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

Chronic Obstructive Pulmonary Disease Clinical Trial

— OCEAN  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628862
• Other study ID #: D5122C00001
• Secondary ID: EudraCT no 2007-
• Status: Completed
• Phase: Phase 3
• First received: January 24, 2008
• Last updated: September 25, 2012
• Start date: December 2007
• Est. completion date: April 2009

Study information

• Verified date: September 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices AgencyBulgaria: Bulgarian Drug AgencyRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 613
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Formoterol Turbuhaler® 4.5mg
4.5 mg inhaled twice daily
• Formoterol Turbuhaler® 9 mg
9 mg inhaled twice daily
• Turbuhaler® placebo
placebo inhaled twice daily

Locations

Country	Name	City	State
Bulgaria	Research Site	Gabrovo
Bulgaria	Research Site	Lovech
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Russe
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Stara Zagora
Bulgaria	Research Site	Troyan
Bulgaria	Research Site	Varna
Japan	Research Site	Asahikawa	Hokkaido
Japan	Research Site	Chitose	Hokkaido
Japan	Research Site	Chiyoda	Tokyo
Japan	Research Site	Hiroshima
Japan	Research Site	Kagoshima
Japan	Research Site	Katano	Osaka
Japan	Research Site	Kawasaki	Kangawa
Japan	Research Site	Kishiwada	Osaka
Japan	Research Site	Kochi
Japan	Research Site	Kyoto
Japan	Research Site	Morioka	Iwate
Japan	Research Site	Nagoya	Aichi
Japan	Research Site	Naka-gun	Ibaraki
Japan	Research Site	Noda	Chiba
Japan	Research Site	Obihiro	Hokkaido
Japan	Research Site	ORA	Gunma
Japan	Research Site	Osaka
Japan	Research Site	OTA	Gunma
Japan	Research Site	Sapporo	Hokkaido
Japan	Research Site	Sendai	Miyagi
Japan	Research Site	Seto	Aichi
Japan	Research Site	Takatsuiki	Osaka
Japan	Research Site	Tomakomai	Hokkaido
Japan	Research Site	Touon	Ehime
Japan	Research Site	UBE	Yamaguchi
Japan	Research Site	Wakayama
Japan	Research Site	Yabu	Hyogo
Japan	Research Site	Yanagawa	Fukuoka
Romania	Research Site	Bucharest
Romania	Research Site	Bucuresti
Romania	Research Site	Constanta
Romania	Research Site	Deva	Hunedoara
Romania	Research Site	Iasi
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	St. Petersburg
Ukraine	Research Site	Dnipropetrovsk
Ukraine	Research Site	Donetsk
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Bulgaria,  Japan,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose	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.	from baseline up to 12 weeks	No
Secondary	Forced Vital Capacity (FVC) 60 Minutes Post-dose	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	from baseline up to 12 weeks	No
Secondary	FEV1 Pre-dose	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	baseline at week 0 and pre-dose at weeks 4, 8 and 12	No
Secondary	FVC Pre-dose	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	baseline at week 0 and pre-dose at weeks 4, 8 and 12	No
Secondary	FEV1 5 Minutes Post-dose	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	baseline and 5 minutes anter first dose	No
Secondary	FVC 5 Minutes Post-dose	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	baseline and 5 minutes anter first dose	No
Secondary	Change in Peak Expiratory Flow (PEF), Morning	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	run-in period and 12 week	No
Secondary	Change in Peak Expiratory Flow (PEF), Evening	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	run-in period and 12 week	No
Secondary	Change in Night-time Awakenings Due to Symptoms	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	run-in period up to 12 weeks	No
Secondary	Breathlessness	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	run-in period up to 12 weeks	No
Secondary	Cough	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	run-in period up to 12 weeks	No
Secondary	Use of Reliever Medication	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	12 weeks (end of run-in to last visit)	No
Secondary	St George's Respiratory Questionnaire (SGRQ)	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.	12 weeks (end of run-in to last visit)	No