ASSESS THE CLINICAL USAGE OF NEBULIZATION THERAPY AND ANTIBIOTICS IN IN-PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE: A RANDOMIZED PROSPECTIVE STUDY AT A TERTIARY CARE TEACHING HOSPITAL

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DIAGNOSIS
Chest X-ray: An abnormal chest X-ray is seldom diagnostic in COPD unless obvious bullous disease is present, but it is valuable in excluding alternative diagnoses and establishing the presence of significant comorbidities. However, when there is doubt about the diagnosis of COPD, high resolution CT (HRCT) scanning might help in the differential diagnosis. In addition, if a surgical procedure such as lung volume reduction is contemplated, a chest CT scan is necessary since the distribution of emphysema is one of the most important determinants of surgical suitability (Pellegrino R et al., 2005).

Arterial blood gas measurement: In advanced COPD, measurement of arterial blood gases while the patient is breathing air is important. This test should be performed in stable patients with FEV1<50% predicted or with clinical signs suggestive of respiratory failure or right heart failure. The inspired oxygen concentration (FiO2-normally 21% at sea level) should be noted, a particularly important point if patient is using an O2-driven nebulizer. Changes in arterial blood gas tensions take time to occur, especially in severe disease. Thus, 20-30 minutes should pass before rechecking the gas tensions when the FiO2 has been changed.

Measurement of Airflow Limitation (Spirometry): Spirometry should be undertaken in all patients who may have COPD. Although spirometry does not fully capture the impact of COPD on a patient’s health, it remains the gold standard for diagnosing the disease and monitoring its progression.
Spirometry should measure the volume of air forcibly exhaled from the point of maximal inspiration (forced vital capacity, FVC) and the volume of air exhaled during the first second of this maneuver (forced expiratory volume in one second, FEV1), and the ratio of these two measurements (FEV1/FVC) should be calculated. Spirometry measurements are evaluated by comparison with reference values based on age, height, sex, and race (Fishman A et al., 2003).

Figure 2: Normal Spirogram and Spirogram Typical of Patients with Mild to Moderate COPD

Alpha-1 antitrypsin deficiency screening: It may be valuable to identify coexisting alpha-1 antitrypsin deficiency. A serum concentration of alpha-1 antitrypsin below 15-20% of the normal value is highly suggestive of homozygous alpha-1 antitrypsin deficiency (Roberts CM et al., 1993).

ASSESSMENT
The goals of COPD assessment are to determine the severity of airflow limitation, its impact on the patient’s health status and the risk of future events (such as exacerbations, hospital admissions or death), guide therapy. To achieve these goals, COPD assessment must consider the following aspects of the disease separately:
• The presence and severity of the spirometric abnormality.
• Current nature and magnitude of the patient’s symptoms.
• Exacerbation history and future risk.
• Presence of comorbidities.

Classification of severity of airflow obstruction: The classification of airflow limitation severity in COPD is shown in following table. Spirometry should be performed after the administration of an adequate dose of at least one short-acting inhaled bronchodilator in order to minimize variability.

Table 1: Classification Of Airflow Limitation Severity In COPD

Assessment of symptoms: In the past, COPD was viewed as a disease largely characterized by breathlessness. A simple measure of breathlessness such as the Modified British Medical Research Council (mMRC) Questionnaire was considered adequate, as the mMRC relates well to other measures of health status and predicts future mortality risk.

Table 2: Modified MRC Dyspnea Scale

However, it is now recognized that COPD impacts patients beyond just dyspnea. For this reason, a comprehensive assessment of symptoms is recommended using measures such as the COPD Assessment Test (CAT) and the COPD Control Questionnaire (The CCQ) have been developed and are suitable.

