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Клинические исследования в Украине

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Описание
Краткое названиеA Comparative Study of Inhaled Ciclesonide Versus Placebo in Children With Asthma (6-11 y) (BY9010/M1-209)
Полное названиеA Comparative Study of Inhaled Ciclesonide Versus Placebo in Children With Asthma
СпонсорALTANA Pharma
Industry
ИсточникALTANA Pharma
Под контролемSouth Africa: Medicines Control Council
No
Краткое описаниеThe purpose of this study is to investigate the efficacy of inhaled ciclesonide at three
different dose levels compared with placebo with respect to pulmonary function, asthma
symptoms, and use of rescue medication in children with asthma. Treatment medication will be
administered as follows: ciclesonide or placebo will be inhaled once daily. The study
consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study
provides further data on safety and tolerability of ciclesonide.
СостояниеЗавершено
Дата началаOctober 2006
ФазаPhase 3
Вид исследованияAllocation: Randomized, Control: Placebo Control, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Набор0
КритерииMain Inclusion Criteria:

- History of asthma for at least 6 months

- Ability to show optimal use of MDI, including inhalation technique

- Lung function and reversibility within specified limits

Main Exclusion Criteria:

- Concomitant severe diseases

- Diseases which are contraindications for the use of inhaled steroids

- Two or more inpatient hospitalizations for asthma within the last year

- Respiratory tract infection or asthma exacerbation within the last 30 days prior to
entry into the study

- Use of systemic steroids within the last 30 days prior to inclusion (depot steroids 6
weeks)

- Beginning of or change in immunotherapy within the last 6 months prior to inclusion

- Inability to follow the procedures of the study
ПолBoth
Минимальный возраст6 Years
Максимальный возраст11 Years
УсловиеAsthma
Применяемое лечение
DrugCiclesonide
DrugPlacebo
Контакты и расположение
Dnipropetrovsk , 49101Altana Pharma/Nycomed
Donetsk , 83045Altana Pharma/Nycomed
Donetsk , 83017Altana Pharma/Nycomed
Kharkiv , 61051Altana Pharma/Nycomed
Kiev , 3680Altana Pharma/Nycomed
Kyiv , 4050Altana Pharma/Nycomed
Kyiv , 1135Altana Pharma/Nycomed
Kyiv , 2125Altana Pharma/Nycomed
Lviv , 79059Altana Pharma/Nycomed
Odesa , 65031Altana Pharma/Nycomed
Poltava , 36011Altana Pharma/Nycomed
Simferopol , 95004Altana Pharma/Nycomed
Vinnytsia Altana Pharma/Nycomed
Zaporizhzhya , 69063Altana Pharma/Nycomed
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