scholarly journals Effect of erdosteine on the rate and duration of COPD exacerbations: the RESTORE study

2017 ◽  
Vol 50 (4) ◽  
pp. 1700711 ◽  
Author(s):  
Roberto W. Dal Negro ◽  
Jadwiga A. Wedzicha ◽  
Martin Iversen ◽  
Giovanni Fontana ◽  
Clive Page ◽  
...  
Keyword(s):  
Chronic Obstructive Lung Disease ◽  
Forced Expiratory Volume ◽  
Disease Stage ◽  
Controlled Study ◽  
Chronic Obstructive ◽  
Double Blind ◽  
Exacerbation Rate ◽  
Copd Exacerbations ◽  
Severity Scores ◽  
Significant Difference

Oxidative stress contributes to chronic obstructive pulmonary disease (COPD) exacerbations and antioxidants can decrease exacerbation rates, although we lack data about the effect of such drugs on exacerbation duration.The RESTORE (Reducing Exacerbations and Symptoms by Treatment with ORal Erdosteine in COPD) study was a prospective randomised, double-blind, placebo-controlled study, enrolling patients aged 40–80 years with Global Initiative for Chronic Obstructive Lung Disease stage II/III. Patients received erdosteine 300 mg twice daily or placebo added to usual COPD therapy for 12 months. The primary outcome was the number of acute exacerbations during the study.In the pre-specified intention-to-treat population of 445 patients (74% male; mean age 64.8 years, forced expiratory volume in 1 s 51.8% predicted) erdosteine reduced the exacerbation rate by 19.4% (0.91 versus. 1.13 exacerbations·patient−1·year−1 for erdosteine and placebo, respectively; p=0.01), due to an effect on mild events; the reduction in the rate of mild exacerbations was 57.1% (0.23 versus 0.54 exacerbations·patient−1·year−1 for erdosteine and placebo, respectively; p=0.002). No significant difference was observed in the rate of moderate and severe exacerbations (0.68 versus 0.59 exacerbations·patient−1·year−1 for erdosteine and placebo, respectively; p=0.054) despite a trend in favour of the comparison group. Erdosteine decreased the exacerbation duration irrespective of event severity by 24.6% (9.55 versus 12.63 days for erdosteine and placebo, respectively; p=0.023). Erdosteine significantly improved subject and physician subjective severity scores (p=0.022 and p=0.048, respectively), and reduced the use of reliever medication (p<0.001), but did not affect the St George's Respiratory Questionnaire score or the time to first exacerbation.In patients with COPD, erdosteine can reduce both the rate and duration of exacerbations. The percentage of patients with adverse events was similar in both the placebo and erdosteine treatment groups.

12-month randomised controlled trial of ginseng extract for moderate COPD

Thorax ◽  
2019 ◽  
Vol 74 (6) ◽  
pp. 539-545 ◽  
Author(s):  
Johannah Linda Shergis ◽  
Francis Thien ◽  
Christopher John Worsnop ◽  
Lin Lin ◽  
Anthony L Zhang ◽  
...  
Keyword(s):  
Short Form ◽  
Controlled Trial ◽  
Chronic Obstructive Lung Disease ◽  
Airflow Limitation ◽  
Chronic Obstructive ◽  
Double Blind ◽  
Ginseng Extract ◽  
Exacerbation Rate ◽  
Significant Difference ◽  
Randomised Controlled

BackgroundPanax ginseng (ginseng) is a therapeutic herb which might be beneficial in COPD. The study investigated if ginseng, compared with placebo, is effective and safe for people with moderate COPD.MethodsThis multicentre, randomised, double-blind, placebo-controlled trial compared 24 weeks of ginseng capsules (100 mg twice daily) with placebo. Participants were followed up for a further 24 weeks. Participants were aged 40 years and over and had airflow limitation in the moderate (Global Initiative for Chronic Obstructive Lung Disease 2) COPD range. The coprimary endpoints were the St George’s Respiratory Questionnaire, the COPD Assessment Test and the Short Form Health Survey. Secondary outcomes included lung function, exacerbation rate and use of relief medication.Findings168 participants were randomised 1:1 from five centres in Australia and China. Baseline characteristics were balanced between groups. There were no significant differences between ginseng and placebo, with overall results improving in both groups. Ginseng seemed safe for, and well tolerated by, people with COPD.InterpretationThere was no significant difference in improvement in health-related quality of life (primary outcome) between the ginseng and placebo groups.Trial registration numberACTRN12610000768099.

