Lung function and long-term safety of tiotropium/olodaterol in East Asian patients with chronic obstructive pulmonary disease
BACKGROUND AND PURPOSE: While the efficacy and safety of combined tiotropium and olodaterol in patients with COPD was established in a large clinical trial program, it is important to assess whether clinical data can be applied to geographic patient groups, particularly for East Asian patients who may have a different phenotypic profile to the global trial population. This study aimed to compare the lung function and safety profiles of tiotropium/olodaterol and monocomponents in East Asian and global populations from the TONADO® trials.
MATERIALS AND METHODS: In the replicate, double-blind, parallel-group, active-controlled, randomized, 52-week, Phase III TONADO studies, patients received tiotropium/olodaterol, tiotropium, or olodaterol. We assessed the forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 3 hours (AUC0-3) response and trough FEV1 response at 24 weeks for the approved doses, tiotropium/olodaterol 5/5 μg, tiotropium 5 μg, and olodaterol 5 μg. Treatment-emergent adverse events were recorded throughout treatment and ≤21 days after study medication.
RESULTS: In the East Asian population, 1,152 patients were randomized (5,163 overall). After 24 weeks, FEV1 AUC0-3 and trough FEV1 responses were greater (P<0.0001) with tiotropium/olodaterol 5/5 μg in both populations versus tiotropium or olodaterol. The East Asian population showed slightly greater trough FEV1 treatment differences between tiotropium/olodaterol 5/5 μg and tiotropium compared to the overall population. Generally, no increase in adverse events was seen with tiotropium/olodaterol 5/5 μg compared to tiotropium and olodaterol in either population.
CONCLUSION: The efficacy and safety profile of tiotropium/olodaterol 5/5 μg has been demonstrated for both East Asian and global populations.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2017 |
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| Erschienen: |
2017 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:12 |
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| Enthalten in: |
International journal of chronic obstructive pulmonary disease - 12(2017) vom: 15., Seite 3329-3339 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Bai, Chunxue [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 16.07.2018 Date Revised 07.12.2022 published: Electronic-eCollection Citation Status MEDLINE |
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| doi: |
10.2147/COPD.S137719 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM278662145 |
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| 100 | 1 | |a Bai, Chunxue |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Lung function and long-term safety of tiotropium/olodaterol in East Asian patients with chronic obstructive pulmonary disease |
| 264 | 1 | |c 2017 | |
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| 500 | |a Date Completed 16.07.2018 | ||
| 500 | |a Date Revised 07.12.2022 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND AND PURPOSE: While the efficacy and safety of combined tiotropium and olodaterol in patients with COPD was established in a large clinical trial program, it is important to assess whether clinical data can be applied to geographic patient groups, particularly for East Asian patients who may have a different phenotypic profile to the global trial population. This study aimed to compare the lung function and safety profiles of tiotropium/olodaterol and monocomponents in East Asian and global populations from the TONADO® trials | ||
| 520 | |a MATERIALS AND METHODS: In the replicate, double-blind, parallel-group, active-controlled, randomized, 52-week, Phase III TONADO studies, patients received tiotropium/olodaterol, tiotropium, or olodaterol. We assessed the forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 3 hours (AUC0-3) response and trough FEV1 response at 24 weeks for the approved doses, tiotropium/olodaterol 5/5 μg, tiotropium 5 μg, and olodaterol 5 μg. Treatment-emergent adverse events were recorded throughout treatment and ≤21 days after study medication | ||
| 520 | |a RESULTS: In the East Asian population, 1,152 patients were randomized (5,163 overall). After 24 weeks, FEV1 AUC0-3 and trough FEV1 responses were greater (P<0.0001) with tiotropium/olodaterol 5/5 μg in both populations versus tiotropium or olodaterol. The East Asian population showed slightly greater trough FEV1 treatment differences between tiotropium/olodaterol 5/5 μg and tiotropium compared to the overall population. Generally, no increase in adverse events was seen with tiotropium/olodaterol 5/5 μg compared to tiotropium and olodaterol in either population | ||
| 520 | |a CONCLUSION: The efficacy and safety profile of tiotropium/olodaterol 5/5 μg has been demonstrated for both East Asian and global populations | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a COPD | |
| 650 | 4 | |a TONADO® | |
| 650 | 4 | |a adverse effects | |
| 650 | 4 | |a pulmonary function | |
| 650 | 7 | |a Adrenergic beta-2 Receptor Agonists |2 NLM | |
| 650 | 7 | |a Benzoxazines |2 NLM | |
| 650 | 7 | |a Bronchodilator Agents |2 NLM | |
| 650 | 7 | |a Cholinergic Antagonists |2 NLM | |
| 650 | 7 | |a Drug Combinations |2 NLM | |
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| 650 | 7 | |a Tiotropium Bromide |2 NLM | |
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| 700 | 1 | |a Ichinose, Masakazu |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Sang Haak |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Kwan Ho |e verfasserin |4 aut | |
| 700 | 1 | |a Jöns, Olaf |e verfasserin |4 aut | |
| 700 | 1 | |a Bothner, Ulrich |e verfasserin |4 aut | |
| 700 | 1 | |a Zhao, Yihua |e verfasserin |4 aut | |
| 700 | 1 | |a Buhl, Roland |e verfasserin |4 aut | |
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