Improvement In Forced Expiratory Volume Research Articles

Onset of effect of budesonide and formoterol administered via one pressurized metered-dose inhaler in patients with asthma previously treated with inhaled corticosteroids

Onset of bronchodilation of budesonide/formoterol in one pressurized metered-dose inhaler (pMDI) has not been evaluated in asthma. To evaluate time to onset of clinically significant bronchodilation (> or = 15% improvement in forced expiratory volume in 1 second) and patient-perceived onset of effect (OE) in patients previously receiving inhaled corticosteroids. In two 12-week studies, patients 12 years and older with moderate to severe (study 1; n = 596) and mild to moderate (study 2; n = 480) persistent asthma received budesonide/formoterol pMDI, budesonide pMDI plus formoterol dry powder inhaler (study 1 only), budesonide pMDI, formoterol dry powder inhaler, or placebo. Postdose time to 15% or greater improvement in forced expiratory volume in 1 second and patient-perceived OE (assessed in a subset of patients 18 years and older [study 1, n=553; study 2, n=405]) were evaluated [corrected] More budesonide/formoterol-treated patients achieved onset of clinically significant bronchodilation within 15 minutes (median, 13 minutes) of administration at randomization vs those taking budesonide or placebo (P < .001). More patients receiving budesonide/formoterol vs budesonide and placebo reported feeling their study medication begin to work right away (P < or = .004; end of week 1). Similar results (P < .001) were observed for patient satisfaction with how quickly they felt their medication begin to work (except budesonide/formoterol vs budesonide, study 1 [P = .073]). Time to onset of clinically significant bronchodilation and patient-perceived OE of budesonide/formoterol and formoterol were similar. Budesonide/formoterol demonstrated a more rapid onset of clinically significant bronchodilation and a greater percentage of patients who perceived their medication working right away vs budesonide or placebo.

Long-term safety and asthma control with budesonide/ formoterol versus budesonide pressurized metered-dose inhaler in asthma patients

Safety concerns have been raised regarding the regular use of long-acting beta(2)-adrenergic agonists (LABAs) alone or with inhaled corticosteroids (ICSs). The purpose of this study was to examine the long-term safety of budesonide/formoterol pressurized metered-dose inhaler (pMDI). This 52-week, double-blind study (SD-039-0728; n=708) included patients >or=12 years of age with moderate to severe persistent asthma previously receiving ICSs. After 2 weeks on budesonide pMDI 320 microg twice daily (b.i.d.), patients were randomized 3:1:1 overall to budesonide/formoterol pMDI 640/18 microg b.i.d., budesonide/formoterol pMDI 320/9 microg b.i.d., or budesonide pMDI 640 microg b.i.d. The incidence of adverse events (AEs) was similar across the groups. Drug-related AEs (>or=2% overall) were oral candidiasis, tremor, and pharyngolaryngeal pain. No clinically meaningful differences in laboratory, electrocardiogram, or Holter monitor variables were observed. The percentage of patients with >or=1 asthma exacerbation was significantly lower (p=0.006) with budesonide/formoterol 640/18 (12.2%) and numerically lower with budesonide/formoterol 320/9 (14.4%) versus budesonide (21.8%). The number of asthma exacerbations per patient-treatment year was lower with budesonide/formoterol 640/18 (0.174; p=0.004) and budesonide/formoterol 320/9 (0.185; p=0.049) versus budesonide (0.315). Improvements in forced expiratory volume in 1 second and diary variables were significantly greater (p<0.001) with both budesonide/formoterol doses versus budesonide. Budesonide/formoterol 640/18 and 320/9 microg b.i.d. showed an acceptable safety profile relative to budesonide, with no significant or unexpected patterns of abnormalities observed by adding a LABA to budesonide for up to 1 year in this patient population. Improvements in asthma control were shown with both doses of budesonide/formoterol versus budesonide.

Bronchodilator response in residual volume in irreversible airway obstruction.

