An Acute Therapeutic Evaluation of Three Regimens of Tiotropium and Formoterol in COPD Patients: A Randomized, Double-blind, Placebo-Controlled Clinical Study.

Aims: To evaluate therapeutic rationality of combining long-acting β2-agonists (formoterol) with duration of action of 12 hours and anticholinergics (tiotropium) with 24 hours as fixed dose inhaled combination (FDC) still widely prescribed in developing countries in COPD patients. Study Design: A randomized, double-blind, placebo-controlled, parallel design study. The three regimens that were used; tiotropium 18 μg once a day in the morning along with the formoterol matched placebo in the evening, the FDC of tiotropium 18 μg plus formoterol 12 μg once a day in the morning and formoterol matched placebo in the evening and the same FDC of the two drugs once a day in the morning and once a day formoterol 12 μg in the evening in patients of COPD without any co-morbidity. Place and Duration of Study: Tertiary care pulmonary medicine university teaching government hospital of Delhi, India; 1 year. Methodology: Sixty COPD patients (Male, Avg. age 56±11 years) divided into 3 groups of 20 each without any comorbidity were admitted in the hospital for 24 hours. The spirometry, perception of dyspnea on Borg's scale and vitals such as blood pressure (BP) and pulse rate (PR) were recorded at the following interval 30 minutes, 2 hours, 12 hours after the morning dose and 30 minutes and 12 hours after the evening dose. Results: Addition of formoterol in the evening along with the FDC in the morning enhanced the peak effects in percentage predicted FEV1 (82.55+/-12.639), FEV1/FVC (0.592±0.097) that remained till the next dose (24 hours) which was statistically (P=.05) superior to the tiotropium alone group (75.55+/-17.981) as well as FDC alone group (74.55+/-12.655). Conclusion: There is no advantage of FDC once a day over tiotropium alone. However addition of evening dose of formoterol has shown therapeutic superiority over once a day FDC of the two in COPD.

Quality of asthma management in an urban community in Delhi, India.

Background & objectives: High prevalence and poor control of asthma make its management a major public health issue worldwide, especially in developing countries. Optimum review of asthma management in the community is essential to improve asthma control. This study was conducted to investigate the quality of asthma management, knowledge about asthma and quality of life of asthma patients referred to a public tertiary care chest hospital in Delhi. Methods: Diagnosis of asthma was confirmed by symptoms and reversible spirometry in 50 referred patients on their first visit. Patients were interviewed using three questionnaires on quality of asthma management before visiting referral hospital, asthma knowledge and asthma quality of life (AQLQ). Correlation amongst quality of treatment, asthma quality of life, and asthma knowledge was also determined. Results: Findings revealed that only 60 per cent of patients were informed about their disease, and 10 per cent had undergone lung function tests previously. Only 44 per cent of patients were prescribed inhalers. None were provided with any educational material. Patients had poor knowledge of aetiology, pathophysiology, medication and how to assess the severity of their asthma. The mean scores in AQLQ indicated a moderate degree of impairment in quality of life. Interpretations & conclusions: This study provides evidence of unsatisfactory asthma management and patient-doctor interaction as patients had limited knowledge of asthma disease, its management and had poor quality of life as measured by a standardized questionnaire. Thus, there is need to implement suitable interventions to improve asthma management according to standard treatment guidelines in the community.

Effect of patient education and standard treatment guidelines on asthma control: an intervention trial

Background: Denial of having a chronic condition, poor knowledge of the disease process and lack of adherence to standard treatment are often considered to be important factors that increase morbidity in asthma. We evaluated the effect of standard treatment guidelines and asthma education programme on asthma control among patients enrolled from a referral health facility of Delhi in India. Methods: Fifty patients who visited the health facility first time for treatment of asthma were enrolled after confirming the diagnosis of asthma by symptoms and reversible spirometry. Patients were interviewed at baseline using three researcher-administered questionnaires - quality of asthma management questionnaire, asthma control questionnaire (ACQ) and asthma knowledge questionnaire (AKQ). All patients were given pharmacotherapy according to standard treatment guidelines. In addition, every alternate patient was also given a face-to-face educational intervention. Patients were followed up at 2, 4, 8 and 12 weeks. The ACQ was used at each visit, and AKQ was reassessed at the twelfth week. The paired t test was used to detect significant changes in various domains of asthma control. Results: The knowledge of asthma among patients and the care provided by previous health-care providers were found to be poor at baseline assessment. The application of standard treatment guidelines improved asthma control by the second week and the changes became significant by the fourth week, which persisted till the twelfth week (p <0.0001). Educational intervention led to improvements in knowledge in several domains. Improvements in asthma symptoms began earlier among those who had additional educational intervention. Conclusions: Standard treatment guidelines and asthma education improved asthma control.

