Trial reportInternational journal of chronic obstructive pulmonary disease2014
Lung function efficacy and symptomatic benefit of olodaterol once daily delivered via Respimat® versus placebo and formoterol twice daily in patients with GOLD 2-4 COPD: results from two replicate 48-week studies.
Trial report in International journal of chronic obstructive pulmonary disease, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 9 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
53 citing papers in PubMed, 9 syntheses or guidelines pooled it.
- Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials.Respiratory research · 2020Pooled it
- Romanian clinical guideline for diagnosis and treatment of COPD.The Journal of international medical research · 2020Guideline
- Dual combination therapy versus long-acting bronchodilators alone for chronic obstructive pulmonary disease (COPD): a systematic review and network meta-analysis.The Cochrane database of systematic reviews · 2018Pooled it
- The impact of olodaterol on the risk of mortality and serious adverse events: a systematic review and meta-analysis.British journal of clinical pharmacology · 2017Pooled it
- Comparative efficacy of long-acting β2-agonists as monotherapy for chronic obstructive pulmonary disease: a network meta-analysis.International journal of chronic obstructive pulmonary disease · 2017Pooled it
- Comparative efficacy of fixed-dose combinations of long-acting muscarinic antagonists and long-acting β2-agonists: a systematic review and network meta-analysis.Therapeutic advances in respiratory disease · 2016Pooled it
- Long-acting beta2-agonist in addition to tiotropium versus either tiotropium or long-acting beta2-agonist alone for chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2015Pooled it
- Inhaled Long-Acting β2-Agonists Do Not Increase Fatal Cardiovascular Adverse Events in COPD: A Meta-Analysis.PloS one · 2015Pooled it
- Once-daily long-acting beta-agonists for chronic obstructive pulmonary disease: an indirect comparison of olodaterol and indacaterol.International journal of chronic obstructive pulmonary disease · 2014Pooled it
- Effectiveness of one-on-one coaching in improving pressurized metered dose inhaler (pMDI) technique among COPD patients: a prospective clinical study.BMC pulmonary medicine · 2021Trial
- Absence of Adverse Effects of Tiotropium/Olodaterol Compared with the Monocomponents on Long-Term Heart Rate and Blood Pressure in Patients with Moderate-to-Very-Severe COPD.International journal of chronic obstructive pulmonary disease · 2020Trial
- Dose Determination for a Fixed-Dose Drug Combination: A Phase II Randomized Controlled Trial for Tiotropium/Olodaterol Versus Tiotropium in Patients with COPD.Advances in therapy · 2019Trial
- Tiotropium/olodaterol versus tiotropium in Japanese patients with COPD: results from the DYNAGITO study.International journal of chronic obstructive pulmonary disease · 2018Trial
- Long-term safety of tiotropium/olodaterol RespimatInternational journal of chronic obstructive pulmonary disease · 2018Trial
- Comprehensive assessment of the safety of olodaterol 5 µg in the RespimatNPJ primary care respiratory medicine · 2017Trial
- Effects of combined tiotropium/olodaterol on inspiratory capacity and exercise endurance in COPD.The European respiratory journal · 2017Trial
- Effect of tiotropium and olodaterol on symptoms and patient-reported outcomes in patients with COPD: results from four randomised, double-blind studies.NPJ primary care respiratory medicine · 2017Trial
- Lung function and long-term safety of tiotropium/olodaterol in East Asian patients with chronic obstructive pulmonary disease.International journal of chronic obstructive pulmonary disease · 2017Trial
- Evaluation of the effects of olodaterol on exercise endurance in patients with chronic obstructive pulmonary disease: results from two 6-week crossover studies.Respiratory research · 2016Trial
- Randomized, Double-Blind, Dose-Finding Study for Tiotropium when Added to Olodaterol, Administered via the Respimat® Inhaler in Patients with Chronic Obstructive Pulmonary Disease.Advances in therapy · 2015Trial
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Two replicate, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase III studies investigated the long-term efficacy and safety of once-daily olodaterol via Respimat® versus placebo and formoterol over 48 weeks in patients with moderate to very severe chronic obstructive pulmonary disease receiving usual-care background therapy. Patients received once-daily olodaterol 5 or 10 μg, twice-daily formoterol 12 μg, or placebo. Co-primary end points were forced expiratory volume in 1 second (FEV1) area under the curve from 0-3 hours response, FEV1 trough response, and Mahler transition dyspnea index total score after 24 weeks; secondary end points included St George's Respiratory Questionnaire. Overall, 904 (Study 1222.13) and 934 (Study 1222.14) patients received treatment. Olodaterol significantly improved FEV1 area under the curve from 0-3 hours versus placebo in both studies (with olodaterol 5 μg, 0.151 L and 0.129 L; with olodaterol 10 μg, 0.165 L and 0.154 L; for all comparisons P<0.0001) and FEV1 trough responses versus placebo (0.053-0.085 L; P<0.01), as did formoterol. Primary analysis revealed no significant difference in transition dyspnea index focal score for any active treatment versus placebo. Post hoc analysis using pattern mixture modeling (accounting for discontinuations) demonstrated statistical significance for olodaterol versus placebo. St George's Respiratory Questionnaire total score was significantly improved with olodaterol, but not formoterol, versus placebo. No safety signals were identified from adverse-event or other safety data. Once-daily olodaterol 5 μg and 10 μg is efficacious in patients with moderate to very severe chronic obstructive pulmonary disease on usual-care maintenance therapy, with a satisfactory safety profile.
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Registered trials
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