Although airway obstruction, as defined by improvement of forced expiratory volume in one second (FEV1) and/or forced vital capacity (FVC), is irreversible in patients with COPD, they clearly seem to benefit from treatment with inhaled bronchodilators. To assess the response pattern of residual volume (RV) compared to FEV1 after bronchodilation in patients with reversible and irreversible airway obstruction. Changes in static lung volumes were compared with improvement in dynamic lung volumes in 396 consecutive patients undergoing reversibility testing with repeat bodyplethysmography. Reversibility was defined as improvement of FEV1 >200 ml and >12% after inhalation of fenoterol hydrobromide. Irreversibility was found in 297 out of 396 patients with airway obstruction. Except for total lung capacity (TLC), all parameters (residual volume [RV], vital capacity [VC], forced inspiratory vital capacity [IVC], forced vital capacity [FVC], forced expiratory volume in one second [FEV1] and the FEV1/VC ratio) showed statistically significant changes after bronchodilation in 396 patients. The multiple linear regression model adjusted for age, sex and BMI showed a non-linear relationship between DeltaFEV1 or DeltaVC compared to DeltaRV after bronchodilation. If the increase in DeltaFEV1 is lower than 0.1 L, DeltaRV remains constant. However, if the increase in DeltaFEV1 is more than 0.1 L, DeltaRV decreases too. The same is found at an increase in VC of 0.3 L. In summary, in patients with irreversible airway obstruction DeltaRV cannot be predicted by DeltaFEV1 or DeltaVC after bronchodilation. Therefore, spirometric assessment should be complemented by bodyplethysmography.

Bronchodilator response in residual volume in irreversible airway obstruction.

Although airway obstruction, as defined by improvement of forced expiratory volume in one second (FEV1) and/or forced vital capacity (FVC), is irreversible in patients with COPD, they clearly seem to benefit from treatment with inhaled bronchodilators. To assess the response pattern of residual volume (RV) compared to FEV1 after bronchodilation in patients with reversible and irreversible airway obstruction. Changes in static lung volumes were compared with improvement in dynamic lung volumes in 396 consecutive patients undergoing reversibility testing with repeat bodyplethysmography. Reversibility was defined as improvement of FEV1 >200 ml and >12% after inhalation of fenoterol hydrobromide. Irreversibility was found in 297 out of 396 patients with airway obstruction. Except for total lung capacity (TLC), all parameters (residual volume [RV], vital capacity [VC], forced inspiratory vital capacity [IVC], forced vital capacity [FVC], forced expiratory volume in one second [FEV1] and the FEV1/VC ratio) showed statistically significant changes after bronchodilation in 396 patients. The multiple linear regression model adjusted for age, sex and BMI showed a non-linear relationship between DeltaFEV1 or DeltaVC compared to DeltaRV after bronchodilation. If the increase in DeltaFEV1 is lower than 0.1 L, DeltaRV remains constant. However, if the increase in DeltaFEV1 is more than 0.1 L, DeltaRV decreases too. The same is found at an increase in VC of 0.3 L. In summary, in patients with irreversible airway obstruction DeltaRV cannot be predicted by DeltaFEV1 or DeltaVC after bronchodilation. Therefore, spirometric assessment should be complemented by bodyplethysmography.

Indikationen und Limitationen einer fixen Kombinationstherapie mit inhalativen Kortikosteroiden und langwirksamen β2-Mimetika bei der chronisch-obstruktiven Lungenerkrankung (COPD)

Inhaled corticosteroids (ICS) used in COPD (chronic obstructive pulmonary disease) are recommended only in combination with a long-acting beta2-agonist (LABA) in stage 3 and higher in COPD treatment guidelines. In comparison to placebo and the single components, a superior control by means of the ICS/LABA fixed combination therapy has been demonstrated for clinical improvement in the following parameters: reduction of exacerbation rate and hospitalisations, reduction of dyspnoea and improvement of forced expiratory volume in one second (FEV1). In contrast to data from database studies, the large prospective TORCH (Towards a Revolution in COPD Health) trial found in the ICS/LABA group a beneficial effect on the reduction of mortality only as a trend in the ICS/LABA group, which did not reach statistical significance. In long-term trials, ICS treated patients experienced up to 10% oral and/or pharyngeal candidiasis. ICS was associated with an excess risk of pneumonia, which doubles the pneumonia incidence in patients not receiving ICS. The probability of having pneumonia reported as an adverse event was 18-19 % in the ICS groups and resulted in a 1.7-2.2 elevated pneumonia risk. Because ICS therapy is recommended only in conjunction with a bronchodilator, fixed ICS/LABA combinations are a logical consequence for COPD long-term therapy.

