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Background Refractory and unexplained chronic cough (RCC and UCC) necessitate frequent referral for specialist evaluations, but data on healthcare resource utilisation and costs are lacking. Methods This observational study enrolled adults with RCC or UCC attending a specialist cough clinic and included a control cohort, both from North West England, matched 1:5 for age, gender and smoking history. Primary and secondary care data were obtained for the 5 years prior to and 2 years post initial clinic visit (index). The primary endpoint was the total 5-year healthcare cost to the UK NHS pre-RCC or UCC diagnosis compared to the control cohort. Results Mean age at index for the 200 RCC or UCC consented patients was 62.2 ± 11.4 years; 71% were female, and 68% had never smoked. Mean duration of symptoms pre-diagnosis was 8.0 ± 9.4 years. Mean cough severity score was 63.7 ± 23.2 mm at index on a Visual Analog Scale, and Leicester Cough Questionnaire total score was 10.9 ± 4.1. GP data were available for 80 patients and mean total cost over the 5 years pre-diagnosis (index date) was 3.0-fold higher (95% CI 2.3, 3.9) than in the control cohort ( p  < 0.001). Most excess costs were related to visits and procedures carried out in secondary care. RCC- or UCC-associated costs decreased post-diagnosis, but remained higher than those of controls. Conclusion Diagnosis of RCC or UCC requires significant health resource utilisation in the 5 years prior to a specialist clinic diagnosis. Resource utilisation was less after diagnosis, but remained higher than in a matched control cohort.

PurposeChronic cough (CC), defined as a cough persisting ≥ 8 weeks, can have a substantial negative impact on health-related quality of life (HRQoL). This is exacerbated by challenges with timely diagnosis and a lack of approved therapies. A systematic literature review (SLR) was conducted to identify evidence on HRQoL and health state utility values associated with refractory CC or unexplained CC.MethodsElectronic database searches were supplemented with searches of conference proceedings and health technology assessment body websites. Two independent reviewers assessed all citations for inclusion based on predefined inclusion/exclusion criteria. Key inclusion criteria were patient populations with CC and reporting of patient-reported outcomes or utilities using generic or disease-specific measures.ResultsFollowing screening, 65 studies were identified for inclusion in the SLR. Of these, 23 studies assessed HRQoL among patients with CC who were not treated or treated with unspecified interventions, and 42 studies in patients who were treated with specified interventions. The studies indicated a substantial decrement to HRQoL as a result of CC, characterized by generic and disease-specific patient-reported outcome measures. HRQoL was impacted across multiple domains, including physical, psychological, and social functioning. The studies also demonstrated the potential for treatments to have a significant positive impact on HRQoL.ConclusionsCC can substantially affect HRQoL in patients, across physical, psychological, and social domains. Although treatments can improve HRQoL in these patients, the available evidence is limited. There remains an unmet need for approved pharmacological treatments to alleviate CC and improve HRQoL for these patients.

In recent years, there has been a substantial increase in the development of antitussive therapies and the first new therapy, gefapixant has been licenced in Europe. This review describes current unlicenced treatments for chronic cough and details treatments currently in development for refractory chronic cough and cough in idiopathic pulmonary fibrosis, as well as compounds previously explored.

Purpose We evaluated gefapixant, a P2X3 receptor antagonist, in participants with recent-onset (≤ 12 months) refractory chronic cough (RCC) or unexplained chronic cough (UCC). Methods Participants (≥ 18 years of age; ≥ 40 mm on a 100-mm cough severity visual analog scale [VAS] at screening and randomization) with chronic cough for < 12 months were enrolled in this phase 3b, double-blind, placebo-controlled, parallel group, multicenter study (NCT04193202). Participants were randomized 1:1 to gefapixant 45 mg BID or placebo for 12 weeks with a 2-week follow-up. The primary efficacy endpoint was change from baseline at Week 12 in Leicester Cough Questionnaire (LCQ) total score. Adverse events were monitored and evaluated. Results There were 415 participants randomized and treated (mean age 52.5 years; median [range] duration 7.5 [1–12] months): 209 received placebo and 206 received gefapixant 45 mg BID. A statistically significant treatment difference of 0.75 (95% CI: 0.06, 1.44; p  = 0.034) for gefapixant vs. placebo was observed for change from baseline in LCQ total score at Week 12. The most common AE was dysgeusia (32% gefapixant vs. 3% placebo participants); serious AEs were rare (1.5% gefapixant vs. 1.9% placebo participants). Conclusion Gefapixant 45 mg BID demonstrated significantly greater improvement in cough-specific health status from baseline compared to placebo, in participants with recent-onset chronic cough. The most common AEs were related to taste and serious AEs were rare.

