Клинические исследования в Украине

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Исследования / № 00361959

Краткое названиеSERETIDE 50/500mcg Versus Tiotropium Bromide On Exacerbation Rates In Severe Chronic Obstructive Pulmonary Disease
Полное названиеA Multicentre, Randomised, Double-Blind, Double Dummy, Parallel Group, 104 Week Study to Compare the Effect of the Salmeterol/Fluticasone Propionate Combination Product (SERETIDE) 50/500mcg With Tiotropium Bromide 18 Mcg on the Rate of Exacerbations in Subjects With Severe Chronic Obstructive Pulmonary Disease (COPD)
Под контролемUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Краткое описаниеThis is a comparator study to assess the relative efficacy of the combination product
fluticasone propionate/salmeterol 50/500 and tiotropium bromide on the rate of exacerbations
of chronic obstructive pulmonary disease (COPD) over a two year study interval.
Дата началаSeptember 2003
ФазаPhase 4
Вид исследованияAllocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
КритерииInclusion criteria:

- Established clinical history of moderate to severe COPD.

- Post bronchodilator FEV1 of < 50% of predicted normal.

- FEV1 / FVC ratio <70%.

- Reversibility to 400mcg albuterol of less or equal to 10 predicted at Visit 1.

- Free from exacerbation in the 6 weeks prior to screening.

- Current or former smoker with a smoking history of = 10 pack-years and has a history
of COPD exacerbations.

Exclusion criteria:

- Current asthma, eczema, atopic dermatitis and/or allergic rhinitis.

- Has a known respiratory disorder other than COPD (e.g. lung cancer, sarcoidosis,
tuberculosis or lung fibrosis).

- Has narrow-angle glaucoma, prostatic hyperplasia or obstruction of the neck of the
bladder that in the opinion of the investigator should prevent the subject from
entering the study.

- Has undergone lung transplantation and/or lung volume reduction.

- Female who is a nursing mother.

- Requires regular (daily) long-term oxygen therapy (LTOT).

- Is receiving beta-blockers (except eye drops).

- Has a serious, uncontrolled disease likely to interfere with the study.

- Has received any other investigational drugs within the 4 weeks prior to Visit 1.

- Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.

- Has a known or suspected hypersensitivity to beta2-agonists, inhaled corticosteroids,
anticholinergic agents or any components of the formulations (e.g. lactose or milk
Минимальный возраст40 Years
Максимальный возраст80 Years
УсловиеChronic Obstructive Pulmonary Disease
Применяемое лечение
DrugTiotropium bromide 18mcg
DrugFluticasone propionate/ salmeterol combination 50/500mcg
Контакты и расположение
Kiev , 3680GSK Clinical Trials - Call centre
Kiev , 0411 2GSK Clinical Trials - Call centre
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