scholarly journals Dual bronchodilation with tiotropium/olodaterol further reduces activity-related breathlessness versus tiotropium alone in COPD

2019 ◽  
Vol 53 (3) ◽  
pp. 1802049 ◽  
Author(s):  
François Maltais ◽  
Joseph-Leon Aumann ◽  
Anne-Marie Kirsten ◽  
Éric Nadreau ◽  
Hemani Macesic ◽  
...  

The 3-min constant speed shuttle test (CSST) was used to examine the effect of tiotropium/olodaterol compared with tiotropium at reducing activity-related breathlessness in patients with chronic obstructive pulmonary disease (COPD).This was a randomised, double-blind, two-period crossover study including COPD patients with moderate to severe pulmonary impairment, lung hyperinflation at rest and a Mahler Baseline Dyspnoea Index <8. Patients received 6 weeks of tiotropium/olodaterol 5/5 µg and tiotropium 5 µg in a randomised order with a 3-week washout period. The speed for the 3-min CSST was determined for each patient such that an intensity of breathing discomfort ≥4 (“somewhat severe”) on the modified Borg scale was reached at the end of a completed 3-min CSST.After 6 weeks, there was a decrease in the intensity of breathlessness (Borg dyspnoea score) at the end of the 3-min CSST from baseline with both tiotropium (mean –0.968, 95% CI −1.238– −0.698; n=100) and tiotropium/olodaterol (mean −1.325, 95% CI −1.594– −1.056; n=101). The decrease in breathlessness was statistically significantly greater with tiotropium/olodaterol versus tiotropium (treatment difference −0.357, 95% CI −0.661– −0.053; p=0.0217).Tiotropium/olodaterol reduced activity-related breathlessness more than tiotropium in dyspnoeic patients with moderate to severe COPD exhibiting lung hyperinflation.

2010 ◽  
Vol 67 (1) ◽  
pp. 36-41
Author(s):  
Ivan Cekerevac ◽  
Zorica Lazic ◽  
Ljiljana Novkovic ◽  
Marina Petrovic ◽  
Vojislav Cupurdija ◽  
...  

Background/Aim. Peripheral muscle weakness and nutritional disorders, firstly loss of body weight, are common findings in patients with chronic obstructive pulmonary disease (COPD). The aim of this study was to analyse the impact of pulmonary function parameters, nutritional status and state of peripheral skeletal muscles on exercise tolerance and development of dyspnea in COPD patients. Methods. Thirty COPD patients in stable state of disease were analyzed. Standard pulmonary function tests, including spirometry, body pletysmography, and measurements of diffusion capacity were performed. The 6-minute walking distance test (6MWD) was done in order to assess exercise tolerance. Level of dyspnea was measured with Borg scale. In all patients midthigh muscle cross-sectional area (MTCSA) was measured by computerized tomography scan. Nutritional status of patients was estimated according to body mass index (BMI). Results. Statistically significant correlations were found between parameters of pulmonary function and exercise tolerance. Level of airflow limitation and lung hyperinflation had significant impact on development of dyspnea at rest and especially after exercise. Significant positive correlation was found between MTCSA and exercise tolerance. Patients with more severe airflow limitation, lung hyperinflation and reduced diffusion capacity had significantly lower MTCSA. Conclusion. Exercise tolerance in COPD patients depends on severity of bronchoobstruction, lung hyperinflation and MTCSA. Severity of bronchoobstruction and lung hyperinflation have significant impact on dyspnea level.


2021 ◽  
pp. 00255-2021
Author(s):  
Sundeep Salvi ◽  
Akash Balki ◽  
Srikanth Krishnamurthy ◽  
Sagar Panchal ◽  
Saiprasad Patil ◽  
...  

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.