The Effect of Low Dose Corticosteroids and Theophylline on the Risk of Acute Exacerbations of COPD. The TASCS Randomised Controlled Trial

2020 ◽  
pp. 2003338
Author(s):  
Christine R. Jenkins ◽  
Fu-Qiang Wen ◽  
Allison Martin ◽  
Peter J. Barnes ◽  
Bartolome Celli ◽  
...  
Keyword(s):  
Low Dose ◽  
Controlled Trial ◽  
Oral Prednisone ◽  
Controlled Study ◽  
Chronic Obstructive ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Exacerbation Rate ◽  
Once Daily ◽  
Significant Difference

BackgroundThe highest burden of Chronic Obstructive Pulmonary Disease (COPD) occurs in low and middle income countries. Low cost oral medications, if effective, could enable affordable, accessible COPD treatment.MethodsIn this randomised, 3 arm, double-blind, double dummy, placebo controlled study conducted in 37 centres in China, symptomatic patients with moderate/very severe COPD were randomised 1:1:1 to low dose (LD) theophylline 100 mg bd+prednisone 5 mg once daily; LD theophylline 100 mg bd+placebo once daily; or placebo bd+placebo once daily for 48 weeks. The primary endpoint was annualised exacerbation rate.Findings1670 subjects were randomised, and 1242 completed the study (1142 with acceptable Week 48 data). Subjects (75.7% male) were mean age 64.4 years, with mean (sd) baseline post-bronchodilator Forced Expiratory Volume in 1 s (FEV1) 1.1 (0.4)L, 42.2% predicted and mean (sd) St Georges Respiratory Questionnaire (SGRQ) score 45.8 (20.1). There were negligible differences between annualised exacerbation rates across the three treatments, being 0.89 (95%CI=0.78–1.02) on Prednisone-LD Theophylline; 0.86 (0.75–0.99) on LD Theophylline plus placebo, and 1.00 (0.87–1.14) on double placebo. The Rate Ratio between the first and the pooled comparative arms was 0.96 (0.83–1.12), and for LD Theophylline+placebo versus placebo was 0.866, 95% CI 0.728; 1.029, p=0.101 and for LD Theophylline+Low dose oral Prednisone versus placebo was 0.895, 95% CI 0.755; 1.061, p=0.201. Secondary outcomes of hospitalisations, FEV1, SGRQ and COPD Assessment Test (CAT) score showed no statistically significant difference between treatment arms. Serious adverse events (SAEs) other than exacerbations were <2% and did not differ between the treatment arms.ConclusionsLD theophylline alone or in combination with prednisone did not reduce exacerbation rates or clinically important secondary endpoints compared to placebo.

Can Simvastatin reduce COPD Exacerbations? A Randomised Double Blind Controlled Study

2021 ◽  
pp. 2001798
Author(s):  
Peter Schenk ◽  
Alexander O. Spiel ◽  
Felix Hüttinger ◽  
Micheline Gmeiner ◽  
Josefine Fugger ◽  
...  
Keyword(s):  
Placebo Group ◽  
Lung Function ◽  
Tertiary Care ◽  
Controlled Study ◽  
Rank Test ◽  
Chronic Obstructive ◽  
Single Center ◽  
Double Blind ◽  
Exacerbation Rate ◽  
Simvastatin Group