TREAMENT
Pharmacologic therapy is used to prevent and control symptoms, reduce the frequency and severity of exacerbations, improve health status, and improve exercise tolerance.
No single pharmacologic class has been proven to provide superior benefit over others, although inhaled therapy is generally preferred. Medication selection is based on likely patient adherence, individual response, and side effects.
Sympathomimetics: β2-Selective sympathomimetics cause relaxation of bronchial smooth muscle and bronchodilation by stimulating the enzyme adenyl cyclase to increase the formation of cyclic adenosine monophosphate. They may also improve mucociliary clearance. The inhalation route is preferred to the oral and parenteral routes in terms of both efficacy and adverse effects.
Short-acting agents can be used for acute relief of symptoms or on a scheduled basis to prevent or reduce symptoms. The duration of action of short-acting β2-agonists is 4 to 6 hours. Long-acting inhaled β2-agonists that are dosed every 12 hours on a scheduled basis and provide bronchodilation throughout the dosing interval.
Anticholinergics: When given by inhalation, anticholinergic agents produce bronchodilation by competitively inhibiting cholinergic receptors in bronchial smooth muscle. This activity blocks acetylcholine, with the net effect being a reduction in cyclic guanosine monophosphate, which normally acts to constrict bronchial smooth muscle.
Ipratropium bromide has a slower onset of action than short-acting β2-agonists. But it is often prescribed as Ipratropium has a more prolonged bronchodilator effect than short-acting ß2-agonists. Its peak effect occurs in 1.5 to 2 hours and its duration is 4 to 6 hours.

Combination Anticholinergics and Sympathomimetics: The combination of an inhaled anticholinergic and β2-agonist is often used, especially as the disease progresses and symptoms worsen over time. Combination of both short- and long acting β2-agonists with ipratropium has been shown to provide added symptomatic relief and improvements in pulmonary function. A combination product containing albuterol and ipratropium (Combivent) is available as an MDI (metered-dose inhaler) for chronic maintenance therapy of COPD.

Methylxanthines: Theophylline and aminophylline may produce bronchodilation by inhibition of phosphodiesterase, thereby increasing cyclic adenosine monophosphate levels and inhibition of release of mediators from mast cells and leukocytes. Chronic theophylline use in COPD has been shown to produce improvements in lung function, including vital capacity and FEV1. Subjectively, theophylline has been shown to reduce dyspnea, increase exercise tolerance, and improve respiratory drive. Methylxanthines are no longer considered first-line therapy for COPD, because of theophylline’s risk for drug interactions and the interpatient variability in dosage requirements. Theophylline may be considered in patients who are intolerant or unable to use an inhaled bronchodilator. As with other bronchodilators in COPD, parameters other than objective measurements such as FEV1 should be monitored to assess efficacy. The role of theophylline in COPD is as maintenance therapy in non acutely ill patients. Therapy can be initiated at 200 mg twice daily and titrated upward every 3 to 5 days to the target dose.

Corticosteroids: The anti-inflammatory mechanisms whereby corticosteroids exert their beneficial effect in COPD include reduction in capillary permeability to decrease mucus, inhibition of release of proteolytic enzymes from leukocytes, and inhibition of prostaglandins. The clinical benefits of systemic corticosteroid therapy in the chronic management of COPD are often not evident, and there is a high risk of toxicity. Appropriate situations to consider corticosteroids in COPD include:
i. Short term systemic use for acute exacerbations.
ii. Inhalation therapy for chronic stable COPD.

Consensus guidelines indicate that inhaled corticosteroid therapy should be considered for symptomatic patients with stage III or IV disease (FEV1 less than 50%) who experience repeated exacerbations despite bronchodilator therapy. Combination therapy with salmeterol plus fluticasone or formoterol plus budesonide is associated with greater improvements in FEV1, health status, and exacerbation frequency than either agent alone (Barbara G. Wells et al., 2009).

CHRONIC OBSTRUCTIVE PULMONARY DISEASE EXACERBATION
An exacerbation of COPD is defined as an event in the natural course of the disease characterized by a change in the patient’s baseline dyspnea, cough and/or sputum that is beyond normal day-to-day variations is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD (Rodriguez-Roisin, 2000; Burge S. Wedzicha JA, 2003).

Controlled oxygen therapy: Oxygen therapy is the cornerstone of hospital treatment of COPD exacerbations. Supplemental oxygen should be titrated to improve the patient’s hypoxemia. Adequate levels of oxygenation (PaO2 > 8.0 kPa, 60 mm Hg, or SaO2 > 90%) are easy to achieve in uncomplicated exacerbations, but CO2 retention can occur insidiously with little change in symptoms. Once oxygen is started, arterial blood gases should be checked 30-60 minutes later to ensure satisfactory oxygenation without CO2 retention or acidosis (Celli BR. MacNee W, 2004).

