13 research outputs found
ACTIVATE: the effect of aclidinium/formoterol on hyperinflation, exercise capacity, and physical activity in patients with COPD
The Phase IV, 8-week, randomized, double-blind,
placebo-controlled ACTIVATE study (NCT02424344) evaluated the
effect of aclidinium/formoterol (AB/FF) 400/12 mug twice daily
on lung hyperinflation, exercise capacity, and physical activity
in patients with moderate-to-severe COPD. Patients received
AB/FF (n=134) or placebo (n=133) (1:1) via the
Genuair/Pressair(R) dry powder inhaler for 8 weeks. From Weeks 5
to 8, all patients participated in behavioral intervention (BI;
daily messages providing step goals). The primary end point was
trough functional residual capacity (FRC) at Week 4. Exercise
endurance time and physical activity were assessed at Week 4
(pharmacotherapy only) and at Week 8 (8 weeks of pharmacotherapy
plus 4 weeks of BI). Other end points included post-dose FRC,
residual volume, and inspiratory capacity (IC) at rest and
during exercise. After 4 weeks, trough FRC improved with AB/FF
versus placebo but did not reach significance (125 mL;
P=0.0690). However, post-dose FRC, residual volume, and IC at
rest improved significantly with AB/FF at Week 4 versus placebo
(all P<0.0001). AB/FF significantly improved exercise
endurance time and IC at isotime versus placebo at Week 4
(P<0.01 and P<0.0001, respectively) and Week 8 (P<0.05
and P<0.0001, respectively). AB/FF achieved higher step
counts (P<0.01) with fewer inactive patients (P<0.0001) at
Week 4 versus placebo. Following BI, AB/FF maintained
improvements in physical activity at Week 8 and nonsignificant
improvements were observed with placebo. AB/FF 400/12 mug
demonstrated improvements in lung hyperinflation, exercise
capacity, and physical activity versus placebo that were
maintained following the addition of BI. A 4-week period of BI
might be too short to augment the improvements of physical
activity observed with AB/FF
Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials
BACKGROUND: Cough and sputum are troublesome symptoms in chronic obstructive pulmonary disease (COPD) and are associated with adverse outcomes. The efficacy of aclidinium bromide 400â
”g twice daily in patients with stable COPD has been established in two phase III studies (ACCORD COPD I and ATTAIN) and a phase IIIb active-comparator study. This analysis evaluated cough-related symptoms across these studies. METHOD: Patients were randomised to placebo, aclidinium 200â
”g or 400â
”g twice daily in ACCORD (12â
weeks) and ATTAIN (24â
weeks), or to placebo, aclidinium 400â
”g twice daily or tiotropium 18â
”g once daily (6-week active-comparator study). Analysed end points included changes from baseline in Evaluating Respiratory Symptoms (E-RS; formerly known as EXAcerbations of Chronic pulmonary disease Tool), total and cough/sputum scores and frequency/severity of morning and night-time cough and sputum symptoms. RESULTS: Data for 1792 patients were evaluated. E-RS cough/sputum domain scores were significantly reduced with aclidinium 400â
”g versus placebo in ATTAIN (â0.7 vs â0.3, respectively; p<0.01) and the active-comparator study (â0.6 vs â0.2, respectively; p<0.01). In the active-comparator study, significantly greater improvements were observed with aclidinium versus placebo for severity of morning cough (â0.19 vs â0.02; p<0.01) and phlegm (â0.19 vs â0.02; p<0.05). In ACCORD, aclidinium reduced night-time cough frequency (â0.36 vs 0.1 for placebo; p<0.001) and severity (â0.24 vs â0.1 for placebo; p<0.05), and frequency of night-time sputum production (â0.37 vs 0.05 for placebo; p<0.001). CONCLUSIONS: Aclidinium 400â
”g twice daily improves cough and sputum expectoration versus placebo in stable COPD. TRIAL REGISTRATION NUMBERS: NCT00891462; NCT01001494; NCT01462929
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Absence of mitochondrial dysfunction in polymyalgia rheumatica: Evidence based on a simultaneous molecular and biochemical approach
Objective: To investigate the molecular and biochemical profile of skeletal muscle mitochondria of patients with isolated polymyalgia rheumatica (PMR). Patients and Methods: We included patients with a recent diagnosis of PMR and as control healthy individuals submitted to orthopedic surgery. Skeletal muscle was obtained from quadriceps, thus was mitochondria immediately isolated. Long polymerase chain reaction and Southern blot transference were performed to detect deleted mtDNA molecules. Mitochondrial oxidative activity using different substrates and individual enzyme activity of respiratory chain complexes were assessed to search for any biochemical dysfunction. Results: Fifty-one individuals (PMR=25, controls=26) were included. Mean age was 72 (11) years; 45% were females. We found no significant increase of deleted mtDNA molecules in PMR patients compared to controls. Both groups differed neither on oxygen consumption (p=NS for all substrates) nor enzymatic activity (p=NS for all complexes). Conclusions: Skeletal muscle mitochondria are molecularly and biochemically unaffected in PMR
ACTIVATE: the effect of aclidinium/formoterol on hyperinflation, exercise capacity, and physical activity in patients with COPD
The Phase IV, 8-week, randomized, double-blind, placebo-controlled ACTIVATE study (NCT02424344) evaluated the effect of aclidinium/formoterol (AB/FF) 400/12 ÎŒg twice daily on lung hyperinflation, exercise capacity, and physical activity in patients with moderate-to-severe COPD. Patients received AB/FF (n=134) or placebo (n=133) (1:1) via the Genuairâą/PressairÂź dry powder inhaler for 8 weeks. From Weeks 5 to 8, all patients participated in behavioral intervention (BI; daily messages providing step goals). The primary end point was trough functional residual capacity (FRC) at Week 4. Exercise endurance time and physical activity were assessed at Week 4 (pharmacotherapy only) and at Week 8 (8 weeks of pharmacotherapy plus 4 weeks of BI). Other end points included post-dose FRC, residual volume, and inspiratory capacity (IC) at rest and during exercise. After 4 weeks, trough FRC improved with AB/FF versus placebo but did not reach significance (125 mL; P=0.0690). However, post-dose FRC, residual volume, and IC at rest improved significantly with AB/FF at Week 4 versus placebo (all P<0.0001). AB/FF significantly improved exercise endurance time and IC at isotime versus placebo at Week 4 (P<0.01 and P<0.0001, respectively) and Week 8 (P<0.05 and P<0.0001, respectively). AB/FF achieved higher step counts (P<0.01) with fewer inactive patients (P<0.0001) at Week 4 versus placebo. Following BI, AB/FF maintained improvements in physical activity at Week 8 and nonsignificant improvements were observed with placebo. AB/FF 400/12 ÎŒg demonstrated improvements in lung hyperinflation, exercise capacity, and physical activity versus placebo that were maintained following the addition of BI. A 4-week period of BI might be too short to augment the improvements of physical activity observed with AB/FF.status: publishe