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

NCT03858348 | Completed

• 1 other identifier: 2019-FLSAL-EL-94
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; COPD Exacerbation

Outcome Measures

Primary Outcomes (2)

• FEV1

  The rate of FEV1 change in patients in both groups A and B during the recording period.

  36 months

• Exacerbations

  The number of exacerbations per year of patients in both groups A and B during the recording period.

  36 months

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients

You may qualify if:

• 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.

You may not qualify if:

• Patients with asthma

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (1)

Papanikolaou Hospital of Thessaloniki

Thessaloniki, Greece

Location

Related Links

• A retrospective evaluation of lung function and exacerbations in COPD patients-RETRIEVE study European Respiratory Journal 2021 58: PA2402; DOI: 10.1183/13993003.
• Factors influencing LAMA addition to COPD patients receiving ICS/LABA in clinical practice-RETRIEVE study European Respiratory Journal 2021 58: PA795; DO

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 28, 2019
• Study Start: May 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

GR (1)