Effect of triple therapy with extra-fine BDP/FF/GB pMDI vs non-triple maintenance therapies on severe COPD exacerbations. A pooled analysis of the TRILOGY, TRINITY and TRIBUTE studies

Author(s):  
Dave Singh ◽  
Enrico Clini ◽  
Alberto Papi ◽  
Alessio Piraino ◽  
Elena Nudo ◽  
...  
2021 ◽  
Vol 31 (1) ◽  
Author(s):  
Sandeep Bansal ◽  
Martin Anderson ◽  
Antonio Anzueto ◽  
Nicola Brown ◽  
Chris Compton ◽  
...  

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.


CHEST Journal ◽  
2015 ◽  
Vol 148 (4) ◽  
pp. 727A
Author(s):  
Edward Kerwin ◽  
Selwyn Spangenthal ◽  
S. David Miller ◽  
Peter D'Andrea ◽  
Michelle Henley ◽  
...  

2021 ◽  
Vol 74 (6) ◽  
pp. 1401-1404
Author(s):  
Liliia V. Burya ◽  
Anna A. Kapustianska ◽  
Nataliia V. Moiseieva ◽  
Andrii V. Vakhnenko ◽  
Mariia O. Rumiantseva ◽  
...  

The aim: To perform a comprehensive evaluation of the effect of paroxetine on the degree of somatoform disorders in exacerbation of severe COPD in women. Materials and methods: The study involved 53 female patients with severe COPD (Group D), confirmed by instrumental methods of study. At hospitalization, patients were divided into 2 groups. Patients of Group 1 (n = 21; aged 52.5 ± 0.8 years old) underwent basic exacerbation therapy. Patients of Group 2 (n = 22; aged 57.9 ± 0.4 years old) underwent basic exacerbation therapy supplemented with paroxetine for 14 days, 1 tablet (0.20 g) once a day. Results: The basic therapy for treatment of COPD exacerbations, supplemented with paroxetine, led to a positive clinical effect, confirmed by increase in skeletal and respiratory muscular system, increased parameters of pulmonary ventilation, increased tolerance to physical load, increased oxygen saturation, decreased heart rate and breathing rate. Conclusions: The strategy for choosing an antidepressant to provide multidisciplinary care for somatoform disorders in women with exacerbation of severe COPD (group D) should take into account the efficacy and favorable safety profile and personalization of the drug. In exacerbation of severe COPD, the degree of somatoform disorders in patients correlates with the severity of the main criteria: FVC1, the distance walked during the 6-minute step test, oxygen saturation after the 6-minute step test, end-expiratory pressure in the oral cavity.


2019 ◽  
Vol 70 (9) ◽  
pp. 1973-1979
Author(s):  
Laurent Hocqueloux ◽  
Camélia Gubavu ◽  
Thierry Prazuck ◽  
Barbara De Dieuleveult ◽  
Jérôme Guinard ◽  
...  

Abstract Background Increasingly, people living with human immunodeficiency virus (HIV) benefit from lower drug regimens (LDRs). Exploring viral genital shedding during LDRs is crucial to ensure their safety. Methods We pooled genital sub-studies from 2 clinical trials in this area. Patients were randomized 1:1 to continue abacavir/lamivudine/dolutegravir or switch to dolutegravir (MONCAY trial), or to continue tenofovir/emtricitabine + a third agent or switch to tenofovir/emtricitabine (TRULIGHT trial). Participants whose plasma HIV-RNA remained &lt;50 copies/mL had sperm or cervicovaginal lavage collected between Weeks 24 and 48. HIV-RNA and HIV-DNA were amplified by ultrasensitive polymerase chain reaction. The main objective was to measure the proportion of participants who had no detectable HIV in genital fluids, both according to each strategy and then in an aggregated analysis (LDR versus triple therapies). Results There were 64 participants (35 males, 29 females) included: 16 received dual therapies and 16 received triple therapies in TRULIGHT; and 16 received monotherapies and 16 received triple therapies in MONCAY. In TRULIGHT, 13/15 (87%) of evaluable participants on dual therapy had no detectable HIV in their genital fluid, versus 14/15 (93%) under triple therapy (P = 1.0). In MONCAY, these figures were 12/15 (80%) on monotherapy versus 13/16 (81%) on triple therapy (P = 1.0). In the pooled analysis, a similar proportion of participants in the LDR and triple therapy groups had no detectable HIV: 25/30 (83%) and 27/31 (87%), respectively (P = .73). Conclusions There was no evidence of increased HIV-RNA and/or -DNA shedding in the genital fluids of people who maintained undetectable plasma HIV-RNA during LDRs. Clinical Trials Registration NCT02302547 and NCT02596334


Author(s):  
Antonio Anzueto ◽  
Dennis E. Niewoenher ◽  
Bartolome Celli ◽  
Marc Decramer ◽  
Donald P. Tashkin ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document