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Previous clinical and in vitro investigations have supported the efficacy of a glycerol throat spray containing cold-adapted cod trypsin (ColdZyme) against respiratory viruses causing the common cold bycreating a protective mucosal barrier shown to deactivate common cold virus in vitro and decrease pharyngeal rhinovirus load. This was a double-blind, randomized, parallel-group, placebo-controlled study conducted at 10 German sites to evaluate the efficacy of the medical device ColdZyme, a glycerol mouth spray containing cold-adapted cod trypsin for a naturally occurring common cold versus placebo spray. Adults experiencing a minimum of three common colds during the previous year, but otherwise healthy, were enrolled to begin treatment with the mouth spray or placebo six times daily at first sign of a common cold. Jackson's symptom scale and the 9-item Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) quality of life (QoL) domain and a sore throat scale were recorded daily by subjects, as well as any use of allowed rescue treatment. Between January and April 2019, 701 subjects were enrolled and randomly assigned to the ColdZyme group (n = 351) or the placebo group (n = 350). Of the 701 subjects, 438 (62.5%) subjects developed symptoms typical of common cold, and all 438 started study treatment (n = 220 in the ColdZyme group and n = 218 in the placebo group). The demographic profile of the treatment groups were comparable with 68.1% female and almost all subjects being Caucasian (98.4%). The age ranged between 18 and 70 years with a mean age of 41.3 (±14.4) years. There were no differences between the groups in primary and major secondary endpoints, however, the assessment using the WURSS-21 QoL domain and Jackson score suggests a slightly faster recovery with ColdZyme as symptoms and complaints affecting the quality of life were shortened by about 1 day. The beneficial effect of ColdZyme was particularly noticeable on the fifth day of the common cold. A positive difference between treatment groups was also seen for the subjects' assessments of global efficacy of the investigational product A robust safety profile for ColdZyme was demonstrated throughout the study. The safety and tolerability of ColdZyme have been confirmed in a large study population and further establishes evidence of a faster recovery from common cold symptoms. Early self-diagnosis and early use of ColdZyme mouth spray is a safe alternative for treatment of naturally occurring colds.

Background Current prevention options for upper respiratory infections (URIs) are not optimal. We conducted a randomized, double-blinded, placebo-controlled pilot clinical trial to evaluate the safety and efficacy of ARMS-I™ (currently marketed as Halo™) in the prevention of URIs. Methods ARMS-I is patented novel formulation for the prevention and treatment of influenza, comprising a broad-spectrum antimicrobial agent (cetylpyridinium chloride, CPC) and components (glycerin and xanthan gum) that form a barrier on the host mucosa, thus preventing viral contact and invasion. Healthy adults (18–45 years of age) were randomized into ARMS-I or placebo group (50 subjects each). The drug was sprayed intra-orally (3× daily) for 75 days. The primary objectives were to establish whether ARMS-I decreased the frequency, severity or duration of URIs. Secondary objectives were to evaluate safety, tolerability, rate of virus detection, acceptability and adherence; effect on URI-associated absenteeism and medical visits; and effect of prior influenza vaccination on study outcomes. Results Of the 94 individuals who completed the study (placebo: n  = 44, ARMS-I: n  = 50), six presented with confirmed URI (placebo: 4, ARMS-I: 2), representing a 55% relative reduction, albeit this was statistically not significant). Influenza, coronavirus or rhinovirus were detected in three participants; all in the placebo group. Moreover, frequency of post-treatment exit visits was reduced by 55% in ARMS-I compared to the placebo group ( N  = 4 and 2, respectively). Fever was reported only in the placebo group. ARMS-I significantly reduced the frequency and severity of cough and sore throat, and duration of cough ( P  ≤ .019 for all comparisons). ARMS-I was safe, well tolerated, had high acceptability and high adherence to medication use. Medical visits occurred only in the placebo group while absenteeism did not differ between the two arms. Prior influenza vaccination had no effect on study outcome. Conclusions This randomized proof-of-concept clinical trial demonstrated that ARMS-I tended to provide protection against URIs in the enrolled study participants, while reducing severity and duration of cough and sore throat. A clinical trial with a larger number of study participants is warranted. Trial registration ClinicalTrials.gov NCT02644135 (retrospectively registered).

