Formoterol and Salmeterol in Partially Reversible Chronic Obstructive Pulmonary Disease: A Crossover, Placebo-Controlled Comparison of Onset and Duration of Action

Çelik, Gülfem; Kayacan, Oya; Beder, Sumru; Durmaz, Gülten

doi:10.1159/000029427

Cited by 67 publications

(44 citation statements)

References 13 publications

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“…In contrast, salbutamol and formoterol elicited a significant increase of IC 5 min after administration, while salmeterol and oxitropium showed a significant IC increase only after 15 and 30 min, respectively. In terms of FEV1, a faster onset of action has been reported for salbutamol and formoterol than salmeterol and oxitropium in COPD patients [30]. In line with previous results [17], these data show that there is a dichotomy in the time course of changes in FEV1 and IC after bronchodilator administration.…”

Section: Discussionsupporting

confidence: 90%

Effect of inhaled bronchodilators on inspiratory capacity and dyspnoea at rest in COPD

Marco¹,

Milic–Emili²,

Boveri³

et al. 2002

Eur Respir J

101

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It has been shown that patients with chronic obstructive pulmonary disease (COPD) develop dynamic hyperinflation (DH), which contributes to dyspnoea and exercise intolerance. Formoterol, salmeterol and oxitropium have been recommended for maintenance therapy in COPD patients, but their effect on DH has only been assessed for salmeterol.The aim of the present study was to compare the acute effect of four inhaled bronchodilators (salbutamol, formoterol, salmeterol and oxitropium) and placebo on forced expiratory volume in one second, inspiratory capacity, forced vital capacity and dyspnoea in COPD patients. A cross-over, randomised, double-blind, placebocontrolled study was carried out on 20 COPD patients.Patients underwent pulmonary function testing and dyspnoea evaluation, in basal condition and 5, 15, 30, 60 and 120 min after bronchodilator or placebo administration.The results indicate that in chronic obstructive pulmonary disease patients with decreased baseline inspiratory capacity, there was a much greater increase of inspiratory capacity after bronchodilator administration, which correlated closely with the improvement of dyspnoea sensation at rest. For all bronchodilators used, inspiratory capacity reversibility should be tested at 30 min following the bronchodilator. On average, formoterol elicited the greatest increase in inspiratory capacity than the other bronchodilators used, though the difference was significant only with salmeterol and oxitropium. The potential advantage of formoterol needs to be tested in a larger patient population. In patients with chronic obstructive pulmonary disease (COPD), bronchodilator reversibility testing is used routinely to exclude a significant asthmatic component. International guidelines recommend that bronchodilator responsiveness be evaluated by the change in forced expiratory volume in one second (FEV1) greater than a cut-off level, calculated in different ways [1,2]. However, in COPD patients, exercise tolerance and dyspnoea are poorly correlated with FEV1 [3][4][5]. Recently, it has been shown that in COPD patients, indices related to dynamic hyperinflation (DH), such as inspiratory capacity (IC), are both reproducible [6] and more closely related to exercise tolerance and dyspnoea than FEV1 and forced vital capacity (FVC) [3,[6][7][8][9][10][11]. PELLEGRINO et al. [11] demonstrated that changes in FEV1 frequently fail to detect significant functional responses to bronchodilators in patients with chronic airflow obstruction. Furthermore, an increase in IC after bronchodilator administration implies a reduction in DH, which is the main cause of reduced exercise capacity and dyspnoea [7][8][9][10][11][12]. Accordingly, an increase in IC should represent the main target for bronchodilator therapy.The effect of bronchodilator administration on IC and other ventilatory variables in COPD patients has been described in several publications [8,10,[13][14][15][16][17][18]. However, bronchodilator-induced changes in IC were correlated with the concurrent chan...

