Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
520 participants
INTERVENTIONAL
2011-11-30
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CIC 160
Two puffs of 40 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 160 mcg)
Ciclesonide
During the treatment period subjects will inhale two puffs of either 40, 80 or 160 μg ciclesonide in the morning and the evening (corresponding to a total daily dose of 160, 320 or 640 μg)
CIC 320
Two puffs of 80 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 320 mcg)
Ciclesonide
During the treatment period subjects will inhale two puffs of either 40, 80 or 160 μg ciclesonide in the morning and the evening (corresponding to a total daily dose of 160, 320 or 640 μg)
CIC 640
Two puffs of 160 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 640 mcg)
Ciclesonide
During the treatment period subjects will inhale two puffs of either 40, 80 or 160 μg ciclesonide in the morning and the evening (corresponding to a total daily dose of 160, 320 or 640 μg)
Interventions
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Ciclesonide
During the treatment period subjects will inhale two puffs of either 40, 80 or 160 μg ciclesonide in the morning and the evening (corresponding to a total daily dose of 160, 320 or 640 μg)
Eligibility Criteria
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Inclusion Criteria
* History of persistent bronchial asthma for at least 6 months
* Current treatment with an Inhaled Corticosteroid (ICS) at a stable dose in the dose range of 200-1000 μg Fluticasone Propionate (FP)/day or equivalent for a minimum of 12 weeks
* Good inhalation technique
* Under the current ICS pre-treatment the ACQ score ranges between ≥ 0.75 and ≥ 2
Exclusion Criteria
* Concomitant severe diseases (e.g. malignant diseases during the past 5 years \[other than basal or squamous cell carcinoma\], hepatitis C, acquired immune deficiency syndrome \[AIDS\])
* Diseases which are contraindications for the use of ICS (e.g. active or inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment)
* Use of systemic glucocorticosteroids within 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months
12 Years
70 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca AstraZeneca
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Buenos Aires, , Argentina
Capital Federal, Buenos Aires, , Argentina
Rosario, , Argentina
Rosario-Santa Fe, , Argentina
Salta, , Argentina
San Miguel de Tucumán, , Argentina
Florianópolis, , Brazil
Goiânia, , Brazil
Porto Alegre, , Brazil
Rio de Janiero, , Brazil
Santo André, , Brazil
São Paulo, , Brazil
Sorocaba, , Brazil
Berlin, , Germany
Bonn, , Germany
Landsberg, , Germany
Rudersdorf, , Germany
Schwetzingen, , Germany
Beersheba, , Israel
Haifa, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Barnaul, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Saint Petersburg, , Russia
Tomsk, , Russia
Countries
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Other Identifiers
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2011-000683-99
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1133-6333
Identifier Type: REGISTRY
Identifier Source: secondary_id
CL-9709-301-RDCTID
Identifier Type: REGISTRY
Identifier Source: secondary_id
CL-9709-301-RD
Identifier Type: -
Identifier Source: org_study_id
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