Bronchodilator therapy: Short-acting inhaled β2-agonists are usually the preferred bronchodilators for treatment of exacerbations of COPD. If a prompt response to these drugs does not occur, the addition of an anticholinergic is recommended. Methylxanthines (theophylline or aminohylline) is currently considered second-line intravenous therapy, used when there is inadequate or insufficient response to short-acting bronchodilators (Celli BR. MacNee W, 2004; National Institute for Clinical Excellence 2004; Barbera JA et al., 1992).

Glucocorticosteroids: Oral or intravenous glucocorticosteroids are recommended as an addition to other therapies in the hospital management of exacerbations of COPD. 30 to 40 mg of oral prednisolone daily for 7-10 days is effective and safe. Prolonged treatment does not result in greater efficacy and increases the risk of side effects (e.g., hyperglycemia, muscle atrophy) (Davies L et al., 1999; Niewoehner DE et al., 1999).

Antibiotics: Randomized placebo-controlled studies of antibiotic treatment in exacerbations of COPD have demonstrated a small beneficial effect of antibiotics on lung function (Saint S et al., 1995) and a randomized controlled trial has provided evidence for a significant beneficial effect of antibiotics in COPD patients who presented with an increase in all three of the following cardinal symptoms: dyspnea, sputum volume, and sputum purulence. There was also some benefit in those patients with an increase in only two of these cardinal symptoms (Anthonisen NR et al., 1987).

Ventilatory support: The primary objectives of mechanical ventilatory support in patients with COPD exacerbations are to decrease mortality and morbidity and to relieve symptoms. Ventilatory support includes both noninvasive intermittent ventilation using either negative or positive pressure devices, and invasive (conventional) mechanical ventilation by oro-tracheal tube or tracheostomy (Clinical indications for noninvasive positive pressure ventilation in chronic respiratory failure due to restrictive lung disease, 1999; Lightowler JV et al., 2003).

OTHER PHARMACOLOGIC CONSIDERATIONS
A number of other treatments have been explored over the years. Among these therapies, there is either insufficient evidence to warrant recommending their use, or they have been proven to not be beneficial in the management of COPD.
Suppressive Antimicrobial Agents: Because COPD patients often are colonized with bacteria and experience recurrent exacerbations of their condition, a common practice employed in the past has been the use of low-dose antimicrobial therapy as preventative or prophylaxis against these acute exacerbations.
Expectorants and Mucolytics: Adequate water intake generally is acceptable to maintain hydration and assist in the removal of airway sections. Beyond this, the regular use of mucolytics or expectorants for COPD patients has no proven benefit. This includes the use of saturated solutions of potassium iodide, ammonium chloride, acetylcysteine, and guaifenesin.
Narcotics: Systemic (oral and parenteral) opioids, especially morphine, can relieve dyspnea in patients with endstage COPD. Nebulized therapy is sometimes used in clinical practice although data about clinical benefit are lacking.

NON PHARMACOLOGICAL TREATMENT
Patients with COPD should receive education about their disease, treatment plans, and strategies to slow progression and prevent complications.

Smoking Cessation: A primary component of COPD management is avoidance of or reduced exposure to risk factors. Exposure to environmental tobacco smoke is a major risk factor, and smoking cessation is the most effective strategy to reduce the risk of developing COPD. As confirmed by the Lung Health Study, smoking cessation is the only intervention proven at this time to affect long-term decline in FEV1 and slow the progression of COPD. In this 5-year prospective trial, smokers with early COPD were randomly assigned to one of three groups: smoking-cessation intervention plus inhaled ipratropium three times a day, smoking-cessation intervention alone, or no intervention. During an 11-year follow up, the rate of decline in FEV among subjects who continued to smoke was more than twice the rate in sustained quitters. Smokers who underwent smoking cessation intervention had fewer respiratory symptoms and a smaller annual decline in FEV1 compared with smokers who had no intervention. Every clinician has a responsibility to assist smokers in smoking cessation efforts. In 2004, a report from the Surgeon General on the health consequences of smoking broadened the scope of the detrimental effects of cigarette smoking, indicating that “Smoking harms nearly every organ of the body, causing many diseases and reducing the health of smokers in general.” Advice should be given to smokers even if they have no symptoms of smoking-related disease or if they are receiving care for reasons unrelated to smoking. Brief interventions (3 minutes) of counseling are proven effective. However, it must be recognized that the patient must be ready to stop smoking because there are several stages of decision making. The usual duration of therapy is 8 to 12 weeks, although some individuals may require longer courses of treatment.

