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Trial record 14 of 186 for:    GLYCOPYRROLATE

Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients (Trigon)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02189577
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate bromide) for the treatment of COPD patients.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: CHF 5259 Drug: Placebo Phase 2

Detailed Description:
A Multinational, Multicentre, Randomised, Double Blind, Placebo-Controlled, 2-way Crossover Study to Evaluate the Efficacy and Safety of Glycopyrrolate Bromide Administered Via pMDI (CHF 5259), for the Treatment of Patients With Chronic Obstructive Pulmonary Disease

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multinational, Multicentre, Randomised, Double Blind, Placebo-Controlled, 2-way Crossover Study to Evaluate the Efficacy and Safety of Glycopyrrolate Bromide Administered Via pMDI (CHF 5259), for the Treatment of Patients With Chronic Obstructive Pulmonary Disease
Study Start Date : June 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: CHF 5259
CHF 5259
Drug: 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.
Other Name: glycopyrrolate bromide

Placebo Comparator: Placebo
Placebo
Drug: 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.




Primary Outcome Measures :
  1. Change from baseline in pre-dose morning FEV1 on Day 28 [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  1. Change from baseline to day 28 in area under the curve for forced expiratory volume in 1 second measured at 11 timepoints between 0 to 12 hours postdose (FEV1 AUC0-12h) [ Time Frame: Day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female adults (40 ≤ age ≤ 80 years) with a diagnosis of COPD
  • 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:

  • Pregnant or lactating women
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189577


Locations
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Bulgaria
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, Bulgaria
Germany
Chiesi Clinical Trial Site 2024
Berlin, Germany
Chiesi Clinical Trial Site 2028
Berlin, Germany
Site 2020 - Pulmonary Research Institute at Hospital Grosshansdorf
Großhansdorf, Germany, D-22927
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
Poland
Chiesi Clinical Trial Site 3039
Bydgoszcz, Poland
Chiesi Clinical Trial Site 3032
Katowice, Poland
Chiesi Clinical Trial Site 3035
Kraków, 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
Wrocław, Poland
Chiesi Clinical Trial Site 3036
Zgierz, Poland
United Kingdom
Site 4040 - Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus
London, United Kingdom, SW7 2AZ
Chiesi Clinical Trial Site 4042
London, United Kingdom
Chiesi Clinical Trial Site 4041
Manchester, United Kingdom
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
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Principal Investigator: Michael POLKEY, MD Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus, London SW7 2AZ; UK

Additional Information:
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Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT02189577     History of Changes
Other Study ID Numbers: CCD-05993AA1-09
2013-005268-25 ( EudraCT Number )
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information.

Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.

Access Criteria: Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
URL: https://www.chiesi.com/en/chiesi-clinical-trial-data-request-portal/
Keywords provided by Chiesi Farmaceutici S.p.A.:
Chronic Obstructive Pulmonary disease
COPD
Additional relevant MeSH terms:
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Glycopyrrolate
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bromides
Anticonvulsants
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs