scholarly journals Triple therapy for COPD: a crude analysis from a systematic review of the evidence

2019 ◽  
Vol 13 ◽  
pp. 175346661988552 ◽  
Author(s):  
Jose Luis Lopez-Campos ◽  
Laura Carrasco-Hernandez ◽  
Esther Quintana-Gallego ◽  
Carmen Calero-Acuña ◽  
Eduardo Márquez-Martín ◽  
...  
Keyword(s):  
Triple Therapy ◽  
Current Knowledge ◽  
Study Groups ◽  
Forced Expiratory Volume ◽  
Fixed Dose ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
St George's Respiratory Questionnaire ◽  
Supplementary Material ◽  
Crude Analysis

We systematically reviewed the current knowledge on fixed-dose triple therapies for the treatment of chronic obstructive pulmonary disease (COPD), with a specific focus on its efficacy versus single bronchodilation, double fixed dose combinations, and open triple therapies. Articles were retrieved from PubMed, Embase, and Scopus up to 3 August 2018. We selected articles with randomized controlled or crossover design conducted in patients with COPD and published as full-length articles or scientific letters, evaluating triple therapy combinations in a single or different inhaler, and with efficacy data versus monocomponents, double combinations, or open triple therapies. Our systematic search reported 108 articles, of which 24 trials were finally selected for the analysis. A total of 7 studies with fixed dose triple therapy combinations, and 17 studies with open triple therapies combinations. Triple therapy showed improvements in lung function [trough forced expiratory volume (FEV1) ranging from not significant (NS) to 147 ml], health status using the St. George’s Respiratory Questionnaire [(SGRQ) from NS to 8.8 points], and exacerbations [risk ratio (RR) from NS to 0.59 for all exacerbations] versus single or double therapies with a variability in the response, depending the specific combination, and the comparison group. The proportion of adverse effects was similar between study groups, the exception being the increase in pneumonia for some inhaled corticosteroid (ICS) containing groups. The reviews of this paper are available via the supplementary material section.

scholarly journals Tiotropium and olodaterol fixed-dose combinationversusmono-components in COPD (GOLD 2–4)

2015 ◽  
Vol 45 (4) ◽  
pp. 969-979 ◽  
Author(s):  
Roland Buhl ◽  
François Maltais ◽  
Roger Abrahams ◽  
Leif Bjermer ◽  
Eric Derom ◽  
...  
Keyword(s):  
Area Under The Curve ◽  
Forced Expiratory Volume ◽  
Phase Iii ◽  
Fixed Dose ◽  
Chronic Obstructive ◽  
Double Blind ◽  
Obstructive Pulmonary Disease ◽  
Once Daily ◽  
Multicentre Phase ◽  
St George's Respiratory Questionnaire

Efficacy and safety of tiotropium+olodaterol fixed-dose combination (FDC) compared with the mono-components was evaluated in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) in two replicate, randomised, double-blind, parallel-group, multicentre, phase III trials.Patients received tiotropium+olodaterol FDC 2.5/5 μg or 5/5 μg, tiotropium 2.5 μg or 5 μg, or olodaterol 5 μg delivered once-dailyviaRespimat inhaler over 52 weeks. Primary end points were forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h (AUC0–3) response, trough FEV1 response and St George's Respiratory Questionnaire (SGRQ) total score at 24 weeks.In total, 5162 patients (2624 in Study 1237.5 and 2538 in Study 1237.6) received treatment. Both FDCs significantly improved FEV1 AUC0–3 and trough FEV1 responseversusthe mono-components in both studies. Statistically significant improvements in SGRQ total scoreversusthe mono-components were only seen for tiotropium+olodaterol FDC 5/5 μg. Incidence of adverse events was comparable between the FDCs and the mono-components.These studies demonstrated significant improvements in lung function and health-related quality of life with once-daily tiotropium+olodaterol FDCversusmono-components over 1 year in patients with moderate to very severe COPD.

