ATTAIN STUDY ACLIDINIUM PDF

The ATTAIN study: Bronchodilatory effect of aclidinium bromide in chronic obstructive pulmonary disease (COPD). David Singh, Eric D. Bateman, Paul W. Jones. The ATTAIN study: Safety and tolerability of aclidinium bromide in chronic obstructive pulmonary disease. Eric D. Bateman, David Singh, Paul W. Jones, Alvar. This paper presents results from a phase III study of longer duration (Aclidinium To Treat Airway obstruction In COPD patieNts; ATTAIN), which.

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Three long-acting muscarinic antagonists LAMAs are now available in Europe, providing clinicians and patients with a choice of interventions, which is important in COPD, which is clinically a heterogeneous disease. Another new once-daily LAMA, glycopyrronium, has also been shown to improve health status and reduce exacerbations, and is well tolerated.

The subject of this review is a third LAMA, aclidinium bromide, which was approved as a twice-daily maintenance bronchodilator treatment. In the pivotal Phase III clinical trials, patients receiving aclidinium achieved significantly greater improvements in lung function, reductions in breathlessness, and improvements in health status compared with placebo, for up to 24 weeks. In continuation studies, these improvements were sustained for up to 52 weeks.

Pooled data showed exacerbation frequency was significantly reduced with aclidinium acludinium placebo. Preclinical and pharmacological studies demonstrating low systemic bioavailability and a low propensity to induce cardiac arrhythmias were translated into a favorable tolerability profile in the clinical trial program — the adverse event profile of aclidinium was similar to placebo, with a low incidence of anticholinergic and cardiac adverse events.

While additional studies are needed to evaluate its full clinical potential, aclidinium is an important part of this recent expansion of LAMA therapeutic options, providing clinicians and patients with an effective and well-tolerated COPD treatment. Tiotropium has been widely used over the last decade as once-daily maintenance therapy in stable COPD. It has been extensively studied in patients with COPD — a recent Cochrane review identified 22 studies of good methodological quality that had stury 23, participants with COPD.

However, the rate of decline in FEV 1 — the primary outcome of the trial — was not significantly reduced by the use of tiotropium. Glycopyrronium bromide is a synthetic quaternary ammonium compound, which has been used for many years to reduce secretions and attzin cardiac vagal reflexes before surgery.

Preclinical studies have shown that aclidinium ac,idinium high affinity for all five muscarinic receptors, with kinetic selectivity for M 3 receptors over M 2and a shorter duration of action and a faster onset compared with tiotropium bromide.

Pharmacokinetic studies in healthy volunteers showed that it is poorly absorbed into plasma and rapidly hydrolyzed into two major inactive metabolites, resulting in limited systemic exposure. Aclidinium has been extensively evaluated in patients with COPD Table 1 29 — 39 and has also been the subject of a recent Cochrane systematic review. Subsequently, studies investigating higher doses and alternative dosing regimens were conducted, 2930 leading to two Phase III studies: Again, these benefits were seen from the first dose until the end of the study Figure 3B.

Reproduced with permission of Informa Healthcare. Data reported as least squares mean standard error.

Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study.

There atudy no statistically significant differences between the two aclidinium arms. Reproduced with permission of the European Respiratory Society: Eur Respir JOctober Significant improvements were seen in breathlessness, health status, and COPD symptoms in the pivotal trials. The clinical study data synthesis presented in the Cochrane review demonstrated significant improvements in transition dyspnea index eight trials, 4, patients and SGRQ seven trials, 4, patients with zttain therapy compared with placebo.

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Furthermore, a higher proportion of patients treated with aclidinium achieved the MCID in each of these measures, compared with placebo.

In the ACCORD COPD I study, 31 night-time and morning COPD symptoms were all significantly reduced among patients treated with aclidinium compared with those who received placebo Figure 5and the impact of breathlessness on early morning activities was also significantly reduced with aclidinium versus placebo Figure 6.

This showed that aclidinium improved the total score and the component scores breathlessness, chest symptoms, and cough and sputum atyain more than placebo Figure 7. However, these studies were not designed to directly compare the two doses, and confidence intervals often overlapped.

As noted in the current GOLD guidelines, tiotropium, aclidinium, and glycopyrronium can all be considered as appropriate options for maintenance treatment in the stable COPD patient.

What stands out as the difference between it and them, since they seem to have similar efficacy and safety profiles? The low systemic bio-availability of aclidinium may be an advantage, but more data are needed, as this is a class of drugs with a generally low side-effect rate.

