Clinical COPD Questionnaire Total Score Research Articles

Improvements in health status with revefenacin, a once-daily, nebulized, long-acting muscarinic antagonist for chronic obstructive pulmonary disease

BackgroundReplicate, 12-week, phase 3 trials (0126 and 0127) of once-daily nebulized revefenacin 175 μg vs placebo demonstrated significant bronchodilation and improvements in health status in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). This post hoc analysis evaluated improvement in patient-reported outcomes (PROs), including the St. George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Clinical COPD Questionnaire (CCQ) in both women and men. MethodsParticipants were pooled from the two 12-week studies (411 [51%] women and 401 [49%] men). Changes in PROs were assessed overall and separately in men and women. ResultsRevefenacin improved SGRQ and CAT total scores from baseline in both studies; improvement in CCQ total score reached significance only in 0126. In pooled data, a greater proportion of patients achieved clinically meaningful response in SGRQ score (≥4-unit decrease from baseline) with revefenacin vs placebo (odds ratio, 1.5; 95% confidence interval, 1.1–2.1; P = 0.012). Clinically meaningful responses were also seen in CAT (≥2-unit decrease from baseline) and CCQ (≥0.4-unit decrease from baseline) scores with revefenacin vs placebo. When stratified by sex, improvements from baseline in SGRQ, CAT, and CCQ scores following revefenacin vs placebo reached statistical significance only in women. ConclusionsMaintenance treatment with revefenacin improved health status in patients with moderate to very severe COPD; however, the effect was more pronounced for women than men. Clinicaltrials.govNCT02459080; NCT02512510.

Brazilian version of the Clinical COPD Questionnaire, administered by interview: reliability and validity measurement properties.

ABSTRACTObjective:To test the reliability, validity, and interpretability of the Brazilian version of the Clinical COPD Questionnaire (CCQ) in patients with COPD. Methods:Fifty patients with COPD completed the CCQ by interview on two occasions. At the first visit, the CCQ was administered twice, by two different raters, approximately 10 min apart; the patients also underwent spirometry and were administered the COPD Assessment Test, the modified Medical Research Council scale, and Saint George’s Respiratory Questionnaire (SGRQ). At the second visit (1-2 weeks later), the CCQ was readministered. We tested the hypothesis that the CCQ total score would correlate positively with the total and domain SGRQ scores (r ≥ 0.5). Results:Of the 50 patients, 30 (60%) were male. The mean age was 66 ± 8 years, and the mean FEV1 was 44.7 ± 17.9% of the predicted value. For all CCQ items, Cronbach’s alpha coefficient (95% CI) was 0.93 (0.91-0.96). To analyze the interrater reliability and test-retest reliability of the CCQ, we calculated the two-way mixed effects model/single measure type intraclass correlation coefficient (0.97 [95% CI: 0.95-0.98] and 0.92 [95% CI: 0.86-0.95], respectively); the agreement standard error of measurement (0.65 for both); the smallest detectable change at the individual level (1.81 and 1.80, respectively) and group level (0.26 and 0.25, respectively); and the limits of agreement (−0.58 to 0.82 and −1.14 to 1.33, respectively). The CCQ total score correlated positively with all SGRQ scores (r ≥ 0.70 for all). Conclusions:The Brazilian version of the CCQ showed an indeterminate measurement error, as well as satisfactory interrater/test-retest reliability and construct validity.

Generic and Respiratory-Specific Quality of Life in Non-Hospitalized Patients with COVID-19.

