The effects of greater frequency of two most prevalent bothersome acute respiratory symptoms on health-related quality of life in the 2020 US general population.

PURPOSE: Upper respiratory tract infections (URTI) and related symptoms are widespread and a common reason for visiting primary care with cough and sore throat being most prevalent. Despite their impact on daily activities, no studies have explored the impact on health-related quality of life (HRQOL) in representative general populations. We aimed to understand the short-term impact of the two most prevalent URTI symptoms on HRQOL. METHODS: Online 2020 surveys including acute (≤ 4 weeks) respiratory symptoms (sore throat and cough) and SF-36® health survey (all with 4-week recall) were analysed using analysis of covariance (ANCOVA) in comparison with adult US population norms. Linear T-score transformation of SF-6D utility (ranging from 0 to 1) enabled direct comparisons with SF-36. RESULTS: In total, 7563 US adults responded (average age: 52 years; range: 18-100 years). Sore throat and cough lasting at least several days were experienced by 14% and 22% participants, respectively. Chronic respiratory conditions were reported by 22% of the sample. A clear and consistent pattern of group HRQOL means declining significantly (p < 0.001) for acute cough and sore throat symptom presence and severity. Declines were observed on SF-36 physical (PCS) and mental component (MCS) and health utility (SF-6D) scores controlling for covariates. Those reporting respiratory symptoms 'most days' declined ≥ 0.5 standard deviation (minimal important difference [MID]) worse with averages at the 19th and 34th centiles for cough on the PCS and MCS, and 21st to 26th centile for sore throat. CONCLUSION: Declines in HRQOL with acute cough and sore throat symptoms consistently exceeded MID standards and should not be ignored as self-limiting without intervention. Future studies on early self-care for symptom relief and its implications on HRQOL and health economics would be valuable to understand the benefits on healthcare burden and need for updating treatment guidelines.

Ivy leaf (Hedera helix) for acute upper respiratory tract infections: an updated systematic review.

PURPOSE: Acute cough due to viral upper respiratory tract infections (URTIs) and bronchitis is a common reason for patients to seek medical care. Non-antibiotic over-the-counter cough medications such as ivy leaf extract are frequently used but their efficacy is uncertain. Our purpose was to update our previous systematic review and evaluate the effectiveness and tolerability of ivy leaf in the treatment of acute URTIs in adult and pediatric populations. METHODS: We searched MEDLINE, EMBASE, the Cochrane Library, and clinical trial registries from December 2009 to January 2020. Randomized controlled trials (RCTs), controlled clinical trials (CCTs), and observational studies (OSs) investigating ivy leaf mono- or combination preparations were included. Two independent reviewers assessed records for eligibility and risk of bias and performed data extraction. RESULTS: Six RCTs, 1 CCT, and 4 OSs were identified. Since the publication of our previous review, the number of RCTs has increased. All studies concluded that ivy leaf extract is an effective and safe option for the treatment of cough due to URTIs and bronchitis. Three RCTs reported a more rapid reduction in cough severity and/or frequency under ivy leaf treatment. The clinical significance of these effects appears to be minimal. No serious adverse effects were reported. The overall quality of reporting was low and the risk of bias was high. CONCLUSIONS: Ivy leaf preparations are safe for use in cough due to acute URTIs and bronchitis. However, effects are minimal at best and of uncertain clinical importance.

The causes of acute cough: a tertiary-care hospital study in Japan.

OBJECTIVES: Cough is the most frequent presenting complaint in general practice and has an adverse effect on an individual's well-being. Understanding the causes of cough is critical for appropriate patient management. According to its duration, cough is classified as acute, subacute, and chronic. While acute respiratory infection is considered to be the major cause of acute cough, there is little evidence. METHODS: We retrospectively assessed the prevalence of acute cough in all patients presenting with cough to the respiratory clinic of Japanese Red Cross Wakayama Medical Center from May 2018 to April 2019. We subsequently assessed the causes of acute cough, after stratifying patients with acute cough into two subgroups based on the chest X-ray findings. RESULTS: Among 685 patients (329 males; mean age, 61.8 ± 18.6 years) who presented with cough as a chief complaint, 274 (125 males; mean age, 57.6 ± 20.9 years) reported to have acute cough; chest X-ray abnormalities were detected in 113 of these patients. The most frequent cause of acute cough among 113 patients with chest X-ray abnormalities was pneumonia (55.8%), followed by lung cancer (9.7%) and pneumonia exacerbating asthma (7.1%). Among the 161 patients with acute cough without chest X-ray abnormalities, the most frequent cause was upper respiratory tract infection (57.1%), followed by asthma (23.6%) and cough variant asthma (6.2%). CONCLUSIONS: Cough is the most frequent presenting complaint in general practice. Infections are the most frequent causes of acute cough regardless of the chest X-ray findings.

Children's Acute Cough-Specific Quality of Life: Revalidation and Development of a Short Form.

PURPOSE: Acute cough in children has a significant impact on the child and family. Relevant quality of life (QoL) instruments are essential for high-quality clinical research. This study aimed to (1) revalidate the 16-item Parent-proxy Children's Acute Cough-specific QoL questionnaire (PAC-QoL16) using a different dataset (i.e., different children), (2) confirm the minimally important difference (MID), and (3) develop and validate a short form. METHODS: Three datasets from two sources were utilized, comprising of 332 children with acute cough (< 2 weeks duration); the first dataset (n = 83, 54 boys; median age 2.04 years, IQR 1.08-4.06 years) was used for revalidation, the second dataset (n = 238, 141 boys; median age 2.17 years, IQR 1.21-4.21 years) was used to develop the short form, and the third dataset (n = 94, 62 boys; median age, 1.75 years, IQR 0.90-3.63 years) was used to confirm the short form. Psychometric properties were investigated. RESULTS: Six items were found to account for 96.4% of the variance in the PAC-QoL16. The PAC-QoL16 and short form (PAC-QoL6) scales correlated with cough scores (rs ≤ - 0.40, p < 0.001), were internally consistent (Cronbach α = 0.94 and 0.87, respectively) and demonstrated sensitivity to change over time. A MID of 0.71 to 1.11 is recommended. CONCLUSION: Both the PAC-QoL16 and newly developed short form (PAC-QoL6) are reliable and valid outcome measures that assess children's acute cough-specific QoL at a given time point, are easy to interpret and reflect changes over time. The new short form addresses the need for outcome measures to be as time effective as possible without loss of information.

Acute cough in children and adolescents: A systematic review and a practical algorithm by the Italian Society of Pediatric Allergy and Immunology.

The current systematic review presented and discussed the most recent studies on acute cough in pediatric age. After that, the Italian Society of Pediatric Allergy and Immunology elaborated a comprehensive algorithm to guide the primary care approach to pediatric patients, such as infants, children, and adolescents, with acute cough. An acute cough is usually consequent to upper respiratory tract infections and is self-resolving within a few weeks. However, an acute cough may be bothersome, and therefore remedies are requested, mainly by the parents. An acute cough may significantly affect the quality of life of patients and their family.Several algorithms for the management of acute cough have been adopted and validated in clinical practice; however, unlike the latter, we developed an algorithm focused on pediatric age, and, also, in accordance to the Italian National Health System, which regularly follows the child from birth to all lifelong. Based on our findings, infants from 6 months, children, and adolescents with acute cough without cough pointers can be safely managed using well-known medications, preferably non-sedative agents, such as levodropropizine and/or natural compounds, including honey, glycerol, and herb-derived components.

Natural remedies for acute post-viral cough in children.

The post-viral acute cough is the most common symptom in childhood. Consequently, the use of cough relievers is frequent. Many products for treating cough contain natural components. An ancient tradition has always established herbal medicine and honey as effective and safe means to relieve cough. Nevertheless, very few studies adequately investigated the real effectiveness and safety of natural products in treating acute cough. There is some evidence, provided by pediatric randomized controlled trials, about honey, one multicomponent product (containing Plantagolanceolata, Grindelia robusta, Helichrysum italicum, and honey), and Pelargonium sidoides. Other group of substances, including glycerol and isolated natural compounds, can help manage cough but robust evidence still lacks in children. There is an urgent need to perform rigorous studies that confirm the natural products' efficacy and safety for relieving post-viral acute cough.Key points: Acute post-viral cough is prevalent in childhood and adolescence. There is a growing interest concerning the use of natural remedies for post-viral cough. Many herbal medicines could be used satisfactorily for this issue.

Incidence and risk factor for short term postoperative cough after thyroidectomy.

BACKGROUND: The prevalence of potential risk factors for postoperative cough after thyroidectomy remain unknown. The current study aimed to research postoperative cough in patients undergoing thyroid surgery prospectively. METHODS: Adult patients who underwent primary thyroid surgery were selected prospectively. Data regarding age, sex, BMI, pathology and surgical procedure were collected and analyzed. The Leicester Cugh Questionnaire (LCQ) was required to be completed by all patients before operation, 2 weeks and 4 weeks after operation. RESULTS: There were 1264 patients enrolled in total. Eleven patients with vocal cord paralysis were excluded. In patients with benign disease, postoperative cough occurred in 61 patients, with an prevalence rate of 17. 0% compared to an prevalence rate of 33.1% in patients with malignant disease; the difference was significant. For benign patients, the factors of smoking and operation time were independently related to the occurrence of postoperative cough. For malignant patients, the factors of smoking, operation time, operation extent, and the number of positive nodes at level 6 were independently related to the occurrence of postoperative cough. There was no significant difference regarding the LCQ score in patients with benign or malignant disease at the preoperative and the postoperative 4-week time periods. Patients with malignant disease had a significantly lower LCQ score than patients with benign disease at the postoperative 2-week time point (p = 0.004). CONCLUSIONS: Patients undergoing thyroid cancer surgery had a higher incidence of postoperative cough and were also associated with a decreased cough-related quality of life. The factors of smoking and operation time were the most important predictors for postoperative cough after thyroidectomy.

An approach to the child with a wet cough.

When children have a wet cough, it suggests the presence of secretions in their airways. This often has an infectious aetiology which is usually a self-limiting viral infection requiring no investigation or treatment. In those with acute wet cough it is, however, important to identify features suggestive of community acquired pneumonia or an inhaled foreign body as these causes require specific management. When there is chronic wet cough, the most common diagnoses are protracted bacterial bronchitis (PBB) and bronchiectasis. The relationship between these two conditions is complex as the development of bronchiectasis manifests as a clinical continuum in which the early features of which are indistinguishable from PBB. It is therefore important to identify PBB and chronic cough endotypes which are associated with an increased risk of bronchiectasis. This article offers a pragmatic approach to the investigation and treatment of children with wet cough. It is hoped this will limit unnecessary investigations whist aiding the prompt diagnosis of conditions needing treatment to reduce symptom burden and prevent further lung damage.

[THE CAUSES OF ACUTE COUGH: A SINGLE-CENTER STUDY IN JAPAN].

BACKGROUND: Cough is the most frequent presenting complaint in clinics, and is classified into the following three groups: acute, subacute and chronic. The major causes of acute cough are infectious diseases, however, few observations on acute cough have been reported. METHODS: We retrospectively assessed the causes of acute cough among patients who had visited the respiratory clinic of our hospital because of acute cough from September 2014 to August 2015. RESULTS: Of 374 patients (195 females, mean age 60.3 years) who visited the clinic complaining of cough, 129 patients (63 females, mean age 61.5 years) suffered from acute cough. All acute cases were stratified into two groups based on the presence (n=43) or absence (n=86) of abnormal findings on the chest X-ray. The main causes of acute cough with abnormal findings were pneumonia (46.5%), interstitial pneumonia (18.6%) and lung cancer (16.3%). The main causes of acute cough without abnormal findings were respiratory tract infection (39.5%), post infectious cough (18.6%) and bronchial asthma (17.4%). Acute cough was the primary complaint in 29.5% and 19.6% of all patients diagnosed with bronchial asthma and cough variant asthma, respectively. CONCLUSION: Non-infectious diseases including asthma as well as infectious diseases could be the causes in acute cough without abnormal findings on the chest X-ray.

An acute cough-specific quality-of-life questionnaire for children: Development and validation.

BACKGROUND: Patient-relevant outcome measures are essential for high-quality clinical research, and quality-of-life (QoL) tools are the current standard. Currently, there is no validated children's acute cough-specific QoL questionnaire. OBJECTIVE: The objective of this study was to develop and validate the Parent-proxy Children's Acute Cough-specific QoL Questionnaire (PAC-QoL). METHODS: Using focus groups, a 48-item PAC-QoL questionnaire was developed and later reduced to 16 items by using the clinical impact method. Parents of children with a current acute cough (<2 weeks) at enrollment completed 2 validated cough score measures, the preliminary 48-item PAC-QoL, and 3 other questionnaires (the State Trait Anxiety Inventory [STAI], the Short-Form 8-item 24-hour recall Health Survey [SF-8], and the Depression, Anxiety, and Stress 21-item Scale [DASS21]). All measures were repeated on days 3 and 14. RESULTS: The median age of the 155 children enrolled was 2.3 years (interquartile range, 1.3-4.6). Median cough duration at enrollment was 3 days (interquartile range, 2-5). The reduced 16-item scale had high internal consistency (Cronbach α = 0.95). Evidence for repeatability and criterion validity was shown by significant correlations between the domains and total PAC-QoL scores and the SF-8 (r = -0.36 and -0.51), STAI (r = -0.27 and -0.39), and DASS21 (r = -0.32 and -0.41) scales on days 0 and 3, respectively. The final PAC-QoL questionnaire was sensitive to change over time, with changes significantly relating to changes in cough score measures (P < .001). CONCLUSION: The 16-item PAC-QoL is a reliable and valid outcome measure that assesses QoL related to childhood acute cough at a given time point and reflects changes in acute cough-specific QoL over time.

Effect of multiple honey doses on non-specific acute cough in children. An open randomised study and literature review.

BACKGROUND: Honey is recommended for non-specific acute paediatric cough by the Australian guidelines. Current available randomised clinical trials evaluated the effects of a single evening dose of honey, but multiple doses outcomes have never been studied. OBJECTIVES: To evaluate the effects of wildflower honey, given for three subsequent evenings, on non-specific acute paediatric cough, compared to dextromethorphan (DM) and levodropropizine (LDP), which are the most prescribed over-the-counter (OTC) antitussives in Italy. METHODS: 134 children suffering from non-specific acute cough were randomised to receive for three subsequent evenings a mixture of milk (90ml) and wildflower honey (10ml) or a dose of DM or LDP adjusted for the specific age. The effectiveness was evaluated by a cough questionnaire answered by parents. Primary end-point efficacy was therapeutic success. The latter was defined as a decrease in cough questionnaire score greater than 50% after treatment compared with baseline values. RESULTS: Three children were excluded from the study, as their parents did not complete the questionnaire. Therapeutic success was achieved by 80% in the honey and milk group and 87% in OTC medication group (p=0.25). CONCLUSIONS: Milk and honey mixture seems to be at least as effective as DM or LDP in non-specific acute cough in children. These results are in line with previous studies, which reported the health effects of honey on paediatric cough, even if placebo effect cannot be totally excluded.

Homeopathic medicine for acute cough in upper respiratory tract infections and acute bronchitis: a randomized, double-blind, placebo-controlled trial.

Cough is a frequent symptom associated to upper respiratory tract infections (URTIs) and, although being self-limiting, it might deeply affect the quality of life. Homeopathic products are often employed by patients to treat cough, but the evidence on their efficacy is scarce. Thus, we tested the efficacy of a homeopathic syrup in treating cough arising from URTIs with a randomized, double blind, placebo controlled clinical trial. Patients were treated with either the homeopathic syrup or a placebo for a week, and recorded cough severity in a diary by means of a verbal category-descriptive score for two weeks. Sputum viscosity was assessed with a viscosimeter before and after 4 days of treatment; patients were also asked to provide a subjective evaluation of viscosity. Eighty patients were randomized to receive placebo (n = 40) or the homeopathic syrup (n = 40). All patients completed the study. In each group cough scores decreased over time, however, after 4 and 7 days of treatment, cough severity was significantly lower in the homeopathic group than in the placebo one (p < 0.001 and p = 0.023, respectively). Sputum was collected from 53 patients: in both groups its viscosity significantly decreased after 4 days of treatment (p < 0.001); however, viscosity was significantly lower in the homeopathic group (p = 0.018). Instead, the subjective evaluation did not significantly differ between the two groups (p = 0.059). No adverse events related to any treatment were reported. We concluded that the homeopathic syrup employed in the study was able to effectively reduce cough severity and sputum viscosity, thereby representing a valid remedy for the management of acute cough induced by URTIs.

