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 Effects of the Chinese herbal formula San-Huang Gu-Ben Zhi-Ke treatment on stable chronic obstructive pulmonary disease: study protocol of a randomized, double-blind, placebo-controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Yaqi Zu ◽  
Demin Li ◽  
Xiang Lei ◽  
Hongchun Zhang
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Pulmonary Disease ◽  
Controlled Trial ◽  
Chronic Obstructive ◽  
Double Blind ◽  
Obstructive Pulmonary Disease ◽  
Double Blind Placebo ◽  
Chinese Herbal Formula ◽  
Chinese Herbal ◽  
Copd Patients

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.

scholarly journals Effects of the Chinese herbal formula San-Huang Gu-Ben Zhi-Ke treatment on Stable Chronic Obstructive Pulmonary disease:study protocol of a randomized, double-blind, placebo-controlled trial

2019 ◽  
Author(s):  
Yaqi Zu ◽  
Demin Li ◽  
Xiang Lei ◽  
Hongchun Zhang
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Pulmonary Disease ◽  
Controlled Trial ◽  
Chronic Obstructive ◽  
Herbal Formula ◽  
Double Blind ◽  
Obstructive Pulmonary Disease ◽  
Chinese Herbal Formula ◽  
Chinese Herbal ◽  
Copd Patients

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.

scholarly journals Effects of the Chinese herbal formula San-Huang Gu-Ben Zhi-Ke treatment on Stable Chronic Obstructive Pulmonary disease:study protocol of a randomized, double-blind, placebo-controlled trial

2019 ◽  
Author(s):  
Yaqi Zu ◽  
Demin Li ◽  
Xiang Lei ◽  
Hongchun Zhang
Keyword(s):  
Controlled Trial ◽  
Chronic Obstructive ◽  
Herbal Formula ◽  
Double Blind ◽  
Obstructive Pulmonary Disease ◽  
Double Blind Placebo ◽  
Chinese Herbal Formula ◽  
Chinese Herbal ◽  
Copd Patients ◽  
Stable Stage

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.

scholarly journals The comparisons of the efficacy of two fixed dose combinations, i.e. Salmeterol and Fluticasone vs. Formoterol and Tiotropium bromide in moderate to severe COPD patients

2018 ◽  
Vol 7 (7) ◽  
pp. 1351
Author(s):  
Dharmaraj B. ◽  
Prashanth G. ◽  
Basavaraj S.
Keyword(s):  
Anticholinergic Drug ◽  
Fixed Dose ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Medical College ◽  
Copd Patients ◽  
Symptomatic Management ◽  
The Difference ◽  
Severe Copd ◽  
Better Than

Background: Bronchodilators are essential for symptomatic management of all stages of chronic obstructive pulmonary disease (COPD). For patients whose COPD is not sufficiently controlled by monotherapy, combining a ß2-agonist with either inhaled steroid or anticholinergic drug is a convenient way of delivering treatment. Currently, there is no documentation to say that one drug is superior to other or the contrary, but a combination of two drugs is more effective than giving single drug alone in patients suffering from COPD.Methods: The study was prospective, open labelled, randomized, comparative interventional clinical study conducted by the Departments of Pharmacology and Medicine, Basaveshwara Medical College and Hospital, Chitradurga in 60 moderates to severe COPD patients.Results: Both the treatments i.e. Salmeterol/Fluticasone and Tiotropium/Formoterol were equally effective as far as the improvement of the lung functions and Borg dyspnoea score are concerned. The difference in improvement with the combination of Salmeterol/Fluticasone was not statistically significant (p>0.05) compared to the combination of Tiotropium/Formoterol. However, Salmeterol/Fluticasone was found to be better than Tiotropium/Formoterol in improving the lung function of moderate to severe COPD patients.Conclusions: Salmeterol/Fluticasone is efficacious and better than Tiotropium /Formoterol combination for maintenance therapy in moderate to severe COPD patients.

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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