The impact of coronavirus disease 2019 (COVID-19) on quality of life appears to be highly underestimated, especially in patients who have not been admitted to the hospital. Therefore, our aim was to assess respiratory-specific quality of life in addition to generic quality of life in former patients with confirmed/suspected COVID-19 who have never been admitted to the hospital. Members of an online Belgian social support group for patients with confirmed/suspected COVID-19 with persistent complaints, completed an online survey. The five-level EQ-5D (EQ-5D-5L) and the Clinical COPD Questionnaire (CCQ) were used to assess generic and respiratory-specific quality of life, respectively. Data of 210 non-hospitalized patients (88% women, 45 ± 11 years, 79 ± 17 days after symptom onset) were included in the analyses. Mean EQ-5D index and visual analogue scale (EQ-VAS) score was 0.62 ± 0.19 and 50.71 ± 18.87, respectively, with 40% of the patients demonstrating an EQ-5D index that was below the fifth percentile of normative values, indicating poor generic quality of life. The mean CCQ score was 2.01 ± 0.98 points, while 123 respondents (59%) had a total score ≥1.9 points, indicating poor respiratory-specific quality of life. The correlation between EQ-5D index score/EQ-VAS score and CCQ total score was moderate (r = −0.524 and r = −0.374; both p < 0.001). In conclusion, both generic and respiratory-specific quality of life are affected in non-hospitalized patients with COVID-19, approximately three months after the onset of symptoms. The combined use of the EQ-5D and the CCQ could identify the broad impact of COVID-19 on quality of life.

Treatable traits qualifying for nonpharmacological interventions in COPD patients upon first referral to a pulmonologist: the COPD sTRAITosphere.

IntroductionThe present study assessed the prevalence of nine treatable traits (TTs) pinpointing nonpharmacological interventions in patients with COPD upon first referral to a pulmonologist, how these TTs co-occurred and whether and to what extent the TTs increased the odds having a severely impaired health status.MethodsData were collected from a sample of 402 COPD patients. A second sample of 381 patients with COPD was used for validation. Nine TTs were assessed: current smoking status, activity-related dyspnoea, frequent exacerbations <12 months, severe fatigue, depressed mood, poor physical capacity, low physical activity, poor nutritional status and a low level of self-management activation. For each TT the odds ratio (OR) of having a severe health status impairment was calculated. Furthermore, a graphic representation was created, the COPD sTRAITosphere, to visualise TTs prevalence and OR.ResultsOn average 3.9±2.0 TTs per patient were observed. These TTs occurred relatively independently of each other and coexisted in 151 unique combinations. A significant positive correlation was found between the number of TTs and Clinical COPD Questionnaire total score (r=0.58; p<0.001). Patients with severe fatigue (OR: 8.8), severe activity-related dyspnoea (OR: 5.8) or depressed mood (OR: 4.2) had the highest likelihood of having a severely impaired health status. The validation sample corroborated these findings.ConclusionsUpon first referral to a pulmonologist, COPD patients show multiple TTs indicating them to several nonpharmacological interventions. These TTs coexist in many different combinations, are relatively independent and increase the likelihood of having a severely impaired health status.

The clinical effectiveness of the COPDnet integrated care model

RationaleIntegrated care models have the potential to improve outcomes for patients with COPD. We therefore designed the COPDnet integrated care model and implemented it in two hospitals and affiliated primary care regions in the Netherlands. The COPDnet model consists of a comprehensive diagnostic trajectory ran in secondary care followed by a non-pharmacological intervention program of both monodisciplinary and multidisciplinary components. ObjectiveTo assess the clinical effectiveness of the COPDnet integrated care model on health status change in patients with COPD. MethodsA total of 402 patients with COPD were offered care according to the COPDnet model. At baseline and between 7- and 9-months later health status was measured with the Clinical COPD Questionnaire (CCQ). Primary analysis was carried out for the sample at large. In addition, subgroup analyses were performed after stratification for the type of non-pharmacological intervention where patients had been referred to. ResultsThe CCQ total score improved statistically significantly from 1.94 ± 1.04 to 1.73 ± 0.96 (P < 0.01) in the 154 patients with valid follow-up measurements. Subgroup analyses revealed significant improvements in the patients receiving pulmonary rehabilitation only. No change in health status was found in patients receiving pharmacotherapy only, carried out self-treatment or who participated in mono-disciplinary primary care offered by allied healthcare professionals. ConclusionsAn improved health status was found in patients with COPD who received care according to the COPDnet integrated care model. Subgroups participating in an interdisciplinary pulmonary rehabilitation program predominantly accounted for this effect.

