Background: Patients with chronic respiratory disease have low exercise capacity and limited physical activity (PA), which is associated with worsening dyspnoea, exacerbations, and quality of life. The literature regarding patients with non-cystic fibrosis bronchiectasis (non-CF BQ) is scarce, especially regarding the use of cardiopulmonary exercise tests (CPET) to assess the effects of home-based pulmonary rehabilitation programmes (HPRP). The aim was to evaluate the effect of an HPRP on the exercise capacity of non-CF BQ patients using CPET and PA using an accelerometer. Methods: Our study describes a non-pharmacological clinical trial in non-CF BQ patients at the Virgen Macarena University Hospital (Seville, Spain). The patients were randomised into two groups: a control group (CG), which received general advice on PA and educational measures, and the intervention group (IG), which received a specific 8-week HPRP with two hospital sessions. The variables included were those collected in the CPET, the accelerometer, and others such as a 6 min walking test (6MWT) and dyspnoea. The data were collected at baseline and at an 8-week follow-up. Results: After the intervention, there was a significant increase in peak VO₂ in the IG, which was not evidenced in the GC (IG 66.8 ± 15.5 mL/min p = 0.001 vs. CG 62.2 ± 14.14 mL/min, p = 0.30). As well, dyspnoea according to the mMRC (modified Medical Research Council), improved significantly in IG (2.19 ± 0.57 to 1.72 ± 0.05, p = 0.047) vs. CG (2.07 ± 0.7 to 2.13 ± 0.64, p = 0.36). In addition, differences between the groups in walked distance (IG 451.19 ± 67.99 m, p = 0.001 vs. CG 433.13 ± 75.88 m, p = 0.981) and in physical activity (IG 6591 ± 3482 steps, p = 0.007 vs. CG 4824 ± 3113 steps, p = 0.943) were found. Conclusion: Participation in a specific HPRP improves exercise capacity, dyspnoea, walked distance, and PA in non-CF BQ patients.

Background: The concept of clinical control has been proposed as an instrument for evaluating patients with COPD. However, the possible association between clinical control, reduced symptom severity and HRQoL has yet to be confirmed. Methods: This multicentre, prospective and observational study was carried out in 15 pulmonology clinics in Spain. The patients were followed up for six months, with a baseline visit (V0), followed by visits at three months (V1) and six months (V2). Clinical control was determined at V1, with the application of both clinical criteria and the COPD assessment test (CAT). All patients reported their symptoms by a validated symptom diary (E-RS) using a portable device, and their HRQoL was assessed using the EQ5D questionnaire. The relationship between clinical control and E-RS and HRQoL during follow-up was assessed with t-test. Results: A total of 126 patients were screened. After application of the inclusion/exclusion criteria, 93 were finally included (mean age 66 ± 8 years, 84.9% male), with a mean FEV₁ predicted of 49.8% ± 16.5%. Of these patients, 44 (47.3%) achieved clinical control at V1, according to CAT criteria, and 50 (53.8%), according to clinical criteria. The E-RS scores differed between controlled and uncontrolled patients at all time points, both according to CAT (mean differences of − 4.6, − 5.6 and − 6.2 units at V0, V1 and V2, respectively, p< 0.005 for all comparisons) and to clinical criteria (mean differences of − 3.3, − 5-6 and − 4.99 units, respectively, p< 0.005 for all comparisons). The controlled patients also presented a significantly better HRQoL, measured by the EQ5D questionnaire (mean difference 0.13 and 0.10 at V2 by CAT or clinical criteria, respectively, p< 0.05). Conclusion: Clinical control in patients with COPD, whether measured by CAT or by clinical criteria, is associated with a lower symptom load and a better HRQoL.

Background: Cytisinicline has proven to be an effective, efficient, and safe molecule in smoking cessation. However, the established 25-day regimen could be insufficient in a high percentage of smokers, so it is necessary to study maintained therapies of this drug. Objective: This study aims to compare the efficacy of the cytisinicline regimen used in routine clinical practice versus 2 maintained regimens of 50 and 75 days, respectively. In addition, the safety and economic impact of each regime will be determined. Methods: A prospective, multicenter, open-label, controlled, parallel, phase IV clinical trial of 402 smoker patients prepared to quit smoking. The study was conducted in 10 hospitals in Spain. A control group is compared to 2 intervention groups in which the duration of the drug is increased without increasing its dose, administering half and all, respectively, of an additional marketed container that includes 100 tablets. Thus, participants will be randomized to three groups in a 1:1:1 ratio to receive cytisinicline: (1) a control group treated with cytisinicline according to the usual clinical guidelines and product information (25 days); (2) a group with a 50-day cytisinicline regimen (an additional 25 days at a dose of 1.5 mg every 12 hours), seeking to increase its efficacy while minimally impacting adherence; and (3) a group with a 75-day regimen (an additional 50 days at a dose of 1.5 mg every 12 hours), attempting to increase its efficacy, although the longer duration of the drug may threaten adherence. Efficacy in the 3 arms will be analyzed through sustained abstinence at 6 and 12 months, point abstinence rate assessed every 7 days, and abstinence rate from Day 25 to Day 50 and from Day 25 to Day 75 in the 3 study arms. (1) The variation in withdrawal and craving symptoms in the 3 groups, (2) safety through the percentage of adverse events in the 3 treatment arms, and (3) economic impact by evaluating the cost-effectiveness and cost-utility ratios of the 2 prolonged regimens versus the usual clinical cytisinicline regimen. To calculate the differences between the 3 groups for each outcome variable, a univariate analysis will be performed. Statistically significant variables will be included in a multivariate model. Results: Recruitment for the trial and patient enrollment were completed in November 2026. Follow-up of all participants will extend to December 2027. Conclusions: In conclusion, this study evaluates the optimization of cytisinicline in daily clinical practice, increasing the benefits of its pharmaceutical properties without affecting patient safety. All of this will improve the effectiveness of smoking cessation by reducing the number of smokers, which implies lower morbidity and mortality and lower costs associated with smoking. Trial Registration: European Clinical Trials Register 2024-518936-36-00; https://euclinicaltrials.eu/ctis-public/view/2024-518936-36-00 International Registered Report Identifier (IRRID): PRR1-10.2196/76815