Several studies have shown that statins have beneficial effects in chronic obstructive pulmonary disease (COPD) regarding lung function decline, rates and severity of exacerbations, hospitalisation and need for mechanical ventilation.We performed a randomised double-blind placebo-controlled single-center trial of simvastatin at a daily dose of 40 mg versus placebo in patients with Global Initiative for COPD criteria II-IV at a tertiary care pulmonology department in Austria. Scheduled treatment duration was 12 months and main outcome parameter was time to first exacerbation.Overall 209 patients were enrolled. In the 105 patients taking simvastatin, time to first exacerbation was significantly longer compared to the 104 patients taking placebo: median 341 versus 140 days, log-rank test p<0.001. Hazard ratio for risk of first exacerbation for the simvastatin group was 0.51 (95% CI 0.34–0.75; p=0.001). Rate of exacerbations was significantly lower with simvastatin: 103 (41%) versus 147 (59%), p=0.003. The annualised exacerbation rate was 1.45 per patient-year in the simvastatin group and 1.9 in the placebo group (IRR 0.77, 95% CI 0.60 to 0.99).We found no effect on quality of life, lung function, 6-minute walk test and high-sensitivity C-reactive protein. More patients dropped out in the simvastatin group compared to the placebo group (39 versus 29).In our single-center RCT, simvastatin at a dose of 40 mg daily significantly prolonged time to first COPD exacerbation and reduced exacerbation rate.

Comparison of Intravenously Administered Doxofylline and Placebo for the Treatment of Severe Acute Airways Obstruction

1988 ◽  
Vol 16 (4) ◽  
pp. 264-269 ◽  
Author(s):  
A. Dolcetti ◽  
D. Osella ◽  
G. De Filippis ◽  
C. Carnuccio ◽  
E. Grossi
Keyword(s):  
Single Dose ◽  
Forced Expiratory Volume ◽  
Controlled Study ◽  
Chronic Obstructive ◽  
Therapeutic Effects ◽  
Double Blind ◽  
Obstructive Airways Disease ◽  
Observation Times ◽  
Chronic Obstructive Airways Disease ◽  
Observation Period

This double-blind, randomized, placebo-controlled study investigated the therapeutic effects of a single dose of doxofylline, a methylxanthine derivative, in 10 patients aged 26–79 years. All patients had acute exacerbation of chronic obstructive airways disease partially reversible with salbutamol inhaler. Doxofylline was administered intravenously at a dose of 200 mg over 15 min on two different occasions separated by at least 24 h. Doxofylline increased forced expiratory volume in the first second of expiration compared with baseline as follows: +20% after 2 h ( P<0.01); +31% after 4 h ( P<0.01); and +13% after 6 h (NS). Changes produced by placebo at these times were −4.4%, −14% and −5% (all NS). The average differences between the groups were significant at all observation times. At the end of the observation period eight out of 10 patients given doxofylline and one out of 10 patients given placebo had improved clinically according to the patients' own opinion. Clinical tolerability of doxofylline proved to be good since no signs of local or general side-effects were observed in any of the patients treated.

scholarly journals INSTEAD: a randomised switch trial of indacaterol versus salmeterol/fluticasone in moderate COPD

2014 ◽  
Vol 44 (6) ◽  
pp. 1548-1556 ◽  
Author(s):  
Andrea Rossi ◽  
Thys van der Molen ◽  
Ricardo del Olmo ◽  
Alberto Papi ◽  
Luis Wehbe ◽  
...  
Keyword(s):  
Forced Expiratory Volume ◽  
Primary Objective ◽  
Chronic Obstructive ◽  
Copd Exacerbation ◽  
Inhaled Corticosteroid ◽  
Double Blind ◽  
Obstructive Pulmonary Disease ◽  
Once Daily ◽  
Copd Exacerbations ◽  
Parallel Group

The Indacaterol: Switching Non-exacerbating Patients with Moderate COPD From Salmeterol/Fluticasone to Indacaterol (INSTEAD) study investigated the effect of switching patients at low risk of chronic obstructive pulmonary disease (COPD) exacerbations from salmeterol/fluticasone (SFC; inhaled corticosteroid (ICS) regimen) to indacaterol monotherapy (non-ICS regimen).This 26-week, double-blind, double-dummy, parallel-group, phase IV study, randomised 581 patients with moderate COPD to indacaterol 150 μg once daily or SFC 50/500 μg twice daily. Patients had been receiving SFC 50/500 μg for ≥3 months, with no COPD exacerbations for more than a year before the study (patients for whom ICS is not recommended). The primary objective was to demonstrate non-inferiority of indacaterol to SFC, measured by trough forced expiratory volume in 1 second (FEV1) after 12 weeks (non-inferiority margin of 0.06 L).The primary objective was met, with a mean treatment difference of 9 mL (95% CI -45–26 mL). There were no significant differences between treatments in terms of breathlessness (transition dyspnoea index) or health status (Saint George’s Respiratory Questionnaire) at weeks 12 or 26, or rescue medication use or COPD exacerbation rates over 26 weeks. Safety profiles of both treatments were as expected.This study demonstrated that patients with moderate COPD and no exacerbations in the previous year can be switched from SFC to indacaterol 150 μg with no efficacy loss.

