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Effectiveness of different treatments in Chronic obstructive pulmonary disease patients: an individual patient data pooled analysis of RCTs








Effectiveness of different treatments in Chronic obstructive pulmonary disease patients: an individual patient data pooled analysis of RCTs


Zihui Wang


National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University






20 September 2023


Chronic obstructive pulmonary disease (COPD) is a respiratory disease characterized by chronic symptoms (dyspnea, cough, sputum production) due to abnormalities of the airways and/alveoli that cause persistent airflow obstruction. The latest medical guideline recommends the therapy strategy (choice of single [Long-Acting Muscarinic Anatgonist, LAMA] or dual therapy [Long-Acting Beta Agonist (LABA)/LAMA]) of COPD based on the individual symptoms and exacerbation history.[1] However, there is no high-quality evidence to support this strategy. In the recent year, an trial suggested the therapy could benefit patients with mild to moderate COPD (forced expiratory valume in 1 second [FEV1] > 50% of predicted value).[2] However, whether choice of single or dual therapy based on lung function level (FEV1 of predicted value) is the well remains unknown. Therefore, the optimal strategy for COPD daily therapy reminds unclear.We aim to compare the effectiveness of single or dual therapy in COPD patients with different lung function levels, symptom scores, and acute exacerbation histories. With this pooled analysis, we could provide an evidence based strategy for the selection of medications for COPD daily therapy.Using a single indicator to assess the benefit of therapy is not reasonable.[3] Therefore, this study will choose the clinically important deterioration (CID, a composite outcome determined by lung function, symptom or health status score, and exacerbations) as the primary outcome to evaluate the effectiveness of therapies.Reference:1.   Global Initiative for Chronic Obstructive Lung Disease (GOLD). GLOBAL STRATEGY FOR PREVENTION, DIAGNOSIS AND MANAGEMENT OF COPD: 2023 Reprot. https://goldcopd.org/2023-gold-reports/. Update 2023.2.   Zhou Y, Zhong NS, Li X, et al. Tiotropium in Early-Stage Chronic Obstructive Pulmonary Disease. N Engl J Med. 2017;377(10):923-935. 3.   Singh, D., Criner, G. J., Naya, I., et al. Measuring disease activity in COPD: is clinically important deterioration the answer?. Respiratory research, 21(1), 134.



[{ "PostingID": 1555, "Title": "GSK-DB2113361", "Description": "A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily via a Novel Dry Powder Inhaler in Subjects with Chronic Obstructive Pulmonary Disease" },{ "PostingID": 1556, "Title": "GSK-DB2113373", "Description": "A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily via a Novel Dry Powder Inhaler in Subjects with Chronic Obstructive Pulmonary Disease" },{ "PostingID": 1641, "Title": "GSK-DB2113374", "Description": "A multi-center trial comparing the efficacy and safety of GSK573719/GW642444 with GSK573719 and with tiotropium over 24 weeks in subjects with COPD" },{ "PostingID": 1642, "Title": "GSK-DB2113360", "Description": "A multicenter trial comparing the efficacy and safety of GSK573719/GW642444 with GW642444 and with tiotropium over 24 weeks in subjects with COPD" },{ "PostingID": 3671, "Title": "GSK-ZEP117115", "Description": "A multicenter, trial comparing the efficacy and safety of Umeclidinium/Vilanterol 62.5/25 mcg once daily with Tiotropium 18 mcg once daily over 24 weeks in subjects with Chronic Obstructive Pulmonary Disease (COPD)." },{ "PostingID": 4329, "Title": "GSK-DB2116961", "Description": "Study DB2116961, A Multicentre, Randomised, Blinded, Parallel Group Study to Compare UMEC/VI (Umeclidinium/Vilanterol) in a Fixed Dose Combination With Indacaterol Plus Tiotropium in Symptomatic Subjects With Moderate to Very Severe COPD" },{ "PostingID": 4739, "Title": "GSK-DB2116960", "Description": "DB2116960: A Randomized, Double-Dummy, Parallel Group, Multicenter Trial Comparing the Efficacy and Safety of UMEC/VI (a fixed combination of Umeclidinium and Vilanterol) With Tiotropium In Subjects with COPD Who Continue To Have Symptoms on Tiotropium" },{ "PostingID": 16129, "Title": "NOVARTIS-CQVA149A2303", "Description": "A 26-week Treatment Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled (Open Label) Study to Assess the Efficacy, Safety and Tolerability of QVA149 (110/50 μg q.d.) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)" },{ "PostingID": 16130, "Title": "NOVARTIS-CQVA149A2339", "Description": "A Placebo and Active Controlled Study to Assess the Long-term Safety of Once Daily QVA149 for 52 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients With Moderate to Severe Airflow Limitation" },{ "PostingID": 16131, "Title": "NOVARTIS-CQVA149A2336", "Description": "A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation." },{ "PostingID": 16132, "Title": "NOVARTIS-CQVA149A2337", "Description": "A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation" },{ "PostingID": 16133, "Title": "NOVARTIS-CQVA149A2304", "Description": "A 64-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Effect of QVA149 (110/50 μg o.d.) vs NVA237 (50 μg o.d.) and Open-label Tiotropium (18 μg o.d.) on COPD Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD)" },{ "PostingID": 20277, "Title": "GSK-201749", "Description": "A 24-week treatment, multi-center, randomized, double-blind, double-dummy, parallel group study to compare Umeclidinium/Vilanterol, Umeclidinium, and Salmeterol in subjects with chronic obstructive pulmonary disease (COPD)" }]

Statistical Analysis Plan