Pulmonary Rehabilitation: Exercise training is beneficial in the treatment of COPD to improve exercise tolerance and to reduce symptoms of dyspnea and fatigue. Pulmonary rehabilitation programs are an integral component in the management of COPD and should include exercise training along with smoking cessation, breathing exercises, optimal medical treatment and health education. High-intensity training (70% maximal workload) is possible even in advanced COPD patients, and the level of intensity improves peripheral muscle and ventilatory function. Studies have demonstrated that pulmonary rehabilitation with exercise three to seven times per week can produce long-term improvement in activities of daily living, quality of life, exercise tolerance, and dyspnea in patients with moderate to severe COPD.

Immunizations: Vaccines can be considered as pharmacologic agents. However, their role is described here in reducing risk factors for COPD exacerbations. Because influenza is a common complication in COPD that can lead to exacerbations and respiratory failure, an annual vaccination with the inactivated intramuscular influenza vaccine is recommended. Immunization against influenza can reduce serious illness and death by 50% in COPD patients.

The polyvalent pneumococcal vaccine, administered one time, is widely recommended for people from 2 to 64 years of age who have chronic lung disease and for all people older than age 65 years. Thus COPD patients at any age are candidates for vaccination. Although evidence for the benefit of the pneumococcal vaccine in COPD is not strong. Currently, administering the vaccine remains the standard of practice and is recommended by the Centers for Disease Control and Prevention and the American Lung Association.

Long-Term Oxygen Therapy: The use of supplemental oxygen therapy increases survival in COPD patients with chronic hypoxemia. Although long-term oxygen has been used for many years in patients with advanced COPD.
Oxygen-conservation devices are available that allow oxygen to flow only during inspiration, making the supply last longer. These may be particularly useful to prolong the oxygen supply for mobile patients using portable cylinders. However, the devices are bulky and subject to failure.

Long-term oxygen therapy provides even more benefit in terms of survival after 5 years of use, and it improves the quality of life of these patients. Before patients are considered for long-term oxygen therapy, they should be stabilized in the outpatient setting, and pharmacotherapy should be optimized. Once this is accomplished, long term oxygen therapy should be instituted if either of two conditions exists:
i. a resting PaO2 of less than 55 mm Hg,
ii. evidence of right-sided heart failure, polycythemia, or impaired neuropsychiatric function with a PaO2 of less than 60 mm Hg.

The most practical means of administering long-term oxygen is with the nasal cannula, at 1 to 2 L/min which provides 24% to 28% oxygen. The goal is to raise the PaO2 above 60 mm Hg. There are three different ways to deliver oxygen, including
• in liquid reservoirs,
• compressed into a cylinder, and
• via an oxygen concentrator.

Adjunctive Therapies: In addition to supplemental oxygen, adjunctive therapies to consider as part of a pulmonary rehabilitation program are psychoeducational care and nutritional support. Psychoeducational care (such as relaxation) has been associated with improvement in the functioning and well-being of adults with COPD.

SURGICAL INTERVENTION
Various surgical options have been employed in the management of COPD. These include bullectomy, lung volume reduction surgery (LVRS) and lung transplantation.
Bullectomy has been performed for many years and may be useful when large bullae (>1 cm) are noted on computed tomographic scan. The presence of bullae may contribute to complaints of dyspnea and their removal can improve lung function and reduce symptoms, although there is no evidence of a mortality benefit. Because of the prevalence of COPD, it is the most frequent indication for lung transplantation.

