The impact of cineole treatment timing on common cold duration and symptoms: Non-randomized exploratory clinical trial.
<h4<Introduction</h4<Common cold (CC) symptoms arise from an inflammatory response treatable with cineole and generally peak within two days, which complicates research implementation. We therefore explored the benefits of early cineole administration with enrolment of participants prior...
Ausführliche Beschreibung
Autor*in: |
Andreas Michalsen [verfasserIn] Kim Goldenstein [verfasserIn] Peter Kardos [verfasserIn] Ludger Klimek [verfasserIn] Jürgen Palm [verfasserIn] Dajana Parganlija [verfasserIn] Johannes Stöckl [verfasserIn] |
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E-Artikel |
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Sprache: |
Englisch |
Erschienen: |
2024 |
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Übergeordnetes Werk: |
In: PLoS ONE - Public Library of Science (PLoS), 2007, 19(2024), 1, p e0296482 |
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Übergeordnetes Werk: |
volume:19 ; year:2024 ; number:1, p e0296482 |
Links: |
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DOI / URN: |
10.1371/journal.pone.0296482 |
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Katalog-ID: |
DOAJ097401285 |
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10.1371/journal.pone.0296482 doi (DE-627)DOAJ097401285 (DE-599)DOAJaab265b9d34a4d0bbd5918749a065a99 DE-627 ger DE-627 rakwb eng Andreas Michalsen verfasserin aut The impact of cineole treatment timing on common cold duration and symptoms: Non-randomized exploratory clinical trial. 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <h4<Introduction</h4<Common cold (CC) symptoms arise from an inflammatory response treatable with cineole and generally peak within two days, which complicates research implementation. We therefore explored the benefits of early cineole administration with enrolment of participants prior to CC onset.<h4<Methods</h4<Out of 522 adults enrolled in our phase IV, open-label, non-randomized, exploratory clinical trial (EudraCT No. 2020-000860-51), 329 developed a CC and used 200 mg cineole (Soledum®, CNL-1976) t.i.d. for max. 15 (± 2) days. Primary endpoint was burden of disease based on the Wisconsin Upper Respiratory Symptom Survey (WURSS-11).<h4<Results</h4<Comparing three strata based on time to treatment (≤ 12 h, < 12 to ≤ 24 h and < 24 h), earliest treatment resulted in lowest AUC-WURSS (Spearman correlation coefficient of 0.36) and reduced the overall burden of disease by 38% (p < 0.0001). Earlier and lower symptom severity peak resulted, with shorter time to remission (average 8.9 vs. 10.7 days with latest treatment initiation, p < 0.05), and higher and faster recovering quality of life (p < 0.05). Tolerability was mostly rated as "very good", with adverse events of suspected causal relationship reported in 4.3% of participants.<h4<Conclusions</h4<Early intervention shows clinical benefits relevant for the effective treatment of CC with cineole. Medicine R Science Q Kim Goldenstein verfasserin aut Peter Kardos verfasserin aut Ludger Klimek verfasserin aut Jürgen Palm verfasserin aut Dajana Parganlija verfasserin aut Johannes Stöckl verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 19(2024), 1, p e0296482 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:19 year:2024 number:1, p e0296482 https://doi.org/10.1371/journal.pone.0296482 kostenfrei https://doaj.org/article/aab265b9d34a4d0bbd5918749a065a99 kostenfrei https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0296482&type=printable kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2024 1, p e0296482 |
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10.1371/journal.pone.0296482 doi (DE-627)DOAJ097401285 (DE-599)DOAJaab265b9d34a4d0bbd5918749a065a99 DE-627 ger DE-627 rakwb eng Andreas Michalsen verfasserin aut The impact of cineole treatment timing on common cold duration and symptoms: Non-randomized exploratory clinical trial. 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <h4<Introduction</h4<Common cold (CC) symptoms arise from an inflammatory response treatable with cineole and generally peak within two days, which complicates research implementation. We therefore explored the benefits of early cineole administration with enrolment of participants prior to CC onset.<h4<Methods</h4<Out of 522 adults enrolled in our phase IV, open-label, non-randomized, exploratory clinical trial (EudraCT No. 2020-000860-51), 329 developed a CC and used 200 mg cineole (Soledum®, CNL-1976) t.i.d. for max. 15 (± 2) days. Primary endpoint was burden of disease based on the Wisconsin Upper Respiratory Symptom Survey (WURSS-11).