Native lung volume reduction surgery relieves functional graft compression after single-lung transplantation for chronic obstructive pulmonary disease

Single-lung transplantation is an accepted treatment for end-stage lung disease caused by chronic obstructive pulmonary disease. A complication unique to single-lung transplantation for chronic obstructive pulmonary disease is graft dysfunction due to compression caused by native lung hyperinflation. We hypothesized that patients with functional compromise from native lung hyperinflation would benefit from native lung volume reduction surgery. The charts of all patients undergoing single-lung transplantation for chronic obstructive pulmonary disease were reviewed for lung volume reduction surgery of their native lung. Data regarding length of stay, surgical morbidity and mortality, overall survival, type of lung volume reduction surgery, and pulmonary function were recorded to evaluate the effect of lung volume reduction surgery. Between February 1992 and May 2007, 206 single-lung transplantations were performed for chronic obstructive pulmonary disease. Ten (5%) patients had clinically significant graft compression from native lung hyperinflation. After excluding other causes for functional decline, these patients underwent a modified lung volume reduction surgery between 12 and 142 months after single-lung transplantation (mean, 50 months). Lung volume reduction surgery consisted of anatomic resection. Two (20%) of 10 patients died during their hospitalization. Of the remaining 8 patients, 7 (87.5%) have demonstrated functional improvement on the basis of forced expiratory volume in 1 second improving from 12% to 200% (mean improvement, 57%). Within 6 months of lung volume reduction surgery, mean 6-minute walk values improved significantly (866 to 1055 feet), whereas desaturation with exertion decreased significantly. Lung volume reduction surgery by means of formal lobectomy in patients with native lung hyperinflation undergoing single-lung transplantation and significant graft compression appears feasible. Additionally, improvements in forced expiratory volume in 1 second can be accomplished in nearly all properly selected patients. Lung volume reduction surgery should be considered in patients with decreasing graft function caused by graft compression from native lung hyperinflation.

Early Bronchodilatory Effects of Budesonide/Formoterol pMDI Compared with Fluticasone/Salmeterol DPI and Albuterol pMDI: 2 Randomized Controlled Trials in Adults with Persistent Asthma Previously Treated with Inhaled Corticosteroids

Two identically designed, randomized, multicenter, single-dose, crossover studies were conducted in patients aged ≥18 years with mild to moderate asthma previously treated with inhaled corticosteroids. After 2 weeks on twice-daily budesonide pressurized metered-dose inhaler (pMDI) 160 μ g, patients received a randomized sequence of budesonide/formoterol pMDI 80/4.5 μ g × 2 inhalations (160/9 μ g), fluticasone/salmeterol dry powder inhaler (DPI) 250/50 μ g × 1 inhalation, albuterol pMDI 90 μ g × 2 inhalations (180 μ g), and placebo pMDI (3-to 14-day washout periods). Improvements in forced expiratory volume in 1 second (FEV1) at 3 minutes were significantly (p < 0.001) greater after treatment with budesonide/formoterol pMDI compared with fluticasone/salmeterol DPI and similar to that of albuterol pMDI. In addition, significantly (p < 0.001) more patients treated with budesonide/formoterol pMDI achieved a 15% improvement in FEV1 within 15 minutes compared with patients treated with fluticasone/salmeterol DPI and placebo. Thus, the early bronchodilatory effects of budesonide/formoterol pMDI were greater than with fluticasone/salmeterol DPI.

Evaluation of in vitro in vivo correlations for dry powder inhaler delivery using artificial neural networks

The aim of these experiments was to investigate the use of artificial neural networks (ANNs) for generating models able to predict the relative lung bioavailability and clinical effect of salbutamol when delivered to healthy volunteers and asthmatic patients from dry powder inhalers (DPIs). ANN software was used to model in vitro, demographic and in vivo data from human subjects for four different DPI formulations containing salbutamol sulfate. In 12 volunteers, a model linking the in vitro aerodynamic characteristics of the emitted dose and volunteer body surface area with the urinary excretion of drug and its metabolite in the 24 h period after inhalation was established. In 11 mild asthmatics, a predictive model correlating in vitro data, baseline lung function, body surface area and age with post-treatment improvements in forced expiratory volume in 1 s (FEV 1) was also generated. Models validated using unseen data from individual subjects receiving the different DPI formulations were shown to give predictions of in vivo performance. The squared correlation coefficients ( R 2) for plots comparing predicted and observed in vivo outcomes were 0.83 and 0.84 for urinary excretion and lung function data, respectively. It can therefore be concluded that ANN models have the potential to predict the in vivo performance of DPIs in individual subjects.

