RANDOMIZED, OPEN LABEL, ACTIVE CONTROLLED STUDY TO ASSESS AND COMPARE HEALTH RELATED QUALITY OF LIFE WITH MOMETASONE & FORMOTEROL VERSUS FLUTICASONE & FORMOTEROL DRY POWDER INHALER IN MILD TO MODERATE PERSISTENT ASTHMA

ABSTRACTObjectives: The present study was under taken to assess and compare the improvement in HRQoL among mild to moderate persistent asthmabetween Mometasone & Formoterol versus Fluticasone & Formoterol using dry powder inhaler using Asthma HRQoL questionnaire which is diseasespecific32-item instrument including 4 domains: symptoms, emotions, exposure to environmental stimuli and activity limitations where impairmentsexperienced during the previous 14 days and respond on 7-point scale.Methods: The present study was conducted in Preventive Medicine Unit and Chest & TB diseases OPD, KIMS & RC, Bangalore during March 2011 toFebruary 2012. 60 patients were recruited in each group based on inclusion and exclusion criteria. PFT was done pre and post bronchodilator withSalbutamol nebulization with Spirometry. Study medications were randomized and were given for 12weeks. HRQoL questionnaire was administeredbefore and after the medications and outcome was compared between them. Statistical test used were descriptive statistics, t- test.Results: There was a significant improvement in HRQoL from baseline to the end of 12 weeks in all domains (symptoms, emotional, exposure toenvironmental stimuli and activity limitations) in both the groups. The overall improvement in the HRQoL was better in Mometasone & Formoterolgroup compared to Fluticasone & Formoterol group but this difference was not statistically significant, which revealed both combinations wereequally effective in improving HRQoL in mild to moderate persistent asthma.Conclusion: Both Mometasone & Formoterol and Fluticasone & Formoterol combinations are equally effective in improving HRQoL in mild tomoderate persistent asthma patients.Keywords: Health-related quality of life, Mild to moderate persistent asthma, Dry powder inhaler

An exploratory study on socio economic status scales in a rural and urban setting

Background: There are many different scales to measure socioeconomic status (SES). The present study was conducted with the objective to compare the most commonly used SES in rural and urban setting. Materials and Methods: This exploratory study was conducted in the rural and urban field practice area of a medical college situated in Bangalore for a period of 3 months between January and April 2010. Statistical Analysis Used: To measure the agreement between the scales spearman′s rank correlations was applied. Results: A total of 120 families were included in the study. Among the 60 families surveyed at rural setting, it was observed that, majority 40 (67%) belonged to high class when the Standard of Living Index (SLI) scale was applied. Among the 60 families surveyed at urban setting, majority 30 (50%) belonged to high class when the SLI scale was applied. Conclusions: The SLI scale gives a more accurate and realistic picture of the SES of the family and hence should be the scale recommended for classification of SES in urban and rural setting

Safety and immunogenicity of rabies vaccine as 4 - dose Essen Intramuscular regimen for post exposure prophylaxis: A non - randomized, comparative controlled study

Introduction: World Health Organization has recommended that in healthy persons with category III exposures, who receive wound care and rabies immunoglobulin infiltration, a vaccine regimen consisting of 4 doses administered intramuscularly on days 0, 3, 7, and 14 can be used as an alternative to the 5-dose intramuscular regimen. Objective: To assess the clinical safety and immunogenicity of rabies vaccine administered as 4-dose Essen intramuscular regimen for post-exposure prophylaxis. Methods: A non-randomized, comparative, controlled study was conducted at the anti-rabies clinic, KIMS Hospital and Research Center, Bangalore, India. The study subjects were divided into study group i.e., 4-dose intramuscular regimen, and control group i.e., 5-dose intramuscular regimen, and were given post-exposure prophylaxis. All subjects were followed for any adverse drug events. Rabies virus neutralizing antibodies was determined on day 14, 90 & 180 at the WHO collaborating center, NIMHANS, Bangalore, India to assess the immunogenicity. Results: The present study included 70 adult animal bite victims, 35 each in study group and control group. The incidence of ADEs was 7.8% in 4-dose Essen group and 7.0% in 5-dose Essen group;the difference between them was not significant (P > .05). Similarly, all the subjects in both the groups had protective antibody titers of ≥ 0.5 IU/mL (100% seroprotective) from day 14 till day 180; the difference between two groups was also not significant (P > .05). Conclusion: The 4-dose intramuscular Essen post-exposure prophylaxis regimen was found to be clinically safe and immunogenic

Assessment of efficacy, safety, and tolerability of 4-n-butylresorcinol 0.3% cream: an Indian multicentric study on melasma

