The impact of cineole treatment timing on common cold duration and symptoms: Non-randomized exploratory clinical trial.

IntroductionCommon 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.MethodsOut 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).ResultsComparing 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 ConclusionsEarly intervention shows clinical benefits relevant for the effective treatment of CC with cineole

MMRM model 1 for WURSS-11 mean daily symptom score (without imputation).

MMRM model 1 for WURSS-11 mean daily symptom score (without imputation).</p

Time to remission; bars represent the AFT model geometric means of the endpoint for individual time to treatment strata (sensitivity analysis), with 95% CIs as whiskers.

Time to remission; bars represent the AFT model geometric means of the endpoint for individual time to treatment strata (sensitivity analysis), with 95% CIs as whiskers.</p

MMRM model 1 for WURSS-11 mean daily QoL score (without imputation).

MMRM model 1 for WURSS-11 mean daily QoL score (without imputation).</p

MMRM model 1 for WURSS-11 mean daily total score (without imputation).

MMRM model 1 for WURSS-11 mean daily total score (without imputation).</p

GLM model 3 for WURSS-11 AUC.

IntroductionCommon 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.MethodsOut 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).ResultsComparing 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 ConclusionsEarly intervention shows clinical benefits relevant for the effective treatment of CC with cineole.</div

Source data tables.

IntroductionCommon 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.MethodsOut 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).ResultsComparing 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 ConclusionsEarly intervention shows clinical benefits relevant for the effective treatment of CC with cineole.</div

Occurrence of acute bronchitis during the trial.

IntroductionCommon 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.MethodsOut 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).ResultsComparing 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 ConclusionsEarly intervention shows clinical benefits relevant for the effective treatment of CC with cineole.</div