Association between patient-reported outcomes and exercise test outcomes in patients with COPD before and after pulmonary rehabilitation

BackgroundOver the years, the scope of outcomes assessment in chronic obstructive pulmonary disease (COPD) has broadened, allowing for the evaluation of various patient-reported outcomes (PROs). As it still remains unclear whether and to what extent PROs mirror the exercise performance of patients with COPD, the current study aimed to assess the association between different exercise test outcomes and PROs, before and after pulmonary rehabilitation (PR).MethodsCorrelations between PROs used to describe health-related quality of life (HRQoL), mood status, level of care dependency and dyspnea in patients with COPD and commonly used laboratory- and field-based exercise test outcomes were evaluated in 518 individuals with COPD attending PR.ResultsOverall, correlations between PROs and exercise test outcomes at baseline were statistically significant. The correlation between modified Medical Research Council (mMRC) dyspnea score and 6-min walking distance (6MWD) was strongest (ρ:-0.65; p<0.001). HRQoL related PROs showed weak correlations with exercise outcomes at baseline. Moderate correlations were found between St George’s Respiratory Questionnaire total score and 6MWD (r:-0.53; p<0.001) and maximal workload achieved during cardiopulmonary exercise testing (ρ:-0.48; p<0.001); and between Clinical COPD Questionnaire (CCQ) total score and 6MWD (r:-0.48; p<0.001) and maximal workload (ρ:-0.43; p<0.001). When significant, correlations between changes in exercise test outcomes and changes in PROs after PR were generally very weak or weak. The highest correlation was found between changes in CCQ total score and changes in 6MWD (ρ: − 0.36; p<0.001).ConclusionsPROs and exercise test outcomes, although significantly correlated with each other, assess different disease features in patients with COPD. Individual PROs need to be supported by additional functional measurements whenever possible, in order to get a more detailed insight in the effectiveness of a PR program.Trial registrationNetherlands Trial Register (NL3263/NTR3416). Registered 2 May 2012.

Improvement in health status with once-daily indacaterol/glycopyrronium 110/50\xa0\u03bcg in COPD patients: real-world evidence from an observational study in Ireland

AimsIndacaterol/glycopyrronium (IND/GLY) 110/50 μg is a once-daily (o.d.) fixed-dose combination of long-acting β2-agonist/long-acting muscarinic antagonist approved in over 90 countries, including Ireland, for the management of COPD. The present study was conducted to evaluate health status of COPD patients, initiated on IND/GLY 110/50 μg o.d., using the Clinical COPD Questionnaire (CCQ) tool in a real-world primary care setting in Ireland.MethodsThis was a real-world, prospective, open-label study. COPD patients aged > 40 years and with a smoking history of > 10 pack-years were included and switched to once-daily IND/GLY 110/50 μg. Enrolment of patients into the study occurred only after the decision had been made by the physician to prescribe IND/GLY 110/50 μg. Data were collected at baseline and Week 26. Health status was assessed using the validated CCQ.ResultsA total of 200 patients were included in study. The mean CCQ total score decreased from 2.36 at baseline to 1.44 at Week 26 (Δ, 0.92; P < 0.0005). Of the 156 patients who completed study, 113 (72.4%) achieved minimum clinically important difference in CCQ total score with IND/GLY 110/50 μg. CCQ domain scores also decreased during the study. Improvement in health status was observed across all GOLD groups and irrespective of prior COPD treatment. Adverse events were reported by 20% of patients with COPD exacerbation/infected COPD being the most common AE, reported by 11 patients.ConclusionsIn real-life clinical practice in Ireland, IND/GLY 110/50 μg o.d. demonstrated statistically significant and clinically important improvement in health status in patients with COPD.

