Browsing by Subject "COPD"

Now showing 1 - 4 of 4
  • Thumbnail Image
    Item
    Open Access
    A blinded evaluation of the efficacy and safety of glycopyrronium, a once-daily long-acting muscarinic antagonist, versus tiotropium, in patients with COPD: the GLOW5 study
    (BioMed Central, 2014-01-17) Chapman, Kenneth R; Beeh, Kai-Michael; Beier, Jutta; Bateman, Eric D; D’Urzo, Anthony; Nutbrown, Robert; Henley, Michelle; Chen, Hungta; Overend, Tim; D’Andrea, Peter
    Abstract Background Two once-daily long-acting muscarinic antagonists (LAMAs) are currently available for the treatment of chronic obstructive pulmonary disease (COPD) – tiotropium and glycopyrronium. Previous studies have compared glycopyrronium with open-label tiotropium. In the GLOW5 study, we compare glycopyrronium with blinded tiotropium. Methods In this blinded, double-dummy, parallel group, 12-week study, patients with moderate-to-severe COPD were randomized 1:1 to glycopyrronium 50 μg once daily or tiotropium 18 μg once daily. The primary objective was to demonstrate the non-inferiority of glycopyrronium versus blinded tiotropium with respect to trough forced expiratory volume in 1 second (FEV1) following 12 weeks of treatment (non-inferiority margin: –50 mL). Secondary objectives were to evaluate glycopyrronium versus tiotropium for other spirometric outcomes, breathlessness (Transition Dyspnea Index; TDI), health status (St George’s Respiratory Questionnaire; SGRQ), daily rescue medication use, COPD exacerbations and COPD symptoms over 12 weeks of treatment. Results 657 patients were randomized (glycopyrronium: 327; tiotropium: 330); 96% (630 patients) completed the study. Least squares mean trough FEV1 for both glycopyrronium and tiotropium was 1.405 L at Week 12, meeting the criterion for non-inferiority (mean treatment difference: 0 mL, 95% CI: –32, 31 mL). Glycopyrronium demonstrated rapid bronchodilation following first dose on Day 1, with significantly higher FEV1 at all time points from 0–4 h post-dose versus tiotropium (all p < 0.001). FEV1 area under the curve from 0–4 h (AUC0–4h) post-dose with glycopyrronium was significantly superior to tiotropium on Day 1 (p < 0.001) and was comparable to tiotropium at Week 12. Glycopyrronium demonstrated comparable improvements to tiotropium in TDI focal score, SGRQ total score, rescue medication use and the rate of COPD exacerbations (all p = not significant). Patients on glycopyrronium also had a significantly lower total COPD symptom score versus patients on tiotropium after 12 weeks (p = 0.035). Adverse events were reported by a similar percentage of patients receiving glycopyrronium (40.4%) and tiotropium (40.6%). Conclusion In patients with moderate-to-severe COPD, 12-week blinded treatment with once-daily glycopyrronium 50 μg or tiotropium 18 μg, provided similar efficacy and safety, with glycopyrronium having a faster onset of action on Day 1 versus tiotropium. Trial registration ClinicalTrial.gov, NCT01613326
  • Thumbnail Image
    Item
    Open Access
    Lack of paradoxical bronchoconstriction after administration of tiotropium via Respimat® Soft Mist™ Inhaler in COPD
    (2011) Hodder, Rick; Lee, Angela; Bateman, Eric
    Bronchoconstriction has been reported in asthma and chronic obstructive pulmonary disease (COPD) patients after administration of some aqueous inhalation solutions. We investigated the incidence of this event during long-term clinical trials of tiotropium delivered via Respimat® Soft Mist™ Inhaler (SMI). We retrospectively analyzed pooled data from two identical Phase III clinical trials, in which 1990 patients with COPD received 48 weeks’ treatment with once-daily tiotropium (5 or 10 μg) or placebo inhaled via Respimat® SMI. We recorded the incidence of bronchospasm and of a range of respiratory events that could suggest bronchoconstriction during the first 30 minutes after inhalation of study treatment on each of the eight test days. No patients reported bronchospasm. Six patients (0.3%) reported a combination of at least two events suggestive of bronchoconstriction, and 21 (1.1%) reported either rescue medication use or a respiratory adverse event. Asymptomatic falls in forced expiratory volume in one second (FEV1) of ≥15% were recorded on all test days, with no change in incidence over time, and affected 8.2% of those in the tiotropium groups and 14.5% of those on placebo. In COPD patients receiving long-term treatment with tiotropium 5 or 10 μg via Respimat® SMI, no bronchospasm was recorded, and the number of events possibly indicative of paradoxical bronchoconstriction was very low.