scholarly journals Efficacy and safety of aclidinium/formoterol versus salmeterol/fluticasone: a phase 3 COPD study

2016 ◽  
Vol 48 (4) ◽  
pp. 1030-1039 ◽  
Author(s):  
Claus Vogelmeier ◽  
Pier Luigi Paggiaro ◽  
Jordi Dorca ◽  
Pawel Sliwinski ◽  
Marcel Mallet ◽  
...  
Keyword(s):  
Adverse Events ◽  
Symptom Control ◽  
Forced Expiratory Volume ◽  
Controlled Study ◽  
Chronic Obstructive ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Obstructive Pulmonary Disease ◽  
St George's Respiratory Questionnaire ◽  
Exacerbation Risk

The efficacy and safety of twice-daily aclidinium bromide/formoterol fumarate was compared with that of salmeterol/fluticasone propionate in patients with stable, moderate-to-severe chronic obstructive pulmonary disease (COPD).AFFIRM COPD (Aclidinium and Formoterol Findings in Respiratory Medicine COPD) was a 24-week, double-blind, double-dummy, active-controlled study. Patients were randomised (1:1) to aclidinium/formoterol 400/12 µg twice-daily via Genuair/Pressair or salmeterol/fluticasone 50/500 µg twice-daily via Accuhaler. The primary end-point was peak forced expiratory volume in 1 s (FEV1) at week 24. Other end-points included Transition Dyspnoea Index (TDI) focal score at week 24, TDI and St George's Respiratory Questionnaire (SGRQ) responders, COPD Assessment Test and SGRQ scores, assessment of COPD symptoms and exacerbations, use of reliever medication, and device preference. Adverse events were monitored throughout.In total, 933 patients were eligible (mean age 63.4 years, 65.1% male). Aclidinium/formoterol was superior to salmeterol/fluticasone in peak FEV1 and noninferior in TDI. Health status and reduction in exacerbation risk were similar in both groups. While both treatments were well tolerated, pneumonia occurred less frequently with aclidinium/formoterol than salmeterol/fluticasone.In stable COPD, aclidinium/formoterol significantly improved bronchodilation versus salmeterol/fluticasone, with equivalent benefits in symptom control and reduction in exacerbation risk. Both treatments were well tolerated and treatment-related adverse events were less common with aclidinium/formoterol.

scholarly journals Prevalence and risk factors for COPD in farmers: a cross-sectional controlled study

2015 ◽  
Vol 47 (1) ◽  
pp. 95-103 ◽  
Author(s):  
Alicia Guillien ◽  
Marc Puyraveau ◽  
Thibaud Soumagne ◽  
Stéphanie Guillot ◽  
Fabrice Rannou ◽  
...  
Keyword(s):  
Smoking Status ◽  
Chronic Obstructive Lung Disease ◽  
Cross Sectional Study ◽  
Forced Expiratory Volume ◽  
Controlled Study ◽  
Chronic Obstructive ◽  
Tobacco Exposure ◽  
Cross Sectional ◽  
Obstructive Pulmonary Disease ◽  
Cattle Breeders

There are conflicting data regarding the magnitude and determinants of chronic obstructive pulmonary disease (COPD) risk in farmers.In a cross-sectional study of 917 nonfarming working controls and 3787 farmers aged 40–75 years, we assessed respiratory symptoms, tobacco exposure, job history (without direct exposure measurement) and lung function. COPD was defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criterion (post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) <0.70) and by the Quanjer reference equation (post-bronchodilator FEV1/FVC <lower limit of normal (LLN)).The prevalence (95% CI) of COPD according to the GOLD criterion was 5.1% (4.4–5.8%) and 2.9% (1.8–4.0%) in farmers and controls, respectively (p=0.005), and 3.1% (2.5–3.6%) and 1.5% (0.7–2.3%), respectively, for the LLN criterion (p<0.01). For both COPD criteria after adjustment for age, sex and smoking status, COPD prevalence was similar in controls and crop farmers. Compared to controls, four job categories had a higher prevalence of COPD according to the GOLD criterion, namely, cattle breeders, swine breeders, poultry breeders and breeders of two or more livestock types. Among cattle breeders, only those from Franche-Comté had higher prevalence of COPD according to both GOLD and LLN criteria.The prevalence of COPD in farmers is higher than in nonfarming working controls, and depends on the farming activity, the region and the criterion used to define COPD.

