov 15;11:51. doi: 10.1186/1471-2466-11-51.


Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00628862 History of Changes
Other Study ID Numbers:	D5122C00001, EudraCT no 2007-003999-19
Study First Received:	January 24, 2008
Results First Received:	March 19, 2010
Last Updated:	September 25, 2012
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency Bulgaria: Bulgarian Drug Agency Romania: National Medicines Agency Russia: Ministry of Health of the Russian Federation Ukraine: Ministry of Health

Keywords provided by AstraZeneca:


Chronic Obstructive Pulmonary Disease COPD

Additional relevant MeSH terms:


Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Formoterol Adrenergic Agents Adrenergic Agonists Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Anti-Asthmatic Agents	Autonomic Agents Bronchodilator Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Respiratory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 26, 2015

Evaluation of Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU (OCEAN)