A Critically Ill Influenza A-Positive Patient With Spontaneous Pneumomediastinum, Superimposed Bacterial Pneumonia, and Bilateral Pneumothoraces.

Influenza most often causes a febrile viral syndrome inclusive of pulmonary irritation with cough, shortness of breath, and congestion. However, severe infection can also occur, causing significant viral pneumonia with Type 1 respiratory failure. and rare but life-altering complications such as pneumomediastinum, secondary bacterial pneumonia, acute respiratory distress syndrome (ARDS), viremia, and death. This was a case of a 20-year-old male with no significant past medical history who presented to the emergency department with shortness of breath and chest discomfort and was found to have Influenza A with Type I respiratory failure requiring High Flow Nasal Cannula (HFNC) and extensive pneumomediastinum, superimposed bacterial pneumonia, and bilateral pneumothoraces. It is possible that complications secondary to influenza A infections could be under-reported due to the extremely high prevalence of the viral infection in this country. In addition, complicated pneumomediastinum from Influenza infection is sparsely documented in young adult males and children, but its clinical course can be dramatic enough to include life-altering complications. This case should serve as a reminder to all emergency medicine providers that when evaluating unstable Influenza A patients, various tests should be considered on a case-by-case basis to risk-stratify the likelihood of emergent pathology.

Use of antibiotics and other treatments in Chinese adults with acute cough: An online survey.

Background: This study aimed to identify use of various treatments and their association with the use of antibiotics and patient reported clinical recovery in Chinese adults with acute cough. Methods: An online survey recruiting people who had recently experienced cough was conducted. Their sociodemographic, clinical characteristics, treatments received and their perceived changes in symptoms were collected. Factors influencing avoidance of antibiotics and improvement in symptoms were explored. Results: A total of 22,787 adults with recent acute cough completed the questionnaire, covering all 34 province-level administrative units in China. Most respondents were male (68.0%), young (89.4%, aged 18-45), educated to university/degree or postgraduate level (44.6%), with a median cough severity of 6/10 on a numerical rating scale. Nearly half of the participants (46.4%) reported using antibiotics, among which 93.1% were for presumed upper respiratory tract infections (URTIs). Pharmacies (48.8%) were the most common source of antibiotics. Fewer patients took antibiotics after taking CHM (14.9%), compared to those who started with home remedies (18.0%), or allopathic non-antibiotic medication (25.0%). Antibiotics, allopathic non-antibiotic medications, CHM and home remedies were all perceived beneficial in relieving cough. Conclusions: Chinese adult responders report use of a considerable variety of treatments alone or in combination for acute cough. Patient-reported clinical recovery was similar regardless of treatment. There is likely a high proportion of inappropriate use of antibiotics for treatment of simple acute cough. As the majority of respondents did not use antibiotics as a first-line, and use of CHM was associated with relief of cough symptoms and reduction in the use of antibiotics, this presents an important opportunity for prudent antibiotic stewardship in China.

Comparative Efficacy of Anti-asthma Therapy in Non-asthmatic Cough: A Cross-Sectional Study in Dubai, United Arab Emirates.

