Estimation and application of the minimum clinically important difference in COPD

Jones, Paul

doi:10.1016/s2213-2600(14)70038-4

Cited by 12 publications

(13 citation statements)

References 6 publications

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“…Since there was no placebo arm, further analysis of the relevance of these improvements is limited. Responder analyses have been proposed as an additional approach to assessing efficacy of treatments in COPD, particularly for studies in which second and third treatments are added to current therapy [28]. In our studies, responder rates, defined as a reduction in SGRQ total score of ≥4 units from baseline, were significantly greater for tiotropium+olodaterol FDC 5/5 μg compared with its monotherapy components and for 2.5/5 µg compared with olodaterol 5 µg.…”

Section: Discussionmentioning

confidence: 67%

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Tiotropium and olodaterol fixed-dose combinationversusmono-components in COPD (GOLD 2–4)

Buhl¹,

et al. 2015

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Efficacy and safety of tiotropium+olodaterol fixed-dose combination (FDC) compared with the mono-components was evaluated in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) in two replicate, randomised, double-blind, parallel-group, multicentre, phase III trials.Patients received tiotropium+olodaterol FDC 2.5/5 μg or 5/5 μg, tiotropium 2.5 μg or 5 μg, or olodaterol 5 μg delivered once-daily via Respimat inhaler over 52 weeks. Primary end points were forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h (AUC0–3) response, trough FEV1 response and St George's Respiratory Questionnaire (SGRQ) total score at 24 weeks.In total, 5162 patients (2624 in Study 1237.5 and 2538 in Study 1237.6) received treatment. Both FDCs significantly improved FEV1 AUC0–3 and trough FEV1 response versus the mono-components in both studies. Statistically significant improvements in SGRQ total score versus the mono-components were only seen for tiotropium+olodaterol FDC 5/5 μg. Incidence of adverse events was comparable between the FDCs and the mono-components.These studies demonstrated significant improvements in lung function and health-related quality of life with once-daily tiotropium+olodaterol FDC versus mono-components over 1 year in patients with moderate to very severe COPD.

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Section: Discussionmentioning

confidence: 67%

“…Improvements in SGRQ that exceeded the minimum clinically important difference of 4 units for this measure were seen in all treatment arms, but the difference between the FDCs and the monotherapies did not meet this threshold [28]. Since there was no placebo arm, further analysis of the relevance of these improvements is limited.…”

Section: Discussionmentioning

confidence: 99%

Tiotropium and olodaterol fixed-dose combinationversusmono-components in COPD (GOLD 2–4)

Buhl¹,

et al. 2015

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“…One explanation for this could be the greater proportion of patients with slightly milder disease in the Japanese sub-population. Furthermore, improvements were seen in all treatment groups for SGRQ total scores (change from baseline), above the minimum clinically important difference of four units 14. These improvements were nominally statistically significant for tiotropium + olodaterol 5/5 μg compared to individual components, with Japanese patients reporting much less severe SGRQ scores in their stable periods and superior improvements in SGRQ scores following treatment.…”

Section: Discussionmentioning

confidence: 85%

The efficacy and safety of combined tiotropium and olodaterol via the Respimat<sup>®</sup> inhaler in patients with COPD: results from the Japanese sub-population of the Tonado<sup>®</sup> studies

Ichinose¹,

Taniguchi²,

Takizawa

et al. 2016

COPD

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BackgroundThe efficacy and safety of once-daily tiotropium + olodaterol (T+O) maintenance treatment was demonstrated in the large, multinational, replicate, randomized, Phase III, Tonado® 1 (NCT01431274) and 2 (NCT01431287) studies in patients with moderate to very severe COPD. However, there may be racial differences in the effects of T+O on lung function in patients with COPD.MethodsIn this Tonado® subgroup analysis, we assessed efficacy and safety of T+O in Japanese participants.ResultsVersus the overall population, the 413 Japanese patients randomized and treated were slightly older, with more men, lower body mass index, lower baseline St George’s Respiratory Questionnaire (SGRQ) scores, fewer current smokers, but with higher pack-year smoking history. A lower proportion of Japanese patients used inhaled corticosteroids, short-acting muscarinic antagonists, or short- or long-acting β-adrenergic agonists at baseline, but use of long-acting muscarinic antagonists was higher. At Week 24, mean improvements with T+O 5/5 μg in forced expiratory volume in 1 second area under the curve from 0–3 hours response were 151 mL versus olodaterol and 134 mL versus tiotropium 5 μg; mean improvements with T+O 2.5/5 μg were 87 mL versus olodaterol and 70 mL versus tiotropium 2.5 μg. Mean improvements with T+O 5/5 μg in trough forced expiratory volume in 1 second were 131 mL versus olodaterol and 108 mL versus tiotropium 5 μg; mean improvements with T+O 2.5/5 μg were 60 mL versus olodaterol and 47 mL versus tiotropium 2.5 μg. SGRQ scores improved from baseline to a greater extent with both doses of T+O versus monotherapies. Responses were similar in the overall population. Adverse-event incidence was generally balanced across treatment groups.ConclusionConsistent with results from the overall population, T+O 5/5 μg was superior to each monotherapy for lung function and SGRQ in the Japanese sub-population of patients with COPD in Tonado®.

