Device-handling study of a novel breath-actuated inhaler, Synchrobreathe®, versus a pMDI.

INTRODUCTION: Synchrobreathe®, a new-generation, novel breath-actuated inhaler (BAI) can address the key issues arising during the use of both pressurised metered dose inhalers ([pMDIs]; hand-breath coordination) and dry powder inhalers ([DPIs]; high inspiratory flow required) with respect to optimal drug deposition. MATERIALS AND METHODS: This was an open-label, prospective, 2-week, multicentre study that assessed device handling, ease of use, errors and participant perception regarding the use of Synchrobreathe® versus a pMDI in patients with chronic obstructive pulmonary disease (COPD) (n = 162) or asthma (n = 239) and inhaler-naïve healthy volunteers (n = 59). Ability to use the device without errors at the first attempt, total number of errors before and after training, time taken to use the device correctly and total number of training sessions, and number of attempts to perform the correct technique on Day 1 and Day 14 were evaluated. Device handling and preference questionnaires were also administered on Day 14. RESULTS: Of 460 participants, 421 completed the study. The number of participants using Synchrobreathe without any error after reading the patient information leaflet (PIL) was significantly low (p < 0.05) on Day 1. On Day 14, significantly more number of participants used Synchrobreathe without any error (p < 0.001). The total number of errors before and after training with Synchrobreathe was significantly less (p < 0.001). The average time required to perform the inhalation technique correctly (p < 0.01) and the total number of attempts (P < 0.001) with Synchrobreathe were significantly lower. The average number of attempts to inhale correctly was significantly (p < 0.001) less with Synchrobreathe on Day1 and Day 14. Most participants rated Synchrobreathe as their choice of inhaler. CONCLUSION: Synchrobreathe is an easy-to-use and easy-to-handle device with significantly less number of errors, which may have positive implications for disease control in asthma and COPD.

Systemic Immuno-metabolic alterations in chronic obstructive pulmonary disease (COPD).

BACKGROUND: Metabolic adaptation in immune cells is necessary to modulate immune cell function as it is intricately coupled with intracellular metabolism. We aimed to characterize the metabolic state of human peripheral blood mononuclear cells (PBMCs) after long-term exposure to tobacco smoke in smokers with preserved lung function and COPD subjects. METHODS: PBMCs were isolated from healthy non-smokers (HNS), healthy smokers (HS) and COPD subjects, cultured and the mitochondrial respiration while utilizing glucose (glycolysis), fatty acids (ß-oxidation) or pyruvate (direct Krebs' cycle substrate) was measured using the XFp Extracellular Flux Analyzer. Plasma levels of inflammatory cytokines IFN-γ, IL-17, TNF-α, IL-5, IL-9 and IFN-α were measured using flow cytometry. RAW264.7 cells were exposed to cigarette smoke condensate (CSC) for 1 h and its effect on cell viability, cellular metabolism and phagocytosis ability were also studied. Patient's data was analyzed using the Mann Whitney U test, whereas Student's t test was performed to analyze the in-vitro data. RESULTS: PBMCs from COPD subjects showed a significant decrease in extracellular acidification rate (ECAR) while utilizing glucose as compared to HNS (151.9 Vs 215%). Mitochondrial oxygen consumption rate (OCR) on palmitate or pyruvate was also found to be significantly lower in COPD subjects as compared to HS and a strong positive correlation between palmitate OCR in PBMCs and FEV1 (r = 0.74, p < 0.05) and FVC (r = 0.79, p < 0.05) values in HS was observed. The metabolic shift towards fatty acid metabolism in healthy smokers promoted an inflammatory cytokine response with a greater increase in the levels of IL-5, IL-9 and IFN-α as compared to IFN-γ, IL-17 and TNF-α. In-vitro experiments with RAW 264.7 cells showed similar metabolic alterations and a reduced ability to phagocytose Streptococcus pneumonia and Haemophilus influenza after cigarette smoke exposure in the presence of glucose or palmitate. CONCLUSIONS: These findings indicate a metabolic basis for the inflammatory response in COPD and could suggest a new therapeutic target for controlling the immune response and delaying the onset of disease. TRIAL REGISTRATION: This observational study was retrospectively registered in the Clinical Trails Registry - India (ICMR - NIMS) on 19th January 2018 with the registration number CTRI/2018/01/011441 .

