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Effect of tiotropium/olodaterol on sedentary and active time in patients with COPD: post hoc analysis of the VESUTO® study.
Minakata, Y, Motegi, T, Ueki, J, Gon, Y, Nakamura, S, Anzai, T, Hirata, K, Ichinose, M
International journal of chronic obstructive pulmonary disease. 2019;:1789-1801
Abstract
BACKGROUND Patients with COPD are less physically active. This post hoc analysis of a randomized, double-blind, active-controlled, crossover trial assessed the efficacy of once-daily tiotropium/olodaterol combination therapy versus tiotropium monotherapy in Japanese patients with COPD. PATIENTS AND METHODS Patients were provided with a three-axis accelerometer to measure sedentary and active behavior defined as 1.0-1.5 metabolic equivalents (METs), ≥2.0 METs, and ≥3.0 METs, respectively. Of the 182 patients enrolled, 131 satisfied the conditions for the present analysis and were randomized to tiotropium monotherapy (n=62) or tiotropium/olodaterol combination therapy (n=69). RESULTS Tiotropium/olodaterol combination therapy significantly reduced the duration of 1.0-1.5 MET activity by 8.64 mins (p=0.040) and significantly increased the duration of ≥2.0 MET and ≥3.0 MET activity by 6.51 mins (p=0.017) and 2.60 mins (p=0.008), respectively, compared with tiotropium alone. Subgroup analyses showed that better lung function, milder dyspnea, and higher levels of physical activity at baseline were associated with reduced sedentary time and increased duration of physical activity. CONCLUSION Tiotropium/olodaterol combination therapy significantly reduced sedentary time and improved physical activity compared with tiotropium monotherapy. This trial was registered in ClinicalTrials.gov (NCT02629965).
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Effect of inhaled MgSO4 on FEV1 and PEF in children with asthma induced by acetylcholine: a randomized controlled clinical trail of 330 cases.
Sun, YX, Gong, CH, Liu, S, Yuan, XP, Yin, LJ, Yan, L, Shi, TT, Dai, JH
Journal of tropical pediatrics. 2014;(2):141-7
Abstract
OBJECTIVES To determine the response of nebulized magnesium sulfate on the lung function of acetylcholine-induced asthma children. METHODS Three hundred and thirty children of asthma with positive bronchial provocation test were randomly divided into three groups: magnesium sulfate, albuterol, and a combination of magnesium sulfate and albuterol. Lung function was compared between the three groups. RESULTS Forced expiratory volume in one second (FEV1) and peak expiratory flow (PEF) as percentage over predicted at 10 min and 20 min in albuterol and combination group were significantly improved when compared to magnesium group. The changes in FEV1 and PEF expressed as absolute and percentage over predicted was not statistically significant from baseline to 20 min in magnesium, albuterol, and combination of magnesium sulfate and albuterol. There was no significant adverse effect observed during the present study. CONCLUSION Nebulized magnesium sulfate alone has a bronchodilatory effect in Ach-induced asthmatic children. The combination of MgSO4 and albuterol did not has a synergistic effect.
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3.
Sodium cromoglycate and eformoterol attenuate sensitivity and reactivity to inhaled mannitol in subjects with bronchiectasis.
Briffa, PJ, Anderson, SD, Burton, DL, Young, IH
Respirology (Carlton, Vic.). 2011;(1):161-6
Abstract
BACKGROUND AND OBJECTIVE Dry powder mannitol has the potential to be used to enhance clearance of mucus in subjects with bronchiectasis. A reduction in FEV1 has been recorded in some subjects with bronchiectasis after inhaling mannitol. The aim of this study was to investigate if pre-medicating with either sodium cromoglycate (SCG) or eformoterol could inhibit this reduction in FEV1. METHODS A double-blind, placebo-controlled, randomized cross-over study was conducted. Lung function and airway response to mannitol was assessed on a control day and then re-assessed after pre-medication with placebo, SCG and eformoterol in nine subjects. Sensitivity to mannitol, expressed as the dose required to induce a 15% fall in FEV1 (PD15), and reactivity to mannitol, expressed as the % fall in FEV1 per mg of mannitol (response-dose ratio, RDR), are reported. RESULTS Subjects had an FEV1 of 68 ± 14% predicted, FVC of 97 ± 15% predicted and FEV1 /FVC of 71 ± 8%. They were mildly hypoxemic and the SpO2 was 95 ± 2%.They had a PD15 to mannitol of 235 mg (95% CI: 150-368 mg) and a RDR of 0.057% fall in FEV1 per mg (95% CI: 0.038-0.085). After pre-medication with SCG, PD15 increased (773 mg, P < 0.05) and RDR was reduced (0.013, P < 0.05). Pre-medication with eformoterol also resulted in an increased PD15 (1141 mg, P < 0.01) and a reduced RDR (0.009, P < 0.01). A small but significant decrease in SpO2 from baseline was noted after mannitol in the presence of SCG (P < 0.05). CONCLUSIONS Pre-medication with either SCG or eformoterol protects patients with bronchiectasis from developing a significant reduction in FEV1 after inhaling mannitol.
