ABSTRACT
Background: Asthma is a chronic inflammatory condition of lung airways resulting in episodic airflow obstruction causing considerable morbidity in paediatric population. The main objective of the study was to find out whether addition of long acting beta agonists to steroids provides better asthma control.Methods: This randomized controlled trial study was performed in children aged 6-15 years of age, with clinically stable and moderate persistent asthma.Results: The findings of this study indicate SABA use in Budesonide/formoterol group patients was significantly less compared to budesonide group patients (1.5±1.1 v/s 2.13±0.9, p-value 0.01). Both groups experienced decrease in night time symptoms and acute exacerbations however there was no significant difference between the two groups in these variables.Conclusions: This study showed addition of LABA to inhaled steroids in moderate persistent asthma provided better asthma control and LABA is mainly recommended to be used as add-on therapy for patients whose asthma is not controlled on low to high doses of inhaled corticosteroids.
ABSTRACT
Background:Asthma is a chronic inflammatory condition of lung airways resulting in episodic airflow obstruction. Aims: The main objective of this study is tofind the effect of antiasthma medication on serum IgE levels and blood eosinophil count.Study Design:Thisrandomizedcontrolled trial studywas performed in children aged 6-15 years of age, with clinically stable and moderate persistent asthma.Results:The findings of this study indicate both group(Budesonide/formoterol group and budesonide group) patients experienced a significant decrease in serum IgE levels and blood eosinophil counts over the study period.However, the difference in two groups was not statistically significant.Conclusions:Inhaled steroids are effective in controlling systemic inflammation in asthma as evidenced by a decrease in IgE levels and eosinophil counts. However addition of LABA doesn’t have any additive effect.
ABSTRACT
Background: As per GOLD (Global initiative for chronic obstructive lung disease) guidelines bronchodilators are required for symptomatic treatment of chronic obstructive pulmonary disease (COPD) patients. Currently there is no evidence to say about the safety of fixed dose combinations used in COPD patients. Since the drugs are to be taken for longer period, it is essential to know the safety aspects of these drugs. Moreover we don’t have adequate studies and documentation to say that a particular drug combination is better and safer for COPD patients.Methods: Prospective, open labelled, randomized, comparative, interventional clinical study conducted by the Departments of Pharmacology and Pulmonary Medicine of Basaveshwara Medical College and Hospital, Chitradurga in 40 COPD patients.Results: The fixed dose combinations of drugs used in both the treatment groups i.e. salmeterol/fluticasone and tiotropium/formoterol were equally safer and well tolerated. Some side effects noticed during the course of treatment were statistically significant when compared between the 2 groups, however they were milder and predictable adverse drug reactions.Conclusions: Systemic and severe adverse drug reactions were not observed during 8 week treatment period and the local side effects observed were mild in both the treatment groups. Hence the fixed dose combinations of salmeterol or fluticasone and tiotropium or formoterol are found to be safer for maintenance therapy in COPD patients.
ABSTRACT
Background: Bronchodilators are essential for symptomatic management of all stages of chronic obstructive pulmonary disease (COPD). For patients whose COPD is not sufficiently controlled by monotherapy, combining a ß2-agonist with either inhaled steroid or anticholinergic drug is a convenient way of delivering treatment. Currently, there is no documentation to say that one drug is superior to other or the contrary, but a combination of two drugs is more effective than giving single drug alone in patients suffering from COPD.Methods: The study was prospective, open labelled, randomized, comparative interventional clinical study conducted by the Departments of Pharmacology and Medicine, Basaveshwara Medical College and Hospital, Chitradurga in 60 moderates to severe COPD patients.Results: Both the treatments i.e. Salmeterol/Fluticasone and Tiotropium/Formoterol were equally effective as far as the improvement of the lung functions and Borg dyspnoea score are concerned. The difference in improvement with the combination of Salmeterol/Fluticasone was not statistically significant (p>0.05) compared to the combination of Tiotropium/Formoterol. However, Salmeterol/Fluticasone was found to be better than Tiotropium/Formoterol in improving the lung function of moderate to severe COPD patients.Conclusions: Salmeterol/Fluticasone is efficacious and better than Tiotropium /Formoterol combination for maintenance therapy in moderate to severe COPD patients.