Prevalence, risk factors and clinical correlates of COPD in a rural setting in Tanzania.

Chronic obstructive pulmonary disease (COPD) causes substantial burden of disease in developed countries, but there are limited data from Africa. We aimed to estimate the prevalence of COPD in Tanzania and identify the risk factors associated with it.This was a cross-sectional descriptive survey involving adults aged ≥35 years. We collected data on symptoms and risk factors using the Burden of Obstructive Lung Diseases questionnaire. Spirometry was performed and COPD diagnosed based on post-bronchodilator forced expiratory volume in 1 s/forced vital capacity <70%. We also measured indoor and outdoor carbon monoxide (CO) levels.A total of 869 participants (49.1% females) completed the questionnaires. Of these, 57.1% completed post-bronchodilator spirometry. Of the 25.2% ever-smokers, only 5.4% were current smokers. COPD prevalence was estimated at 17.5% (21.7% in males and 12.9% in females). COPD was associated with a history of cough, phlegm production and wheezing. 51.7% of COPD patients reported cough and 85% had mild to moderate airway limitation. Females had a higher rate of exacerbation. Pulmonary tuberculosis (TB) was reported in 10% of patients. Only 1.7% of patients who were diagnosed as COPD had ever received any medication, with only one female COPD patient having received an inhaler. 99.5% of the population used biomass fuels for cooking. The majority of households had CO levels up to 20 ppm.The prevalence of COPD in Tanzania is high, with a peak at a relatively young age and a preponderance in males. A history of TB, cigarette smoking and male sex are important risk factors. Indoor air pollution coupled with use of biomass fuel for cooking and heating may be an important risk factor for developing COPD in rural Tanzania. However, these factors need to be studied further.

Household air pollution and its effects on health.

Household air pollution is a leading cause of disability-adjusted life years in Southeast Asia and the third leading cause of disability-adjusted life years globally. There are at least sixty sources of household air pollution, and these vary from country to country. Indoor tobacco smoking, construction material used in building houses, fuel used for cooking, heating and lighting, use of incense and various forms of mosquito repellents, use of pesticides and chemicals used for cleaning at home, and use of artificial fragrances are some of the various sources that contribute to household air pollution. Household air pollution affects all stages of life with multi-systemic health effects, and its effects are evident right from pre-conception to old age. In utero exposure to household air pollutants has been shown to have health effects which resonate over the entire lifetime. Exposures to indoor air pollutants in early childhood also tend to have repercussions throughout life. The respiratory system bears the maximum brunt, but effects on the cardiovascular system, endocrine system, and nervous system are largely underplayed. Household air pollutants have also been implicated in the development of various types of cancers. Identifying household air pollutants and their health implications helps us prepare for various health-related issues. However, the real challenge is adopting changes to reduce the health effects of household air pollution and designing innovative interventions to minimize the risk of further exposure. This review is an attempt to understand the various sources of household air pollution, the effects on health, and strategies to deal with this emergent risk factor of global mortality and morbidity.

Symptoms and medical conditions in 204 912 patients visiting primary health-care practitioners in India: a 1-day point prevalence study (the POSEIDON study).

BACKGROUND: India has one of the highest disease burdens in the world. A better understanding of what ails India will help policy makers plan appropriate health-care services and infrastructure development, design medical education curricula, and identify health research priorities that are relevant to the needs of the country. The POSEIDON study aimed to record the prevalence of symptoms and medical conditions for which patients visit a primary health-care practitioner in India. METHODS: We randomly selected 12 000 general practitioners, general physicians, and paediatricians from 880 cities and towns and invited them to record demographic details, symptoms, and medical conditions for every patient they saw on Feb 1, 2011. A further 1225 practitioners volunteered to participate and their responses were included. We did simple descriptive analyses of prevalence rates and used χ(2) tests to study comorbid associations. Through application of systems biology methods, we visualised inter-relations between organ involvement of diseases and symptoms and deciphered how these associations change with age and gender. FINDINGS: We included responses from 7400 health-care practitioners, which represented data for 204 912 patients, who presented with 554 146 reasons for visit. Fever (35·5%) was the most common presenting symptom. More than half of all patients presented with respiratory symptoms across all age groups and regions of India. Other common presentations were digestive system symptoms (25%), circulatory symptoms (12·5%), skin complaints (9%), and endocrine disorders (6·6%). Hypertension (14·52%), obstructive airways diseases (14·51%), and upper respiratory tract infections (12·9%) were the most common diagnoses reported. Of note was that 21·4% of all patients with hypertension reported by the primary health-care practitioners were younger than 40 years. Anaemia was the fourth most common disease reported by these health-care practitioners and was most common in women of menstrual age living outside metro cities. INTERPRETATION: The POSEIDON study provides insight into the reasons that patients visit primary health-care practitioners in India; our results highlight important social and medical challenges in the developing world. FUNDING: Chest Research Foundation, Council of Scientific and Industrial Research-Institute of Genomics and Integrated Biology (CSIR-IGIB), and Cipla Ltd.