Background Cough is one of the most common presenting complaints for physicians across the world, with the potential to result in a significant influence on one's daily life. It is typically categorized into acute cough (<3 weeks), subacute cough (three to eight weeks), and chronic cough (>8 weeks). The lack of specific treatment guidelines and evidence-based recommendations for resolving cough creates reasonable controversy in the medical field. This retrospective study aims to identify the clinical features of cough and evaluate the comparative efficacy between different anti-asthmatic treatment modalities in the urban city of Dubai, United Arab Emirates. Methods A retrospective cross-sectional study was performed on patients presenting to pulmonology or respiratory outpatient clinics with complaints of cough in the absence of any known history of chronic respiratory illness (e.g., asthma). Analysis was conducted via chi-squared and analysis of variance (ANOVA) testing. Results A total of 308 patients were eligible for inclusion, with 273 patients presenting for follow-up. Overall, patients with acute, subacute, and chronic coughs had similar clinical presentations, with no statistically significant differences noted. However, patients with pets were more likely to develop an acute cough (p = 0.04). Moreover, the follow-up outcomes of acute, subacute, and chronic cough were similar, with no significant statistical difference noted. Furthermore, patients receiving dual therapy using budesonide and montelukast, and patients receiving triple therapy using budesonide, montelukast, and tiotropium/ipratropium were most likely to gain complete relief of their symptoms, although triple therapy treatment was also associated with the highest rate of null improvement (p = 0.012). Additionally, chronic cough patients were more likely to be subject to higher C-reactive protein (CRP) levels in comparison to other cohorts (p = 0.26). Conclusion The comparative superiority of dual therapy using budesonide and montelukast, and triple therapy using budesonide, montelukast, and tiotropium/ipratropium were highlighted in this study. In the sparseness of specific treatment guidelines and evidence-based recommendations for cough, the use of anti-asthmatic therapy for cough patients has shown favorable results. Moreover, the lack of clinical differences between acute, subacute, and chronic cough may result in difficulties with the treatment of cough patients. To arrive at a valid conclusion, further comprehensive studies with larger and more diversified sample populations are encouraged.

Usefulness Analysis of Fraction of Exhaled Nitric Oxide for the Differential Diagnosis of Acute Cough.

BACKGROUND/AIM: Measuring the fraction of exhaled nitric oxide (FeNO) is useful in the diagnosis of asthma and cough variant asthma. The aim of this study was to clarify the significance of measuring the FeNO in the differential diagnosis of acute cough. PATIENTS AND METHODS: We analyzed 80 patients who visited the clinic with the chief complaint of acute cough having experienced an asthma-like episode from January 2014 to July 2015. RESULTS: Infectious cough alone was present in 21% of patients, while 30% had asthmatic cough alone and 49% had a combination of infectious and asthmatic cough. The values of FeNO in those with asthmatic cough (30.4±24.7 ppb) and asthmatic/infectious cough (33.2±17.4 ppb) were significantly higher than those with just infectious cough (13.7±3.2 ppb) (p=0.0089 and p<0.0001, respectively). CONCLUSION: FeNO measurement is useful for distinguishing asthmatic diseases, even in the differential diagnosis of acute cough.

[Acute Cough in Adult Patients]. / Akuter Husten bei erwachsenen Patient*innen.

Background: Acute cough (< 8 weeks) is a frequent complaint in family practice consultations. The most common cause are respiratory infections. The Guideline "Acute and chronic cough" of the German College of General Practitioners and Family Physicians (DEGAM) was updated in 2021 and contains recommendations for an evidence-based approach for the management of acute cough in primary care. Methods: The guideline has been updated in accordance with the findings of a systematic search of the literature for international guidelines and systematic reviews. All recommendations were developed by an interdisciplinary guideline committee and agreed by formal consensus. Results: History-taking, exclusion of red flags and a physical examination are the basis of diagnostic evaluation. If an acute, uncomplicated bronchitis is likely, no laboratory tests, sputum diagnostics, or chest x-rays should be performed, and antibiotics should not be administered. Evidence based strategies to avoid antibiotic therapy (delayed prescribing, shared decision making, point-of-care-tests) can be used. There is inadequate evidence for the efficacy of antitussive or expectorant drugs against acute cough. The state of the evidence for phytotherapeutic agents is heterogeneous; clinical importance is minimal. COVID-19 should currently be considered in cases of acute respiratory symptoms. If specific symptoms or red flags occur, further diagnoses in the context of acute cough such as community-acquired pneumonia, influenza disease and exacerbations of chronic respiratory diseases (bronchial asthma, COPD) should be taken into consideration. Conclusions: These evidence-based recommendations are intended to reduce the use of antibiotics to treat colds and acute bronchitis, for which they are not indicated. Further clinical trials of symptomatic treatments for cough should be performed in order to extend the evidence base.

Treatment with the P2X3-Receptor Antagonist Gefapixant for Acute Cough in Induced Viral Upper Respiratory Tract Infection: A Phase 2a, Randomized, Placebo-Controlled Trial.