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Section: Discussionsupporting

confidence: 90%

Effect of inhaled bronchodilators on inspiratory capacity and dyspnoea at rest in COPD

Marco¹,

Milic–Emili²,

Boveri³

et al. 2002

Eur Respir J

101

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“…(23,24) In a study involving 20 patients with partially reversible COPD and similar to the present study in design (formoterol and a placebo were compared), a significant response was observed even within 10 or 20 min after formoterol administration. (25) In our study, patients with stable COPD presented a substantial improvement in FEV 1 at 30 min after formoterol administration, indicating that formoterol has an immediate bronchodilator effect. Other studies have indicated that formoterol administraIn a study involving 133 patients with asthma and 116 with COPD, (20) the mean increase in FEV 1 was 307 and 120 mL , respectively, indicating that an increase in FEV 1 of 200 mL is a good cut-off point to differentiate one disease from the other.…”

Section: Discussionsupporting

confidence: 56%

Resposta broncodilatadora imediata ao formoterol em doença pulmonar obstrutiva crônica com pouca reversibilidade

et al. 2008

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Objective: To evaluate, using pulmonary function tests, the effectiveness of formoterol as a bronchodilator at 30 min after its administration in patients with poorly reversible COPD. Methods: A prospective study including 40 COPD patients not responding to the short-acting bronchodilator used in the spirometric test-variation of less than 200 mL and less than 7% of predicted in forced expiratory volume in one second (FEV 1 ). All patients were classified as having stage II, III, or IV COPD (Brazilian Thoracic Society/Global Initiative for Chronic Obstructive Lung Disease) and presented FEV 1 ≤ 70% of predicted value. The patients were randomized into two groups of 20, with similar clinical characteristics, receiving, via a dry powder inhaler, either formoterol or a placebo. The pulmonary function testing (plethysmography) was repeated at 30 min after formoterol or placebo administration. Results: In the formoterol group, the mean values obtained for FEV 1 , inspiratory capacity, and forced vital capacity were significantly greater than those obtained in the placebo group (p = 0.00065, p = 0.05, and p = 0.017, respectively), whereas that obtained for airway resistance was significantly lower (p = 0.010). Less pronounced differences were observed for residual volume, vital capacity and specific airway conductance, which were lower, higher and higher, respectively, in the formoterol group. Conclusions: In COPD patients not responding to the short-acting bronchodilator used in the spirometric test, formoterol promoted significant improvement in lung function at 30 min after of administration. Further studies are required to confirm whether formoterol can also be used as a medication for immediate relief of symptoms in COPD.Keywords: Chronic obstructive pulmonary disease; Respiratory function tests; Bronchodilator agents. ResumoObjetivo: Avaliar, por meio de provas de função pulmonar, a eficácia broncodilatadora do formoterol após 30 min de sua administração em portadores de doença pulmonar obstrutiva crônica (DPOC) com pouca reversibilidade. Métodos: Estudo prospectivo incluindo 40 pacientes portadores de DPOC com resposta negativa ao broncodilatador de curta duração utilizado no teste espirométrico-variação menor que 200 mL e 7% do previsto do volume expiratório forçado no primeiro segundo (VEF 1 ). Os pacientes encontravam-se nos estágios II, III ou IV da DPOC (Sociedade Brasileira de Pneumologia e Tisiologia/Global Initiative for Chronic Obstructive Lung Disease) e apresentavam VEF 1 ≤ 70% do previsto. Foram randomizados em dois grupos de 20, com características clínicas semelhantes, e cada grupo recebeu formoterol ou placebo por meio de inalador de pó seco. As provas de função pulmonar (por pletismografia) foram repetidas após 30 min da administração de formoterol ou placebo. Resultados: Observaram-se aumento significativo de VEF 1 (p = 0,00065), capacidade inspiratória (p = 0,05) e capacidade vital forçada (p = 0,017) e redução significativa da resistência das vias aéreas (p = 0,010) no grupo formotero...

