P57 Figure 1Cough severity analogue scale (a) and cough-specific health status LCQ (b) ranges for Pateint Global Impression of Severity categories[Figure omitted. See PDF]ConclusionThe PGI-S scale is a simple tool that characterises cough severity in a format familiar to clinicians, and allows comparisons with other conditions. The PGI-S has a strong relation with validated cough measures such as VAS and LCQ. Future studies should investigate the reproducibility and clinically important threshold for change of the PGI-S.
BackgroundStress Urinary Incontinence (SUI) is one of the major physical consequences suffered by individuals with chronic cough (CC). We investigated the prevalence of CC among women who reported having SUI.MethodsParticipants completed an online structured quantitative questionnaire in April 2021, to identify adult women with SUI. Demographic characteristics, causes/triggers of urinary incontinence, current or previous CC, cough frequency and duration, COVID-19 infection and its impact on CC were included.ResultsA total of 835 adult women reported having SUI, of whom, 153 (18.3%) concomitantly had urgency incontinence, 59 (7.1%) had overflow incontinence, and 28 (3.4%) had functional incontinence. The mean age was 52.3 years (Range: 21–86), the majority (604 (72.3%)) reported cough as a cause of their urinary incontinence, of whom 67.0% reported suffering incontinence because of cough at least once a week. One hundred and twenty-three (14.7%) women reported experiencing CC within the last year, and 84 (10.1%) reported still having CC currently. Fifty-seven (6.8%) women stated their CC had been diagnosed by a physician, and 150 (18.0%) women reported having suspected or confirmed COVID-19 (with or without CC). Of the 123 women who had CC in the last year, ninety-three (75.6%) had CC onset before COVID-19.ConclusionA majority of women with SUI reported cough as one of the leading triggers of their urinary incontinence. Almost 15% of the sample reported experiencing CC, but less than half of those had a formal diagnosis from a physician. Most cases of CC were not related to COVID-19. Future studies would be useful to further explore the burden of CC on SUI patients.Please refer to page A191 for declarations of interest related to this abstract.
BACKGROUND:The Patient Global Impression of Severity (PGI-S) scale is a self-reported, single-item categorical scale that is increasingly used when assessing chronic cough (CC). OBJECTIVE:This study aimed to establish validity, repeatability, and responsiveness of the PGI-S scale in CC and use the scale to define discrete categories of severity when measured with other commonly used patient-reported outcome (PRO) tools. METHODS:Consecutive patients with CC completed the PGI-S scale, cough severity and urge to cough visual analog scales (VAS), and cough-specific health status Leicester Cough Questionnaire (LCQ) at a clinic visit. Validity, repeatability, and responsiveness were assessed, and threshold scores for PRO severity categories determined. RESULTS:A total of 482 participants completed the assessments; the median (interquartile range [IQR]) age was 57 (46-67) years, 71% were female, and the median (IQR) duration of cough was 48 (24-120) months. They reported a median (IQR) PGI-S score of 3 (3-4; moderate severity), cough severity VAS of 57 (31-75) mm, urge to cough VAS of 62 (40-81) mm, and LCQ of 11.5 (8.7-14.4). There were strong associations between PGI-S scores and cough severity VAS (ρ = 0.81), urge to cough VAS (ρ = 0.73), and LCQ (ρ = -0.73) (all P < .001). Repeatability of the PGI-S scale was high (n = 77); the intraclass correlation coefficient (95% confidence interval) was 0.85 (0.77-0.91) (P < .001). The PGI-S scale was responsive in participants with a treatment response (P < .001). The suggested PRO thresholds to define severe cough are ≥61 mm (cough severity VAS), ≥71 mm (urge to cough VAS), and ≤10 (LCQ). CONCLUSION:The PGI-S scale is a simple and valid tool that characterizes cough severity and is repeatable and responsive in CC. The proposed categorical severity thresholds for VAS and LCQ can provide intuitive meaning for patients and clinicians.