INTRODUCTION: Available therapies for acute cough, a condition frequently caused by a viral upper respiratory tract infection (URTI), have shown limited evidence of efficacy. Gefapixant, a P2X3-receptor antagonist, has demonstrated efficacy and safety in studies of the treatment of refractory or unexplained chronic cough, but its efficacy for treating acute cough has not been previously studied. METHODS: This was a phase 2a, randomized, double-blind, placebo-controlled, parallel-group, pilot study. Healthy volunteers were randomized 1:1 to receive twice-daily gefapixant 45 mg or placebo and inoculated with human rhinovirus 16 to induce URTI and cough. Participants were observed while quarantined for 7 days after the start of treatment. The primary endpoint was awake cough frequency on day 3, which was objectively measured with a cough-recording device. Secondary endpoints included change from baseline to day 3 in subjective cough severity measures (cough severity visual analog scale, Cough Severity Diary) and cough-specific quality of life (Leicester Cough Questionnaire-acute). RESULTS: Of the 46 participants who met inclusion criteria [mean (standard deviation, SD) age, 24.6 (6.5) years; females, n = 8], 40 completed the study (gefapixant, n = 21; placebo, n = 19). There was no significant difference in awake cough frequency on day 3 between the gefapixant and placebo groups [least squares means, 2.4 versus 2.7 coughs per hour, respectively; mean difference (95% confidence interval, CI), -0.3 (-2.3, 1.7); P = 0.75]. There were no significant between-group differences for any of the secondary endpoints. Peak cough frequency was low and occurred later in the study than expected (days 4-5). The safety profile was consistent with that of previous studies of gefapixant. CONCLUSION: Compared with placebo, gefapixant did not reduce the frequency or severity of acute cough secondary to induced URTI. Induced viral URTI produced mild symptoms, including lower cough frequency than observed in previous studies of patients selected for acute cough associated with naturally occurring URTI. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03569033; EudraCT, 2017-000472-28; protocol number, MK-7264-013.

Effects of Pelargonium sidoides extract EPs 7630 on acute cough and quality of life - a meta-analysis of randomized, placebo-controlled trials.

Background: Cough is a leading symptom of viral acute respiratory infections such as acute bronchitis (AB) and the common cold (CC), which can be debilitating and may persist for several weeks. We investigated whether treatment with Pelargonium extract EPs 7630 may reduce cough and improve disease-related quality of life (QoL). Methods: We performed a meta-analysis of randomized, placebo-controlled trials investigating the efficacy of EPs 7630 in AB or CC. Efficacy analyses included change from baseline in a cough intensity score, remission of cough, and disease-associated impairments of QoL. Results: Data of 2,195 participants from 11 trials (3 in children/adolescents with AB, 3 in adults with AB, 5 in adults with CC) were eligible. In children/adolescents with AB, 79.6% of participants treated with EPs 7630 and 41% treated with placebo showed a reduction in the intensity of cough by at least 50% of baseline values at day 7 [meta-analysis rate/risk ratio (RR), EPs 7630 / placebo: 1.86 (95% CI: 1.34; 2.95)], and 18.0% vs 5.5% presented with complete remission of cough [RR: 2.91 (95% CI: 1.26; 6.72)]. In adults with AB, 88.7% of participants in the EPs 7630 group and 47.6% in the placebo group showed a ≥50% response for cough intensity [RR: 2.13 (95% CI: 1.37; 3.31)], while 26.0% vs 6.3% did not cough any more at day 7 [RR: 5.00 [95% CI: 3.10; 8.07)]. Cough scale results were supported by significant improvements over placebo in the pursuit of normal daily activities and other QoL measures. In CC, 56.8% of participants treated with EPs 7630 and 38.8% treated with placebo showed a ≥50% cough intensity reduction [RR: 1.40 (95% CI: 1.19; 1.65)] at day 5, while 26.1% versus 18.4% showed complete remission of cough for EPs 7630 and placebo, respectively [RR: 1.40 (95% CI: 1.06; 1.84)]. CCassociated pain/discomfort and impairment of usual activities were no longer present in 41.5% and 48.8% of participants treated with EPs 7630 compared to less than 40% of patients in the placebo group. Conclusions: The results show that EPs 7630 reduces the burden and leads to earlier remission of cough. Advantages for EPs 7630 were also reflected in self-rated measures of disease-associated QoL. Of note, patients treated with the herbal product felt able to resume their usual daily activities sooner.