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“…The AE profile was similar in each group, although proportionally more patients reported COPD events in the placebo group than in the active treatment groups (17,13,19 and 26% in the budesonide/formoterol, budesonide, formoterol and placebo groups, respectively). No treatment-related patterns were discernable regarding the incidence or cause of death (table 2).…”

Section: Safetymentioning

confidence: 87%

“…Studies have also shown that formoterol and salmeterol can improve exercise tolerance [9,10] and HRQL [11,12] in patients with COPD compared with other treatments. The unique rapid-and long-acting properties of formoterol, however, give this treatment a faster onset of effect [13], similar to salbutamol [14].Treatment with inhaled corticosteroids has shown clinical benefits in COPD by improving exacerbations, symptoms, lung function and HRQL [15][16][17][18]. SIN and TU [19] observed that elderly patients recently…”

mentioning

confidence: 99%

See 1 more Smart Citation

Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease

Szafrański¹,

Cukier²,

Ramírez³

et al. 2003

Eur Respir J

799

657

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The efficacy and safety of budesonide/formoterol in a single inhaler compared with placebo, budesonide and formoterol were evaluated in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).In a 12-month, randomised, double-blind, placebo-controlled, parallel-group study in 812 adults (mean age 64 yrs, mean forced expiratory volume in one second (FEV1) 36% predicted normal), patients received two inhalations twice daily of either budesonide/ formoterol (Symbicort1) 160/4.5 mg (delivered dose), budesonide 200 mg (metered dose), formoterol 4.5 mg or placebo. Severe exacerbations and FEV1 (primary variables), peak expiratory flow (PEF), COPD symptoms, health-related quality of life (HRQL), mild exacerbations, use of reliever b 2 -agonist and safety variables were recorded.Budesonide/formoterol reduced the mean number of severe exacerbations per patient per year by 24% versus placebo and 23% versus formoterol. FEV1 increased by 15% versus placebo and 9% versus budesonide. Morning PEF improved significantly on day 1 versus placebo and budesonide; after 1 week, morning PEF was improved versus placebo, budesonide and formoterol. Improvements in morning and evening PEF versus comparators were maintained over 12 months. Budesonide/formoterol decreased all symptom scores and use of reliever b 2 -agonists significantly versus placebo and budesonide, and improved HRQL versus placebo. All treatments were well tolerated.These results suggest a role for budesonide/formoterol in the long-term management of moderate-to-severe chronic obstructive pulmonary disease. Chronic obstructive pulmonary disease (COPD) is currently the fourth leading cause of death in the world [1], with increasing prevalence and mortality predicted in the coming decades [2]. COPD is a serious and disabling disease, which imposes a large burden on patients, healthcare systems and society.In patients with COPD, lung function deteriorates progressively over several years with increasing symptoms (e.g. dyspnoea, chest tightness, cough and sputum production); acute exacerbations are common, particularly in later stages, and these have considerable impact on patients9 daily activities and well-being [3]. Cigarette smoking is the major aetiological factor in COPD and smoking cessation is the only factor which has been shown to influence the decline in forced expiratory volume in one second (FEV1) [4,5]. However, the COPD-related inflammatory process in the airways initiated by smoking persists after cessation of smoking [6], and effective treatment is needed in past smokers with COPD [7].The pharmacotherapy of COPD largely consists of mucolytics, bronchodilators, such as b 2 -agonists, anticholinergics, theophylline and anti-inflammatory drugs i.e. inhaled corticosteroids, often taken in combination [2]. Consequently, there is a need for better treatment options to relieve symptoms, reduce exacerbations and to provide better health-related quality of life (HRQL) for individual patients. The long-acting b 2 -agonists formoterol a...

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Formoterol and Salmeterol in Partially Reversible Chronic Obstructive Pulmonary Disease: A Crossover, Placebo-Controlled Comparison of Onset and Duration of Action

Cited by 67 publications

References 13 publications

Effect of inhaled bronchodilators on inspiratory capacity and dyspnoea at rest in COPD

Effect of inhaled bronchodilators on inspiratory capacity and dyspnoea at rest in COPD

Resposta broncodilatadora imediata ao formoterol em doença pulmonar obstrutiva crônica com pouca reversibilidade

Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease

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