Cross-over Study to Evaluate the Effect on Trough Forced Expiratory Volume in One Second (FEV1) After 4 Weeks Treatment With CHF 5188 pMDI qd in Adult Patients With Persistent Asthma
NCT ID: NCT01070524
Last Updated: 2017-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
113 participants
INTERVENTIONAL
2010-01-31
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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CHF 5188 pMDI
CHF 5188 pMDI
CHF 5188: fixed combination budesonide/carmoterol
Budesonide extrafine pMDI
Budesonide extrafine pMDI
Budesonide extrafine pMDI
Seretide(r) Evohaler(r)
Seretide(r) Evohaler(r)
Seretide(r) Evohaler(r): fixed combination fluticasone/salmeterol
Interventions
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CHF 5188 pMDI
CHF 5188: fixed combination budesonide/carmoterol
Budesonide extrafine pMDI
Budesonide extrafine pMDI
Seretide(r) Evohaler(r)
Seretide(r) Evohaler(r): fixed combination fluticasone/salmeterol
Eligibility Criteria
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Inclusion Criteria
* FEV1 ≥ 60% and ≤ 90% of predicted for the patient normal value
Exclusion Criteria
* History or current evidence of significant cardiovascular disease
* Uncontrolled concomitant disease
18 Years
ALL
No
Sponsors
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Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
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The Medicines Evaluation Unit Ltd
Principal Investigators
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Dave Singh, MD
Role: PRINCIPAL_INVESTIGATOR
The Medicines Evaluation Unit Ltd
Locations
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The Medicines Evaluation Unit Ltd, The Langley Building, Southmoor Road
Manchester, , United Kingdom
Countries
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Related Links
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Study Record on EU Clinical Trials Register including results
Other Identifiers
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2009-013759-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CCD-0909-PR-0020
Identifier Type: -
Identifier Source: org_study_id
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