Effectiveness of erdosteine in elderly patients with bronchiectasis and hypersecretion: A 15-day, prospective, parallel, open-label, pilot study

Mucus plugging and hypersecretion have been associated with an increased relative risk of death in patients with bronchiectasis who may or may not have chronic obstructive pulmonary disease (COPD), which is of prognostic relevance in the elderly. However, chest physiotherapy and/or the use of mucoactive agents is considered to be an effective therapeutic model in treating patients with COPD and bronchiectasis. The objective of this study was to test the effectiveness of oral erdosteine in treating elderly patients with bronchiectasis and chronic mucus hypersecretion who have been referred to a pulmonary rehabilitation program. In this 15-day, prospective, parallel, open label, pilot study, elderly patients with bronchiectasis, hypersecretion, a noncurrent smoking status, who had been consecutively enrolled at Ospedale Villa Pineta's Pulmonary Rehabilitation Center, Pavullo-Modena, Italy, were randomized into 2 treatment groups. Group 1 consisted of those patients receiving PO erdosteine 225 mg BID and chest physiotherapy; group 2 comprised those patients receiving chest physiotherapy alone. Forced lung volumes, arterial blood gases, respiratory muscle strength, walking capacity (as measured by 6-minute walking test [6MWT]), and visual analog scale (VAS) symptoms (cough and dyspnea) were recorded at enrollment and at the conclusion of the study. Mucus density (MD), mucus purulence (MP), and mucus volume produced (MVP) were assessed using a 3-point scale (0 = best or low; 1 = moderate; and 2 = worst or high) at baseline and at 5-day time points during the study period. All measurements were assessed by personnel blinded and not directly associated with the study administration. Thirty patients (21 [70%] male and 9 [30%] female; mean [SD] age, 71 [11] years; and mean [SD] weight, 66 [3] kg) were enrolled. Characteristics were similar in the 2 groups at baseline. At day 15, significant improvements were observed in 6MWT, VAS cough, and VAS dyspnea (P < 0.01) in both groups. However, a significant improvement in forced expiratory volume in 1 second and forced vital capacity (in milliliters) was observed only in group i (0.2 [0.3]; P < 0.05). At day 15, improvement was observed in mean (SD) in MD, MP, and MVP scores for both groups. Significant changes, however, were observed in all 3 measurements in group 1 (-0.80 [0.22], -0.71 [0.51], and 1.01 [0.39], respectively), whereas a significant improvement was observed only in MD (-0.55 [0.44]) and MVP (0.45 [0.62]) in group 2. The improvement in MVP observed in group 1 was significantly better than that observed in group 2 (P < 0.05). This pilot study found that a regimen of PO erdosteine 225 mg BID in addition to routine chest physiotherapy provided some physiologic and clinical benefits in the treatment of these elderly patients with bronchiectasis and chronic mucus hyper-secretion.

Responsiveness to montelukast is associated with bronchial hyperresponsiveness and total immunoglobulin E but not polymorphisms in the leukotriene C4 synthase and cysteinyl leukotriene receptor 1 genes in Korean children with exercise‐induced asthma (EIA)

As previous studies have shown that cysteinyl leukotrienes are important mediators in exercise-induced bronchoconstriction (EIB), and leukotriene receptor antagonists (LTRAs) such as montelukast have been shown to improve post-exercise bronchoconstrictor responses, we herein investigated whether clinical responsiveness to montelukast was associated with polymorphisms in the genes encoding leukotriene C4 synthase (LTC4S) and cysteinyl leukotriene receptor 1 (CysLTR1) and/or clinical parameters in Korean asthmatic children with EIB. The study population consisted of 100 asthmatic children with EIB. The individuals studied were given exercise challenge tests before and after receiving montelukast (5 mg/day) for 8 weeks. Responders were defined as children showing>10% post-treatment improvement in forced expiratory volume in 1 s (FEV1). The LTC4S A(-444)C and CysLTR1 T(+927)C polymorphisms were genotyped by PCR-restriction fragment length polymorphism analysis. Of 100 enrolled children, 68 were classified as responders and 32 were classified as non-responders. No significant association was observed between montelukast responsiveness and LTC4S or CysLTR1 genotype, either alone or in combination. In contrast, montelukast-induced improvement in FEV(1) after exercise was correlated with higher pre-treatment PC20 (methacholine) values (r=0.210, P=0.036) and lower total IgE levels (r=-0.216, P=0.031). The LTC4S A(-444)C and CysLTR1 T(+927)C genotypes do not appear to be useful for predicting clinical responsiveness to montelukast, whereas bronchial hyperresponsiveness and total IgE appear to predict the degree of montelukast responsiveness in Korean asthmatic children with EIB.