scholarly journals Validation of Clinical Characteristics and Effectiveness of Pulmonary Rehabilitation in a COPD Population with Discrepancy between Exercise Tolerance and FEV1

Healthcare ◽  
2021 ◽  
Vol 9 (1) ◽  
pp. 53
Author(s):  
Jun Horie ◽  
Koichiro Takahashi ◽  
Shuuichi Shiranita ◽  
Kunihiko Anami ◽  
Shinichiro Hayashi
Keyword(s):  
Gait Speed ◽  
Pulmonary Rehabilitation ◽  
Exercise Tolerance ◽  
Respiratory Illness ◽  
Forced Expiratory Volume ◽  
Walking Distance ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
St George's Respiratory Questionnaire ◽  
History Of

This study’s objective was to examine the characteristics of patients with chronic obstructive pulmonary disease (COPD) presenting with various exercise tolerance levels. A total of 235 patients with stable COPD were classified into 4 groups: (1) LoFlo + HiEx—patients with a six-minute walking distance (6MWD) ≥350 m and percentage of predicted forced expiratory volume in 1 s (%FEV1.0) <50%; (2) HiFlo + HiEx—patients with a 6MWD ≥350 m and a %FEV1.0 ≥50%; (3) LoFlo + LoEx—patients with a 6MWD < 350 m and %FEV1.0 < 50%; and (4) HiFlo + LoEx—patients with a 6MWD <350 m and %FEV1.0 ≥ 50%. Aspects of physical ability in the HiFlo + LoEx group were significantly lower than those in the HiFlo + HiEx group. The HiFlo + LoEx group was characterized by a history of hospitalization for respiratory illness within the past year, treatment with at-home oxygen therapy, and lacking daily exercise habits. Following three months of pulmonary rehabilitation, the LoFlo + HiEx group significantly improved in the modified Medical Research Council dyspnea score, maximum gait speed, and 6MWD, while the HiFlo + LoEx group significantly improved in the percentage of maximal expiratory pressure, maximum gait speed, 6MWD, incremental shuttle walking distance, and St. George’s Respiratory Questionnaire score. The HiFlo + LoEx group had the greatest effect of three-month pulmonary rehabilitation compared to other groups.

scholarly journals Efficacy and safety of single-inhaler triple therapy of glycopyrronium, formoterol, and fluticasone in patients with chronic obstructive pulmonary disease: a double-blind, randomised controlled trial

2021 ◽  
pp. 00255-2021
Author(s):  
Sundeep Salvi ◽  
Akash Balki ◽  
Srikanth Krishnamurthy ◽  
Sagar Panchal ◽  
Saiprasad Patil ◽  
...  
Keyword(s):  
Triple Therapy ◽  
Controlled Trial ◽  
Dual Therapy ◽  
Fixed Dose ◽  
Comparable Efficacy ◽  
Chronic Obstructive ◽  
Double Blind ◽  
Obstructive Pulmonary Disease ◽  
Copd Patients ◽  
The Difference

BackgroundInvestigating the safety and efficacy of single-inhaler triple therapy with glycopyrronium (GB) 12.5 μg/formoterol fumarate (FF) 12 μg/fluticasone propionate (FP) 250 μg, compared to GB 50 μg co-administered with a fixed dose of FF 12 μg/FP 250 μg in subjects with COPD.MethodsA phase 3, randomised, double-blind, active-control, parallel-group, noninferiority study conducted at 20 sites across India. COPD patients aged ≥40 to ≤75 years, with FEV1/FVC <0.70, using mono/dual therapy with ICS, LAMA, or LABA for ≥1 month, were included. Subjects were randomised 1:1 to GB/FF/FP or GB+FF/FP for 12 weeks. Primary efficacy endpoint was the change from baseline in trough FEV1 at the end of 12 weeks. The study is registered with the Clinical Trials Registry of India (CTRI Reg No: CTRI/2019/01/017156).ResultsBetween March 23, 2019 and February 14, 2020, 396 subjects were enrolled, 198 patients each in the fixed-triple (GB/FF/FP) and open-triple (GB+FF/FP) groups. The difference in LSM changes in predose FEV1 from baseline at 12 weeks was noninferior between the groups (p<0.05). The LSM change from baseline in postdose FEV1 was comparable (p=0.38). Superiority test showed comparable efficacy (p =0.12) for the difference in mean change from baseline in trough FEV1 between the groups. Adverse events (mild or moderate) were recorded in 25.3% and 24.9% of subjects in the GB/FF/FP and GB+FF/FP groups.ConclusionsFixed triple therapy with GB/FF/FP provides comparable bronchodilation and lung function improvement like open triple therapy. It is safe and well-tolerated in symptomatic COPD patients with a history of exacerbations.

