Efficacy and Safety of Iota-Carrageenan Nasal Spray Versus Placebo in Early Treatment of the Common Cold in Adults

BMI body mass index, SD standard deviation

CI confidence interval, SE standard error
*For ANCOVA-adjusted comparison of placebo with I-C
^aThe means were adjusted for TSS₀
^bA negative treatment difference favored I-C
^cTSS₀ values are unadjusted means

CI confidence interval, SE standard error
*For ANCOVA-adjusted comparison of placebo with I-C
^aThe means were adjusted for baseline SSS, LSS, or TSS
^bA negative treatment difference favored I-C

CI confidence interval
*For ANCOVA-adjusted comparison of placebo with I-C
^aThe means were adjusted for baseline TSS
^bA negative treatment difference favours I-C

Categories are not exclusive; patients may appear in more than one category
^aEight patients were positive for 2 different viruses
^bNo patient tested positive for influenza B, human bocavirus, human paraecho virus, or parainfluenza 3
^cDetectable (quantifiable or non-quantifiable) result at baseline

CI confidence interval, SE standard error
*For ANCOVA-adjusted comparison of placebo with I-C
^aThe means were adjusted for baseline viral load
^bA negative treatment difference favored I-C
^cBaseline values are unadjusted means
^dCalculated according to Eccles et al. [5]

Authors and Disclosures

R. Eccles¹, B. Winther², S.L. Johnston³, P. Robinson⁴, M. Trampisch⁵ and S. Koelsch^6*

¹Common Cold Centre, Cardiff School of Biosciences, Cardiff University, Cardiff, UK. ²Respiratory Disease Study Center, University of Virginia, Charlottesville, VA, USA. ³Airway Disease Infection Section & MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, National Heart and Lung Institute, Imperial College, London, UK. ⁴Boehringer Ingelheim Pharmaceuticals Inc., Therapeutic Area Virology, Ridgefield, CT, USA. ⁵Boehringer Ingelheim Pharma GmbH & Co. KG, Biometrics & Data Management, Ingelheim/Rhein 55216, Germany. ⁶Boehringer Ingelheim Pharma GmbH & Co. KG, CHC Development, Medicine & Regulatory Affairs, Ingelheim/Rhein 55216, Germany

*Correspondence
stephan.koelsch@boehringer-ingelheim.com

Competing interests
The study was sponsored by Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany.
Patrick Robinson, Matthias Trampisch and Stephan Koelsch are employees of the sponsor.
Ronald Eccles was remunerated by the sponsor for his services as principal and coordinating investigator. Birgit Winther and Sebastian Johnston were reimbursed for their scientific advice for this study on a contractual basis by the sponsor.

Authors' contributions
Conception and design of the study was developed by the sponsor under the responsibility of SK. Principal investigator was RE. Statistical design and analysis was the responsibility of MT. Overall evaluation, interpretation of the data and preparation of the manuscript was the joint effort of all listed authors as coordinated by SK. All authors reviewed the manuscript critically and approved the final version to be published. At no time the sponsor took undue influence on the data presented here and the conclusions drawn from them.