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Effect of Lactobacillus GG supplementation on pulmonary exacerbations in patients with cystic fibrosis: a pilot study.
Bruzzese, E, Raia, V, Spagnuolo, MI, Volpicelli, M, De Marco, G, Maiuri, L, Guarino, A
Clinical nutrition (Edinburgh, Scotland). 2007;(3):322-8
Abstract
BACKGROUND & AIMS Probiotics reduce intestinal inflammation in children with cystic fibrosis (CF). We want to determine the effects of Lactobacillus GG (LGG) on pulmonary exacerbations in CF. METHODS A prospective, randomized, placebo-controlled, cross-over study was performed. Nineteen children received LGG for 6 months and then shifted to oral rehydration solution (ORS) for 6 months. In parallel nineteen received ORS and then shifted to LGG. Main outcome parameters were: incidence of pulmonary exacerbations and of hospital admissions, forced expiratory volume (FEV1), and modifications of body weight. RESULTS Patients treated with LGG showed a reduction of pulmonary exacerbations (Median 1 vs. 2 , range 4 vs. 4, median difference 1, CI 95% 0.5-1.5; p=0.0035) and of hospital admissions (Median 0 vs. 1, range 3 vs. 2, median difference 1, CI 95% 1.0-1.5; p=0.001) compared to patients treated with ORS. LGG resulted in a greater increase in FEV1 (3.6% +/- 5.2 vs. 0.9% +/- 5; p=0.02) and body weight (1.5 kg +/- 1.8 vs. 0.7 kg +/- 1.8; p=0.02). CONCLUSIONS LGG reduces pulmonary exacerbations and hospital admissions in patients with CF. These suggest that probiotics may delay respiratory impairment and that a relationship exists between intestinal and pulmonary inflammation.
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Spirometry, rapid FEV1 decline, and lung cancer among asbestos exposed heavy smokers.
Chien, JW, Au, DH, Barnett, MJ, Goodman, GE
COPD. 2007;(4):339-46
Abstract
We assessed whether spirometric measurements are associated with the development of accelerated FEV(1) decline and lung cancer among active and previous smokers with a wide range of lung function. Bivariate and multivariate analyses that adjusted for age, intervention arm, smoking status at enrollment and smoking history, years exposed to asbestos, and evidence of asbestosis were used to assess whether baseline FEV(1) and FEV(1)/FVC ratio were associated with accelerated FEV(1) decline and incident lung cancer. The 3,041 participants enrolled from 1985 to 1994 were followed through April 30, 2005. Baseline FEV(1)/FVC ratio<0.7 was significantly associated with an increased risk for rapid lung function decline (OR=1.73; 95% CI 1.31-2.28; p<0.001). Baseline FEV(1)/FVC ratio<0.7 was also significantly associated with an increased risk of developing lung cancer, even when baseline FEV(1) was >80%. Lung cancer risk among participants with baseline airflow obstruction and FEV(1)<60% was 4-fold higher than participants without baseline airflow obstruction and FEV(1)>80% (p<0.001), even among former smokers. These data indicate an FEV(1)/FVC<0.7 among smokers is significantly associated with faster airflow loss, and an increased risk for developing lung cancer, even among those individuals with a normal FEV(1).
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Improvements in distal lung function correlate with asthma symptoms after treatment with oral montelukast.
Kraft, M, Cairns, CB, Ellison, MC, Pak, J, Irvin, C, Wenzel, S
Chest. 2006;(6):1726-32
Abstract
STUDY OBJECTIVES The distal airways are likely to contribute to asthma pathobiology and symptoms but have rarely been specifically evaluated in relation to systemic oral therapy. We hypothesized that treatment with montelukast, an oral cysteinyl-leukotriene receptor antagonist, would improve both proximal and distal lung physiology in patients with mild asthma. DESIGN Randomized, double-blind, crossover design. SETTING Academic referral center. PATIENTS Subjects with mild asthma limited to using short-acting inhaled beta(2)-agonists. INTERVENTIONS Nineteen subjects with mild asthma underwent a baseline assessment of lung function, lung mechanics, and symptoms, followed by randomization to therapy with montelukast, 10 mg taken in the evening, or placebo in a crossover, double-blind fashion. Each treatment phase lasted 4 weeks, with a 2-week washout period. A repeat evaluation was performed during the last week of each treatment phase. MEASUREMENTS AND RESULTS Montelukast resulted in improvement in (mean +/- SD) proximal and distal lung function parameters (change in FEV(1): montelukast, 0.16 +/- 0.06 L; placebo, -0.05 +/- 0.05 L; p = 0.008); change in specific conductance: montelukast, 7.2 +/- 2.9% predicted; placebo, -17 +/- 8% predicted; p = 0.007; change in % predicted residual volume [RV]: montelukast, 18.4 +/- 8.3% predicted; placebo, 3.0 +/- 2.9% predicted; p = 0.05). Improvement in symptoms (ie, wheeze and chest tightness) correlated with improvements in RV while receiving montelukast, but not while receiving placebo (Pearson coefficients: 0.55 and 0.66, respectively; p < 0.008 and 0.04, respectively). CONCLUSIONS The systemically acting oral agent montelukast improves proximal and distal lung physiology. Improvements in distal lung function correlate with improvements in asthma symptoms.
