Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients
NCT ID: NCT02189577
Last Updated: 2021-10-29
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
100 participants
INTERVENTIONAL
2014-06-30
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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CHF 5259
CHF 5259
CHF 5259
Comparison of CHF 5259 versus placebo over a treatment period. Allocation of 1 of the 2 possible treatments performed in sequence during a cross over design.
Placebo
Placebo
Placebo
Comparison of CHF 5259 versus placebo over a treatment period. Allocation of 1 of the 2 possible treatments performed in sequence during a cross over design.
Interventions
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CHF 5259
Comparison of CHF 5259 versus placebo over a treatment period. Allocation of 1 of the 2 possible treatments performed in sequence during a cross over design.
Placebo
Comparison of CHF 5259 versus placebo over a treatment period. Allocation of 1 of the 2 possible treatments performed in sequence during a cross over design.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current smokers or ex-smokers
* A post-bronchodilator FEV1 \< 60% of the predicted normal value and a post-bronchodilator FEV1/FVC \< 0.7
* Positive response to the reversibility test at screening defined as change in FEV1 ≥ 5%.
* BDI score ≤ 10
* Patients free of exacerbations for at least 1 month
Exclusion Criteria
* Diagnosis of asthma
* Patients treated for exacerbations in the 4 weeks prior to screening visit
* Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as PRN
* Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia
* Known respiratory disorders other than COPD
* Patients who have clinically significant cardiovascular condition
40 Years
80 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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Michael POLKEY, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus, London SW7 2AZ; UK
Locations
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Chiesi Clinical Trial Site 1017
Sevlievo, , Bulgaria
Chiesi Clinical Trial Site 1010
Sofia, , Bulgaria
Chiesi Clinical Trial Site 1011
Sofia, , Bulgaria
Chiesi Clinical Trial Site 1014
Sofia, , Bulgaria
Chiesi Clinical Trial Site 1015
Sofia, , Bulgaria
Chiesi Clinical Trial Site 1016
Sofia, , Bulgaria
Chiesi Clinical Trial Site 1012
Stara Zagora, , Bulgaria
Chiesi Clinical Trial Site 1013
Troyan Municipality, , Bulgaria
Chiesi Clinical Trial Site 2024
Berlin, , Germany
Chiesi Clinical Trial Site 2028
Berlin, , Germany
Site 2020 - Pulmonary Research Institute at Hospital Grosshansdorf
Großhansdorf, , Germany
Chiesi Clinical Trial Site 2027
Hamburg, , Germany
Chiesi Clinical Trial Site 2026
Leipzig, , Germany
Chiesi Clinical Trial Site 2023
Magdeburg, , Germany
Chiesi Clinical Trial Site 2021
Radebeul, , Germany
Chiesi Clinical Trial Site 2022
Witten, , Germany
Chiesi Clinical Trial Site 3039
Bydgoszcz, , Poland
Chiesi Clinical Trial Site 3032
Katowice, , Poland
Chiesi Clinical Trial Site 3035
Krakow, , Poland
Chiesi Clinical Trial Site 3037
Lubin, , Poland
Chiesi Clinical Trial Site 3031
Ostrowiec Świętokrzyski, , Poland
Chiesi Clinical Trial Site 3033
Oświęcim, , Poland
Chiesi Clinical Trial Site 3038
Rzeszów, , Poland
Chiesi Clinical Trial Site 3034
Tarnów, , Poland
Chiesi Clinical Trial Site 3030
Wroclaw, , Poland
Chiesi Clinical Trial Site 3036
Zgierz, , Poland
Site 4040 - Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus
London, , United Kingdom
Chiesi Clinical Trial Site 4042
London, , United Kingdom
Chiesi Clinical Trial Site 4041
Manchester, , United Kingdom
Countries
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Related Links
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Study Record on EU Clinical Trials Register including results
CSR Synopsis available in the CHIESI Clinical Study Register
Other Identifiers
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2013-005268-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CCD-05993AA1-09
Identifier Type: -
Identifier Source: org_study_id