BACKGROUND Cytisinicline has proven to be an effective, efficient, and safe molecule in smoking cessation. However, the established 25-day regimen could be insufficient in a high percentage of smokers, so it is necessary to study maintained therapies of this drug. OBJECTIVE This study aims to compare the efficacy of the cytisinicline regimen used in routine clinical practice versus 2 maintained regimens of 50 and 75 days, respectively. In addition, the safety and economic impact of each regime will be determined. METHODS A prospective, multicenter, open-label, controlled, parallel, phase IV clinical trial of 402 smoker patients prepared to quit smoking. The study was conducted in 10 hospitals in Spain. A control group is compared to 2 intervention groups in which the duration of the drug is increased without increasing its dose, administering half and all, respectively, of an additional marketed container that includes 100 tablets. Thus, participants will be randomized to three groups in a 1:1:1 ratio to receive cytisinicline: (1) a control group treated with cytisinicline according to the usual clinical guidelines and product information (25 days); (2) a group with a 50-day cytisinicline regimen (an additional 25 days at a dose of 1.5 mg every 12 hours), seeking to increase its efficacy while minimally impacting adherence; and (3) a group with a 75-day regimen (an additional 50 days at a dose of 1.5 mg every 12 hours), attempting to increase its efficacy, although the longer duration of the drug may threaten adherence. Efficacy in the 3 arms will be analyzed through sustained abstinence at 6 and 12 months, point abstinence rate assessed every 7 days, and abstinence rate from Day 25 to Day 50 and from Day 25 to Day 75 in the 3 study arms. (1) The variation in withdrawal and craving symptoms in the 3 groups, (2) safety through the percentage of adverse events in the 3 treatment arms, and (3) economic impact by evaluating the cost-effectiveness and cost-utility ratios of the 2 prolonged regimens versus the usual clinical cytisinicline regimen. To calculate the differences between the 3 groups for each outcome variable, a univariate analysis will be performed. Statistically significant variables will be included in a multivariate model. RESULTS Recruitment for the trial and patient enrollment were completed in November 2026. Follow-up of all participants will extend to December 2027. CONCLUSIONS In conclusion, this study evaluates the optimization of cytisinicline in daily clinical practice, increasing the benefits of its pharmaceutical properties without affecting patient safety. All of this will improve the effectiveness of smoking cessation by reducing the number of smokers, which implies lower morbidity and mortality and lower costs associated with smoking. CLINICALTRIAL European Clinical Trials Register 2024-518936-36-00; https://euclinicaltrials.eu/ctis-public/view/2024-518936-36-00 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/76815

The pathogenetic relationship underlying the high prevalence of gastroesophageal reflux disease (GERD) in patients with obstructive sleep apnea (OSA) remains unclear. Objective: 1.To investigate the GER in patients with severe OSA and to corroborate variations in the pH-metry register using auto-CPAP. 2.To test symptoms of GERD at baseline and after beginning treatment for OSA. METHOD: Prospective study with 22 severe OSA patients to study GERD by endoscopic placement of a record of continuous wireless pH monitoring(BravoTM capsule, up to 96 hours recording). After placing the capsule, nocturnal polysomnography study was done and then the auto-CPAP treatment began. Symptoms of GERD were assessed using specific questionnaires (GSRS and QOLARD),filled prior to placement of the capsule, at 96 hours and at a month. RESULTS: 77.2 % were man and obese (63.6%). The incidence of GERD was 65%. After starting auto-CPAP, we observed a significant improvement of parameters associated with the GER in 48 hours, with normalization of pH monitoring in 61.5 % of cases, although without reaching statistical significance. Significant symptomatic changes in the score of the questionnaires at baseline, at 96 hours and at a month after initiation of treatment with auto-CPAP were found. There were with a baseline score for GSRS>2.5 in 40.9% of cases and with the QOLARD<5.5 in 31.8%. CONCLUSIONS: We found a high prevalence of symptomatic GERD in patients with severe OSA. There are significant improvement in symptoms of GERD and tendency to normalization of pathological GER after initiation of treatment with CPAP. These findings could justify the active pursuit of GERD in patients with severe OSA.