INFLOW study: a prospective observational study for assessment of indacaterol and other bronchodilators in symptomatic chronic obstructive pulmonary disease patients from Egypt

BackgroundThe INdacaterol eFfectiveness and utiLizatiOn in COPD: real-World evaluation (INFLOW) study demonstrated significant improvements in health status with decreasing Clinical COPD Questionnaire (CCQ) scores in routine clinical practice with indacaterol (IND) and other bronchodilators from 12 countries in Asia, the Middle East and South Africa. Here, we report the data on real-life effectiveness of IND and other bronchodilators from Egypt.MethodsIn this 6-month, noninterventional, open-label study, patients were prescribed IND (150 or 300 μg) or other longacting β2-agonists (LABAs) or tiotropium (TIO) (monotherapy or in combination with IND or LABAs) as a part of routine medical care. Health status (CCQ scores), patient and physician satisfaction and safety were assessed.ResultsData were analysed from 152 patients (IND, n=88; IND+TIO, n=27; other-LABAs, n=6; TIO, n=10; and other- LABAs+TIO, n=21). At the end of the study, reduction from baseline CCQ total score was significant (P<0.0001) with IND and other treatments. Approximately 80% of patients were satisfied and physicians rated the current prescribed treatments as ‘good’ or ‘very good’ for over 70% of the patients. More than 80% of patients rated the indacaterol inhaler (Breezhaler) device as ‘easy’ and ‘very easy to use’, and physicians rated over 70% of patients as ‘clearly understood the use of the device’. No adverse events related to premature discontinuation were reported.ConclusionIn real-world settings, IND as monotherapy or in combination with TIO was effective in improving the health status in COPD patients and is well tolerated. The majority of patients reported that the Breezhaler device was easy to use.

Evaluating the Clinical COPD Questionnaire: A systematic review.

The Clinical COPD Questionnaire (CCQ) is recommended by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) to evaluate health status in patients with COPD. The objective of this work was to systemically assess the reliability, validity, responsiveness and minimum clinically important difference (MCID) of the CCQ. A structured search was conducted in three databases to identify articles that evaluated the psychometric properties of the CCQ in individuals with COPD. Two investigators screened the title, abstract and full text of the articles to determine study eligibility and performed the data extraction. Quality assessment of included studies was assessed by the COSMIN (Consensus-Based Standards for the Selection of Health Measurement Instruments) checklist. Finally, 43 studies were included, over half of which had fair methodological quality. Internal consistency (reliability) of the CCQ total score ranged from 0.84 to 0.94, and test-retest reliability was 0.70-0.99. The overall CCQ had a better correlation with St George's Respiratory Questionnaire (SGRQ; from 0.71 to 0.88) and COPD Assessment Test (CAT; from 0.64 to 0.88) than modified Medical Research Council (mMRC; from 0.392 to 0.668) and forced expiratory volume in 1 s (FEV1 % predicted; from -0.31 to -0.68). Scores were different within GOLD stages, groups, composite events and co-morbidities. CCQ was sensitive to exacerbations, pulmonary rehabilitation and smoking cessation with the MCID of 0.4. The CCQ is a very useful and practical tool that can be used in clinical populations with good reliability, validity and responsiveness to interventions.

Health Status of Patients with Moderate to Severe COPD after Treatment with Nebulized Arformoterol Tartrate or Placebo for 1 Year

PurposeChronic obstructive pulmonary disease (COPD) is a progressive disease that impairs both objectively measured lung function and patient-reported health status. In a randomized clinical trial of patients with moderate to severe COPD, we compared changes in health status after adding arformoterol tartrate or placebo to patients’ treatment regimens. MethodsIn this multicenter, double-blind trial, patients were randomized to receive nebulized arformoterol 15 µg BID (n = 420) or matched placebo (n = 421). Treatment with other COPD medications was permitted, except for long-acting β2-agonists. Inclusion criteria were a forced expiratory volume in 1 second (FEV1) ≤65% of predicted, FEV1 >0.50 L, age ≥40 years, smoking history ≥15 pack-years, and a baseline breathlessness severity grade ≥2. The Clinical COPD Questionnaire (CCQ) was used to measure health status at randomization and at months 3, 6, and 12. CCQ scores range from 0 to 6, with higher scores indicating worse health status, and a decrease from baseline in total score by 0.4 point is considered clinically significant. Outcomes were analyzed by using mixed models for repeated measures. FindingsAt baseline, patients’ mean age was 63.8 years; 42.9% of patients were female, and 51.4% were current smokers. The mean baseline CCQ total scores were 2.88 and 2.91 for the arformoterol and placebo groups, respectively. A total of 841 patients were randomized to receive either arformoterol (n = 420) or placebo (n = 421); among them, 211 (50.1%) who received placebo and 255 (60.7%) who received arformoterol completed the trial. Arformoterol-treated patients had greater mean improvement from baseline in CCQ total score (−0.18 vs 0.02; P = 0.001), symptoms (−0.21 vs 0.01; P = 0.002), functional state (−0.15 vs 0.02; P = 0.018), and mental state (−0.18 vs 0.02; P = 0.023) than patients receiving placebo. At study end, 38.3% of the arformoterol-treated patients and 30.8% of patients receiving placebo reported clinically significant improvements on the CCQ (P = 0.026). These improvements were only modestly correlated with improvements in FEV1 (r = −0.15; P < 0.01). ImplicationsIn this 52-week trial, arformoterol-treated patients had greater improvements in health status than patients receiving placebo. Assessing health status along with lung function seems to provide additional information regarding the effectiveness of COPD maintenance treatments. ClinicalTrials.gov identifier: NCT00909779.