Infection control in the pulmonary function test laboratory.

Pulmonary function testing plays a crucial role in the diagnostic evaluation of patients with lung diseases. Cases of cross infection acquired from the pulmonary function laboratory, although rare, have been reported from various countries. It is therefore imperative to identify the risks and potential organisms implicated in cross infections in a pulmonary function test (PFT) laboratory and implement better and more effective infection control procedures, which will help in preventing cross infections. The infrastructure, the daily patient flow, and the prevalent disinfection techniques used in a PFT laboratory, all play a significant role in transmission of infections. Simple measures to tackle the cross infection potential in a PFT laboratory can help reduce this risk to a bare minimum. Use of specialized techniques and equipment can also be of much use in a set up that has a high turnover of patients. This review aims at creating awareness about the possible pathogens and situations commonly encountered in a PFT laboratory. We have attempted to suggest some relevant and useful infection control measures with regard to disinfection, sterilization, and patient planning and segregation to help minimize the risk of cross infections in a PFT laboratory. The review also highlights the lacuna in the current scenario of PFT laboratories in India and the need to develop newer and better methods of infection control, which will be more user-friendly and cost effective. Further studies to study the possible pathogens in a PFT laboratory and evaluate the prevalent infection control strategies will be needed to enable us to draw more precious conclusions, which can lead to more relevant, contextual recommendations for cross infections control in PFT lab in India.

Asthma Insights and Management in India: Lessons Learnt from the Asia Pacific - Asthma Insights and Management (AP-AIM) Study.

BACKGROUND: Despite a better understanding of the pathophysiology of asthma, presence of reliable diagnostic tools, availability of a wide array of effective and affordable inhaled drugs and simplified national and international asthma management guidelines, asthma remains poorly managed in India. OBJECTIVE: The Asia-Pacific Asthma Insight and Management (AP-AIM) study was aimed at understanding the characteristics of asthma, current management, level of asthma control and its impact on quality of life across Australia, China, Hong Kong, India, Malaysia, Singapore, South Korea, Taiwan and Thailand. This paper describes the results of asthma management issues in India in detail and provides a unique insight into asthma in India. METHODOLOGY: The AP-AIM India study was conducted in eight urban cities in India, viz: Ajmer, Delhi, Kolkata, Rourkela, Chennai, Mangalore, Mumbai and Rajkot from February to July 2011. Face-to-face interviews were conducted in adult asthmatics and parents of asthmatic children between the ages of 12 and 17 years with a confirmed diagnosis or a treatment history of 1 year for asthma. RESULTS: Four hundred asthmatics (M:F::1:1.273), with a mean age of 50 ± 17.8 years, from across India were studied. 91% of the asthmatics in India perceived their asthma to be under control, however, none of the asthmatics had controlled asthma by objective measures. Asthmatics in India believed that their asthma was under control if they have up to 2 emergency doctor visits a year. The quality of life of these patients was significantly affected with 93% school/work absenteeism and a loss of 50% productivity. Seventy-five percent of the asthmatics have never had a lung function test. The common triggers for asthmatics in India were dust (49%) and air pollution (49%), while only 5% reported of pollen as triggers. Eighty-nine percent of Indian asthmatics reported an average use of oral steroids 10.5 times a year. Only 36% and 50% of Indian asthmatics used controller and rescue inhalers with a majority preferring the oral route of asthma medication. CONCLUSIONS: This study has clearly highlighted the fact that asthma management in India remains very poor, with a significant proportion of patients experiencing bothersome symptoms and worsened quality of life. There is a need for an urgent review of this situation and initiate active measures at local as well as national levels to improve asthma care in India.