Community-based intervention for prevention and management of chronic obstructive pulmonary disease in Nepal (COBIN-P trial): study protocol for a cluster-randomized controlled trial.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death worldwide and the commonest of non-communicable diseases (NCDs) in Nepal. Risk factors like indoor and outdoor air pollution, a high prevalence of smoking, and the lack of awareness of COPD make it a serious public health concern. However, no attempt has been made in Nepal to estimate its burden and address the disease at the community level. METHOD: This study aims to evaluate the effect of a community-based health educational intervention administered by Female Community Health Volunteers (FCHVs) on the prevention and management of COPD. An open-label, two-group, community-based, cluster-randomized controlled trial will be implemented in the semi-urban area of Pokhara Metropolitan city (former Lekhnath Municipality) located in the Kaski district of Nepal. The estimated sample size of the intervention will be 1143. The unit of randomization is the ward (administrative unit) of the study area. The follow-up survey will be conducted immediately after 12 months of FCHVs-led interventions. The difference in the rate of decline of forced expiratory volume in 1 s (FEV1) and FEV1/FVC (forced vital capacity) ratio are the primary outcomes and the change in the proportion of modifiable risk factors of COPD, health-related quality of life scores, and change in knowledge of COPD will be secondary outcomes. DISCUSSION: This study will estimate the burden of COPD, the magnitude of risk factors and generate evidence to mobilize community health workers for COPD prevention and management at the community level in Nepal. TRIAL REGISTRATION: ClinicalTrials.gov NCT03797768 . Registered on January 9, 2019.

Health-Related Quality of Life of People Living with COPD in a Semiurban Area of Western Nepal: A Community-Based Study.

Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality in Nepal. It is a progressive lung disease and has a significant impact on the quality of life of patients. Health-related quality of life (HRQOL) reflects the health- and disease-related facets of quality of life. Limited studies have assessed the impact of COPD on HRQOL and associated factors in Nepal. This study is based on a cross-sectional household survey data from a semiurban area of Western Nepal. A validated Nepali version of St George's Respiratory Questionnaire (SGRQ) was used to measure the HRQOL. COPD was defined together with post-bronchodilator airflow obstruction and the presence of respiratory symptoms. Post-bronchodilator airflow obstruction was defined as Forced Expiratory Volume in 1st second (FEV1) to Forced Vital Capacity (FVC) ratio < 0.70. COPD was diagnosed in 122 participants, and their median (IQR) total score of HRQOL was 40 (26 - 69); the score of symptoms, activity, and impact area were 53 (37 - 74), 57 (36 - 86), and 26 (13 - 62), respectively. The overall HRQOL was significantly different in terms of age, occupational status, physical activity, and comorbidities. Disease severity and the presence of respiratory symptoms had a significant difference in HRQOL (p = 0.0001). Appropriate measures to improve conditions and addressing the associated factors like respiratory symptoms and enhancing physical activity are necessary and important.

Prevalence of Chronic Obstructive Pulmonary Disease and its Associated Factors in Nepal: Findings from a Community-based Household Survey.

Background: Despite chronic obstructive pulmonary disease (COPD) being the commonest non-communicable disease in Nepal, there is limited research evidence estimating the spirometry-based burden of COPD. This study aims to estimate the prevalence of COPD and its correlates through a community-based survey in Pokhara Metropolitan City, a semi-urban area of Western Nepal. Methods: A cross-sectional household survey was conducted among 1459 adults ≥40 years. COPD was defined according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria as a post-bronchodilator ratio of forced expiratory volume in 1st second (FEV1) to forced vital capacity (FVC) <0.70 with the presence of symptoms. COPD was also defined by the lower limit of normal (LLN) threshold - FEV1/FVC < LLN cut-off values with the presence of symptoms. Study participants were interviewed about sociodemographic and behavioural characteristics and respiratory symptoms. Descriptive statistics and logistic regression analysis were applied. Results: Spirometry reports were acceptable in 1438 participants. The mean age of the participants was 55 (±10) years, and, 54% were female. The prevalence of GOLD-defined COPD was 8.5% (95% CI: 7.1-10.0) and based on the LLN threshold of 5.4% (95% CI: 4.2-6.6). The multivariate logistic regression showed that increasing age, low body mass index, illiterate, current or former smoker, and biomass fuel smoke increased the odds of COPD in both the definitions. Conclusion: COPD is highly prevalent at community level and often underdiagnosed. Strategies aiming at early diagnosis and treatment of COPD, especially for the elderly, illiterate, and reducing exposure to smoking and biomass fuel smoke and childhood lung infection could be effective.

Relationship between total serum immunoglobulin E levels, fractional exhaled breath nitric oxide levels and absolute blood eosinophil counts in atopic and non-atopic asthma: a controlled comparative study.

OBJECTIVE: Asthma is a prevalent non-communicable disease both in low- and high-income countries, including Nepal. Total serum immunoglobulin E levels and peripheral blood absolute eosinophil counts are known inflammatory markers of asthma. Fractional exhaled nitric oxide measurement in breath has also been proposed as a non-invasive biomarker to assess eosinophilic airway inflammation. This study explores the correlation between these three variables with the intent that one may replace the other in resource-limited setups. APPROACH: This prospective controlled trial evaluated 314 subjects with and without asthma, with the asthma group sub-divided into atopic and non-atopic categories. Total serum immunoglobulin E level, absolute eosinophil count in peripheral blood and fractional exhaled nitric oxide level were measured in all categories. RESULTS: The geometric mean of immunoglobulin E levels, absolute eosinophil count and fractional exhaled nitric oxide were 221.07 ± 774.55 IU/mL, 214 ± 360/uL and 37 ± 49 ppb in the asthma group and 59.13 ± 174.32 IU/mL, 164 ± 137/uL and 12 ± 21 ppb in the control group, respectively. Significantly higher levels were seen in the asthma group for total serum immunoglobulin E (p < 0.001), AEC (p = 0.002) and FENO (p < 0.001) levels. Total serum immunoglobulin E levels, absolute eosinophil count and fractional exhaled nitric oxide were 436.79 ± 822.40 IU/mL, 269 ± 395/uL and 76 ± 52 ppb in atopic asthma group. Similarly, total serum immunoglobulin E levels, absolute eosinophil count and fractional exhaled nitric oxide were 131.17 ± 692.96 IU/mL, 182 ± 328/uL and 23 ± 22.5 ppb in non-atopic asthma group. Significantly higher levels were seen in all three variables: tIgE (p < 0.001), AEC (p =  0.008) and FENO (p < 0.001). A moderate degree of positive correlation was identified between tIgE and FENO50 (Spearman's rho = 0.461) and tIgE and AEC (Spearman's rho = 0.315) with only small correlation between FENO50 and AEC (Spearman's rho = 0.299). SIGNIFICANCE: tIgE levels, FENO50 and AEC levels are higher in asthma, specifically in the atopic phenotype, as compared to normal. Total serum IgE levels have moderate correlation with FENO50 and AEC but FENO50 and AEC are weakly correlated.