Impact of fatigue in patients with chronic obstructive pulmonary disease: results from an exploratory study.

Fatigue, which is also present in the healthy population, is a common but understudied symptom in chronic obstructive pulmonary disease (COPD). We hypothesized that clinically significant fatigue is also frequent in COPD and can be associated with an increased disease burden. An exploratory analysis derived from an ongoing cross-sectional study was carried out to evaluate levels of fatigue and impact on health-related quality of life/health status in patients with COPD (COPD group; n = 20) and healthy subjects (control group; n = 5). Health-related quality of life was measured using the Short Form Health Survey 36 (SF-36), health status with the Clinical COPD Questionnaire (CCQ), and airways obstruction with postbronchodilator forced expiratory volume in 1 s (FEV1 %predicted). Fatigue was measured with the vitality score of the SF-36, its clinical significance being defined by values of 50 or less. Fatigue was also measured using the Functional Assessment of Chronic Illness Therapy scale for fatigue (FACIT-F). Vitality scores were significantly worse in the COPD group (45.60 versus 76.25; p = 0.004). FACIT-F scores were significantly lower in the COPD group versus the control group (74.5 versus 95.0; p = 0.03). Clinically significant fatigue was detected in 60% of the COPD group, and was associated with a worse FEV1 %predicted (47.71 versus 65.82%; p = 0.016), worse symptoms burden (CCQ symptoms score 3.75 versus 2.43; p = 0.019), and worse overall health status (CCQ total score 3.30 versus 2.11; p = 0.011). Its link with systemic inflammation remains to be clarified further. Clinically significant fatigue is common among patients with COPD and is associated with an increased disease burden. It should therefore be integrated as a measure of disease prognosis and control in patients with COPD.

Telemedicine, the effect of nurse-initiated telephone follow up, on health status and health-care utilization in COPD patients: a randomized trial.

Telemedicine, care provided by electronic communication, may serve as an alternative or extension to traditional outpatient visits. This pilot study determined the effects of telemedicine on health-care utilization and health status of chronic obstructive pulmonary disease (COPD) patients. One hundred and one patients were randomized, 52 patients received telemedicine care and 49 had traditional outpatient visits. The primary outcome was COPD-specific health status, measured with the Clinical COPD Questionnaire (CCQ). Secondary outcomes included St. George's Respiratory Questionnaire (SGRQ) and the Short Form-36 (SF-36) and resource use in primary and secondary care. The mean age of the participants was 68 ± 9 years and the mean per cent of predicted forced expiratory volume in 1 s was 40.4 ± 12.5. The CCQ total score deteriorated by 0.14 ± 0.13 in the telemedicine group, and improved by -0.03 ± 0.14 in the control group (difference 0.17 ± 0.19, 95% confidence interval (CI): -0.21-0.55, P = 0.38). The CCQ symptom domain showed a significant and clinically relevant difference in favour of the control group, 0.52 ± 0.24 (95% CI: 0.04-0.10, P = 0.03). Similar results were found for the SGRQ, whereas results for SF-36 were inconsistent. Patients in the control group had significantly fewer visits to the pulmonologist in comparison to patients in the telemedicine group (P = 0.05). The same trend, although not significant, was found for exacerbations after 6 months. This telemedicine model of initiated phone calls by a health-care provider had a negative effect on health status and resource use in primary and secondary care, in comparison with usual care and therefore cannot be recommended in COPD patients in its current form.