Breathing-enhanced upper extremity exercises for patients with multiple sclerosis

Objective: To explore the effectiveness of breathing-enhanced upper extremity exercises on the respiratory function of patients with multiple sclerosis. Design: Randomized controlled study of six-week duration. Subjects: Forty patients with multiple sclerosis (age 39.2 ± 7 years; Kurtzke Expanded Disability Status Scale scores: 4.51 ± 1.55) randomly divided into two groups. Methods: The training group followed a six-week home training programme designed to strengthen accessory respiratory muscles. Controls performed no exercises. All subjects submitted to baseline and post-training tests of spirometry, respiratory muscle strength and 6-minute walking. They were also assessed with pulmonary dysfunction and exertion fatigue indices. Results: Spirometry revealed clear improvement in forced expiratory volume in 1 second (FEV 1) (+13%, P = 0.003) resulting in higher FEV1/FVC (forced vital capacity) (+8.5%, P = 0.03). Maximal inspiratory pressure (P Imax) increased by +7.1% but not significantly. Maximal expiratory pressure (P Emax) and FVC were significantly higher (by +7.1%, P = 0.0066 and +4.8%, P = 0.036 respectively) with respect to baseline measures. Pulmonary dysfunction was reduced (—9%, P = 0.002) while 6-minute walking distance was longer (+16%, P = 0.029) at equal exertion fatigue level. Conclusions: The programme improved most pulmonary performance measures and had clinical significance. Its sustained application may prevent respiratory complications frequently observed in the later stages of multiple sclerosis.

Acupuncture Therapy Results in Immediate Bronchodilating Effect in Asthma Patients

According to previous data on asthma in the English literature, there are some results that show encouraging effects of acupuncture improving pulmonary function in asthma patients. We designed a prospective randomized crossover controlled study to determine the efficacy of acupuncture in asthma patients. Eighteen asthma patients with bronchodilator response >20% improvement of forced expiratory volume in 1 second (FEV1) were initially randomly assigned to receive 1 performance of real acupuncture (RA) or sham acupuncture (SA) in a blinded manner. After a washout period, the patients were crossed over. Spirometry was done and recorded before and after acupuncture. Sixteen of 18 patients completed the study. The mean (+/-SD) FEV1 values before and after RA were 1.52 +/- 0.45L and 1.67 +/- 0.40L, respectively (p < 0.001). The mean (+/-SD) FEV1 values before and after SA were 1.49 +/- 0.40L and 1.49 +/- 0.41L, respectively (p = 0.838, not significant). The percentage change in FEV1 values after RA was better than after SA (RA, 11.57 +/- 8.11%; SA, 0.32 +/- 7.76%; p = 0.003), while the bronchodilator response of FEV1 from simple inhalation bronchodilator was better than that for RA (p < 0.001). In asthma patients, acupuncture treatment may result in immediate improvement of FEV1, but the degree of improvement is less than that from inhalation bronchodilator.