scholarly journals The minimal important difference for the St George's Respiratory Questionnaire in patients with severe COPD

2015 ◽  
Vol 46 (6) ◽  
pp. 1598-1604 ◽  
Author(s):  
Jorrit B.A. Welling ◽  
Jorine E. Hartman ◽  
Nick H.T. Ten Hacken ◽  
Karin Klooster ◽  
Dirk-Jan Slebos
Keyword(s):  
Clinical Trials ◽  
Minimal Important Difference ◽  
Forced Expiratory Volume ◽  
Sample Size Determination ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Copd Patients ◽  
St George's Respiratory Questionnaire ◽  
Severe Copd

The St George's Respiratory Questionnaire (SGRQ) is a validated, commonly used questionnaire for measuring quality of life in patients with chronic obstructive pulmonary disease (COPD). The current established minimal important difference (MID) for SGRQ scores in an average COPD population is −4 units. However, for patients with severe COPD, the MID has not been thoroughly validated. We re-determined the SGRQ MID for this patient group.115 severe COPD patients (forced expiratory volume in 1 s (FEV1) 26±9% of predicted, SGRQ score 62±11 units; mean±sd,) who participated in seven different bronchoscopic lung volume reduction clinical trials were included in the analysis. Anchor- and distribution-based methods were used to define the MID for SGRQ scores. FEV1, 6-min walk distance and residual volume were used as anchors.Combining both anchor- and distribution-based methods, we identified a SGRQ MID of −8.3 units at 1 month and −7.1 units at 6 months.This study proposes an alternative SGRQ MID for patients with severe COPD of −8.3 units at 1 month and −7.1 units at 6 months follow-up after intervention. Our new MID estimates could be applied for both interpreting SGRQ outcomes as well as sample size determination in future clinical trials investigating interventions in severe COPD patients.

scholarly journals Efficacy and cardiovascular safety of LAMA in patients with COPD: a systematic review and meta-analysis

2021 ◽  
pp. jim-2021-001931
Author(s):  
Chuchu Zhang ◽  
Meng Zhang ◽  
Yalei Wang ◽  
Huaiyu Xiong ◽  
Qiangru Huang ◽  
...  
Keyword(s):  
Weighted Mean Difference ◽  
Meta Analysis ◽  
Forced Expiratory Volume ◽  
Cochrane Library ◽  
Chronic Obstructive ◽  
Cardiovascular Safety ◽  
Obstructive Pulmonary Disease ◽  
Significant Difference ◽  
St George's Respiratory Questionnaire ◽  
Long Acting