Depression and heart failure associated with clinical COPD questionnaire outcome in primary care COPD patients: a cross-sectional study.

Background:Improvement in health-related quality of life (HRQoL) is one of the main goals in treating chronic obstructive pulmonary disease (COPD). Impaired HRQoL in COPD is associated with increased morbidity and mortality, hospitalisations and burden on our health-care system. The Clinical COPD Questionnaire (CCQ) is a validated, reliable, short questionnaire for the evaluation of disease-specific HRQoL in patients with COPD in primary care.Aims:To investigate factors that might be associated with CCQ outcome in COPD in a primary care setting.Methods:In a population of COPD patients in primary care, multiple regression analyses were used to assess associations between CCQ outcome and depression, heart failure, FEV1% predicted, FEV1/FVC, age, sex, body mass index and current smoking.Results:Data from 341 patients (mean age 68.1±10.3, COPD GOLD class I–III) were used for analyses. Together, heart failure and depression explained 23% of the variance in CCQ total score (P<0.001, N=93). Heart failure was most strongly associated with CCQ functional score (27% explained variance, P<0.001, N=100), whereas depression was most strongly associated with CCQ mental score (22% explained variance, P<0.001, N=93).Conclusions:CCQ outcomes are higher in COPD patients with heart failure and depression. These findings might imply that heart failure and depression affect HRQoL of patients with COPD, and thus emphasise the importance of a holistic approach of this complex disease, leading to a correct diagnosis of COPD and its comorbidities, to achieve better tailored treatment of chronic patients.

Health-related quality of life in chronic obstructive pulmonary disease patients in Korea.

BackgroundThere are few publications on quality measurement of COPD health state according to the severity level using EQ-5D in Korea. The present study aimed to evaluate the health-related quality of life (HRQoL) in patients with chronic obstructive pulmonary disease (COPD) in terms of disease severity in Korea.MethodsTotally two hundred patients with COPD were consecutively recruited in one tertiary hospital of Korea. Each respondent was asked to fill out the questionnaire through a face-to-face interview after providing informed consent. The questionnaire included general and clinical characteristics as well as the EQ-5D and Clinical COPD Questionnaire (CCQ). HRQoL was evaluated according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and severity of breathlessness.ResultsThe adjusted mean EQ-5D index scores were 0.83, 0.88, 0.81 and 0.60 in stage I, II, III and IV, respectively. The EQ-5D index tended to decrease with GOLD criteria. The adjusted mean EQ-Visual Analog Scale (VAS) scores ranged from 65.1 in stage IV to 73.9 in stage I. The CCQ total scores deteriorated with an increasing GOLD stage and severity of breathlessness (all P < 0.001). The correlation between CCQ total score and EQ-5D index was −0.69.ConclusionsOur study shows that HRQoL in COPD measured by EQ-5D and CCQ worsens with the GOLD stage and severity of breathlessness. EQ-5D and CCQ could be useful instruments for an evaluation of HRQoL in COPD patients in Korea.

Health status during hospitalisations for chronic obstructive pulmonary disease exacerbations: the validity of the Clinical COPD Questionnaire

Hospitalisations for chronic obstructive pulmonary disease (COPD) exacerbations are characterised by a significant worsening of the respiratory symptoms which can impair the health status (HS). However little is known on the HS behaviour during such events. Prospective study evaluating the validity of the Clinical COPD Questionnaire (CCQ) as a HS measure in hospitalisations for COPD exacerbations. The CCQ total score (CCQ-T) correlated with EQ-VAS (-0.51, p < 0.0001), was able to discriminate between longer and shorter duration hospitalisation (CCQ-T 3.83 vs 3.03, respectively p = 0.001), had a Cronbach-α of 0.86, and improved significantly over the hospitalisation period (CCQ-T on day 7 of hospitalisation 2.55 vs 3.77 at baseline, p < 0.0001). CCQ is an excellent tool for the assessment of the HS dynamics in hospitalisations for COPD exacerbations.

