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Background
Long-acting bronchodilators represent the backbone of available treatments for chronic obstructive pulmonary disease (COPD) [1]. Both long-acting muscarinic antagonists (LAMA) and long acting beta-agonists (LABA) confer significant benefits to patients with COPD, which include but are not limited to improvement in lung function, symptoms, health status and reduction in the exacerbations rate [2-4]. Fixed-dose combinations (FDC) of a LAMA with a LABA were recently introduced and there are increasing number of studies supporting their efficacy and safety [5-7]. LAMA/LABA combination was included in the most recent Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy as a first line choice therapy for group D (high risk and symptoms) and recommended second option in B (low risk, high symptoms) and C (high risk, low symptoms) groups [1], and the Spanish COPD guidelines recommend the use of LABA/LAMA combinations as first line therapy in patients highly symptomatic and/or at risk for exacerbations [8].
The efficacy and safety of both tiotropium (TIO), the first LAMA introduced in clinical practice, and the LABA olodaterol (OLO) have been extensively evaluated in trials and also in clinical practice [3, 4, 9]. TIO/OLO FDC (5/5 ?g), recently approved for the treatment of COPD, has been thoroughly assessed for its efficacy and safety in COPD [10, 11].
Since the combination TIO/OLO is now approved for first line therapy in COPD it is necessary to evaluate the evidence accumulated about its efficacy and safety in these patients. Therefore, the aim of this systematic review was to assess the comparative efficacy, in terms of trough forced expiratory volume in 1 s (trough FEV1), quality of life with St. George’s Respiratory Questionnaire (SGRQ), dyspnea (Mahler Transition Dyspnoea Index focal score), exercise capacity, use of rescue medication and safety outcomes of TIO/OLO in combination, either administered in separate or same inhaler, versus the mono-components or any other active comparator (inhaled), in adult patients with COPD.
Methods
This systematic review methodology is based on a protocol which was registered in PROSPERO register of systematic reviews (CRD42016040162). The report follows the Preferred Reporting Items for Systematic Reviews and Meta-analyses Statement (PRISMA) guidance [12].
Study selection criteria
Eligible studies were randomized controlled trials (RCT) with a period of treatment and follow up of at least 6 weeks, in patients...