2019 ◽  
Author(s):  
Yaqi Zu ◽  
Demin Li ◽  
Xiang Lei ◽  
Hongchun Zhang

Abstract Background Due to the large number of patients, high mortality rate as well as high social costs and economic burden, Chronic obstructive pulmonary disease(COPD)has become one of the most important health problem around the world, which has attracted people's attention. Currently, Chinese herbs have been widely used as alternative medicine(CAM)for COPD patients. Chinese herbal formula San-Huang Gu-Ben Zhi-Ke(SHGBZK)have shown good clinical efficacy in COPD in preclinical studies. Animal experiments have enhanced that it has mucosal immune barrier function, it can maintain airway wall integrity, reduce inflammatory cell infiltration, promote inflammatory damage repair, and relieve airway narrow conditions. Methods/design The study is a randomized, double-blind, placebo-controlled trial. A total of 100 COPD patients at stable stage that diagnosed with syndrome of deficiency of lung qi and spleen qi will be recruited and randomly assigned to one of the two treatments group, with 50 in each group. One hundred COPD patients were randomly assigned to two treatment groups(SHGBZK treatment, N=50; placebo treatment, N=50).The two groups will receive basic treatment for COPD according to the 2017 GOLD Guidelines for Chronic Obstructive Pulmonary Disease. Patients will stick to the treatment they used to take as much as possible, and will be given present general treatment when AECOPD occurs during the study. Both groups will receive an 24-weeks intervention, and patient status was assessed at 24 weeks later and 28 weeks after treatment. After the 24-weeks treatment, another 28 weeks will be followed up. The outcome measures including the frequency and duration of acute exacerbation, lung function, TCM symptom score, exercise capacity, and quality of life will be assessed. Discussion It is hypothesized that SHGBZK will have beneficial effects in reducing the frequency and duration of acute exacerbation, improving exercise capacity function of COPD patients at stable stage that diagnosed with syndrome of deficiency of lung qi and spleen qi. This study may establish a new method for COPD patients, and thus differentiation from other drugs used for similar clinical indications in clinical use.


2020 ◽  
Author(s):  
Haoyan Wang ◽  
Fang Lin ◽  
Shan Nie ◽  
Ranran Zhao ◽  
Min Cao ◽  
...  

Abstract Background: Ventilatory inefficiency is known to be a contributor to exercise intolerance in chronic obstructive pulmonary disease (COPD). The intercept of the minute ventilation (V̇E) vs. carbon dioxide output (V̇CO2) plot is a key ventilator inefficiency parameter. However, its relationships with lung hyperinflation (LH) and airflow limitation are not known. This study aimed to evaluate the correlations between the V̇E/V̇CO2 intercept and LH in COPD to determine its utility as an index of functional impairment.Methods: We conducted a retrospective analysis of data from 53 COPD patients and 14 healthy controls performed incremental cardiopulmonary exercise tests and resting pulmonary function. Ventilatory inefficiency was represented by parameters reflecting the V̇E/V̇CO2 nadir and slope (linear region), and intercept of the V̇E/V̇CO2 plot. Their correlations with measures of LH and airflow limitation were evaluated.Results: Compared to the control, the slope (30.58±3.62) and intercept (4.85±1.11) higher in COPDstages1-2, leading to a higher nadir (31.47±4.47) (p<0.05). Despite an even higher intercept in COPDstages3-4 (7.16±1.41), the slope diminished with disease progression (from 30.58±3.62 in COPDstages1-2 to 28.36±4.58 in COPDstages3-4). Compared to the V̇E/V̇CO2 nadir and V̇E/V̇CO2 slope, the intercept was better correlated with peak V̇E/maximal voluntary ventilation (MVV) (r=0.489, p<0.001) and peak V̇O2/watt (r=0.354, p=0.003). The intercept was also significantly correlated with RV/TLC (r=0.588, p<0.001), IC/TLC (r=-0.574, p<0.001), peak VT/TLC (r=-0.585, p<0.001); and airflow limitation forced expiratory volume in 1s (FEV1) % predicted (r=-0.606, p<0.001) and FEV1/forced vital capacity (FVC) (r=-0.629, p<0.001).Conclusion: V̇E/V̇CO2intercept was consistently better correlated with worsening static and dynamic lung hyperinflation and airflow limitation in COPD. V̇E/V̇CO2 intercept emerged as a useful index of ventilatory inefficiency across the severity spectrum of COPD patients.


Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Yaqi Zu ◽  
Demin Li ◽  
Xiang Lei ◽  
Hongchun Zhang

Abstract Background Due to the large number of patients, high mortality rate as well as high social costs and economic burden, chronic obstructive pulmonary disease (COPD) has become one of the most important health problems around the world, which has attracted people’s attention. Currently, Chinese herbs have been widely used as alternative medicine (CAM) for COPD patients. The Chinese herbal formula San-Huang Gu-Ben Zhi-Ke (SHGBZK) has shown good clinical efficacy in COPD in preclinical studies. Animal experiments have shown that it has mucosal immune barrier function and can maintain airway wall integrity, reduce inflammatory cell infiltration, promote inflammatory damage repair, and relieve narrow airway conditions. Methods/design This study is a randomized, double-blind, placebo-controlled trial. A total of 100 patients with stable COPD diagnosed with deficiency of lung qi and spleen qi will be recruited and randomly assigned to one of two treatment groups: SHGBZK treatment, N = 50; placebo treatment, N = 50. The two groups will receive basic treatment for COPD according to the 2017 GOLD Guidelines for Chronic Obstructive Pulmonary Disease. Patients will stick to the treatment they used to take as much as possible, and will be given present general treatment when acute exacerbation of COPD occurs during the study. Both groups will receive a 24-week intervention and patient status will be assessed at 24 weeks and then 28 weeks after treatment. After the 24-week treatment, patients will be followed up for another 28 weeks. Outcome measures, including the frequency and duration of acute exacerbation, lung function, traditional Chinese medicine symptom score, exercise capacity, and quality of life will be assessed. Discussion It is hypothesized that SHGBZK will have beneficial effects in reducing the frequency and duration of acute exacerbations, improving the exercise capacity function of patients with stable COPD diagnosed with a deficiencies in lung qi and spleen qi. This study may establish a new treatment method for COPD patients, differentiating it from other drugs in clinical use used for similar clinical indications. Trial registration Chinese Clinical Trial Registry, ChiCTR1800016349. Registered on 26 May 2018.


2019 ◽  
Author(s):  
Yaqi Zu ◽  
Demin Li ◽  
Xiang Lei ◽  
Hongchun Zhang

Abstract Background: Due to the large number of patients, high mortality rate as well as high social costs and economic burden, Chronic obstructive pulmonary disease(COPD)has become one of the most important health problem around the world, which has attracted people's attention. Currently, Chinese herbs have been widely used as alternative medicine(CAM)for COPD patients. Chinese herbal formula San-Huang Gu-Ben Zhi-Ke(SHGBZK)have shown good clinical efficacy in COPD in preclinical studies. Animal experiments have enhanced that it has mucosal immune barrier function, it can maintain airway wall integrity, reduce inflammatory cell infiltration, promote inflammatory damage repair, and relieve airway narrow conditions. Methods/design: The study is a randomized, double-blind, placebo-controlled trial. A total of 100 COPD patients at stable stage that diagnosed with syndrome of deficiency of lung qi and spleen qi will be recruited and randomly assigned to one of the two treatments group, with 50 in each group. One hundred COPD patients were randomly assigned to two treatment groups(SHGBZK treatment, N=50; placebo treatment, N=50).The two groups will receive basic treatment for COPD according to the 2017 GOLD Guidelines for Chronic Obstructive Pulmonary Disease. Patients will stick to the treatment they used to take as much as possible, and will be given present general treatment when AECOPD occurs during the study. Both groups will receive an 24-weeks intervention, and patient status was assessed at 24 weeks later and 28 weeks after treatment. After the 24-weeks treatment, another 28 weeks will be followed up. The outcome measures including the frequency and duration of acute exacerbation, lung function, TCM symptom score, exercise capacity, and quality of life will be assessed. Discussion: It is hypothesized that SHGBZK will have beneficial effects in reducing the frequency and duration of acute exacerbation, improving exercise capacity function of COPD patients at stable stage that diagnosed with syndrome of deficiency of lung qi and spleen qi. This study may establish a new method for COPD patients, and thus differentiation from other drugs used for similar clinical indications in clinical use. Trial registration: Chinese Clinical Trial Registry, ID: ChiCTR1800016349. Registered on 26 May 2018. Keywords: Chronic obstructive pulmonary disease; traditional Chinese medicine; Chinese herbal formula San-Huang Gu-Ben Zhi-Ke; clinical trials; clinical protocols.


2020 ◽  
Vol 7 (1) ◽  
pp. e000741
Author(s):  
Felix Herth ◽  
Jens M Hohlfeld ◽  
Johannes Haas ◽  
Alberto de la Hoz ◽  
Xidong Jin ◽  
...  