  • No Thumbnail Available
    Item
    Open Access
    Pulmonary rehabilitation in Africa (community-driven citizen science approach): (a focus on COPD in low-resourced communities in South Africa)
    (2025) Isiagi, Moses; Van Zyl-Smit, Richard; Okop, Kufre Joseph
    Chronic Obstructive Pulmonary Disease (COPD) represents a significant global health challenge, particularly in low-and middle-income countries (LMICs), especially in Africa. Pulmonary rehabilitation (PR) is a well-established intervention to address COPD in High income countries (HICs) and has been incorporated into the healthcare systems in many settings. However, its implementation and population-level delivery in Africa are almost non-existent. This dissertation explored COPD management and PR services in low-resourced African settings, specifically focusing on a disadvantaged peri-urban community in South Africa. The study utilized a 3-pronged approach which we believe holds significant potential to investigate and perhaps, address these challenges. The purpose of this study was to examine the current state of PR services in low-resourced settings in LMICs, evaluate healthcare providers' clinical awareness and support in Africa, and explore COPD risk perceptions and prevention preference in the study setting. In addition, the study utilizes the findings and lessons learnt to support the development of community-driven PR implementation strategies in the disadvantaged African setting using a participatory approach. Methods: The methodology encompassed three distinct components: First, a systematic review was conducted to gain understanding and map the landscape of home-based and community-based PR programmes in low-resourced African settings registered with PROSPERO (CRD42023480324). Second, a cross-sectional virtual electronic survey was administered between January and March 2020, targeting African clinicians with Pan-African Thoracic Society and South African Thoracic Society networks. Finally, a participatory community-based Citizen science project was implemented in the Klipfontein health district, incorporating focus group discussions, Citizen science interviews, and advocacy workshops. Results: The study revealed a significant gap in research regarding PR programmes in African settings, with no published studies comparing home-based and community-based PR delivery models in the region. The closest relevant research was a Brazilian protocol for home-based cardiac rehabilitation. However, the survey of healthcare professionals from 23 countries demonstrated awareness and recognition of PR as an effective intervention for COPD. Despite significant implementation challenges, over 85% of the surveyed healthcare professionals expressed confidence in PR programmes' ability to improve symptoms and reduce patient exacerbation. Insights from Citizen science indicate limited community awareness of COPD, often confused with general respiratory conditions like asthma. Discussions and EpiCollect findings show that while communities recognize risk factors such as smoking and environmental exposure, there is a pressing need for targeted education about COPD before effectively implementing PR interventions. Furthermore, participants in the study were willing to participate in a community-driven PR intervention and listed important strategies that would make this intervention accessible, acceptable, and sustainable. Conclusion: This study presents a novel approach to COPD risk perception and PR implementation in resource-limited settings. The need for pulmonary rehabilitation is well documented and understood at a scientific and specialist pulmonologist level. Local logistics, training, funding, and staffing challenges hindered the implementation. Community-based "out-of-hospital" PR programmes are well-described in high-income countries. However, they are almost non- existent in low-income settings. At the patient level, the lack of awareness of the diagnosis, understanding and access to treatment may inadvertently be the most important factor limiting the access of patients with COPD to an effective PR intervention. While traditional 'medical science' methods have been instrumental in increasing access to PR in low-income settings, the potential of a more Citizen science approach with engagement at the community level with healthcare staff, patients, and community members is promising. This approach may facilitate the development and implementation of a better multilayered and acceptable programme to those who need it most (the vulnerable population in disadvantaged communities in Africa), offering hope for the future of COPD management in Africa.
  • Thumbnail Image
    Item
    Open Access
    Sputum colour as a marker for bacteria in acute exacerbations of COPD: protocol for a systematic review and meta-analysis
    (2021-07-27) Spies, Ruan; Potter, Matthew; Hollamby, Ruan; van der Walt, Stefan; Hohlfeld, Ameer; Ochodo, Eleanor; van Zyl-Smit, Richard N
    Background Chronic obstructive pulmonary disease (COPD) is a major cause of years of life lost globally. Acute exacerbations of COPD (AECOPD) drive disease progression, reduce quality of life and are a source of mortality in COPD. Approximately 50% of AECOPD are due to bacterial infections. Diagnosing bacterial infection as the aetiology of AECOPD however remains challenging as investigations are limited by practicality, accuracy and expense. Clinicians have traditionally used sputum colour as a marker of bacterial infection in AECOPD, despite the lack of high-quality evidence for this practice. The aim of this systematic review and meta-analysis is to determine the diagnostic accuracy of sputum colour in the diagnosis of bacterial causes of AECOPD. Methods Articles will be searched for in electronic databases (MEDLINE, Google Scholar Scopus, Web of Science, Africa-Wide, CINAHL and Health Source Nursing Academy) and we will conduct a review of citation indexes and the grey literature. Two reviewers will independently conduct study selection, against pre-defined eligibility criteria, data extraction and quality assessment of included articles using the QUADAS-2 tool. We will perform a meta‐analysis using a bivariate logistic regression model with random effects. We will explore heterogeneity through the visual examination of the forest plots of sensitivities and specificities and through the inclusion of possible sources of heterogeneity as covariates in a meta-regression model if sufficient studies are included in the analysis. We also perform a sensitivity analysis to explore the effect of study quality on our findings. The results of this review will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement and will be submitted for peer-review and publication. Discussion The findings of this review will assist clinicians in diagnosing the aetiology of AECOPD and may have important implications for decision making in resource-limited settings, as well as for antimicrobial stewardship. Systematic review registration PROSPERO CRD42019141498