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
211 participants
INTERVENTIONAL
2014-04-30
2015-03-31
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 5259 25 µg plus Foster 100/6 µg
CHF 5259 plus Foster 100/6 µg
Comparison of different doses of CHF 5259 (on top of Foster 100 /6 µg) versus Foster 100/6 µg over a treatment period of 6 weeks. Each subject will be allocated to 3 ouf of the 4 possible treatments performed in sequence during a cross over design (incomplete block)
CHF 5259 50 µg plus Foster 100/6 µg
CHF 5259 plus Foster 100/6 µg
Comparison of different doses of CHF 5259 (on top of Foster 100 /6 µg) versus Foster 100/6 µg over a treatment period of 6 weeks. Each subject will be allocated to 3 ouf of the 4 possible treatments performed in sequence during a cross over design (incomplete block)
CHF 5259 100 µg plus Foster 100/6 µg
CHF 5259 plus Foster 100/6 µg
Comparison of different doses of CHF 5259 (on top of Foster 100 /6 µg) versus Foster 100/6 µg over a treatment period of 6 weeks. Each subject will be allocated to 3 ouf of the 4 possible treatments performed in sequence during a cross over design (incomplete block)
Foster 100/6 µg
Foster 100/6 µg
Active comparator
Comparison of different doses of CHF 5259 (on top of Foster 100 /6 µg) versus Foster 100/6 µg over a treatment period of 6 weeks. Each subject will be allocated to 3 ouf of the 4 possible treatments performed in sequence during a cross over design (incomplete block)
Interventions
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CHF 5259 plus Foster 100/6 µg
Comparison of different doses of CHF 5259 (on top of Foster 100 /6 µg) versus Foster 100/6 µg over a treatment period of 6 weeks. Each subject will be allocated to 3 ouf of the 4 possible treatments performed in sequence during a cross over design (incomplete block)
Foster 100/6 µg
Active comparator
Comparison of different doses of CHF 5259 (on top of Foster 100 /6 µg) versus Foster 100/6 µg over a treatment period of 6 weeks. Each subject will be allocated to 3 ouf of the 4 possible treatments performed in sequence during a cross over design (incomplete block)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Uncontrolled asthma on medium doses of ICS+LABA with ACQ \>=1.5
* Pre-bronchodilator FEV1 ≥40% and \<80% of their predicted normal value
Exclusion Criteria
* Diagnosis of COPD
* Patients treated for asthma exacerbations in the 4 weeks prior to study entry
* Patients who are in therapy for gastroesophageal reflux disease
* Patients who have a clinically significant cardiovascular condition
18 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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Dave Singh, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of South Manchester, MANCHESTER M23 9 QZ, UK
Locations
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Chiesi Clinical Trial Site 0105
Dupnitsa, , Bulgaria
Chiesi Clinical Trial Site 0101
Rousse, , Bulgaria
Chiesi Clinical Trial Site 0106
Sevlievo, , Bulgaria
Chiesi Clinical Trial Site 0107
Sofia, , Bulgaria
Chiesi Clinical Trial Site 0108
Sofia, , Bulgaria
Chiesi Clinical Trial Site 0102
Sofia, , Bulgaria
Chiesi Clinical Trial Site 0110
Sofia, , Bulgaria
Chiesi Clinical Trial Site 0109
Sofia, , Bulgaria
Chiesi Clinical Trial Site 0103
Stara Zagora, , Bulgaria
Chiesi Clinical Trial Site 0104
Troyan Municipality, , Bulgaria
Chiesi Clinical Trial Site 0208
Berlin, , Germany
Chiesi Clinical Trial Site 0207
Berlin, , Germany
Chiesi Clinical Trial Site 0206
Großhansdorf, , Germany
Chiesi Clinical Trial Site 0201
Leipzig, , Germany
Chiesi Clinical Trial Site 0203
Lübeck, , Germany
Chiesi Clinical Trial Site 0202
Magdeburg, , Germany
Chiesi Clinical Trial Site 0204
Radebeul, , Germany
Chiesi Clinical Trial Site 0210
Witten, , Germany
Chiesi Clinical Trial Site 0307
Balassagyarmat, , Hungary
Chiesi Clinical Trial Site 0302
Budapest, , Hungary
Chiesi Clinical Trial Site 0304
Deszk, , Hungary
Chiesi Clinical Trial Site 0305
Gödöllő, , Hungary
Chiesi Clinical Trial Site 0303
Komárom, , Hungary
Chiesi Clinical Trial Site 0301
Siófok, , Hungary
Chiesi Clinical Trial Site 0306
Szarvas, , Hungary
Chiesi Clinical Trial Site 0403
Brescia, , Italy
Chiesi Clinical Trial Site 0402
Parma, , Italy
Chiesi Clinical Trial Site 0401
Pisa, , Italy
Chiesi Clinical Trial Site 0408
Trieste, , Italy
Chiesi Clinical Trial Site 0404
Verona, , Italy
Chiesi Clinical Trial Site 0510
Bialystok, , Poland
Chiesi Clinical Trial Site 0507
Gdansk, , Poland
Chiesi Clinical Trial Site 0502
Giżycko, , Poland
Chiesi Clinical Trial Site 0511
Krakow, , Poland
Chiesi Clinical Trial Site 0505
Lodz, , Poland
Chiesi Clinical Trial Site 0509
Lodz, , Poland
Chiesi Clinical Trial Site 0512
Lublin, , Poland
Chiesi Clinical Trial Site 0503
Ostróda, , Poland
Chiesi Clinical Trial Site 0501
Oświęcim, , Poland
Chiesi Clinical Trial Site 0506
Proszowice, , Poland
Chiesi Clinical Trial Site 0508
Rzeszów, , Poland
Chiesi Clinical Trial Site 0504
Wroclaw, , Poland
Chiesi Clinical Trial Site 0602
London, , United Kingdom
Chiesi Clinical Trial Site 0601
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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2013-003043-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CCD-1206-PR-0088
Identifier Type: -
Identifier Source: org_study_id
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