Efficacy and safety of AZD1981, a CRTH2 receptor antagonist, in patients with moderate to severe COPD

To evaluate the efficacy and tolerability of the selective CRTh2 (DP2) receptor antagonist AZD1981 compared with placebo in patients with moderate to severe COPD. In this multicentre, randomised, double-blind, parallel-group, phase IIa study (ClinicalTrials.gov identifier: NCT00690482) patients with moderate to severe COPD received either AZD1981 1000mg twice daily or matching placebo for 4 weeks. Inhaled terbutaline was used as-needed as reliever medication throughout. The co-primary endpoints were change from baseline to end of treatment in pre-bronchodilator forced expiratory volume in 1s[FEV1] and the Clinical COPD Questionnaire (CCQ). Additional endpoints included other lung function measures, 6-minwalk test (6-MWT), COPD symptom score, reliever medication use and tolerability. 118 patients were randomised to treatment (AZD1981 n=61; placebo n=57); 83% of patients were male and the mean age was 63 years (range 43-83). There were no significant differences in the mean difference in change from baseline to end of treatment between AZD1981 and placebo for the co-primary endpoints of pre-bronchodilator FEV1 (AZD1981-placebo: -0.015, 95% CI: -0.10 to 0.070; p=0.72) and CCQ total score (difference: 0.042, 95% CI: -0.21 to 0.30; p=0.75). Similarly, no differences were observed between treatments for the other outcomes of lung function, COPD symptom score, 6-MWT, BODE index, and use of reliever medication. AZD1981 was well tolerated. There was no beneficial clinical effect of AZD1981, at a dose of 1000mg twice daily for 4 weeks, in patients with moderate to severe COPD. AZD1981 was well tolerated and no safety concerns were identified.

Lung function and respiratory symptoms in a 1-year randomized smoking cessation trial of varenicline in COPD patients

There are few data concerning changes in lung function and respiratory symptoms in smokers with chronic obstructive pulmonary disease (COPD) weeks to months after quitting smoking. We examined serial changes in spirometry and Clinical COPD Questionnaire (CCQ) scores (measuring respiratory symptoms and health-related quality of life) in COPD participants by smoking status during a smoking cessation trial. In this randomized, double-blind trial, smokers with mild-to-moderate COPD were treated with varenicline 1 mg b.i.d. or placebo for 12 weeks and followed to Week 52. Primary endpoints of abstinence were previously reported. Secondary endpoints were mean changes from baseline in post-bronchodilator forced expired volume in 1 s (FEV(1)) and CCQ scores. Change from baseline in post-bronchodilator FEV(1) was significantly improved in continuous abstainers (121.8 mL) vs. continuous smokers (37.9 mL) at Week 12 (P = 0.0069), but not at Weeks 24 or 52. Mean change from baseline at Week 12 in CCQ Total Score was significantly better in continuous abstainers (-1.04) vs. continuous smokers (-0.53; P < 0.0001): this improvement was sustained at Weeks 24 and 52. In a 1-year cessation trial of smokers with COPD, continuous abstinence compared with continuous smoking significantly improved post-bronchodilator FEV(1) at Week 12 (although the difference narrowed subsequently) and CCQ Total Scores at Week 12, with sustained improvement thereafter. ( http://www.clinicaltrials.gov; trial identifier: NCT00285012).