Long-Term Follow-Up of Ultraflex Metallic Stents in Benign and Malignant Central Airway Obstruction

We report experience with Ultraflex metallic stents (Boston Scientific, Natick, MA) inserted at rigid bronchoscopy under general anesthesia for palliation of benign and malignant upper airway obstruction. Notes of all patients treated with Ultraflex stents from 1999 to 2003 were reviewed for symptomatic response, spirometric data, and any complications before discharge home. Long-term outcome was assessed by questionnaires sent to patients' general practitioners. Recruited were 66 patients (12 benign, 54 malignant airway obstructions). Before discharge home, breathlessness improved in 11 of 12 patients with benign obstruction and in 39 of 54 with malignancies. Postoperative complications in 10 patients with malignant obstructions and in 2 patients with benign obstruction were successfully controlled. It was not possible to perform preoperative pulmonary function tests in most of the patients who presented as emergencies. Mean improvement in forced expiratory volume in 1 second was 0.88 liters in 3 patients with benign obstruction and 0.28 liters in 14 patients with malignant obstruction, and mean peak expiratory flow rate improved by 109 L/min and 97 L/min, respectively. General practitioners completed questionnaires for 12 benign patients and 46 of 54 patients with malignancies. At a mean follow-up of 1017 days (range, 46 to 1120 days), 10 of the 12 patients with benign disease were alive and 7 of 46 patients with malignant airway obstruction were alive, with a median survival of 128 days (mean, 361; range, 3 to 1859 days). Most survivors had Medical Research Council grade III breathlessness or better, with few stent-related symptoms. Ultraflex stents proved safe and effective in prolonged palliation of benign and malignant airways obstruction.

Recovery of Pulmonary Function Following Endoscopic Anterior Scoliosis Correction: Evaluation at 3, 6, 12, and 24 Months After Surgery

A series of patients with scoliosis undergoing endoscopic anterior instrumentation and fusion undertaking repeated pulmonary function assessments. To assess recovery of pulmonary function in the 2 years following endoscopic anterior scoliosis correction. Recent studies have found that pulmonary function returns to preoperative levels 12-24 months following endoscopic anterior scoliosis correction, and a small improvement in forced expiratory volume (FEV1) has also been reported. A series of 44 patients with endoscopic anterior scoliosis correction had pulmonary function tests before surgery, and at 3, 6, 12, and 24 months after surgery. Forced vital capacity (FVC), FEV1, and total lung capacity (TLC) were measured. Nonparametric statistical analysis was used to investigate changes in pulmonary function between successive assessments. Pulmonary function decreased by approximately 10% at 3 months after surgery. At 24 months after surgery, FVC and FEV1 recovered to 5% to 8% higher than preoperative levels, while TLC returned to preoperative levels. Statistically significant improvements in most pulmonary function values occurred between 3 and 6, and 6-12 months. Improvements in mean FVC, FEV1, and TLC continue between 12 and 24 months, although only the increase in absolute FVC for this time is statistically significant. Endoscopic anterior scoliosis surgery has no lasting negative effect on pulmonary function, and with prolonged follow-up, pulmonary capacity improves beyond preoperative levels.

Characterization of Within-Subject Responses to Fluticasone and Montelukast in Childhood Asthma

Purpose of the Study. Asthmatic individuals vary in their responses to inhaled corticosteroids (ICSs) and leukotriene antagonists (LTRAs). The authors of this study sought to determine if responses are concordant for both types of drugs and sought markers for responses. Study Population. Children (aged 6–17 years) with mild-to-moderate asthma. They had asthma symptoms or bronchodilator use on average at least 3 days/week over the preceding 4 weeks and improvement in forced expiratory volume in 1 second (FEV1) of ≥12% after maximal bronchodilation or methacholine PC20 (provocative concentration causing a 20% decrease in FEV1) of ≤12.5 mg/mL. Children with severe asthma were excluded, as were those with recent use of corticosteroid or LTRA. Methods. After a 5- to 10-day characterization phase, participants were randomly assigned to 1 of 2 crossover treatment sequences with 8-week periods of either active ICS (fluticasone 100 μg twice daily) or an age-appropriate dose of montelukast. During the active-treatment period for one drug, the participant received a placebo for the alternative drug. Baseline-only characterization included various asthma biomarkers. The primary outcome measure was percentage change in prebronchodilator FEV1 from baseline to the end of the treatment period. “Response” was defined as improvement in FEV1 of at least 7.5%. Results. Fifty-five percent of the 126 participants showed no response to either drug, whereas 23% responded to fluticasone alone, 17% responded to both, and 5% responded to montelukast alone. Compared with those who responded to neither drug, those who responded to fluticasone alone had higher exhaled nitric oxide, serum immunoglobulin E, serum eosinophilic cationic protein, and total eosinophil count, along with lower methacholine PC20 and lower pulmonary function. Favorable response to montelukast alone was associated with younger age and shorter disease duration. Greater differential response to fluticasone over montelukast was associated with higher bronchodilator use and response, along with higher exhaled nitric oxide and serum eosinophilic cationic protein levels and lower methacholine PC20 and pulmonary function. Conclusions. Responses to fluticasone and montelukast vary. Children with low pulmonary function or high levels of biomarkers should start with ICSs. In children with less severe disease, it would be reasonable to start with either ICSs or LTRAs. Asthma therapy might soon move from the current approach, which is based on mean responses in populations, to one predicated on a given person’s asthma phenotype and genotype. Reviewer Comments. The vast majority of asthmatic patients in a primary care practice can maintain excellent control with one or the other of the above-mentioned drugs as simple monotherapy. History is paramount in assessing asthma severity, especially because the above-described biomarkers are largely unavailable to the pediatrician. It is tantalizing to consider a time when we will be able to more accurately target successful treatment in advance.