scholarly journals Spirometric Values of Greek People and Comparison with ECSC and GLI Values in COPD People

2018 ◽  
Vol 12 (1) ◽  
pp. 29-38
Author(s):  
Nikolaos Tatsis ◽  
Sotirios Kakavas ◽  
Evgenios Metaxas ◽  
Evangelos Balis ◽  
George Tatsis ◽  
...  
Keyword(s):  
Chronic Obstructive Lung Disease ◽  
Forced Expiratory Volume ◽  
Greek Population ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Copd Patients ◽  
Significant Difference ◽  
Global Initiative ◽  
Predicted Values

Background: During the past few years, the use of criteria introduced by Global Initiative for Chronic Obstructive Lung Disease (GOLD) is recommended for the diagnosis and classification of Chronic Obstructive Pulmonary Disease(COPD),taking into account the values of a Forced Expiratory Volume In 1 second (FEV1) and a Forced Expiratory Volume In 1 second (FEV1) to Forced Vital Capacity (FVC) ratio. In Europe, the reference values of the European Coal and Steel Community (ECSC), that were originally developed in 1993 are still used. Aim of the Study: The study aimed to carry out measurement of spirometric values in a healthy, non smoking Greek population, development of local equations and comparison with ECSC and Global Lung Initiative(GLI) equations, in order to see if there is a need for separate ones in everyday use. Methods: Normal predicted values for FEV1 and FEV1/FVC% were obtained from a group of 500 healthy subjects, aged 18-89 years. In addition, a group of 124 COPD patients, with no other comorbidities was studied. Patients were classified according to GOLD criteria in four groups with ECSC, GLI predicted values or with our own predicted values. Results: The statistical analysis has revealed that there is no significant difference among the three sets of predicted values and no statistical difference was detected among the classification of COPD patients. Conclusion: It is shown that the 3 sets of predicted values are almost identical, despite the fact that they have been collected from different study populations.Αccording to the study, there is no need in recalculating values for Greek population.

scholarly journals Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD

2021 ◽  
Vol 31 (1) ◽  
Author(s):  
Sandeep Bansal ◽  
Martin Anderson ◽  
Antonio Anzueto ◽  
Nicola Brown ◽  
Chris Compton ◽  
...  
Keyword(s):  
Health Status ◽  
Triple Therapy ◽  
Treatment Guidelines ◽  
Forced Expiratory Volume ◽  
Chronic Obstructive ◽  
Fluticasone Furoate ◽  
Double Blind ◽  
Once Daily ◽  
Copd Patients ◽  
Severe Copd

AbstractChronic obstructive pulmonary disease (COPD) treatment guidelines do not currently include recommendations for escalation directly from monotherapy to triple therapy. This 12-week, double-blind, double-dummy study randomized 800 symptomatic moderate-to-very-severe COPD patients receiving tiotropium (TIO) for ≥3 months to once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 mcg via ELLIPTA (n = 400) or TIO 18 mcg via HandiHaler (n = 400) plus matched placebo. Study endpoints included change from baseline in trough forced expiratory volume in 1 s (FEV1) at Days 85 (primary), 28 and 84 (secondary), health status (St George’s Respiratory Questionnaire [SGRQ] and COPD Assessment Test [CAT]) and safety. FF/UMEC/VI significantly improved trough FEV1 at all timepoints (Day 85 treatment difference [95% CI] 95 mL [62–128]; P < 0.001), and significantly improved SGRQ and CAT versus TIO. Treatment safety profiles were similar. Once-daily single-inhaler FF/UMEC/VI significantly improved lung function and health status versus once-daily TIO in symptomatic moderate-to-very-severe COPD patients, with a similar safety profile.

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