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Описание
Краткое названиеThe FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)
Полное названиеThe FLASH Study: A Randomized, Controlled Study of Roflumilast 250 Mcg and 500 Mcg Versus Placebo in Patients With Asthma
СпонсорALTANA Pharma
Industry
ИсточникALTANA Pharma
Под контролемUnited States: Food and Drug Administration
Краткое описаниеThe purpose of this study is to confirm the dose of roflumilast to be used for asthma
management by comparing the effects of 250 mcg and 500 mcg oral roflumilast with placebo on
pulmonary function and asthma symptoms.
СостояниеЗавершено
Дата началаDecember 2003
ФазаPhase 3
Вид исследованияAllocation: Randomized, Control: Placebo Control, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Набор822
КритерииMain Inclusion Criteria:

- Diagnosis of persistent chronic bronchial asthma

- Baseline lung function within specified parameters

- No change in asthma treatment during the last 4 weeks prior to start of baseline
period

- Stable clinical state

- Except for asthma, in good health

- Non-smokers or ex-smokers

Main Exclusion Criteria:

- Poorly controlled asthma

- Diagnosis of chronic pulmonary disease and/or other relevant lung diseases

- Patients using continuously (more than 3 days per week) > 8 puffs/day rescue
medication
ПолBoth
Минимальный возраст18 Years
Максимальный возрастN/A
УсловиеAsthma
Применяемое лечение
DrugRoflumilast
Контакты и расположение
Cities in the Ukraine ALTANA Pharma
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