Recent trials have evaluated the effect of bilateral LVRS for management of severe COPD. Short-term trials comparing the effects of pulmonary rehabilitation plus LVRS with pulmonary rehabilitation alone reported that the combination of treatments resulted in greater improvements in lung function, gas exchange, and quality of life at 3 months. The National Emphysema Treatment Trial, a prospective, randomized trial evaluating the long-term effects of LVRS plus pulmonary rehabilitation compared with pulmonary rehabilitation alone, followed 1,218 patients for 3 years. The primary end points for the study were mortality and maximal exercise capacity 2 years after randomization. Secondary end points included pulmonary function, distance walked in 6 minutes, and quality-of life measurements. At an interim analysis, patients with an FEV1 of less than 20% of predicted or a carbon monoxide diffusing capacity of less than 20% of predicted were noted to be at high risk of death after surgery and subsequently were excluded from the study. Results of the study showed no mortality benefit with LVRS compared with pulmonary rehabilitation alone. Patients undergoing surgery had improved exercise capacity, lung function, and quality of life at 2 years, but these patients also had a higher risk of short-term morbidity and mortality associated with the surgery. A subgroup analysis of the study noted that patients with predominately upper-lobe emphysema and low exercise capacity undergoing surgery had lower mortality rates at 2 years compared with patients treated with medical therapy alone. Because of the costs and risks associated with LVRS (Robert L. Talbert et al., 2008).

CURRENT RESEARCH STATUS ON COPD
Maryam Mahmoodan et al (2017) carried out a study on Drug Utilization Evaluation in Chronic Obstructive Pulmonary Disease Patients. Chronic obstructive pulmonary disease (COPD) requires extensive treatment with multiple drug therapy. Due to its increasing prevalence and complications, it is rapidly becoming one of the world’s most serious health issues. It is necessary to treat the disease at the earliest with proper monitoring and evaluation of the therapy to prevent further progression and associated complications. Drug utilization evaluation is mainly used to understand the drug use pattern; use of irrational drugs; intervention to improve drug use and continuous quality improvement. Hence the present study was undertaken to understand the prescription pattern of patients diagnosed with COPD in a teaching hospital of South India. A total of 100 patients diagnosed with COPD was included in the study. The severity level of COPD was analyzed using Modified Medical Research Council Questionnaire (mMRC) scale and the medications prescribed for treating were analyzed using GOLD treatment guidelines. Most of the patients were admitted with Grade-2 of modified Medical Research Council (mMRC) dyspnoea scale. Corticosteroids (22%) were the most prescribed class of drugs in which inhaled corticosteroids (budesonide and fluticasone) were preferred. The most prescribed combination therapy was salbutamol with ipratropium bromide. The majority of patients was treated with multiple drug therapy, in which combination of corticosteroids, β2-agonists, methylxanthines and anticholinergics along with antibiotics were used. Independent of socioeconomic status, poor health literacy is associated with greater COPD severity (Maryam Mohmoodan et al., 2017).

Dr. R. Kothai et al (2017) carried out a study on Analysis of Prescribing Pattern of COPD Patients in a Tertiary Care Hospital Salem. Chronic obstructive pulmonary disease (COPD), a common preventable and treatable disease, is one of the leading causes of morbidity and mortality in the industrialized and the developing countries. An attempt was made to assess the current prescribing pattern with the WHO prescribing indicators to see whether the prescription pattern followed WHO guidelines in a tertiary care hospital in Salem. Retrospective analysis of 150 patients admitted in the General Medicine department over a period of six months from November 2015 to April 2016 in Vinayaka Mission’s Kirupananda Variyar Medical College And Hospitals, Salem, Tamil Nadu were selected for analyzing the drug use pattern using WHO prescribing indicators and drug-drug interactions in the prescriptions. The prescriptions were analyzed using descriptive statistics and results were expressed in percentage. A total of 1015 drugs were prescribed and the average number of drugs per prescription was found to be 7.69±2.24. Most of the drugs were prescribed by brand name (63.34%). The percentage of drugs prescribed as per EDL-WHO 2015 was 22.36%. The most commonly prescribed COPD drug was Deriphylline [123(20.5%)]. The prescribing patterns were not in accordance with WHO guidelines so it is necessary to make doctors aware about the use of drugs, importance of prescribing drugs with generic names, safety of prescribing drugs from EDL and patient’s point of view (Dr. R. Kothai et al., 2017).

