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Описание
Краткое названиеEvaluation of Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU
Полное названиеA 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-National, Phase III, Efficacy and Safety Study of Inhaled Formoterol 4.5 ??g and 9 ??g Twice Daily in Japanese and European Patients With Chronic Obstructive Pulmonary Disease (COPD)
СпонсорAstraZeneca
Industry
ИсточникAstraZeneca
Под контролемJapan: Pharmaceuticals and Medical Devices Agency
Bulgaria: Bulgarian Drug Agency
Romania: National Medicines Agency
Russia: Ministry of Health and Social Development of the Russian Federation
Ukraine: Ministry of Health
No
Краткое описаниеThe 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.
СостояниеЗавершено
Дата началаDecember 2007
ФазаPhase 3
Вид исследованияAllocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Набор0
КритерииInclusion 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.
ПолBoth
Минимальный возраст40 Years
Максимальный возрастN/A
УсловиеChronic Obstructive Pulmonary Disease
Применяемое лечение
DrugFormoterol Turbuhaler 4.5mg
DrugFormoterol Turbuhaler 9 mg
DrugTurbuhaler placebo
Контакты и расположение
Dnipropetrovsk Research Site
Donetsk Research Site
Kharkiv Research Site
Kyiv Research Site
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