IntroductionThis study aims to characterize the patient journey for refractory chronic cough (RCC) or unexplained chronic cough (UCC) before visiting the Isala Chronic Cough Clinic (ICCC) in the Netherlands.MethodData from 152 patients with RCC or UCC was collected between January 2017 and September 2021from General Practitioner (GP) and hospital charts, the EQ-5D-5L questionnaire, and a patient survey about the care pathway and cough impact on everyday life, based on a single-centre, observational, retrospective study design.ResultsMean age at first ICCC visit was 60.3 ± 11.6 years; 66.4% of patients was female. More patients had RCC (80.9%) than UCC (19.1%). Mean cough duration before ICCC visit was 8.5 ± 6.5 years. 41.4% of patients reported cough >10 years. Common patient-reported problems were social embarrassment (58.0%), exhaustion (54.2%), and sleep disturbance (45.0%). Urinary incontinence was prevalent among women (48.9%). Prior to ICCC, 59.2% had consulted 2-4 specialists for their cough and 16.2% had seen more than 4.ConclusionThis study highlights the long time to diagnosis of RCC or UCC, and the negative effect on patients' physical and psychological health, and everyday activities. Increased awareness may shorten time for diagnosis, and novel therapies may help reduce this disease burden.

Introduction Chronic cough (persisting for ≥ 8 weeks) is a common disorder that includes refractory chronic cough (RCC; cough that persists despite treatment of underlying disease) and unexplained chronic cough (UCC; cough with no identifiable cause). We evaluated self-reported health-related quality of life (HR-QoL) and work/activity impairment associated with RCC/UCC in Canada. Methods Our exploratory study included Canadians in the Leger Opinion Panel with RCC or UCC. Key entry criteria were ≥ 18 years of age, cough for ≥ 8 weeks, not currently smoking/quit ≥ 1 year ago, no serious respiratory disease or lung cancer, and not taking angiotensin-converting enzyme inhibitors. Respondents completed a 30-min online survey with general and cough-specific HR-QoL questionnaires, including the EuroQol (EQ) visual analogue scale (VAS), EQ-5-dimension 5-level (EQ-5D-5L), cough severity VAS, Leicester Cough Questionnaire (LCQ), and Work Productivity and Activity Impairment-Specific Health Problem (WPAI-SPH). Results Of 49,076 individuals who completed the chronic cough screening questionnaire (July 30-September 1, 2021), 1,620 (3.3%) met entry criteria for RCC/UCC and 1,046 (2.1%) completed the survey. The mean age of respondents was 45 years and 61% were female. Respondents reported impairments in global HR-QoL (EQ-VAS 73.8, 61% with anxiety/depression on the EQ-5D-5L) and cough-specific HR-QoL (mean cough severity VAS score 29.7, LCQ index 15.2). Work and non-work activities were reduced by 34% and 30%, respectively, on the WPAI-SPH. Conclusion RCC/UCC is prevalent in Canada and associated with impaired HR-QoL, particularly in mental health domains. Additional support and management options may be required to fully address this burden.

Purpose Chronic cough (cough that persists for ≥ 8 weeks) can cause a range of physical symptoms and psychosocial effects that significantly impair patients’ quality of life. Refractory chronic cough (RCC) and unexplained chronic cough (UCC) are challenging to diagnose and manage, with substantial economic implications for healthcare systems. Methods This retrospective multicenter non-interventional study aimed to characterize the profile and health resource consumption of patients with RCC or UCC who attended outpatient clinics at Spanish hospitals. Data were collected from medical records of patients with RCC or UCC for up to 3 years before study inclusion. Results The patient cohort (n = 196) was representative of the chronic cough population (77.6% female, mean age 58.5 years). Two-thirds of patients (n = 126) had RCC. The most frequently visited doctors were pulmonologists (93.4% of patients) and primary care physicians (78.6%), with a mean of 5 visits per patient over three years’ observation. The most common diagnostic tests were chest x-ray (83.7%) and spirometry with bronchodilation (77.0%). The most commonly prescribed treatments were proton pump inhibitors (79.6%) and respiratory medications (87.8%). Antibiotics were prescribed empirically to 56 (28.6%) patients. Differences between RCC or UCC groups related mainly to approaches used to manage cough-associated conditions (gastroesophageal reflux disease, asthma) in patients with RCC. Conclusion RCC and UCC are responsible for high health resource utilization in Spanish hospitals. Specific treatments targeting the pathological processes driving chronic cough may provide opportunities to reduce the associated burden for patients and healthcare systems.

