Study to Investigate the Effect of Formoterol vs Salmeterol on Small Airways Physiological Parameters in COPD Patients
NCT ID: NCT01344655
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
PHASE4
16 participants
INTERVENTIONAL
2011-04-30
2012-09-30
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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Formoterol 12 μg pMDI (Atimos®)
Atimos®
Formoterol 12 μg pMDI
Salmeterol 25 µg pMDI HFA (Serevent™)
Serevent™
Salmeterol 25 µg pMDI
Matched Placebo
Placebo
placebo
Interventions
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Atimos®
Formoterol 12 μg pMDI
Serevent™
Salmeterol 25 µg pMDI
Placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* Post bronchodilator FEV1 between 30% and 80% predicted values at screening
* Post-bronchodilator FEV1/FVC \< 0.7
Exclusion Criteria
* History of another medical condition contraindicating participation in the study
* Clinical evidence of heart failure
40 Years
ALL
No
Sponsors
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Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Omar S Usmani, MD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Airway Disease Section, NHLI, Imperial College London
London, , 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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2008-008656-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CCD-0901-PR-0012
Identifier Type: -
Identifier Source: org_study_id
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