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Change in forced expiratory volume in 1 second after sham bronchoconstrictor in suggestible but not suggestion-resistant asthmatic subjects: a pilot study.
Leigh, R, MacQueen, G, Tougas, G, Hargreave, FE, Bienenstock, J
Psychosomatic medicine. 2003;(5):791-5
Abstract
OBJECTIVE Randomized controlled trials in asthma often demonstrate a benefit from placebo interventions, although no study has yet characterized this group of placebo responders. Literature points to the importance of suggestion in asthma, and we reasoned that patients' level of suggestibility might influence their likelihood of responding to placebo-like suggestion. METHODS To determine whether suggestion differentially influenced airway tone in preselected suggestible compared with suggestion-resistant asthmatics, we performed a prospective, double-blind, crossover pilot study in which subjects were identified as being suggestible or suggestion-resistant using the Creative Imagination Scale. Responses to inhaled saline were assessed using FEV1 and a modified Borg scale after the suggestion that the saline was a bronchoconstrictor and subsequently a bronchodilator. RESULTS Five of eight suggestible subjects compared with one of nine suggestion-resistant subjects demonstrated a fall in FEV1 greater than 150 ml in response to inhaled saline and suggestion of bronchoconstriction (p =.027). Fourteen subjects experienced dyspnea in response to sham bronchoconstrictor, but none reported increased dyspnea after sham bronchodilator. CONCLUSIONS This is the first time that subjects with asthma have been categorized as suggestible or nonsuggestible with this distinction then used to predict response to an intervention. The results of this pilot study suggest that a subgroup of suggestible asthmatic patients is more likely to respond to a placebo-like sham bronchoconstriction challenge. The data support earlier observations that psychological factors may influence asthma, and provide insights into the placebo response.
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Antibiotic treatment and baseline severity of disease in acute exacerbations of chronic bronchitis: a re-evaluation of previously published data of a placebo-controlled randomized study.
Allegra, L, Blasi, F, de Bernardi, B, Cosentini, R, Tarsia, P
Pulmonary pharmacology & therapeutics. 2001;(2):149-55
Abstract
The study was designed to extend retrospectively the analysis of a previously reported study on chronic bronchitis patients with acute exacerbations treated with amoxicillin-clavulanic acid or matched placebo. We retrospectively re-clustered patients on the basis of severity of baseline lung function: Cluster 1 (104 patients) mean screening FEV(1)32.67+/-6.83 (SD); Cluster 2 (109 patients) mean screening FEV(1)54.12+/-5.56; Cluster 3 (122 patients) mean screening FEV(1)71.54+/-5.51. The success rate in the antibiotic group was significantly greater compared to the placebo group (P<0.001). When clinical improvement was analysed on the basis of patient re-clustering, 31.4% of Cluster 1 (severe COPD) patients treated with amoxicillin/clavulanate showed clinical improvement, whereas success was recorded in 58.8%. Conversely, 13.2% of Cluster 1 patients receiving placebo improved and 17% successfully recovered (P<0.001). Mild and moderate COPD patients (Clusters 2 and 3) were grouped together. In these two groups, 31.2% and 53.6% of patients receiving antibiotic treatment showed improvement or recovery, respectively, compared to 29.2% improvements and 30.2% successful recoveries among placebo-treated patients (P<0.001). In placebo-treated patients the improvement/success vs. failure rate was significantly different in Cluster 1 patients compared to Cluster 2+3 subjects (P<0.01, (2)test). The differences in final FEV(1)values in the treatment group and placebo group were significantly different (P<0.01) in favour of the active treatment group. Among more severe patients (Cluster 1), the comparison between screening and follow up FEV(1)values showed an improvement following antibiotic treatment and worsening after placebo (P<0.01). In Clusters 2 and 3 the difference between screening and follow up FEV(1)values was not significant for both treatment groups. Our patients with severe functional impairment and higher number of exacerbations per year are those who derive the greatest benefit from antibiotic treatment.