Aswathy Unni et al (2015) carried out a study On Drug Utilization Pattern In Chronic Obstructive Pulmonary Disease In patients At A Tertiary Care Hospital. Drug utilization studies provide useful insights into the current prescribing practices. In this retrospective study, all patient data relevant to the study were obtained by examination of patient’s medical records and hospital information system. A total of 237 patients with acute exacerbation were evaluated. The population predominantly consisted of males and most of the patients were in the age group of 61 to 70 years. Hypertension was the most common co-morbidity. Candida albicans and Pseudomonas aeruginosa were the most common microorganisms isolated from sputum samples. Majority of the patients were on multidrug therapy. During hospital stay, the most commonly prescribed drugs were ipratropium and levosalbutamol. The prescribing trend observed at our hospital appears to be in concordance with the current guidelines for the management of COPD patients (Aswathy Unni et al., 2015).

SK Veettil et al (2014) carried out a prospective study to recognize The Drug Utilization Pattern for the Treatment of Acute Exacerbation of COPD for 7-Days Under Non-Experimental Settings. The information related to the study was collected from the case records and discussed with the inpatients during ward rounds, with the support of physician. The results indicates that only those above 40 years of age were admitted into the hospital and the majority of patients were of the male sex. The percentage of drugs used were as follows: Salbutamol accounts for about 74% use, Parenteral steroid is 78%, all of them received hydrocorticosteroid, steroid inhalers-25%, Anticholinergics-77.5% and Antibiotics were used in 86.7% patients. The study suggested that despite the use of drugs according to the availability and physician's preference, it was found in the analysis that majority were in accordance with Global Initiative for Chronic Obstructive Lung Disease criteria recommendations (Sajesh Kalkandi Vettil et al., 2014).

Anderw Woods J et al (2014) carried out a study to review The Use of Corticosteroid in the Treatment of Acute Exacerbations of COPD. All reference citations from identified publications were reviewed for possible inclusion. All identified randomized, placebo-controlled trials, meta-analyses, and systematic reviews evaluating the efficacy of systemic corticosteroids in the treatment of AECOPD were reviewed and summarized. The result indicates that are in comparison. The study suggests that the Systemic corticosteroids are efficacious in the treatment of AECOPD and considered a standard of care for patients experiencing an AECOPD. Therefore, systemic corticosteroids should be administered to all patients experiencing AECOPD severe enough to seek emergent medical care. The lowest effective dose and shortest duration of therapy should be considered (Woods JA et al., 2014).

WW Wu et al (2014) carried out a study to know The Effect of Oxygen-Driven Nebulization (ODN) at Different Oxygen Flows on Heart Rate, Respiratory Rate, SpO2, SaO2, PaO2, PaCO2 and pH of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) Patients. In this study a total of 9 AECOPD patients were randomly divided into 3 groups, numbered A, B and C and treated with ODN. Oxygen flow of groups A, B and C was 4-5, 6-7 and 8-9 L/min, respectively. Heart rate, respiratory rate, SpO2, SaO2, PaO2, PaCO2 and pH were recorded before ODN and 30 minutes after ODN. Statistical differences of data before or after ODN were analyzed by analysis of variance and F-test, whereas data before and after ODN were tested by paired t test. The results indicate that there was no significant difference of heart rate, respiratory rate, SpO2, PaO2, PaCO2, SaO2 and pH among 3 groups before ODN or after ODN. The heart rate was increased in all groups after ODN. But significant increase was only present in groups A and C but not in group B. SaO2 was significantly increased in group C after ODN but no statistical difference was observed between before and after ODN in groups A and B. There was no significant change in respiratory rate, SpO2, PaO2, PaCO2, SaO2 and pH between before and after ODN in all groups (Wu WW et al., 2014).

Dhand R et al (2012) carried out a study To Evaluate the Role of Nebulized Therapy in the Management of COPD. Current guidelines recommend inhalation therapy as the preferred route of drug administration for treating chronic obstructive pulmonary disease (COPD). Previous systematic reviews in COPD patients found similar clinical outcomes for drugs delivered by handheld inhalers - pressurized metered-dose inhalers (pMDIs), dry powder inhalers (DPIs) - and nebulizers, provided the devices were used correctly. However, in routine clinical practice critical errors in using handheld inhalers are highly prevalent and frequently result in inadequate symptom relief. In comparison with pMDIs and DPIs, effective drug delivery with conventional pneumatic nebulizers requires less intensive patient training. Moreover, by design, newer nebulizers are more portable and more efficient than traditional jet nebulizers. The study show despite several known drawbacks associated with nebulized therapy, we recommend that maintenance therapy with nebulizers should be employed in elderly patients, those with severe disease and frequent exacerbations, and those with physical and/or cognitive limitations. Likewise, financial concerns and individual preferences that lead to better compliance may favor nebulized therapy over other inhalers. For some patients, using both nebulizers and pMDI/DPI may provide the best combination of efficacy and convenience (Dhand R et al., 2012).