IntroductionChronic cough (CC) is a relatively common condition often associated with comorbidities such as asthma, gastroesophageal reflux disease, or upper-airway cough syndrome. A subset of patients experience CC that does not resolve after treatment of cough-associated conditions (refractory CC [RCC]) or for which there is no known cause of CC despite clinical evaluation according to published guidelines (unexplained CC [UCC]). However, no treatments are currently approved for RCC or UCC. In two large phase 3 trials (COUGH-1, NCT03449134; COUGH-2, NCT03449147), the P2X3-receptor antagonist gefapixant demonstrated significant reductions in the primary endpoint (24-hour cough frequency) in participants with RCC or UCC at a dosage of 45 mg twice daily (BID) vs placebo.1 The current analysis assessed objective cough frequency in the pooled population of COUGH-1 and COUGH-2.MethodsAdults aged ≥18 years with CC lasting ≥1 year, a diagnosis of RCC or UCC according to CHEST guidelines, and a baseline cough severity visual analog scale score ≥40 mm were eligible for COUGH-1 and COUGH-2. Participants were randomized to placebo, gefapixant 15 mg BID, or gefapixant 45 mg BID. Objective cough frequency was measured using the VitaloJAK™ (Vitalograph; Buckinghamshire, England) recording device. Cough frequency endpoints included 24-hour and awake cough frequency assessed through Weeks 12 and 24 (COUGH-1 and COUGH-2, respectively). Data were pooled across trials and analyzed at Week 12 using longitudinal analysis of covariance based on log-transformed data.ResultsThe pooled population from COUGH-1 and COUGH-2 included 2044 total participants. Baseline 24-hour and awake cough frequency were similar across treatment groups (table 1). Relative reductions in 24-hour and awake cough frequency for gefapixant 45 mg BID vs placebo were 18.6% (95% CI: 9.2, 27.1) and 17.4% (95% CI: 7.5, 26.2), respectively. No differences in serious adverse events (AEs) were observed across treatment groups. The most common AEs with gefapixant were taste related.ConclusionsCOUGH-1 and COUGH-2 are the largest clinical trials investigating treatment of CC. In this pooled analysis, gefapixant 45 mg BID demonstrated significant reductions in 24-hour and awake cough frequency vs placebo, with no increase in serious AEs.ReferenceMcGarvey, et al. Eur Respir J. 2020;56(suppl 64):3800. Please refer to page A192 for declarations of interest related to this abstract.
Introduction Previous studies characterizing patients with chronic cough (CC) have typically included patients with CC without a specific focus on patients with guidelines-diagnosed refractory CC (RCC) or unexplained CC (UCC). This analysis assessed the medical history, cough severity, and cough-related quality of life (QOL) at baseline in participants with RCC and UCC enrolled in two global phase 3 trials. Methods Pooled data from participants enrolled in two phase 3, randomized, placebo-controlled clinical trials of the P2X3-receptor antagonist gefapixant (COUGH-1, NCT03449134; COUGH-2, NCT03449147) were used in this analysis. Participants were adults with cough lasting ≥1 year, a diagnosis of RCC or UCC according to guidelines from the American College of Chest Physicians, and a baseline cough severity score ≥40 mm on a 100-mm visual analog scale. Comorbidities and prior medications were identified from participant medical records. Baseline cough metrics included the Cough Severity Diary (CSD) and Leicester Cough Questionnaire (LCQ). The CSD measures cough severity across 3 domains (frequency, intensity, and disruption), with items measured on an 11-point scale (higher scores indicate greater severity). The LCQ assesses health-related QOL, including physical, psychological, and social domains, with a total score ranging from 3 to 21 (lower scores indicate a more impaired QOL). Results Of 2044 participants randomized and treated in COUGH-1 or COUGH-2, 41%, 41%, and 29% had prior diagnoses of asthma, gastroesophageal reflux disease, and rhinitis/upper-airway cough syndrome, respectively; 8% had prior diagnoses of all 3 conditions. Prior medications were consistent with treatments indicated for these comorbidities or cough and included drugs for obstructive airway diseases (70%), acid-related disorders (55%), rhinitis preparations (nasal preparations, 53%; systemic antihistamines, 35%), and cough/cold preparations (34%). Baseline mean total CSD score (N=2038) was 6.0 and baseline mean total LCQ score (N=1949) was 10.4 (table 1). Conclusions Participants in COUGH-1 and COUGH-2 with RCC or UCC had medical histories consistent with diagnostic and treatment workup of CC according to published guidelines. Participants also reported severe cough with significant cough-related QOL impairment. These data help characterize the profile of patients with RCC or UCC and highlight unmet needs for treatments that can relieve their cough burden. Please refer to page A191 for declarations of interest related to this abstract.