The aim of the study was to determine if a bovine lactoferrin/whey protein Ig-rich fraction (Lf/IgF) combination was effective in reducing the number of colds and in turn improving symptom recovery in a cohort of males and females that reported frequently contracting a cold. A double blind randomized placebo-controlled clinical trial. One-hundred and twenty-six participants matched by age, BMI, dietary and physical parameters with self-reported frequent upper respiratory tract symptoms and infections were randomly assigned to receive 600mg of Lf/IgF or a placebo daily for 90 days. A total of 90 participants (47 receiving the active and 43 placebo) completed the 90 day trial and 15 completed 45 days participation (6 in the active and 9 in the placebo group). The total number of colds recorded over the study period was 48 for the treatment group versus 112 for the placebo group (p<0.001). The significant trend was retained when the data was corrected for medications returned (p<0.001) and for guessing treatment allocations (p<0.001). Non-parametric analysis demonstrated that the total number of cold-associated symptoms reported by participants that received Lf/IgF was significantly less than those in the placebo group (p<0.05). Also, total days sick with a cold and cold severity were reduced over the clinical trial period for Lf/IgF over placebo, but the trend was not significant. These findings demonstrate that the Lf/IgF combination significantly decreased the incidence of colds and the cumulative number of cold-related symptoms over placebo. This therapeutic combination may be indicated for the prevention of colds and its most common symptoms in the general population when administered as a preventative supplement.

Dietary supplements have been suggested in the prevention of the common cold, but previous investigations have been inconsistent. The present study was designed to determine the preventive effect of a dietary supplement from fruits and vegetables on common cold symptoms. In a randomised, double-blind, placebo-controlled trial, healthcare professionals (mainly nursing staff aged 18–65 years) from a university hospital in Berlin, Germany, were randomised to four capsules of dietary supplement (Juice Plus+®) or matching placebo daily for 8 months, including a 2-month run-in period. The number of days with moderate or severe common cold symptoms within 6 months (primary outcome) was assessed by diary self-reports. We determined means and 95 % CI, and differences between the two groups were analysed by ANOVA. A total of 529 subjects were included into the primary analysis (Juice Plus+®: 263, placebo: 266). The mean age of the participants was 39·9 (sd 10·3) years, and 80 % of the participants were female. The mean number of days with moderate or severe common cold symptoms was 7·6 (95 % CI 6·5, 8·8) in the Juice Plus+® group and 9·5 (8·4, 10·6) in the placebo group (P = 0·023). The mean number of total days with any common cold symptoms was similar in the Juice Plus+® and in the placebo groups (29·4 (25·8, 33·0) v. 30·7 (27·1, 34·3), P = 0·616). Intake of a dietary supplement from fruits and vegetables was associated with a 20 % reduction of moderate or severe common cold symptom days in healthcare professionals particularly exposed to patient contact.

Variation at chromosome 17q21 is associated with susceptibility to asthma, as is previous respiratory infection. This study suggests that the genetic risk locus confers risk among children with previous wheezing illness caused by rhinovirus but not by respiratory syncytial virus. The first genomewide association study of childhood-onset asthma revealed a susceptibility locus on chromosome 17q21. 1 The association of this locus with asthma has since been replicated in both genomewide and candidate-gene association studies, 2 , 3 and the locus represents one of the most consistently associated genetic risk factors for childhood asthma. Variation at the 17q21 locus is associated primarily with childhood-onset asthma, 4 – 6 but not with atopy, 4 , 7 , 8 and the effects are larger among children who had been exposed to environmental tobacco smoke in early life 4 , 9 – 11 and in children with reported respiratory infections in infancy. 10 The disease-associated variants . . .

Upper respiratory symptoms are often treated with over the counter drugs, antibiotics, and antiviral medications. Due to concerns about safety and efficacy, there is a demand for an alternative solution. Black elderberry (Sambucus nigra) has been used to treat cold and flu symptoms, but there are no large-scale studies or meta-analyses. This meta-analysis quantifies the effects of elderberry supplementation and evaluates moderators including vaccination status and the underlying pathology. This analysis included a total of 180 participants and evaluates moderators such as vaccination status and cause of the upper respiratory symptoms. Supplementation with elderberry was found to substantially reduce upper respiratory symptoms. The quantitative synthesis of the effects yielded a large mean effect size. These findings present an alternative to antibiotic misuse for upper respiratory symptoms due to viral infections, and a potentially safer alternative to prescription drugs for routine cases of the common cold and influenza.

