Conclusions
Although the ICICC study failed to reach statistically significant outcomes for the primary and secondary endpoints, strong trends favouring treatment effect of I-C were observed. The primary and secondary endpoints consistently tended to be improved in the I-C spray group compared to the placebo group, with clinically relevant effect sizes, even though the population included patients with low baseline scores. Several rational and important exploratory analyses led to statistically significant and clinically relevant outcome differences. Unfortunately, the relatively low numbers of subjects with demonstrated viral infection limited study conclusions. Nonetheless, the outcome of the ICICC study is supported by previous evidence of I-C's in vitro antiviral activity and symptom and viral reduction in prior cold studies. The ICICC trial's outcome supports I-C spray as representing a potentially useful treatment option for the common cold. Trial results show it to be safe, well-tolerated, and minimally invasive, as well as suggesting efficacy.
Trial registration
NCT01944631 (clinicaltrials.gov)
Acknowledgements
We acknowledge Dr. Jill Holbrook who provided medical writing services on behalf of BI Pharma GmbH & Co. KG. We thank the staff at the Common Cold Centre: Dr. Moutaz Jawad, Dr. Eugene Wong, Miss Suhair Jawad, Mr. Ben Pope and Miss Edyta Zwolska. We acknowledge Prof Laurent Kaiser, University Hospitals of Geneva, Division of Infectious Diseases, Division of Laboratory Medicine - Laboratory of Virology, Geneva, Switzerland and his staff, Dr. Caroline Tapparel, Aline Mamin and Yves Thomas, for performing the virus analysis.
Respiratory Research. 2015;16(121) © 2015 BioMed Central, Ltd.
© 1999-2006 BioMed Central Ltd