Smoking cessation and development of respiratory health in smokers screened with normal spirometry

Case-finding of chronic obstructive pulmonary disease (COPD) using spirometry may deter people with normal lung function from stopping smoking. The objective of this study was to observe the percentage of smokers screened with normal lung function that quit smoking. As part of a study on early detection of COPD, 518 smokers were screened with normal lung function (post-bronchodilator FEV(1)/FVC ≥ 70%). They were invited for a follow-up measurement after an average of 2.4 years. Non-smoking was validated by carbon monoxide (<10 ppm), and respiratory health related quality of life was measured with the Clinical COPD Questionnaire (CCQ). A total of 255 participants were followed up (49%). The point prevalence rate of non-smoking at follow-up was 18% (N = 47), and 9% assuming that all non-respondents were smokers. This rate was not lower than the expected rate of quitting in the Dutch population (8-9%) and primary "care as usual" in smokers screened with abnormal lung function (10%; p > 0.05 for all comparisons). The average decline in post-bronchodilator FEV(1) was 26 mL/year, which was unrelated to smoking status at follow-up. Non-smokers showed a clinically meaningful and statistically significant (p < 0.001) improvement in CCQ respiratory symptoms (-0.96) and total score (-0.51). Our results do not suggest that early detection of airflow limitation to motivate smoking cessation reduces the rate of quitting in smokers shown to have normal lung function. Such smokers should be advised to quit smoking on the grounds that they are likely to improve their respiratory health in the short term and reduce their risk for smoking related diseases in the long term.

Detecting exacerbations using the Clinical COPD Questionnaire

BackgroundEarly treatment of COPD exacerbations has shown to be important. Despite a non-negligible negative impact on health related quality of life, a large proportion of these episodes is not reported (no change in treatment). Little is known whether (low burden) strategies are able to capture these unreported exacerbations.MethodsThe Clinical COPD Questionnaire (CCQ) is a short questionnaire with great evaluative properties in measuring health status. The current explorative study evaluates the discriminative properties of weekly CCQ assessment in detecting exacerbations.ResultsIn a multicentre prospective cohort study, 121 patients, age 67.4 ± 10.5 years, FEV1 47.7 ± 18.5% pred were followed for 6 weeks by daily diary card recording and weekly CCQ assessment. Weeks were retrospectively labeled as stable or exacerbation (onset) weeks using the Anthonisen symptom diary-card algorithm. Change in CCQ total scores are significantly higher in exacerbation-onset weeks, 0.35 ± 0.69 compared to -0.04 ± 0.37 in stable weeks (p < 0.001). Performance of the Δ CCQ total score discriminating between stable and exacerbation onset weeks was sufficient (area under the ROC curve 0.75). At a cut off point of 0.2, sensitivity was 62.5 (50.3-73.4), specificity 82.0 (79.3-84.4), and a positive and negative predictive value of 43.5 (35.0-51.0) and 90.8 (87.8-93.5), respectively. Using this cut off point, 22 (out of 38) unreported exacerbations were detected while 39 stable patients would have been false positively 'contacted'.ConclusionsWeekly CCQ assessment is a promising, low burden method to detect unreported exacerbations. Further research is needed to validate discriminative performance and practical implications of the CCQ in detecting exacerbations in daily care.

Health status measurement in COPD: the minimal clinically important difference of the clinical COPD questionnaire.

BackgroundPatient-reported outcomes (PRO) questionnaires are being increasingly used in COPD clinical studies. The challenge facing investigators is to determine what change is significant, ie what is the minimal clinically important difference (MCID). This study aimed to identify the MCID for the clinical COPD questionnaire (CCQ) in terms of patient referencing, criterion referencing, and by the standard error of measurement (SEM).MethodsPatients were ≥40 years of age, diagnosed with COPD, had a smoking history of >10 pack-years, and were participating in a randomized, controlled clinical trial comparing intravenous and oral prednisolone in patients admitted with an acute exacerbation of COPD. The CCQ was completed on Days 1–7 and 42. A Global Rating of Change (GRC) assessment was taken to establish the MCID by patient referencing. For criterion referencing, health events during a period of 1 year after Day 42 were included in this analysis.Results210 patients were recruited, 168 completed the CCQ questionnaire on Day42. The MCID of the CCQ total score, as indicated by patient referencing in terms of the GRC, was 0.44. The MCID of the CCQ in terms of criterion referencing for the major outcomes was 0.39, and calculation of the SEM resulted in a value of 0.21.ConclusionThis investigation, which is the first to determine the MCID of a PRO questionnaire via more than one approach, indicates that the MCID of the CCQ total score is 0.4.