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A Retrospective rEal-life daTa Study to Assess the exaceRbations and Lung functIon in Chronic Obstructive Pulmonary Disease ( COPD ) patiEnts receiVing Fluticasone/Salmeterol Comparing to Those Εscalating in Open-triple Fluticasone/Salmeterol, Long Acting Muscarinic Antagonist (LAMA) Combination (RETRIEVE)

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ClinicalTrials.gov Identifier: NCT03858348
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.

Study Description
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Brief Summary:
Inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) combination is commonly prescribed to treat COPD; we will perform a retrospective analysis on the effect of adding a long-acting muscarinic receptor antagonist (LAMA) to ICS/LABA combination in COPD.

Condition or disease
COPD COPD Exacerbation

Detailed Description:
According to the current guidelines for the treatment of COPD, it is recommended to use combination therapies with different or complementary mechanisms of action . Data suggest that open triple therapy incorporating LAMA with ICS / LABA combination products administered through different delivery devices may be beneficial for improving pulmonary function in patients with COPD. However, there is little evidence of the effect of triple therapy on pulmonary function and the incidence of exacerbations in COPD patients.
Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: A Retrospective rEal-life daTa Study to Assess the Incidence of exaceRbations and Change in Lung functIon Forced Expiratory Volume (FEV1) in Chronic Obstructive Pulmonary Disease ( COPD ) patiEnts receiVing Fluticasone/Salmeterol Fixed Dose Combination (FDC) Comparing to Those Εscalating in Open-triple Fluticasone/Salmeterol, Long Acting Muscarinic Antagonist (LAMA) Combination
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

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Groups and Cohorts
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Group/Cohort
fluticasone / salmeterol treatment
The evaluation of pulmonary function in patients with COPD receiving and maintaining a stable combination of fluticasone / salmeterol (Group A)
fluticasone / salmeterol and extra LAMA
The evaluation of pulmonary function in patients with COPD receiving and maintaining a stable combination of fluticasone / salmeterol and extra a long-acting muscarinic receptor antagonist (anticholinergic, LAMA) (Group B).


Outcome Measures
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Primary Outcome Measures :
  1. FEV1 [ Time Frame: 36 months ]
    The rate of FEV1 change in patients in both groups A and B during the recording period.

  2. Exacerbations [ Time Frame: 36 months ]
    The number of exacerbations per year of patients in both groups A and B during the recording period.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COPD patients
Criteria

Inclusion

  • Patients with COPD who started treatment with a fixed combination of fluticasone / salmeterol via the Elpenhaler® device after 01/01/2012 and were treated continuously for at least 1 year during the recording period.
  • Patients for whom spirometric data are available per monitoring year during recording.
  • Patients for whom exacerbation data are available per monitoring year during recording.

Exclusion

•Patients with asthma

Contacts and Locations
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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): NCT03858348


Locations
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Greece
Papanikolaou Hospital of Thessaloniki Recruiting
Thessaloniki, Greece
Contact: Stavros Tryfon, MD    0030 2310316816    statripneumo@yahoo.gr   
Sponsors and Collaborators
Elpen Pharmaceutical Co. Inc.
More Information
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Responsible Party: Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier: NCT03858348    
Other Study ID Numbers: 2019-FLSAL-EL-94
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases