Introduction
Ah, the common cold: that pesky little nuisance we all love to hate. It’s like the uninvited guest that just won’t leave your living room carpet, isn’t it? Acute respiratory infections (AURI) typically involve the upper airways and are predominantly viral in nature—think of it as your nose and throat hosting a viral rave. But here’s the kicker: while the cold itself is a trivial condition, the prolonged cough can feel like a lingering relationship gone sour; it may last weeks! And don’t even get me started on the ‘flu-like syndrome’ that tags along like that friend who just can’t take a hint.
In typical clinical fashion, we find ourselves without diagnostic tests; because who doesn’t enjoy a little guesswork with their mucus, right? Clinical features of AURI come decked out in nasal complaints, sore throats, and coughs. You might even think you’ve caught the latest flu strain. But brace yourself, because an overflow of mucus might just add a little melodrama to your respiratory infection saga—it can actually worsen things and lead to more infections. A prime candidate for troublemaking, if you will.
And speaking of mucus, let’s talk about sobrerol—the underappreciated hero of mucus modulation! This is no ordinary medication; sobrerol has been on the scene for over 50 years, a true veteran of mucolytics. Its multifaceted action can make your mucus less viscous, increase ciliary motility (yes, those tiny hair-like structures in your airways get a workout!), and even pack in some goodness by aiding immune function. Think of it as the cleaning crew swooping in to tidy up the mess made by your infection.
Materials and Methods
Study Design
Now, let’s dive into the science. An observational case–series study in Italy, which is just as fancy as it sounds, had family pediatricians and general practitioners teaming up to collect data faster than you can say “why do I always get sick in winter?” Picture this: a scenario where each doctor knows their patients well enough to swing by with just the right treatment at the first sneeze.
This wasn’t just any old data gathering; they tracked 177 patients over the cold season (a.k.a. the time of year when staying indoors becomes a competitive sport). They established four groups: one clinging to standard care—which seems as daring as jumping into a pool with no water—while the others adventured into the bold world of sobrerol, either oral, nebulized, or even a combination of both! That’s right, folks; the showdown was real!
Results
The results? Buckle up, because it’s going to be a wild ride! Across the patient pool, there was no significant difference in the number of infections, which might make you think, “Well, that’s less exciting than I hoped.” But wait! When you start looking into specific symptoms like cough and nasal woes, sobrerol illustrated its prowess like a superhero revealing their true identity. The combined route was associated with an optimal resolution of symptoms, proving that sometimes two heads (or in this case, two routes) are better than one.
Discussion
The findings are certainly compelling! It appears that coughs aren’t just annoying; they are also manifestations of mucus drama. When mucus is overproduced, it becomes a wet cough that could drown out the competition—gross, right? But if it’s too shy, we’ve got a dry cough that brings its own set of issues. The ideal scenario? A Goldilocks approach: not too much, not too little—just right!
Surprisingly enough, sobrerol isn’t just a one-trick pony; it’s also got a history of effective long-term use. Time keeps marching on, and while the recommended treatment duration is just three days—bringing back visions of speed-dating—some might argue this isn’t enough. The combined administration magic seems to offer more confidence in symptomatic relief for our AURI patients, even if it does feel like we’re playing Russian roulette with the coughs.
Conclusion
To wrap up this little respiratory saga, sobrerol’s role—especially when combined in both oral and nebulized forms—shines through. A three-day treatment course could be the golden ticket to better managing coughs associated with acute upper respiratory infections. But let’s remember, this is real life, not a fairy tale, and while it’s tempting to think every sneeze can be banished by a magic remedy, sobrerol is simply a smart ally in our quest for better respiratory health.
Acknowledgments
Thanks to Lingomed in Naples for helping gather these vital data, making the analysis as crisp as your favorite snacks during a Netflix binge!
Disclosure
No conflicts of interest here—just a healthy dose of science and a bit of cheeky commentary!
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Introduction
Acute respiratory infections predominantly target the upper airways and are largely caused by viral pathogens. Among these, the common cold serves as the primary example of acute upper respiratory infections (AURI), typically recognized as a minor ailment that tends to be self-limiting, resolving in a matter of days.1 Despite the quick resolution of most symptoms, lingering coughs can persist for several weeks. Meanwhile, viral infections can escalate into a more significant clinical phenomenon known as ‘flu-like syndrome’, presenting symptoms akin to those of influenza.3
In clinical practice, diagnostic tests remain underutilized, leading to a common overlap in the clinical features of AURI across various acute upper respiratory infections, which mainly encompass nasal congestion, sore throat, and persistent cough.
Excessive mucus production could exacerbate the severity of the infection and heighten the likelihood of recurrent illnesses.4 Therefore, effectively modulating mucus production is considered pivotal for managing AURI patients.5 Historically, muco-active medications have been applied for this purpose. Sobrerol, a well-known muco-active agent, has been available for over five decades.6 As a monocyclic monoterpene compound, sobrerol falls under the pharmacological category of mucolytics (ATC code: R05CB07). Notably, sobrerol’s multifaceted mechanism of action includes reducing airway mucus viscosity through hydration, enhancing ciliary motility to facilitate mucociliary clearance, increasing the phospholipid component of surfactant, promoting secretory IgA secretion, and exhibiting antioxidant properties, functioning as a scavenger for free radicals.6
Sobrerol’s availability spans various formulations such as syrup, granules, ampoules, and suppositories since the early 1970s, with its primary indication being the treatment of respiratory conditions marked by excessive thick mucus production. This agent has been rigorously researched regarding its therapeutic efficacy in addressing respiratory, infectious, and inflammatory diseases across all age demographics, including children and the elderly.6
The recommended dosage for adults is 600 mg (equivalent to two sachets) per day for no more than three days, while for children, this dosage is adjusted to half. In nebulization, the advised dosage is a vial containing 40 mg of sobrerol, administered one to two times a day.
Usage is contraindicated in children under 30 months, those with a history of epilepsy or febrile convulsions, and patients exhibiting hypersensitivity to sobrerol or its excipients. Nonetheless, careful precautions should be undertaken for individuals suffering from severe respiratory insufficiency, asthmatics, and those with significant physical debilitation, as the increased fluidity of secretions may necessitate effective expectoration.
Recent guidelines recommend limiting sobrerol treatment duration to just three days. However, this timeframe may be insufficient for some patients, prompting the exploration of a new combined treatment strategy that involves simultaneous oral and nebulized administration. This adjusted approach aims to ensure that the three-day treatment remains effective in managing symptoms.
Given sobrerol’s capabilities as a mucoregulatory, antioxidant, and immunomodulating agent (specifically on humoral immunity), a retrospective assessment of its effectiveness was conducted in a primary care setting. This evaluation sought to monitor symptom progression and infection status over time while comparing three different administration methods: oral, nebulized, and a combination of both (oral plus nebulized). This practical study was executed under the framework of self-management and telemedicine.
Materials and Methods
Study Design
This observational case-series study was retrospectively implemented across various geographical locations in Italy, adhering to the ethical guidelines of the Helsinki Declaration. It was sanctioned by the independent Review Board of the Associazione Italiana Vie Superiori (AIVAS), which determined that patient consent for medical record review was unnecessary due to guaranteed data anonymity and confidentiality. The Italian primary care health service assures a dedicated physician for each patient, establishing a trusted relationship between doctor and patient.
Five family pediatricians and five general practitioners in primary care actively participated in gathering clinical data from their patients during the autumn-spring period of 2023/24 (starting in early September and concluding at the end of April) to capture the peak of respiratory infections. The study commenced with the onset of the autumn season and continued throughout the colder months, allowing an assessment of which therapeutic options can effectively mitigate the severity of infection during this timeframe.
The selected subjects were monitored throughout the study, either through in-person consultations or via telemedicine platforms such as WhatsApp, SMS, or email.
The inclusion criteria detailed subjects over the age of three, regardless of gender, who had a clinical history of frequent respiratory infections. Participating doctors were tasked with prescribing sobrerol to their patients, in addition to creating a control group composed of AURI patients solely receiving standard treatment for their infections. Standard treatments were individualized and could include antibiotics, antipyretics, and anti-inflammatory medications based on clinical presentation.
Exclusion criteria comprised individuals younger than 30 months, those with epilepsy, severe respiratory failure, uncontrolled asthma, or significant physical debility.
Patients were stratified into four distinct therapeutic groups. The Standard Therapy (ST) group received only conventional treatment for acute viral infections. The Oral Sobrerol (OS) group utilized sobrerol in sachets or syrup form, dosed twice daily for three days. The Nebulized Sobrerol (NS) group received nebulized sobrerol via a micronizing device twice daily for three days, and the combined sobrerol (CS) group was administered both oral and nebulized forms once daily for three days. Patients were instructed to initiate sobrerol therapy independently upon the onset of infectious symptoms, thereby endorsing self-management. This regimen was recommended for each subsequent infection episode.
Telemedicine engagement was initiated autonomously by patients simultaneously with the commencement of therapy. Patients utilized WhatsApp, SMS, or email to self-report their clinical status, assessing parameters such as symptom intensity using a visual analog scale (VAS), cough presence, and any school or work absenteeism. Clinical data were recorded at the onset of infection (D0) and followed up at days four (D4) and seven (D7).
This approach was reiterated for every respiratory infection episode recorded during the study, and doctors would decide on patient visits and any necessary pharmacological interventions based on clinical findings.
Doctors systematically gathered and compiled patient data utilizing a specifically designed Excel database, which was subsequently analyzed. Typically, clinical data were collected following each AURI occurrence.
Statistical Analysis
Results
The present study encapsulated retrospective data from 177 patients. The demographic distribution is detailed in Table 1, presenting stratified characteristics of subjects across groups. Analysis revealed homogeneity in gender and age across the four groups.
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Table 1 Demographic Data of Patients, Considered Globally and After Stratification per Group
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Table 2 illustrates the varying incidences of respiratory infections across groups throughout the study duration. Analysis indicated no significant differences in the total or average number of respiratory infection events across groups. Additionally, no noteworthy discrepancies were found regarding the frequency of two or three respiratory infection events among the groups (Table 3).
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Table 2 Number of Respiratory Infections (RI) During the Observation Period in the Four Groups
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Table 3 Number of RI Events During the Experience
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Table 4 provides insights into the presence and intensity of clinical data at the initiation of all RI events. Importantly, a significant difference was observed among groups related to the presence of cough (p < 0.05).
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Table 4 Presence and Intensity of the Different Recorded Clinical Data at the Onset of All RI Events
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Table 5 details the Odds Ratio (along with Confidence Interval) reflecting the likelihood that a specific therapeutic option influenced the resolution of a clinical parameter at Day 4 relative to standard treatment. The combined sobrerol approach correlated with significantly higher odds of cough resolution (OR 15.2) by Day 4. In contrast, nebulized sobrerol demonstrated elevated odds for alleviating nasal symptoms (OR 6.7) within the same period. These results were adjusted for both age and gender.
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Table 5 Therapeutic Options Associated with the Disappearance of Clinical Feature at Day 4 in Comparison with Standard Therapy
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Table 6 illustrates the Odds Ratio (with Confidence Interval) regarding the probability that a therapeutic option helped in the disappearance of a clinical parameter by Day 7 when compared to standard treatment. The combined sobrerol option reflected increased odds for resolving cough (OR 4.47) and nasal symptoms (OR 3.2) by Day 7, adjusted for age and gender.
