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. 2016 Sep 23;17(1):120.
doi: 10.1186/s12931-016-0433-5.

Eligibility of real-life patients with COPD for inclusion in trials of inhaled long-acting bronchodilator therapy

David M G Halpin  1 , Marjan Kerkhof  2 , Joan B Soriano  3 , Helga Mikkelsen  4 , David B Price  5
Affiliations

Eligibility of real-life patients with COPD for inclusion in trials of inhaled long-acting bronchodilator therapy

David M G Halpin et al. Respir Res. .

Abstract

Background: Management guidelines of chronic obstructive pulmonary disease (COPD) are mainly based on results of randomised controlled trials (RCTs), but some authors have suggested limited representativeness of patients included in these trials. No previous studies have applied the full range of selection criteria to a broad COPD patient population in a real-life setting.

Methods: We identified all RCTs of inhaled long-acting bronchodilator therapy, during 1999-2013, at ClinicalTrials.gov and translated trial selection criteria into definitions compatible with electronic medical records. Eligibility was calculated for each RCT by applying these criteria to a uniquely representative, well-characterised population of patients with COPD from the Optimum Patient Care Research Database (OPCRD).

Results: Median eligibility of 36 893 patients with COPD for participation in 31 RCTs was 23 % (interquartile range 12-38). Two studies of olodaterol showed the highest eligibility of 55 and 58 %. Conversely, the lowest eligibility was observed in two studies that required a history of exacerbations in the past year (3.5 and 3.9 %). For the patient subgroup with modified Medical Research Council score ≥2, the overall median eligibility was 27 %.

Conclusions: By applying an extensive range of RCT selection criteria to a large, representative COPD patient population, this study highlights that the interpretation of results from RCTs must take into account that RCT participants are variably, but generally more representative of patients in the community than previously believed.

Keywords: Chronic obstructive pulmonary disease; Long-acting bronchodilator; Randomised controlled trial; Real-life research.

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Figures

Fig. 1
Fig. 1
Selection of clinical trials. Flow chart showing the criteria and stepwise selection process of eligible randomised controlled trials (RCTs). Search parameters are outlined in the supplementary methods. Abbreviations: COPD = chronic obstructive pulmonary disease; FDC = fixed-dose combination; ICS = inhaled corticosteroids; LA-BD = long-acting bronchodilator; LABA = long-acting β-agonist; LAMA = long-acting muscarinic antagonist; PDE-4 = phosphodiesterase-4; RCT = randomised controlled trial
Fig. 2
Fig. 2
Selection of study population. Patient flow chart showing selection of study population from the Optimum Patient Care Research Database (OPCRD). Abbreviations: COPD = chronic obstructive pulmonary disease; FEV1 = forced expiratory volume in one second; mMRC = modified Medical Research Council score [2]
Fig. 3
Fig. 3
Eligibility to participate in randomised controlled trials (RCT). Eligibility of patients from the Optimum Patient Care Research Database (OPCRD) to be included in individual randomised controlled trials (RCTs) by RCT start year. Data show fraction of; a total population of patients with chronic obstructive pulmonary disease (COPD) and b patients with COPD and modified Medical Research Council (mMRC) score ≥2. Data on trials investigating long-acting β-agonists (LABA) are indicated by ○, long-acting muscarinic antagonists (LAMA) by ▲, and LABA + LAMA combination therapy by ■
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