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Background: Fixed-dose combinations of Inhaled corticosteroids (ICS) and Long acting beta agonist (LABA) are established and widely used treatment for bronchial asthma when ICSs as monotherapy are ineffective. This study attempted to compare the efficacy of salmeterol and fluticasone with formoterol (newer LABA) and fluticasone in patients of bronchial asthma.Methods: An open label, randomized, prospective, parallel and comparative study of eight-week duration was conducted on 80 patients of bronchial asthma, with the collaboration of Department of pharmacology and Department of Tuberculosis and Chest Diseases Hospital, Government medical college, Amritsar. Patients in Group A were treated with 2 actuations of Formoterol and Fluticasone (6/125µg) twice daily and group B patients were treated with 2 actuations of Salmeterol and Fluticasone (50/125µg) twice daily for 8 weeks with metered dose inhaler (MDI). Patients in group A and B were assessed on day zero, 4 weeks and 8 weeks for clinical assessment and computerized spirometry for FVC, FEV1, FEV1/FVC and PEFR.Results: In group A mean±SD of FEV1 statistically significantly increased (<0.001) after eight week of therapy (1.50±0.12) from its baseline values (1.34±0.11). Similarly, in group B mean ± SD of FEV1 statistically significantly increased (<0.001) after eight weeks (1.48±0.13) from its baseline values (1.36±0.12). There was statistically significant (<0.001) improvement in other parameters of spirometry in patients of both the groups.Conclusions: It was observed that both the combination of Fluticasone + Formoterol and Fluticasone + Salmeterol are effective in the treatment of bronchial asthma.
ABSTRACT
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.
ABSTRACT
Los broncodilatadores beta 2 agonistas (B2A), forman parte muy importante en la farmacoterapia del asma bronquial, enfermedad que avanza en el mundo, de manera epidémica. Los B2A, son prescritos a millones de personas en el mundo, por consiguiente; los aspectos de seguridad son de interés público. Los broncodilatadores B2A de acción corta (Short-Acting B2 Agonists o SABA) como salbutamol inhalatorio, según las evidencias actuales, confirman su seguridad, en su uso como fármaco de rescate o a demanda. Los broncodilatadores B2A de acción prolongada (Long-Acting B2 Agonists o LABA), se utilizan asociados a corticoides inhalatorios, como medicamentos controladores de exacerbaciones de accesos asmáticos, por razones de seguridad los LABAs se usan asociados a corticoides inhalatorios...
Beta 2 agonist bronchodilators (B2A) are very important part in the pharmaco therapy of bronchial asthma, a disease that progresses in the world in an epidemic way. The B2A are prescribed to millions of people around the world, there fore the safety aspects is of public interest. Short-Acting B2 Agonists (SABAs), such as albuterol inhaler, according to current evidence, have confirmed their safety when used as a quick-relief or rescue medication. The long-acting B2 agonists (LABAs) are used associated with inhaled corticosteroids as controller drugs for asthma exacerbations, for safety reasons LABAs are used associated with inhaled corticoid...
Subject(s)
Humans , Asthma/therapy , Bronchodilator Agents/therapeutic useABSTRACT
A recent meta-analysis of clinical trials found that long-acting beta2-agonists (LABA) increased life-threatening asthma exacerbations and deaths, which led to warnings concerning regular use of LABA by U.S. Food and Drug Administration (FDA). It is now obvious that LABA monotherapy in asthma increases the risk of serious adverse events. However, the risk is reduced with concomitant use of inhaled corticosteroid (ICS). Hence the FDA's recommendations that LABA should not be used in patients whose asthma is well controlled with a medium dose of ICS, or LABA should be withdrawn once asthma control is achieved, remain still controversial. It seems reasonable to follow current guidelines which recommend the use of LABA when asthma is not controlled with ICS, although more well-designed research on the safety of LABA, especially when combined with ICS, is required.
Subject(s)
Humans , Asthma , United States Food and Drug AdministrationABSTRACT
Asthma is characterized by chronic inflammation of the airways with variable airflow limitation resulting in recurrent wheezing, chest tightness, and cough. Long term management is essential to prevent symptom and asthma exacerbation with using daily controller medications. Asthma control was much improved by combining inhaled corticosteroids with long-acting beta2 agonists. Recent several studies demonstrated the effectiveness of a new asthma management strategy, a single inhaler containing budesonide and formoterol for both maintenance therapy and symptom relief (called SMART) which was approved in GINA guideline, 2006. This SMART strategy could reduce the frequency of severe exacerbations and the need for rescue medicine with systemic steroids as well as improved lung function and asthma controls at relatively lower doses of corticosteroid with lesser costs for treatment.