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Proposal 1322

Title of the Proposed Research

Comparative efficacy of different therapeutic approaches in the "naïve" patient with chronic obstructive pulmonary disease (COPD): analysis of patient-level data

Lead Researcher

Giulio Pareto



Funding Source


Potential Conflicts of Interest


Data Sharing Agreement Date

16 August 2016

Lay Summary

Chronic obstructive pulmonary disease (COPD) is a frequent disease, preventable and treatable, characterized by persistent airflow limitation that is usually evolutionary and is associated with increased chronic inflammatory response to inhaled pollutants in the airways and lung parenchyma (1). At present is the fourth leading cause of death with 2.75 million deaths per year worldwide (2) and is growing both in industrialized and in developing countries, with a prevalence of about 5% in the general population, but concentrated in the adult and elderly, predominantly male, where it can reach, above 60, rates of 20% prevalence1.The insidious onset is the main reason why the disease is now often diagnosed late, when the symptoms are severe, and the addition of a significant proportion of affected patients non intercepted by the doctor, make the disease at the time greatly underdiagnosed (3).

Our study aims to select from the database made available by the companies a naïve population of patients using data from the studies TORCH (4), TRISTAN (5) and MAHLER (6) in the absence of a bias as important as the exposure to previous respiratory treatments.

As part of the evaluation of the drug efficacy, we would assess “objective” parameters as lung function (expressed as change in FEV1 over time), the “most common used” patient related outcomes (PORs) as symptom and quality of life indicators (Saint George Respiratory Questionnaire [SGRQ] score and transition dyspnea index [TDI]) and, when possible, the mortality from all causes.

The aim will be to determine whether the impact of drug treatment in “naïve” patients leads to better improvements in the indicators starting form a different initial maintenance treatment as LABA/ICS, LABA or ICS alone.

Study Data Provided

Study GSK-SCO30003: A multicentre, randomised, double-blind, parallel group, placebo-controlled study to investigate the long-term effects of salmeterol/fluticasone propionate (SERETIDE® inhaler) 50/500mcg BD, salmeterol 50mcg BD and fluticasone propionate 500mcg BD, all delivered via the DISKUS®/ACCUHALER® inhaler, on mortality and morbidity of subjects with chronic obstructive pulmonary disease (COPD) over 3 years of treatment
Study GSK-SFCB3024: A multicentre, randomised, double-blind, parallel group study to compare the efficacy and safety of the Salmeterol/Fluticasone combination product (50/500mg strength) twice daily with Salmeterol 50mg twice daily alone and Fluticasone Propionate 500mg twice daily alone, all delivered via the Diskus/Accuhaler inhaler, in the treatment of patients with chronic obstructive pulmonary disease.
Study GSK-SFCA3006: A randomized, double-blind, placebo-controlled, parallel-group, trial evaluating the safety and efficacy of the Diskus formulations of salmeterol 50mcg twice daily and fluticasone propionate 500mcg twice daily individually and in combination as compared to placebo in COPD patients.

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.