K Richard et al (2011) carried out a prospective parallel group, Placebo-Controlled Design Study. Participants were randomly selected in a 1:1 ratio to receive azithromycin, at a dose of 250 mg orally, or an identical-appearing placebo, once daily. The participants should be atleast of 40 years of age. Among subjects at increased risk for acute exacerbations of COPD who received azithromycin-250 mg once daily, for 1 year, the frequency of acute exacerbations was decreased. The results indicates that among 1577 subjects who were screened, 1142 (72%) were randomly selected to receive azithromycin at a dose of 250mg daily (570 participants) or placebo (572 participants) for 1 year and the rate of 1-year follow-up was 89% in the azithromycin group and 90% in the placebo group. The frequency of exacerbations was 1.48 exacerbations per patient-year in the azithromycin group, as compared with 1.83 per patient-year in the placebo group (P=0.01), and the hazard ratio for having an acute exacerbation of COPD per patient-year in the azithromycin group was 0.73 (95% CI, 0.63 to 0.84; P<0.001). The study shows that among selected subjects with COPD azithromycin taken daily for 1 year, when added to usual treatment, decreased the frequency of exacerbations and improved quality of life but caused hearing decrements in a small percentage of subjects (Albert RK et al., 2011).

Paolo Montuschi (2006) carried out a study on Pharmacological Treatment Of Chronic Obstructive Pulmonary Disease. None of the drugs currently available for chronic obstructive pulmonary disease (COPD) are able to reduce the progressive decline in lung function which is the hallmark of this disease. Smoking cessation is the only intervention that has proved effective. The current pharmacological treatment of COPD is symptomatic and is mainly based on bronchodilators, such as selective β2-adrenergic agonists (short and long-acting), anticholinergics, theophylline, or a combination of these drugs. Glucocorticoids are not generally recommended for patients with stable mild to moderate COPD due to their lack of efficacy, side effects, and high costs. New pharmacological strategies for COPD need to be developed because the current treatment is inadequate (Paolo Montuschi et al., 2006).

P Moayyedi et al (1995) carried out a study to known any benefit in adding ipratropium bromide to salbutamol in acute exacerbations of COPD and Combination therapy with the two drugs was compared with salbutamol alone in the treatment of acute exacerbations of COPD during a hospital admission Seventy patients admitted to hospital with an acute exacerbation of COPD were randomly allocated to receive either nebulised salbutamol 5 mg and ipratropium bromide 500 mg, or nebulised salbutamol 5 mg alone (all four times a day) on admission. All other treatment was prescribed at the discretion of the attending physician. Length of stay in hospital and spirometeric values on days 1, 3, 7, 14, and discharge were assessed. The results indicates that there was no difference between the two groups in the mean (SD) length of stay (salbutamol 10-5 (4.7) days, salbutamol + ipratropium bromide 11*8 (4.4) days; 95% CI -1-02 to 3.62). There was no difference in spirometric values on days 1, 3, 7, 14 or discharge between the two groups. The subjective improvement was similar with both treatments. The study show that the routine addition of nebulised ipratropium bromide to salbutamol appears to be of no benefit in the treatment of acute exacerbations of COPD (P Moayyedi et al., 1995).

AIMS AND OBJECTIVES
The present study aims to document the evaluation of clinical use of nebulization therapy and antibiotics in in-patients with chronic obstructive pulmonary disease.
1. To assess the clinical usage of nebulization therapy.
2. To assess the clinical usage of antibiotic therapy.
3. To assess the social history of COPD patients.
4. To assess Changes in Oxygen saturation before and after nebulization.
5. To assess organism causing COPD by Culture sensitivity.