This exploratory, randomised, double-blind, double-dummy, multicentre, cross-over study explored the effect of 6 weeks of treatment with tiotropium/olodaterol (T/O) versus fluticasone propionate/salmeterol (F/S) on left ventricular filling in patients with chronic obstructive pulmonary disease with functional residual capacity (FRC) >120% predicted and postbronchodilator improvement of FRC ≥7.5%. Overall, 76 patients were randomised across nine sites. Treatment with T/O or F/S increased left ventricular end-diastolic volume index from baseline (adjusted mean change: T/O: 2.317 mL/m2, F/S: 2.855 mL/m2), with no statistically significant difference between treatments. However, T/O resulted in a significantly greater reduction in lung hyperinflation versus F/S (FRC plethysmography absolute change from baseline: F/S: –0.329 L, T/O: –0.581 L).


2020 ◽  
Vol 11 (Vol.11, no.3) ◽  
pp. 269-273
Author(s):  
Georgeta PATRASCA ◽  
Gilda POPESCU ◽  
Doina Ecaterina TOFOLEAN ◽  
Anca MAIEREAN ◽  
Gabriela DOGARU ◽  
...  

Introduction. Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and mortality throughout the world. At present, the pharmacological therapy is not enough for a patient with COPD in regard to heath status and exercise tolerance. It requires additional therapies aimed to improve the quality of life, delay the lung function decline, increase exercise capacity, and reduce the respiratory symptoms and the number of exacerbations. Pulmonary rehabilitation program (PRP) has been shown to improve respiratory muscle, to optimize functional, psychosocial, behavioral and nutritional status. The aim of the present study was to asses the impact of PRP on COPD patients, focusing on the clinical benefits of PRP, which may further provide to the patients a good support for change. Material and method. Sixty-seven patients with clinically stable COPD were enrolled in this prospective study, consisting in a 6-weeks of PRP. There were recorded demographic data, smoking and medical history, and abnormal findings at the physical examination. All patients completed CAT (COPD Assessment Test) questionnaire and dyspnea on Borg scale, they performed spirometry, and six minutes walking test (6MWT), before and after the completion of the rehabilitation program. Results and Discussions. After the 6-week period of PRP, a large proportion of patients presented higher values of spirometric parameters, although the change was no statistically significant. The impact of COPD on the patient’s health was significantly improved, 58.2% of patients registered < 10 points of CAT questionnaire after PRP (p<0.05). 75% of patients reported a 0-5 points of dyspnea on Borg scale comparing with 29% before the PRP (p=0.0147), and 56% a 0-5 points of fatigue while only 25% of patients had the same score before the rehabilitation programme (p=0,022). Only 8 patients (11.94% vs 31.34%, p<0.05) reported a SaO2 lower than 90% after the PRP. The 6MWD was longer than 250m at the end of the 6-weeks of PRP for 38 patients (56.7% vs 22.38%, p<0.05). Conclusions. The present study showed that a PRP added to pharmacological treatment had a beneficial role of increasing the patient’ health status and exercise tolerance for COPD patients.


2022 ◽  
Vol 12 (1) ◽  
pp. 46-56
Author(s):  
Marc Spielmanns ◽  
Sebastian Schildge ◽  
Jens Peter Diedrich ◽  
Arschang Valipour

Health-related quality of life (HRQoL) in patients with moderate to severe chronic obstructive pulmonary disease (COPD) is often reduced by high symptom burden and frequent exacerbations. So far, data on therapeutic success in Swiss COPD patients receiving dual bronchodilation therapy as COPD maintenance treatment are limited. Data from a recently published, non-interventional study on clinical benefit after the start of combined tiotropium–olodaterol treatment were analyzed focusing on Swiss patients compared to the overall cohort including patients from various European countries. Demographic data on the changes in Clinical COPD Questionnaire (CCQ) for the assessment of HRQoL in correlation to symptoms and the number of exacerbations, as well as physician’s global assessment (PGE), were evaluated 6 weeks after treatment start. In Switzerland (n = 61), significantly more patients had comorbidities and exacerbations but showed less symptoms compared to the overall cohort (n = 4639). HRQoL improved in both cohorts, with a negative correlation to symptom burden and number of exacerbations in the overall cohort. PGE scores improved after 6 weeks with a better general condition at baseline in Swiss patients (PGE score 4/5: 68.9% [Swiss cohort] vs. 49.0% [overall cohort]. Despite significant differences regarding the presence of symptoms and exacerbations, therapeutic success was similar in both patient groups. Highly symptomatic patients benefited mostly from tiotropium–olodaterol treatment.


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