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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

Evaluation of efficacy and safety of formoterol in patients with COPD compared with placebo in patients in Japan, EU

Research Site

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)

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.

Age Continuous

Gender, Male/Female

Forced Expiratory Volume in 1 second (FEV1; L) 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

Forced Vital Capacity (FVC) 60 minutes post-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

FEV1 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

FVC pre-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

FEV1 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

FVC 5 minutes post-dose

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), morning

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 Peak expiratory flow (PEF), evening

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

change in Night-time awakenings due to symptoms

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

Breathlessness

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

Cough

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

Use of reliever medication

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.

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

Evaluation of efficacy and safety of formoterol in patients with COPD compared with placebo in patients in Japan, EU - OCEAN

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=369&filename=CSR-D5122C00001.pdf

CSR-D5122C00001.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator