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Completed

NCT Number: NCT00628862

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

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.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Gabrovo, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Formoterol Turbuhaler® 4.5mg

Drug

4.5 mg inhaled twice daily

Other names: Oxis

Formoterol Turbuhaler® 9 mg

Drug

9 mg inhaled twice daily

Other names: Oxis

Turbuhaler® placebo

Drug

placebo inhaled twice daily

Primary outcomes

  1. Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose

    Time frame: from baseline up to 12 weeks

    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 outcomes

  1. Forced Vital Capacity (FVC) 60 Minutes Post-dose

    Time frame: from baseline up to 12 weeks

    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

  2. FEV1 Pre-dose

    Time frame: baseline at week 0 and pre-dose at weeks 4, 8 and 12

    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

  3. FVC Pre-dose

    Time frame: baseline at week 0 and pre-dose at weeks 4, 8 and 12

    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

  4. FEV1 5 Minutes Post-dose

    Time frame: baseline and 5 minutes anter first 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

  5. FVC 5 Minutes Post-dose

    Time frame: baseline and 5 minutes anter first 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

  6. Change in Peak Expiratory Flow (PEF), Morning

    Time frame: run-in period and 12 week

    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

  7. Change in Peak Expiratory Flow (PEF), Evening

    Time frame: run-in period and 12 week

    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

  8. Change in Night-time Awakenings Due to Symptoms

    Time frame: run-in period up to 12 weeks

    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

  9. Breathlessness

    Time frame: run-in period up to 12 weeks

    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

  10. Cough

    Time frame: run-in period up to 12 weeks

    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

  11. Use of Reliever Medication

    Time frame: 12 weeks (end of run-in to last visit)

    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. St George's Respiratory Questionnaire (SGRQ)

    Time frame: 12 weeks (end of run-in to last visit)

    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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Acronym: OCEAN

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 5, 2008
Registry last updated
Oct 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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