Methodology for surveillance of antimicrobials use among out-patients in Delhi.

Background & objectives: Determining antibiotic use in the population is problematic in India, as there are no population level databases on prescriptions and over-the-counter sales. This study attempts to establish a methodology for surveillance of antibiotic use in the community. Methods: Antibiotic use was monitored in fi ve municipal wards of Delhi, from January-December 2004. Thirty co-operative retail pharmacies were enrolled in Inderpuri (7), Karol Bagh (3), Patel Nagar (5), Rajinder Nagar (6) and Rajouri Garden (9); data on antibiotic use were collected in two ways. Firstly, bulk purchase data were collected by recording the quantities of all antibiotics purchased by these pharmacies every month over one year. Secondly, 15-25 ‘exit interviews’ were conducted with patients leaving the enrolled pharmacies every month. Antibiotic use from bulk purchase data was measured as defi ned daily dose (DDD)/1000 population and from exit interview data as DDD/1000 patients visiting the pharmacy during data collection and also as per cent patients receiving an antibiotic. Results: Bulk purchase and exit interview data showed some similar patterns of antibiotic use with a growing peak in the consumption of most antibiotics classes in the months of February and March. Use of the fl uoroquinolone group (J01MA) was much higher than other antibiotic classes by both methods. Exit interviews revealed that 21 per cent of persons who visited the pharmacies bought antibiotics. Both measures of use from exiting patient interviews showed the same trend over time. Interpretation & conclusions: Both drug use methods can be used to measure antibiotic use in the private retail pharmacies and outpatient department of public facilities. Surveillance of antimicrobial drug use from private retail pharmacies in a municipal zone in Delhi indicated overuse of antimicrobial drugs, particularly fluoroquinolines.

Prices & availability of common medicines at six sites in India using a standard methodology.

BACKGROUND & OBJECTIVE: The price and availability of medicines are key components in determining access to effective treatment. Data on prices and availability of common medicines in public and private sector in different States of India are scarce. Hence, surveys were undertaken in different States of India to evaluate these metrics. METHODS: During October 2004 to January 2005, six surveys were undertaken simultaneously in five States of India to assess medicine prices and availability of essential medicines (n = 21-28) using the World Health Organization and Health Action International methodology. Surveys were conducted at Chennai, Haryana, Karnataka, West Bengal, and at two sites in Maharashtra. For each medicine, data were collected for the Innovator Brand (IB), Most Sold Generic (MSG), and Lowest Priced Generic (LPG) at randomly selected public and private facilities in each site surveyed. Prices were compared to an international reference benchmark (expressed as median price ratio - MPR). RESULTS: The procurement price of medicines in the public sector was 0.27 to 0.48 times the international reference price. However, these medicines were inadequately available and the median availability in the public sector ranged from 0 to 30 per cent. The median prices of medicines in the private sector were less than twice the IRP, although a few innovator brands were more expensive. No difference was observed between the prices of the most sold generic (MSG) and the lowest priced generic (LPG) available at the facilities. Interestingly, price variation was observed among different generic equivalents of ciprofloxacin in each region. The price of LPG diazepam in the private sector was thirty three times its procurement price in the public sector. INTERPRETATION & CONCLUSION: The survey revealed low procurement prices and poor availability in the public sector. Thus, the majority of the population purchased medicines from private pharmacies, where generics were usually available although prices of certain medicines were high. Various policy measures could increase the availability and accessibility of medicines for the population.