<h4<Results</h4<Comparing three strata based on time to treatment (≤ 12 h, < 12 to ≤ 24 h and < 24 h), earliest treatment resulted in lowest AUC-WURSS (Spearman correlation coefficient of 0.36) and reduced the overall burden of disease by 38% (p < 0.0001). Earlier and lower symptom severity peak resulted, with shorter time to remission (average 8.9 vs. 10.7 days with latest treatment initiation, p < 0.05), and higher and faster recovering quality of life (p < 0.05). Tolerability was mostly rated as "very good", with adverse events of suspected causal relationship reported in 4.3% of participants.<h4<Conclusions</h4<Early intervention shows clinical benefits relevant for the effective treatment of CC with cineole. Medicine R Science Q Kim Goldenstein verfasserin aut Peter Kardos verfasserin aut Ludger Klimek verfasserin aut Jürgen Palm verfasserin aut Dajana Parganlija verfasserin aut Johannes Stöckl verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 19(2024), 1, p e0296482 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:19 year:2024 number:1, p e0296482 https://doi.org/10.1371/journal.pone.0296482 kostenfrei https://doaj.org/article/aab265b9d34a4d0bbd5918749a065a99 kostenfrei https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0296482&type=printable kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2024 1, p e0296482 |
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10.1371/journal.pone.0296482 doi (DE-627)DOAJ097401285 (DE-599)DOAJaab265b9d34a4d0bbd5918749a065a99 DE-627 ger DE-627 rakwb eng Andreas Michalsen verfasserin aut The impact of cineole treatment timing on common cold duration and symptoms: Non-randomized exploratory clinical trial. 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <h4<Introduction</h4<Common cold (CC) symptoms arise from an inflammatory response treatable with cineole and generally peak within two days, which complicates research implementation. We therefore explored the benefits of early cineole administration with enrolment of participants prior to CC onset.<h4<Methods</h4<Out of 522 adults enrolled in our phase IV, open-label, non-randomized, exploratory clinical trial (EudraCT No. 2020-000860-51), 329 developed a CC and used 200 mg cineole (Soledum®, CNL-1976) t.i.d. for max. 15 (± 2) days. Primary endpoint was burden of disease based on the Wisconsin Upper Respiratory Symptom Survey (WURSS-11).<h4<Results</h4<Comparing three strata based on time to treatment (≤ 12 h, < 12 to ≤ 24 h and < 24 h), earliest treatment resulted in lowest AUC-WURSS (Spearman correlation coefficient of 0.36) and reduced the overall burden of disease by 38% (p < 0.0001). Earlier and lower symptom severity peak resulted, with shorter time to remission (average 8.9 vs. 10.7 days with latest treatment initiation, p < 0.05), and higher and faster recovering quality of life (p < 0.05). Tolerability was mostly rated as "very good", with adverse events of suspected causal relationship reported in 4.3% of participants.<h4<Conclusions</h4<Early intervention shows clinical benefits relevant for the effective treatment of CC with cineole. Medicine R Science Q Kim Goldenstein verfasserin aut Peter Kardos verfasserin aut Ludger Klimek verfasserin aut Jürgen Palm verfasserin aut Dajana Parganlija verfasserin aut Johannes Stöckl verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 19(2024), 1, p e0296482 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:19 year:2024 number:1, p e0296482 https://doi.org/10.1371/journal.pone.0296482 kostenfrei https://doaj.org/article/aab265b9d34a4d0bbd5918749a065a99 kostenfrei https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0296482&type=printable kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2024 1, p e0296482 |
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10.1371/journal.pone.0296482 doi (DE-627)DOAJ097401285 (DE-599)DOAJaab265b9d34a4d0bbd5918749a065a99 DE-627 ger DE-627 rakwb eng Andreas Michalsen verfasserin aut The impact of cineole treatment timing on common cold duration and symptoms: Non-randomized exploratory clinical trial. 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <h4<Introduction</h4<Common cold (CC) symptoms arise from an inflammatory response treatable with cineole and generally peak within two days, which complicates research implementation. We therefore explored the benefits of early cineole administration with enrolment of participants prior to CC onset.