Evidence map›Paper›PMID 26438038›Full record

Trial reportRespiratory research2015

Efficacy and safety of iota-carrageenan nasal spray versus placebo in early treatment of the common cold in adults: the ICICC trial.

R Eccles, B Winther, S L Johnston, P Robinson, M Trampisch, S Koelsch

3 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IVComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Respiratory research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 49 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 3 pooled it
3.0field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01944631 phase4completednot on this map

Efficacy and Safety of Iota-Carrageenan Nasal Spray 1.2 g/l (0.12 Percent) (Bisolviral) Versus Placebo Nasal Spray in the Early Treatment of Common Cold

TypeinterventionalSponsorBoehringer IngelheimRan2013 to 2014Enrolled200ConditionsCommon ColdArmsPlacebo, Iota-Carrageenan
NCT04590365 nacompletednot on this mapstarted 2020, after this paper: background citation

Efficacy of Carrageenan Nasal and Throat Spray for COVID-19 Prophylaxis - A Double Blind Randomised Placebo-controlled Trial

TypeinterventionalSponsorSwansea UniversityRan2020 to 2022Enrolled480ConditionsCOVID-19, SARS-CoV 2ArmsCarrageenan nasal and throat spray, Saline nasal and throat spray
NCT06531707 phase3unknown statusnot on this mapstarted 2024, after this paper: background citation

Efficacy and Safety of Ibuprofen/Loratadine Fixed-dose Combination Versus the Fixed-dose Administration of Monotherapy as Symptomatic Treatment for Patients With the Common Cold

TypeinterventionalSponsorLaboratorios Silanes S.A. de C.V.Ran2024 to 2025Enrolled177ConditionsCommon ColdArmsIbuprofen + Loratadine fixed dose, Ibuprofen, Loratadine
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 3 syntheses or guidelines pooled it, 97 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 3 countries.

R EcclesCommon Cold Centre, Cardiff School of Biosciences, Cardiff University, Cardiff, UK.
B WintherRespiratory Disease Study Center, University of Virginia, Charlottesville, VA, USA.
S L JohnstonAirway Disease Infection Section & MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, National Heart and Lung Institute, Imperial College, London, UK.
P RobinsonBoehringer Ingelheim Pharmaceuticals Inc., Therapeutic Area Virology, Ridgefield, CT, USA.
M TrampischBoehringer Ingelheim Pharma GmbH & Co. KG, Biometrics & Data Management, Ingelheim/Rhein, 55216, Germany.
S KoelschBoehringer Ingelheim Pharma GmbH & Co. KG, CHC Development, Medicine & Regulatory Affairs, Ingelheim/Rhein, 55216, Germany. stephan.koelsch@boehringer-ingelheim.com.
Boehringer Ingelheim (Germany) · DEAsthma UK · GBBoehringer Ingelheim (United States) · USCardiff University · GBUniversity of Virginia · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledIota-carrageenan (I-C) is active against respiratory viruses in vitro and was effective as nasal spray in three previous clinical trials. The current trial served to further investigate I-C in patients with early common cold symptoms.

methodsThis randomized, placebo-controlled, double-blind phase IV trial was conducted in 200 adult patients with self-diagnosed colds of <48 h' duration that were confirmed by baseline cold symptom scores. Patients were to self-administer 0.12 % I-C or placebo spray (NaCl 0.5 %) four times daily for four to ten days and record symptom information for ten days. Common respiratory viruses were quantified by RT-PCR during pretreatment and on Day 3 or 4. The primary endpoint was the mean total symptom score (TSS) of eight cold symptoms on Days 2-4 (TSS2-4).

resultsPatients in both treatment groups had similar baseline TSSs (mean TSS: 6.75 for I-C and 6.79 for placebo). Viruses were detected in baseline samples from 53 of 98 I-C patients (54.1 %) and 54 of 97 placebo patients (55.7 %). Mean ± SE for TSS2-4 was 5.78 ± 0.25 for I-C patients and 6.39 ± 0.25 for placebo (p = 0.0895). Exploratory analyses after unblinding (TSS2-4 excluding a patient with aberrantly high symptom scores [TSS2-4, ex 1pt]; mean of TSS over Days 1-4 [TSS1-4]; change in TSS1-4 relative to baseline [TSS1-4, rel]) demonstrated treatment differences in favor of I-C (p = 0.0364, p = 0.0495 and p = 0.0421, respectively). For patients with quantifiable rhinovirus/enterovirus at baseline, there was a trend towards greater reduction of virus load at Day 3 or 4 (p = 0.0958; I-C: 90.2 % reduction in viral load; placebo: 72.0 %). Treatments were well tolerated with no differences in adverse event rates.

conclusionsThe primary endpoint did not demonstrate a statistically significant difference between I-C and placebo but showed a trend towards I-C benefit. Exploratory analyses indicated significant reduction of cold symptoms in the I-C group relative to placebo during the first four days when symptoms were most severe, and also substantiated I-C's activity against rhinovirus/enterovirus.

trial registrationNCT01944631 (clinicaltrials.gov).

Indexed as

Administration, IntranasalAdolescentAerosolsAntiviral AgentsCarrageenanCommon ColdDouble-Blind MethodDrug Administration ScheduleEnterovirusFemaleHumansMaleRhinovirusSelf AdministrationSeverity of Illness IndexTime FactorsAerosolsAntiviral AgentsCarrageenan

Identifiers

PMID26438038
PMCPMC4595062
OpenAlexW1892798832

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.