Mars and Venus in the GP's office

Discussions about the differences between men and women are age-old, but usually of great interest to both sexes and, despite our increasing understanding of gender psychology, likely to be prone to bias and misconstruction for centuries to come. The mix of gender differences in the pathogenesis, perception and presentation of disease is a potent brew for confusion, but needs further research if we are to completely understand the variety of ways in which nature and nurture interact in the development and manifestations of obstructive lung disease. For some time, it has been known that men and women perceive and relate their symptoms differently 1. For many diseases, it is also becoming clear that males and females develop different symptoms and clinical manifestations, at different stages of a disease, and respond differently to treatment 2, 3. Traditionally, women have been considered to be more likely to report symptoms and to be more sensitive to changes in underlying disease 4, 5. In relation to the presenting features of chronic obstructive pulmonary disease (COPD) in males and females, two papers published in the present issue of the European Respiratory Journal have some important contributions to make. In the first of these papers, Watson et al. 6 investigated predictors for the presence, development and remission of COPD symptoms in participants completing 3 yrs of the European Respiratory Society Study on Chronic Obstructive Pulmonary Disease (EUROSCOP). Over these 3 yrs similar proportions of males and females reported symptoms, although in males better lung function was associated with a reduction in new symptoms of wheeze and dyspnoea, and symptom prevalence reduced with annual improvement of forced expiratory volume in one second (FEV1). The prevalence of phlegm was reduced with budesonide treatment, an effect seen only in males. An increase in …

Plant-Based Formulation for Bronchial Asthma: A Controlled Clinical Trial to Compare Its Efficacy with Oral Salbutamol and Theophylline

Background: Plant-based medicine is the 3rd most popular choice of both adults (11%) and children (6%) suffering from Asthma. While several plant-based formulations have been reported for the treatment of asthma in the past, many authors have published their reservations on clinical trials carried out using complementary and alternative medicines. Objectives: The authors desired to eliminate the shortcomings of the earlier clinical trials carried out by many investigators in a structured study. Therefore, a 12-week randomized double-blind placebo-controlled clinical study was conducted to investigate the efficacy of a plant-based formulation (DCBT4567-Astha-15) in comparison with oral salbutamol, salbutamol + theophylline and a matching placebo in patients with reversible asthma. Methods: Ninety-four patients between 15 and 50 years of age, showing 15% improvement in forced expiratory volume in 1 s (FEV₁) 15 min after a bronchial challenge of inhaled salbutamol (200 µg) were recruited, and the end point of the study was determined as a 15% improvement in FEV₁ and clinical symptoms like dyspnoea, wheezing, cough, expectoration, disability, sleep disturbances and respiration rate. Results: DCBT4567-Astha-15, salbutamol and salbutamol + theophylline patients showed statistically significant improvement in FEV₁, while placebo patients did not show any improvement. Fifty percent of DCBT4567-Astha-15, 48% of salbutamol, 58% of salbutamol + theophylline and 26% of placebo patients showed the desired 15% improvement in FEV₁. Improved mean FEV₁ values at the end of the trial indicated that the salbutamol - theophylline combination was superior followed by salbutamol and DCBT4567-Astha-15. Clinical symptoms like dyspnoea, wheezing, cough, expectoration, disability, and sleep disturbances were significantly reduced in DCBT4567-Astha-15 patients compared to patients of the other three arms. Conclusions: DCBT4567-Astha-15 was as efficacious as salbutamol (12 mg/day) or salbutamol (12 mg/day) in combination with theophylline (200 mg/day) in the treatment of reversible asthmatics. Quality of life of patients also improved with DCBT4567-Astha-15 drug treatment.