<h4<Methods</h4<Out of 522 adults enrolled in our phase IV, open-label, non-randomized, exploratory clinical trial (EudraCT No. 2020-000860-51), 329 developed a CC and used 200 mg cineole (Soledum®, CNL-1976) t.i.d. for max. 15 (± 2) days. Primary endpoint was burden of disease based on the Wisconsin Upper Respiratory Symptom Survey (WURSS-11).<h4<Results</h4<Comparing three strata based on time to treatment (≤ 12 h, < 12 to ≤ 24 h and < 24 h), earliest treatment resulted in lowest AUC-WURSS (Spearman correlation coefficient of 0.36) and reduced the overall burden of disease by 38% (p < 0.0001). Earlier and lower symptom severity peak resulted, with shorter time to remission (average 8.9 vs. 10.7 days with latest treatment initiation, p < 0.05), and higher and faster recovering quality of life (p < 0.05). Tolerability was mostly rated as "very good", with adverse events of suspected causal relationship reported in 4.3% of participants.<h4<Conclusions</h4<Early intervention shows clinical benefits relevant for the effective treatment of CC with cineole. Medicine R Science Q Kim Goldenstein verfasserin aut Peter Kardos verfasserin aut Ludger Klimek verfasserin aut Jürgen Palm verfasserin aut Dajana Parganlija verfasserin aut Johannes Stöckl verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 19(2024), 1, p e0296482 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:19 year:2024 number:1, p e0296482 https://doi.org/10.1371/journal.pone.0296482 kostenfrei https://doaj.org/article/aab265b9d34a4d0bbd5918749a065a99 kostenfrei https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0296482&type=printable kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2024 1, p e0296482 |
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10.1371/journal.pone.0296482 doi (DE-627)DOAJ097401285 (DE-599)DOAJaab265b9d34a4d0bbd5918749a065a99 DE-627 ger DE-627 rakwb eng Andreas Michalsen verfasserin aut The impact of cineole treatment timing on common cold duration and symptoms: Non-randomized exploratory clinical trial. 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <h4<Introduction</h4<Common cold (CC) symptoms arise from an inflammatory response treatable with cineole and generally peak within two days, which complicates research implementation. We therefore explored the benefits of early cineole administration with enrolment of participants prior to CC onset.<h4<Methods</h4<Out of 522 adults enrolled in our phase IV, open-label, non-randomized, exploratory clinical trial (EudraCT No. 2020-000860-51), 329 developed a CC and used 200 mg cineole (Soledum®, CNL-1976) t.i.d. for max. 15 (± 2) days. Primary endpoint was burden of disease based on the Wisconsin Upper Respiratory Symptom Survey (WURSS-11).<h4<Results</h4<Comparing three strata based on time to treatment (≤ 12 h, < 12 to ≤ 24 h and < 24 h), earliest treatment resulted in lowest AUC-WURSS (Spearman correlation coefficient of 0.36) and reduced the overall burden of disease by 38% (p < 0.0001). Earlier and lower symptom severity peak resulted, with shorter time to remission (average 8.9 vs. 10.7 days with latest treatment initiation, p < 0.05), and higher and faster recovering quality of life (p < 0.05). Tolerability was mostly rated as "very good", with adverse events of suspected causal relationship reported in 4.3% of participants.<h4<Conclusions</h4<Early intervention shows clinical benefits relevant for the effective treatment of CC with cineole. Medicine R Science Q Kim Goldenstein verfasserin aut Peter Kardos verfasserin aut Ludger Klimek verfasserin aut Jürgen Palm verfasserin aut Dajana Parganlija verfasserin aut Johannes Stöckl verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 19(2024), 1, p e0296482 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:19 year:2024 number:1, p e0296482 https://doi.org/10.1371/journal.pone.0296482 kostenfrei https://doaj.org/article/aab265b9d34a4d0bbd5918749a065a99 kostenfrei https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0296482&type=printable kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2024 1, p e0296482 |
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The impact of cineole treatment timing on common cold duration and symptoms: Non-randomized exploratory clinical trial. |
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The impact of cineole treatment timing on common cold duration and symptoms: Non-randomized exploratory clinical trial |
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Andreas Michalsen Kim Goldenstein Peter Kardos Ludger Klimek Jürgen Palm Dajana Parganlija Johannes Stöckl |