NT Madan Mohan,1 Adarsh Gowda,2 Ashok Kumar Jaiswal,1 BC Sharath Kumar,2 P Shilpashree,1 Bilugumba Gangaboraiah,3 Manjula Shamanna4 1Department of Dermatology, Dr BR Ambedkar Medical College (BRAMC), Bangalore, Karnataka, India; 2Department of Dermatology, 3Department of Community Medicine, Kempegowda Institute of Medical Sciences (KIMS), Bangalore, Karnataka, India; 4Medical Services, Micro Labs Ltd, Bangalore, Karnataka, India Introduction: Melasma is one of the commonly reported pigmentory disorders in the Indian population. Numerous therapeutic modalities are available. However, very few have produced complete satisfactory response. 4-n-Butylresorcinol 0.3% cream has recently been introduced in India as a new hypopigmenting agent. It is a resorcinol derivative and acts by inhibiting both tyrosinase and tyrosinase-related protein-1. Objective: The available published literatures are with 4-n-butylresorcinol 0.1% cream, and there is paucity of clinical studies with 4-n-butylresorcinol 0.3% cream. Furthermore, considering the fact that Indian skin is more prone to irritation with hypopigmenting agents, our study explores the efficacy, safety, and tolerability of 4-n-butylresorcinol 0.3% cream in Indian subjects with melasma. Methods: Fifty-two subjects with melasma participated in this open-label, single arm, observational study. All the patients were advised twice daily application of 4-n-butylresorcinol 0.3% cream for 8 weeks over the areas of melasma. Assessment parameters included modified Melasma Area Severity Index (mMASI) score. Digital photographs of all the patients at baseline, week 4, and week 8 were taken. During this 8-week study period, all the adverse events were observed and recorded. Results: All the 52 subjects completed the study. Out of 52 subjects, 90.38% were females. The mean age of patients was 38.5±7.8 years. Mean ± standard error of MASI score measurements showed a significant decrease from baseline score of 14.73±0.59 to 11.09±0.53 after week 4 (P<0.001) and 6.48±0.43 at week 8 (P<0.001). The digital photographs of the study subjects taken at week 4 and week 8 also showed decrease in melasma pigmentation compared to baseline photograph and correlated with the changes in the mMASI score. The treatment was well tolerated by all the study subjects. No adverse reactions were reported throughout the study period. Conclusion: Our data suggest that the 4-n-butylresorcinol 0.3% cream is safe, effective, and well tolerated in Indian patients with melasma. Keywords: 4-n-butylresorcinol, melasma, topical treatment, tyrosinase inhibitors&nbsp

Prevalence of chronic obstructive pulmonary disease and its association with tobacco smoking and environmental tobacco smoke exposure among rural population

A field survey was conducted for chronic obstructive pulmonary disease (COPD) epidemiology in the rural field practice area of Kempegowda Institute of Medical Sciences, Bangalore, India, which covers a population of 44,387 to find out the prevalence of COPD in adult subjects of 35 years and above using cluster sampling technique and to determine the association of tobacco smoking, environmental tobacco smoking (ETS) exposure and type of cooking fuel used with COPD. The overall prevalence of COPD was 4.36%. The prevalence among males and females were 5.32% and 3.41% respectively. The prevalence was found to be increasing with an increase in age. The tobacco smoke and exposure to ETS was significantly associated with higher odds of COPD with adjusted odds ratio 2.97 and 2.67 respectively. Thus, there was a significant association between tobacco smoking and ETS exposure with COPD

Assessing the relationship between antigenicity and immunogenicity of human rabies vaccines when administered by intradermal route: Results of a metaanalysis

The metadata of 10 published studies and 3 vaccine trial reports comprising of 19 vaccine cohorts from four countries conducted over a period of 23 years (1986–2009) was used for metaanalysis. The vaccines studied were purified chick embryo cell vaccine (Rabipur, India and Germany), purified vero cell rabies vaccine (Verorab, France; Indirab, India) and human diploid cell vaccine (MIRV, France). The potency of these vaccines varied from 0.55 IU to 2.32 IU per intradermal dose of 0.1 ml per site. The vaccines were administered to 1,011 subjects comprising of 19 cohorts and using five different ID regimens. The immunogenicity was measured by assays of rabies virus neutralizing antibody (RVNA) titres using rapid fluorescent focus inhibition test (RFFIT) [15 cohorts] and mouse neutralization test (MNT) [4 cohorts]. The statistical analysis of the data was done by Karl Pearson's correlation coefficient to measure the relationship between antigenicity and immunogenicity. It was revealed that, there was no significant linear relationship between antigenicity and immunogenicity of rabies vaccines when administered by intradermal route (p > 0.230 and p > 0.568)