Background Nebulised Hypertonic Saline (HTS) has been shown to increase water content of airway surface liquid, enhance mucociliary clearance, reduce exacerbation frequency and improve quality of life in Cystic Fibrosis (CF) and non-CF Bronchiectasis. Historically HTS was associated with bronchoconstriction, therefore formal first dose bronchoconstriction trials (BCT) were performed. Recent studies have shown better tolerance that improves over up to 10 doses (Elkins 2006). We have observed that a fall in FEV1 >15% following nebulised HTS rarely correlates with adverse signs or symptoms, questioning the need for a BCT. This study aimed to assess our use of HTS, its safety and tolerance without BCT, and its positive effects. Methods A senior physiotherapist completed a proforma for all patients commencing HTS over 6 months. HTS was used for different respiratory conditions to aid mucociliary clearance. All patients were pre-dosed with a bronchodilator, and had a closely supervised 1 st test dose, replacing formal BCT. Results 54 patients aged 19-87 years (mean 54, median 61) commenced 7% HTS. 35 were inpatients and 19 outpatients. The primary diagnoses were: non-CF Bronchiectasis (20), post thoracic surgery (17), CF (13), Pneumonia (2), long term tracheostomy (1), and COPD with Laryngectomy (1). All patients experienced positive effects, listed in table 1. HTS prescription was individualised: BD regime (42), TDS (8), QDS (4). 13 patients (24%) experienced adverse effects-increased cough (13), slight chest tightness (3), a 5% decrease in oxygen saturations (1). All 13 patients and physiotherapists considered the adverse effects sufficiently mild to continue HTS and they subsequently reduced significantly after up to 5 doses. If no adverse effects were experienced during the test dose, no further adverse effects occurred with continued use. Conclusion This observational study demonstrates that HTS has positive effects in a wide variety of respiratory conditions. We have replaced BCT with a supervised test dose as it was found to a be a safe and efficient evaluation. Over 6 months HTS was well tolerated, with only mild adverse effects, which reduced over subsequent doses. Importantly, there were no adverse effects in patients who had previously undergone an uneventful test dose.
Introduction The antiplatelet therapy in the primary prevention of cardiovascular disease in patients with chronic obstructive pulmonary disease (APPLE COPD-ICON2) trial is a prospective 2×2 factorial, double-blinded proof-of-concept randomised controlled trial targeting patients with chronic obstructive pulmonary disease (COPD) at high risk of cardiovascular disease. The primary goal of this trial is to investigate if treatment with antiplatelet therapy will produce the required response in platelet function measured using the Multiplate test in patients with COPD. Methods and analysis Patients with COPD are screened for eligibility using inclusion and exclusion criteria. Eligible patients are randomised and allocated into one of four groups to receive aspirin plus placebo, ticagrelor plus placebo, aspirin plus ticagrelor or placebo only. Markers of systemic inflammation, platelet reactivity, arterial stiffness, carotid intima-media thickness (CIMT), lung function and quality of life questionnaires are assessed. The primary outcome consists of inhibition (binary response) of aspirin and ADP-induced platelet function at 6 months. Secondary outcomes include changes in inflammatory markers, CIMT, non-invasive measures of vascular stiffness, quality of life using questionnaires (EuroQol–five dimensions–five levels of perceived problems (EQ5D-5L), St. George’s COPD questionnaire) and to record occurrence of repeat hospitalisation, angina, myocardial infarction or death from baseline to 6 months. Safety outcomes will be rates of major and minor bleeding, forced expiratory volume in 1 s, forced vital capacity and Medical Research Council dyspnoea scale. Ethics and dissemination The study was approved by the North East-Tyne and Wear South Research Ethics Committee (15/NE/0155). Findings of the study will be presented in scientific sessions and published in peer-reviewed journals. Trial registration number NCT43245574.
IntroductionThere is currently limited information about bronchiectasis available to patients. We co-developed a novel patient and carer information resource, based on needs identified in previous work.1 The resource was evaluated in the BRIEF study with the following objectives:-1. To establish the feasibility of carrying out a multi-centre randomised controlled trial (RCT) to determine effect on understanding, self-management and health outcomes.2. To evaluate and refine the intervention.MethodsThis was a feasibility study with a single-centre RCT design, comparing use of the resource to usual care in bronchiectasis.2 Adults with bronchiectasis were recruited from respiratory clinics in the North of England. Those randomised to the intervention received the information resource (website www.bronchiectasis.me and booklet). Outcome measures (resource satisfaction, bronchiectasis knowledge, quality of life, unscheduled healthcare visits, exacerbation frequency, and lung function) were recorded at baseline, 2 weeks and 3 months. Feasibility outcomes included recruitment, retention and study form completion rates. A patient and carer focus group was held to discuss the intervention and the trial process.ResultsRecruitment rate was 50% of those assessed for eligibility (See Figure). Questionnaire completion rates were excellent with very few missing data. 24 participants were male and 38 female. Median age was 63 years (range 18–82).Participants reported using the information provided, and feedback was positive, particularly highlighting the usefulness of the video clips and self-management information. The most popular pages of the website included diet and lifestyle advice, advice for carers, and symptoms and prognosis. Focus group data reinforced users’ positive experiences of the resource and the trial process. Full analysis is ongoing.Discussion and conclusionsWe have co-developed a multi-format, accessible information resource that could be made widely available outside of the specialist clinic setting. The BRIEF study suggests larger, definitive studies using interventions to improve understanding, compliance and self-management are warranted. Full results of the feasibility study are expected by December 2016.Abstract M15 Figure 1ReferencesHester KLM, Newton J, De Soyza A, et al. Living your life with bronchiectasis: an exploration of patients and carers information needs informing development of a novel information resource. Thorax 2015;70(suppl. 3):A178.Hester KLM, Newton J, Rapley T, et al. Evaluation of a novel information resource for patients with bronchiectasis: study protocol for a randomised controlled trial. Trials 2016;17:210.
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