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impact of cineole treatment timing on common cold duration and symptoms: non-randomized exploratory clinical trial |
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The impact of cineole treatment timing on common cold duration and symptoms: Non-randomized exploratory clinical trial. |
abstract |
<h4<Introduction</h4<Common cold (CC) symptoms arise from an inflammatory response treatable with cineole and generally peak within two days, which complicates research implementation. We therefore explored the benefits of early cineole administration with enrolment of participants prior to CC onset.<h4<Methods</h4<Out of 522 adults enrolled in our phase IV, open-label, non-randomized, exploratory clinical trial (EudraCT No. 2020-000860-51), 329 developed a CC and used 200 mg cineole (Soledum®, CNL-1976) t.i.d. for max. 15 (± 2) days. Primary endpoint was burden of disease based on the Wisconsin Upper Respiratory Symptom Survey (WURSS-11).<h4<Results</h4<Comparing three strata based on time to treatment (≤ 12 h, < 12 to ≤ 24 h and < 24 h), earliest treatment resulted in lowest AUC-WURSS (Spearman correlation coefficient of 0.36) and reduced the overall burden of disease by 38% (p < 0.0001). Earlier and lower symptom severity peak resulted, with shorter time to remission (average 8.9 vs. 10.7 days with latest treatment initiation, p < 0.05), and higher and faster recovering quality of life (p < 0.05). Tolerability was mostly rated as "very good", with adverse events of suspected causal relationship reported in 4.3% of participants.<h4<Conclusions</h4<Early intervention shows clinical benefits relevant for the effective treatment of CC with cineole. |
abstractGer |
<h4<Introduction</h4<Common cold (CC) symptoms arise from an inflammatory response treatable with cineole and generally peak within two days, which complicates research implementation. We therefore explored the benefits of early cineole administration with enrolment of participants prior to CC onset.<h4<Methods</h4<Out of 522 adults enrolled in our phase IV, open-label, non-randomized, exploratory clinical trial (EudraCT No. 2020-000860-51), 329 developed a CC and used 200 mg cineole (Soledum®, CNL-1976) t.i.d. for max. 15 (± 2) days. Primary endpoint was burden of disease based on the Wisconsin Upper Respiratory Symptom Survey (WURSS-11).<h4<Results</h4<Comparing three strata based on time to treatment (≤ 12 h, < 12 to ≤ 24 h and < 24 h), earliest treatment resulted in lowest AUC-WURSS (Spearman correlation coefficient of 0.36) and reduced the overall burden of disease by 38% (p < 0.0001). Earlier and lower symptom severity peak resulted, with shorter time to remission (average 8.9 vs. 10.7 days with latest treatment initiation, p < 0.05), and higher and faster recovering quality of life (p < 0.05). Tolerability was mostly rated as "very good", with adverse events of suspected causal relationship reported in 4.3% of participants.<h4<Conclusions</h4<Early intervention shows clinical benefits relevant for the effective treatment of CC with cineole. |
abstract_unstemmed |
<h4<Introduction</h4<Common cold (CC) symptoms arise from an inflammatory response treatable with cineole and generally peak within two days, which complicates research implementation. We therefore explored the benefits of early cineole administration with enrolment of participants prior to CC onset.<h4<Methods</h4<Out of 522 adults enrolled in our phase IV, open-label, non-randomized, exploratory clinical trial (EudraCT No. 2020-000860-51), 329 developed a CC and used 200 mg cineole (Soledum®, CNL-1976) t.i.d. for max. 15 (± 2) days. Primary endpoint was burden of disease based on the Wisconsin Upper Respiratory Symptom Survey (WURSS-11).<h4<Results</h4<Comparing three strata based on time to treatment (≤ 12 h, < 12 to ≤ 24 h and < 24 h), earliest treatment resulted in lowest AUC-WURSS (Spearman correlation coefficient of 0.36) and reduced the overall burden of disease by 38% (p < 0.0001). Earlier and lower symptom severity peak resulted, with shorter time to remission (average 8.9 vs. 10.7 days with latest treatment initiation, p < 0.05), and higher and faster recovering quality of life (p < 0.05). Tolerability was mostly rated as "very good", with adverse events of suspected causal relationship reported in 4.3% of participants.<h4<Conclusions</h4<Early intervention shows clinical benefits relevant for the effective treatment of CC with cineole. |
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