METHODOLOGY

PLAN OF WORK
A study was carried out to evaluate the clinical use of nebulization therapy and antibiotics in in-patients with COPD. All the nebulizers and antibiotics containing prescription were monitored to know the frequency extent of nebulizer and antibiotic use and also the conditions in which it was prescribed. Rationality of prescriptions was evaluated by using the WHO core drug prescribing indicators, that is, (a) average number of drugs per encounter, (b) percentage of  encounters with an antibiotic, (c) percentage of encounters with an injection, (d) percentage of encounters with nebulizer. Literatures which support the study were collected and were reviewed for study on clinical use of nebulizer and antibiotic therapy in Chronic Obstructive Pulmonary Disease. A standard data entry format for collecting patient’s details was designed and during the ward rounds the entire patient data with special reference to the nebulizers and antibiotics prescribe were recorded in the format.

STUDY SITE
In-Patient of Pulmonology Department at  Gleneagles Global Hospitals, Bairamalguda, LB Nagar, Hyderabad.
The study was conducted in the Pulmonology Department, Gleneagles Global Hospitals. It is a 300 bedded multispecialty hospital which has intensive care units with 50 beds, General wards with 80 beds and twin sharing rooms with 96 beds and medical sharing with 74 beds providing its health care services with around 40 physicians, 8 surgeons and around 30 Duty medical officers and 1 clinical pharmacist located in Bairamalguda, LB Nagar, Hyderabad. It has rendered its services in the entire state. It is a massive building with expertise in various fields in hospital services.

STUDY DESIGN
A hospital based prospective observational study was carried out on 102 in-patients in general medicine wards.
The data was collected which contains patients demographics (age, sex), date of admission, date of discharge, history of present illness, past medical history, diagnosis, name of the drugs, dosage regimen (form, dose, route, frequency and duration). The knowledge assessment questionnaire form contains about 21 questions to assess the knowledge of patient towards the medications used.

SAMPLE SIZE
A total of 102 in-patients from the in-patient of Pulmonolgy department in Gleneagles Global Hospital, who were prescribed nebulizers and antibiotics and those who fulfilled the exclusion and inclusion criteria were selected for the study.

STUDY PERIOD
The study was carried out for a period of six months.

STUDY CRITERIA
Inclusion Criteria:
• Patients aged between 30 years to 80 years.
• Patients of either sex with a prescription of mentioned drugs.
• Patients with and without co-morbidities.
• Smoking status.
• Alcoholic status.
Exclusion Criteria:
• Outpatients.
• Pregnant.

STUDY APPROVAL
The study was approved by Ethical Committee of Sree Dattha Institute of Pharmacy. Permission for collection of data and to accompany physician in the Pulmonology Department was taken from the Head of the Pulmonology Department before starting the study. The authors were permitted to utilize the hospital facilities and make a follow up with prescriptions in the department.

SOURCES OF DATA
Patient Profile Form:
• Patient demographic details (age, sex, alcoholic status, smoking status),
• Chief complaints,
• History of present illness,
• Past medical and medication history,
• Family history,
• Final diagnosis,
• Name of the drugs,
• Dosage regimen (form, dose, route, frequency and duration),
• Date on which pharmacotherapy was initiated,
• Laboratory data.

Knowledge Assessment Questionnaire Contains The Following Questions:
• Do you cough?
• Does your cough produce phlegm?
• What kind of mucus is produced?
• What is the colour of the mucus?
• Does your cough disturb your sleep?
• Do you have shortness of breath?
• Do you have shortness of breath when hurrying or walking up a straight hill?
• Are you a smoker?
• Do you smoke now?
• How many cigarettes a day do you smoke?
• When did you quit smoking?
• Do you smoke even though you are sick in bed for most of the time?
• Do you have wheezing?
• If you have wheeze, is it worse in the morning?
• Do you feel shortness of breath when you wheeze?
• Do you have chest problem?
• How would you describe your chest condition?
• Do you consume alcohol?
• When did you Quit Alcohol?
• How frequently do you consume Alcohol?
• Have you ever felt you should stop consuming alcohol?

DETERMINATION OF PRESCRIBING PATTERNS:
A suitable data collection form was designed and used.
Data was collected with respect to:
• Demographic details: name, age, sex,
• Condition and reasons for hospital admission were recorded,
• Drug data: Brand and generic name of the drugs prescribed, dose, route of administration, frequency and their follow up for few days was recorded.

STATISTICAL SOFTWARE:
• SPSS Software.

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