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Table 6 Therapeutic Options Associated with the Disappearance of Clinical Feature at Day 7 in Comparison with Standard Therapy
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Figure 1 panel A depicts the ∆VAS between Day 4 and Day 0 across different groups, with combined sobrerol being linked to the most substantial improvement (p = 0.001). Figure 1 panel B demonstrates the ∆ VAS between Day 7 and Day 0, showing combined sobrerol again yielding the highest ∆ improvements.
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Figure 1 Subpart (A) Delta VAS of symptom perception at Day 4 in relation to Day 0 for the four subgroups. Subpart B: Delta VAS of symptom perception at Day 7 in regard to Day 0 for the four subgroups.
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Discussion
Respiratory infections impose a significant burden on patients, their families, and society at large. Acute upper respiratory infections are particularly common and can lead to more serious complications, such as common colds progressing to rhinosinusitis.
The symptoms of AURI typically manifest over a short time, although coughs may linger longer, negatively impacting overall quality of life.7 Coughing may arise from two opposing conditions: excessive mucus production or insufficient mucus secretion. These scenarios translate to wet coughs versus dry coughs, and each type demands suitable treatment. Mucus serves vital protective functions, but when produced in excess, it can have adverse effects.8 Consequently, an objective in patient management with cough is to maintain balanced mucus production that mitigates complications by ensuring it is neither excessive nor inadequate.9 Sobrerol emerges as a particularly beneficial muco-active agent for patients suffering from AURI.
This clinical consideration demonstrated notable findings within the primary care framework, specifically that combined sobrerol administration—both orally and through nebulization—corresponded with the highest likelihood of resolving cough and nasal symptoms by days 4 and 7.
While the results align with anticipated outcomes, they still require validation through further research. Hence, this combined administration method seems optimal, especially in light of a strict three-day treatment limitation instigated by previous adverse neurological reactions in select patients. Nevertheless, sobrerol has experienced extensive prescription durations across decades with a notable absence of severe adverse reaction events.
Under current regulations, treatment with sobrerol is restricted to a brief three-day period. However, utilizing combined administration routes could optimize efficacy, as reaffirmed through this practical experience. Furthermore, patients receiving combined treatment exhibited the lowest symptom intensity after 4 and 7 days, corroborating the higher probability of cough and nasal symptom resolution.
Ultimately, this experience sheds light on the advantages associated with the combined administration of oral and nebulized sobrerol.
Nonetheless, this study has limitations, including its retrospective nature, the absence of biomarkers, and challenges in discerning specific infection types. Moreover, patient selection lacked stringent criteria, aligning only with a predetermined number of patients across treatment arms. This arbitrary patient selection process may unintentionally bias the outcomes of the study. Additional limitations stem from the lack of sample size calculations, which led to smaller subgroup sizes that diluted statistical power, particularly for evaluating minor effects or subgroup analyses. Furthermore, the lack of a standardized management procedure meant that each physician approached patient treatment based on individual experience. Each physician had the discretion to select the most suitable treatment (and administration method) for every patient, potentially skewing the proportion of more serious cases towards the combined therapy approach (oral plus nebulization). Consequently, significant variations in symptom presence were noted, particularly concerning coughing among subgroups (though no distinctions arose between the combined strategy and the oral route). This is another limitation warranting attention.
When combining these factors, we recognize the concerns they represent regarding the results’ interpretation. Despite this, the study was situated within a real-world context, aligned with daily clinical practice realities. The involvement of both pediatricians and general practitioners enriched the diversity of patient ages, ensuring applicability of results for both children and older adults. This study emerged spontaneously and was devoid of any sponsorship influence.
Conclusion
The retrospective analysis indicated that a three-day combined course of oral and nebulized sobrerol is a promising option in managing coughs related to acute upper respiratory infections.
Acknowledgments
We would like to thank Lingomed (Naples, Italy) that provided the platform to collect clinical data and the statistical analysis.
Disclosure
The authors report no conflicts of interest in this work.
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