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“…Patients were classed as responders or deteriorators if SGRQ total score was decreased or increased by ≥4 units from baseline, respectively, based on the proposed MCID for SGRQ. 33 …”

Section: Methodsmentioning

confidence: 99%

Effect of tiotropium and olodaterol on symptoms and patient-reported outcomes in patients with COPD: results from four randomised, double-blind studies

Ferguson¹,

Karpel

Bennett

et al. 2017

npj Prim Care Resp Med

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Chronic obstructive pulmonary disease is associated with significant morbidity and mortality. Trials of maintenance chronic obstructive pulmonary disease treatments focus on improvement in lung function and reductions in exacerbations, while patients are much more concerned about symptoms and health status. Our aim was to investigate the effects of tiotropium + olodaterol on patient-reported health outcomes, breathlessness and night-time rescue medication use in patients with chronic obstructive pulmonary disease, compared to placebo, tiotropium or olodaterol monotherapy. Two pairs of replicate, phase III studies of 12 (OTEMTO 1 + 2) and 52 weeks’ (TONADO 1 + 2) duration were evaluated, in which patients received either tiotropium + olodaterol 2.5/5 or 5/5 μg, tiotropium 2.5 or 5 μg, olodaterol 5 μg or placebo, all delivered once daily via Respimat inhaler. Patient-reported outcomes included breathlessness assessed by transition dyspnoea index focal score, health status assessed by St George’s Respiratory Questionnaire total score and night-time rescue medication use at 12 or 24 weeks. Outcomes from the pooled study data are reported. Overall, 1621 and 5162 patients were treated in the OTEMTO and TONADO trials, respectively. Significantly larger improvements in St George’s Respiratory Questionnaire and transition dyspnoea index focal scores were observed and a greater proportion of patients were responders to therapy (based on minimum clinically important differences in St George’s Respiratory Questionnaire and transition dyspnoea index) with tiotropium + olodaterol compared to either monotherapy or to placebo. Tiotropium + olodaterol 5/5 µg significantly reduced night-time rescue medication usage.

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Estimation and application of the minimum clinically important difference in COPD

Cited by 12 publications

References 6 publications

Tiotropium and olodaterol fixed-dose combinationversusmono-components in COPD (GOLD 2–4)

Tiotropium and olodaterol fixed-dose combinationversusmono-components in COPD (GOLD 2–4)

The efficacy and safety of combined tiotropium and olodaterol via the Respimat<sup>®</sup> inhaler in patients with COPD: results from the Japanese sub-population of the Tonado<sup>®</sup> studies

Effect of tiotropium and olodaterol on symptoms and patient-reported outcomes in patients with COPD: results from four randomised, double-blind studies

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Estimation and application of the minimum clinically important difference in COPD

Cited by 12 publications

References 6 publications

Tiotropium and olodaterol fixed-dose combinationversusmono-components in COPD (GOLD 2–4)

Tiotropium and olodaterol fixed-dose combinationversusmono-components in COPD (GOLD 2–4)

The efficacy and safety of combined tiotropium and olodaterol via the Respimat<sup>&reg;</sup> inhaler in patients with COPD: results from the Japanese sub-population of the Tonado<sup>&reg;</sup> studies

Effect of tiotropium and olodaterol on symptoms and patient-reported outcomes in patients with COPD: results from four randomised, double-blind studies

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The efficacy and safety of combined tiotropium and olodaterol via the Respimat<sup>®</sup> inhaler in patients with COPD: results from the Japanese sub-population of the Tonado<sup>®</sup> studies