Chronic obstructive pulmonary disease (COPD) is at present the third leading cause of death in the world. Long-acting muscarinic antagonist (LAMA) is widely used as a bronchodilator in patients with COPD. However, there is controversy concerning their cardiovascular safety. This meta-analysis aims to assess the efficacy and cardiovascular safety of LAMAs versus placebo in patients with COPD. We searched Pub Med, Embase, Cochrane Library, and Web of Science to identify studies that compared LAMA with placebo in patients with COPD. Twenty-one studies involving 24,987 participants were finally included in the analysis. There was no significant difference in the incidence of all adverse events (risk ratio (RR)=1.01, 95% CI 1.00 to 1.02, I2=15.2%) and cardiovascular events (RR=0.98, 95% CI 0.88 to 1.09, I2=4.9%) in patients treated with LAMAs versus placebo. LAMAs significantly improved trough forced expiratory volume in 1 s (weighted mean difference (WMD)=0.12, 95% CI 0.10 to 0.14, I2=86.6%), Transitional Dyspnea Index (WMD=0.75, 95% CI 0.56 to 0.94, I2=0%), and St. George’s Respiratory Questionnaire (WMD=‒2.50, 95% CI ‒3.32 to ‒1.69, I2=39.8%). Moreover, LAMAs significantly reduced the incidence of exacerbation in patients with COPD (RR=0.85, 95% CI 0.79 to 0.91, I2=69.9%). LAMAs are safe therapy and play a pivotal role in improving lung function, dyspnea, and health status, and reducing the exacerbation in patients with COPD.

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 Identification of Clinical Phenotypes Using Cluster Analyses in COPD Patients with Multiple Comorbidities

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Pierre-Régis Burgel ◽  
Jean-Louis Paillasseur ◽  
Nicolas Roche
Keyword(s):  
Current Knowledge ◽  
Clinical Manifestations ◽  
Forced Expiratory Volume ◽  
Airflow Limitation ◽  
Chronic Obstructive ◽  
Special Focus ◽  
Obstructive Pulmonary Disease ◽  
Future Studies ◽  
Cluster Analyses ◽  
Copd Patients

Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation, the severity of which is assessed using forced expiratory volume in 1 sec (FEV1, % predicted). Cohort studies have confirmed that COPD patients with similar levels of airflow limitation showed marked heterogeneity in clinical manifestations and outcomes. Chronic coexisting diseases, also called comorbidities, are highly prevalent in COPD patients and likely contribute to this heterogeneity. In recent years, investigators have used innovative statistical methods (e.g., cluster analyses) to examine the hypothesis that subgroups of COPD patients sharing clinically relevant characteristics (phenotypes) can be identified. The objectives of the present paper are to review recent studies that have used cluster analyses for defining phenotypes in observational cohorts of COPD patients. Strengths and weaknesses of these statistical approaches are briefly described. Description of the phenotypes that were reasonably reproducible across studies and received prospective validation in at least one study is provided, with a special focus on differences in age and comorbidities (including cardiovascular diseases). Finally, gaps in current knowledge are described, leading to proposals for future studies.

Screening of High-risk Patients for Chronic Obstructive Pulmonary Disease in Primary Care: A Narrative Review (Preprint)

2020 ◽  
Author(s):  
Ponrathi Athilingam ◽  
Andrew Bugajski ◽  
Usha Menon
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Lung Function ◽  
Pulmonary Disease ◽  
Current Knowledge ◽  
Screening Tools ◽  
Chronic Obstructive ◽  
Early Screening ◽  
Obstructive Pulmonary Disease ◽  
Impaired Lung Function ◽  
Risk Patients

UNSTRUCTURED Chronic obstructive pulmonary disease (COPD) predominantly affects older adults, and claimed 3 million lives in 2016, making it the third leading cause of death worldwide. Over 35 million Americans aged 40 or older have lung function consistent with diagnosable COPD. COPD and cardiovascular disease (CVD) have a bidirectional relationship, in that one is a risk factor for developing the other. National and international consortiums recommend early screening of adults at risk of COPD, such as those with CVD. Recommended screening strategies include screening tools to assess symptoms, medical history, and handheld spirometry. Handheld spirometry has high diagnostic accuracy and if impaired lung function is indicated, these patients are referred for pulmonary function testing (PFT), the diagnostic gold standard for COPD. However, there is no clinical consensus for pulmonary screening in people with CVD. Current knowledge relating to the prevalence and incidence of CVD in people with COPD and the mechanisms that underlie their coexistence is key in combating the global burden of COPD.

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