Chronic cough (CC) is associated with high healthcare resource utilization (HCRU) due to challenges in diagnosis and treatment and is anticipated to have a substantial economic impact. This systematic literature review (SLR) sought to identify evidence on the cost-effectiveness of treatments and the economic burden associated with CC. Electronic database searches were supplemented with searches of conference proceedings and health technology assessment body websites. Two independent reviewers assessed all citations for inclusion based on predefined inclusion/exclusion criteria. Key inclusion criteria were patient population with CC, and outcomes related to cost-effectiveness and HCRU and costs. After screening, one cost-effectiveness analysis was identified, alongside eight studies reporting HCRU and costs related to CC. Though evidence was limited, studies suggest that patients with CC incur higher costs and use more resources than those with acute cough. Types of resource use reported included healthcare contacts and prescriptions, diagnostic tests, referrals and specialist evaluations, and treatment use. There is a paucity of literature on HCRU and costs in CC, and very limited cost-effectiveness analyses. The economic burden appears higher in these patients however, without direct comparison to the general population it is difficult to determine the total impact. The increased burden is expected to be a result of the challenges with diagnosis and lack of approved treatments. However, limited conclusions can be drawn in the absence of further data. Future studies should endeavor to quantify the HCRU and cost attributable to patients with CC. Take home message Patients with CC encounter multiple physicians and specialists to seek a definitive diagnosis, resulting in delayed diagnosis and appropriate treatment. This SLR reported a paucity of economic data; however, it found patients with CC to incur higher costs and more resource use than those with acute cough.

Introduction Current literature reveals that up to 88% of individuals undergoing behavioral speech therapy (BST) for chronic refractory cough (CRC) demonstrate benefit at 4–8 weeks post-treatment. However, investigations of BST are confounded by overlapping use of neuromodulators, missing follow-up data, and an absence of long-term outcomes. This study investigated treatment outcomes beyond 6 months in individuals diagnosed with CRC, and whose treatment outcomes were clinically undocumented. Methods Participants with CRC 6 months or greater beyond treatment completion were recruited. Participants completed a post-treatment Leicester Cough Questionnaire (LCQ) and a telephone interview. Demographic data, cough characteristics, treatment adherence, BST outcomes, and pre- and post-treatment LCQ scores were evaluated. Results 80 individuals met inclusion criteria and 29 consented to participate. Of these, 27 were recommended BST. The majority were female (19/27) with average age of 58 years (SD = 12). Mean cough duration was 60 months (SD = 98) and mean post-BST duration was 20 months (SD = 9). A significant increase in pre- to post-treatment LCQ scores occurred [4.4 (SD = 4.2)] ( p  < 0.0001). Conclusion This study addressed long-term BST benefit for CRC and demonstrated a significant improvement in long-term post-treatment LCQ total scores more than a year after BST for CRC. More than half of participants indicated improvement or elimination of their cough. These findings further support the benefit of BST for CRC. Future research should consider patient perspectives about treatment outcomes given that 44% of participants reported no benefit from BST.

Background: Chronic cough, a cough lasting >8 weeks, includes refractory chronic cough (RCC) and unexplained chronic cough (UCC). Patient-reported outcome (PRO) measures are needed to better understand chronic cough impacts that matter most to patients. The 19-item Leicester Cough Questionnaire (LCQ), an existing PRO measure of chronic cough, assesses impacts of cough across physical, psychological, and social domains. However, the content validity of the LCQ evaluating these concepts in patients with RCC/UCC had not been established. Objectives: To evaluate the content validity of the LCQ in patients with RCC/UCC. Design: A cross-sectional, qualitative interview study. Methods: First, previously completed qualitative interview results in adults with RCC/UCC (N = 30) were evaluated and mapped to LCQ concepts. Next, a clinical cough expert reviewed each LCQ item and assessed the salience of its concepts for patients with RCC/UCC. Finally, semistructured interviews—including both concept elicitation and cognitive debriefing—were conducted in adults with RCC/UCC (N = 20) to elicit a comprehensive set of participant experiences and to assess the appropriateness of using the LCQ in this population. Results: Concepts reported in the past and present qualitative interviews were included across all LCQ items, and most impacts reported to be the “most bothersome” were assessed in the LCQ. In the current study, all participants indicated that reduced cough frequency would be an important treatment target. During cognitive debriefing, each LCQ item was endorsed by ⩾70% of participants. Additionally, participants were generally able to understand, recall, and select a response for each LCQ item. All participants and the clinical expert indicated that the LCQ was appropriate and assessed the impacts most relevant to patients with RCC/UCC. Conclusion: Our findings support the content validity of the LCQ and demonstrate that this measure is fit-for-purpose and includes important cough impacts in adults with RCC/UCC.