The American Thoracic Society’s Spirometric Criteria Alone is Inadequate in Asthma Diagnosis

The diagnosis of asthma is based on clinical symptoms, physical examination and pulmonary function tests, and can be very challenging. Most patients with asthma have a significant postbronchodilator response on spirometry indicating airway hyperresponsiveness. However, having a significant bronchodilator response by itself is not diagnostic of asthma. The definition of a 'significant' response has also been controversial. Many respirologists use the American Thoracic Society (ATS) postbronchodilator response criteria of 12% (provided it is 200 mL or greater) improvement in forced expiratory volume in 1 s (or forced vital capacity) from the baseline spirometry. In the present study, 644 patients who met the ATS criteria for a significant postbronchodilator spirometric response were retrospectively reviewed. The staff respirologist's diagnosis of asthma, based on all clinical and pulmonary function data, was used as the standard for the diagnosis of asthma. Relying on spirometric criteria alone was inadequate in asthma diagnosis because only 54.7% of 310 patients who met the ATS bronchodilator response criteria were thought to have clinical asthma. Increasing the postbronchodilator percentage improvement from the ATS criteria only marginally improved diagnostic specificity and resulted in a decline in sensitivity. The results of the present study further emphasize the need to use spirometric criteria as a guide but not as an unimpeachable gold standard with which to make a diagnosis of asthma. The diagnosis of asthma depends on expert physician correlation of patient history, physical examination and pulmonary function test results.

Initial corticosteroid therapy for asthma

This review examines the commencement of maintenance pharmacotherapy for asthma: inhaled corticosteroids alone or in combination with long-acting beta2 agonists. A systematic review of randomized controlled trials has examined the starting dose of inhaled corticosteroids (high, moderate, low) and the dose regimen (step down versus constant) in asthma. There was no significant difference in key asthma outcomes for step down compared with a constant inhaled corticosteroid dose. There was no significant difference between high or moderate dose inhaled corticosteroid groups (n=11) for morning peak expiratory flow, symptoms and rescue medication use. There may be a benefit from high-dose inhaled corticosteroids for airway hyperresponsiveness. There was a significant improvement in peak expiratory flow and nocturnal symptoms in favour of a moderate inhaled corticosteroid dose compared with low-dose treatment. Long-acting beta2 agonists combined with inhaled corticosteroids as initial asthma therapy has been examined in a systematic review of nine randomized controlled trials. Inhaled corticosteroids combined with long-acting beta2 agonists led to significant improvements in forced expiratory volume in 1 s, morning peak expiratory flow, symptom score and symptom-free days but no difference in exacerbations requiring oral corticosteroids. A randomized controlled trial of patients with uncontrolled asthma found a benefit of escalating doses of salmeterol/fluticasone compared with fluticasone on asthma control. Initial inhaled corticosteroid therapy should begin with a constant, moderate dose. Initial therapy with long-acting beta2 agonist and inhaled corticosteroids achieves superior improvement in symptoms and lung function, and at a quicker rate than inhaled corticosteroids alone. There is no benefit in terms of reduced exacerbations unless an escalating inhaled corticosteroid dose strategy is used.

Acupuncture Resulting in Immediate Bronchodilating Response in Asthma Patients

There are some encouraging results in the English literature that show acupuncture resulting in an immediate improvement in pulmonary function, but there are also studies that have not demonstrated any benefit. We present 3 patients with persistent asthma who experienced immediate bronchodilatation after acupuncture without the use of any short-acting bronchodilator. After needle stimulation on selected acupoints, clinical symptoms such as dyspnea and wheezing improved. Pulmonary function test showed immediate improvement in forced expiratory volume in 1 second (FEV1), more than 20% as compared with baseline FEV1. Pulmonary function returned to baseline within 4 hours after acupuncture in 2 patients. From our observations of these 3 asthma patients, acupuncture may improve clinical dyspnea symptoms and performance on pulmonary function tests. Further large-scale controlled studies should be conducted to determine the effectiveness of acupuncture in the treatment of asthma.