Common cold is a common respiratory disease caused by a viral infection of the upper respiratory tract, leading to various symptoms including cough, sneezing, nasal congestion, and sore throat. As the medications used to treat the common cold may cause adverse effects such as gastrointestinal symptoms, drowsiness, and decreased concentration, it is necessary to explore alternative treatments for patients with the common cold. The aim of this study is to assess the effectiveness and safety of Galgeun-tang-ga-cheongung-sinyi (GGTCS), an herbal formula used to treat respiratory diseases, as an alternative medicine for nasal congestion with common cold. This is a randomized, double-blind, placebo-controlled, parallel, multicenter clinical trial. A total of 176 participants will be recruited and randomly allocated to the GGTCS group and control (placebo) group in a 1:1 allocation ratio. GGTCS or placebo will be administered three times per day for 7 days. The participants will be instructed to discontinue the medicine if the symptoms of the common cold disappear within 7 days of the treatment period and return the remaining medicine to the investigators. The primary outcome measures are changes in the total score of the Wisconsin Upper Respiratory Symptom Survey-21-Korean version (WURSS-21-K) (symptom score + quality of life score) on day 7 compared with baseline. Secondary outcome measures include the total, symptom, and quality of life scores of the WURSS-21-K, nasal congestion severity score, nasal and systemic symptom score visual analogue scale (VAS), duration of common cold symptoms, recovery from common cold, global evaluation of efficacy, and 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5L). The exploratory outcome measure is a questionnaire for common cold pattern identification (QCCPI), and the safety assessment factors include adverse effects, vital signs, electrocardiograms, and clinical laboratory tests. The goal of this study is to assess the effectiveness and safety of GGTCS for nasal congestion with the common cold and the clinical use of herbal medicine. The results are expected to help researchers design further clinical trials using herbal medicines to treat the common cold. This trial was registered on February 28, 2025 at the National Clinical Trial Registry Clinical Research Information Service (https://cris.nih.go.kr) with the identifier number KCT0010251.

Viral upper respiratory infections are associated with significant health and economic impact. This study sought to determine the efficacy of routine immune system micronutrient supplementation on the incidence, duration and severity of common cold symptoms. This pilot study was a randomized, double-blinded, placebo-controlled trial of N = 259 with asymptomatic participants aged 18 to 65 in two cold seasons of 2016 and 2017. The treatment group received an immune system targeted micronutrient caplet, while the placebo group received a micronized cellulose caplet externally identical to the treatment caplet. Weekly surveys were sent electronically to participants to document common cold incidence, duration and severity. Primary statistical results were obtained using mixed-effects logistic regressions to account for longitudinal measurements for participants. The odds of acquiring an upper respiratory infection, adjusted for potential confounders, was estimated to be 0.74 times lower in the treatment group (p = 0.14). The odds of reporting specific symptoms were statistically lower in the treatment arm compared to the placebo arm for runny nose (OR = 0.53, p = 0.01) and cough (OR = 0.51, p = 0.04). Shorter durations of runny nose and cough were also observed in the treatment arm compared to placebo (both p < 0.05). There was no significant difference in severity of symptoms in either group. The observed proportion of reported cold symptoms in the treatment group was lower compared to the placebo group between late January and February in two consecutive cold seasons. Given the physical, workplace and economic impact of upper respiratory infections, this low cost and low risk intervention should be further studied with more robust investigation and meticulous experimental design.

Background. LL-37 is a host defense peptide with antimicrobial and immunomodulatory properties. We examined the relation of serum LL-37 levels to the severity of bronchiolitis and viral etiology. Methods. We performed a 17-center prospective cohort study in infants hospitalized with bronchiolitis over 3 winters (2011–2014). Site teams collected clinical data, nasopharyngeal aspirates and serum. We used real-time polymerase chain reaction to test nasopharyngeal aspirates for 16 viruses. We tested serum for LL-37. Severity of bronchiolitis was defined by intensive care use and hospital length of stay. Viral etiology was defined as respiratory syncytial virus (RSV) or rhinovirus (RV), including coinfections with other viruses. Results. The median age of the 1005 enrolled infants was 3 months (interquartile range, 2–6 months). After adjustment for 12 variables, LL-37 levels in the lowest quartile, compared with the highest, were associated both with intensive care use (adjusted odds ratio [aOR], 1.97; P = .01) and longer hospital stay (1.34; P < .001). In separate multivariable models, infants with LL-37 levels in the lowest 3 quartiles, compared with the highest, were more likely to have RSV (eg, aOR, 2.6 [lowest quartile]; P < .001 [all quartiles]). By contrast, infants with the lowest 3 LL-37 quartiles were less likely to have RV (eg, aOR, 0.5 [lowest quartile]; Pall quartiles ≤ .03 [all quartiles]). Conclusions. In a large multicenter study of infants hospitalized with bronchiolitis, lower levels of serum LL-37 were associated with increased severity of illness. There was also an inverse relationship between LL-37 levels and the most common virus causing bronchiolitis, RSV. These findings highlight the role of LL-37 in the pathogenesis of bronchiolitis.