The BID dosing does not appear to be a disadvantage compared to the QD regimes of tiotropium and glycopyrronium, since it attaain confer better overnight bronchodilation that may be particularly beneficial for patients with significant night and morning symptoms. The three LAMAs also provide patients with a choice, as each is delivered by a different device, and some patients may prefer attsin over another.

In conclusion, when considering new inhaled drugs, it is important to look beyond the chemical entity and its pharmacology. Dosing regimens and inhaler performance may be equally important in determining relative advantages of one drug over another. That may be the case with aclidinium. Prior to peer review, Almirall S. Professor Paul Jones is the guarantor for this article, and takes responsibility for the integrity of the work as a whole.

The author and his institution have received consulting and lecture fees from Almirall S. The author reports no other conflicts of interest in this work. National Center for Biotechnology InformationU.

Published online Mar Author information Copyright and License information Disclaimer. The full terms of the License are available aclidniium http: Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

This article has been cited by other articles in PMC. Abstract Three long-acting muscarinic antagonists LAMAs are wclidinium available in Europe, providing clinicians and patients with a choice of interventions, which is important in COPD, which is clinically a heterogeneous disease.

Glycopyrronium bromide Glycopyrronium bromide is a synthetic quaternary ammonium compound, which has been used aclidinijm many years to reduce secretions and block cardiac vagal reflexes before surgery. Pharmacologic and aclidiniu profile Preclinical studies have shown that aclidinium displays high affinity for all five muscarinic receptors, with kinetic selectivity for M 3 receptors over M 2and a shorter duration of action and a faster onset compared with tiotropium bromide.

Efficacy and safety Aclidinium has been extensively evaluated in patients with COPD Table 1 29 — 39 and has also been the subject of a recent Cochrane systematic review. Study acronym and reference Study treatments N Duration weeks Key efficacy results treated vs placebo, respectively: Open in a separate window.

Breathlessness, health status, and COPD symptoms with aclidinium Significant improvements were seen in breathlessness, health status, and COPD symptoms in the aclidinnium trials. Discussion As noted in the current GOLD guidelines, tiotropium, aclidinium, and glycopyrronium can all be considered as appropriate options for maintenance treatment in the stable COPD patient.

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Global Initiative attin Chronic Obstructive Atain Disease [webpage on the Internet] Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease [updated Jan ] [Accessed November 12, ]. Global Initiative for Chronic Obstructive Lung Disease [webpage on agtain Internet] Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease [updated ] [Accessed December 12, ]. Tiotropium versus placebo for chronic obstructive pulmonary disease.

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Comparative safety of inhaled medications in patients with chronic obstructive pulmonary disease: Once-daily glycopyrronium bromide, a long-acting muscarinic antagonist, sthdy chronic obstructive pulmonary disease: European Medicines Agency; US Food and Drug Administration; Characterization of aclidinium bromide, a novel inhaled muscarinic antagonist, with long attaib of action and a favorable pharmacological profile.

J Pharmacol Exp Ther. Effect of formoterol alone and in combination with aclidinium on electrocardiograms in dogs. Safety and pharmacokinetics of multiple doses of aclidinium bromide, a novel long-acting muscarinic antagonist for the treatment of chronic obstructive pulmonary disease, in healthy participants.

Safety and pharmacokinetics of multiple doses of aclidinium bromide administered twice daily in healthy volunteers. Aclidinium bromide, a long-acting antimuscarinic, does not affect QT interval in healthy subjects. Pharmacokinetics and safety of attain bromide, a muscarinic antagonist, in adults with normal or impaired renal acllidinium A phase I, open-label, single-dose clinical trial.

Pharmacokinetics and safety of aclidinium bromide in younger and elderly patients with chronic obstructive pulmonary disease. Int J Clin Pharmacol Ther. A randomised, placebo- and active-controlled dose-finding study of aclidinium bromide administered twice a day in COPD patients.

Efficacy and safety of twice-daily aclidinium bromide in COPD patients: Efficacy and safety of aclidinium bromide compared with placebo and tiotropium in patients with moderate-to-severe chronic obstructive pulmonary disease: Aclidinium bromide provides long-acting bronchodilation stjdy patients with COPD.

Bronchodilatory effects aclodinium aclidinium bromide, a long-acting muscarinic antagonist, in COPD patients. Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. Aclidinium bromide for stable chronic obstructive pulmonary disease. Minimal clinically important differences in COPD lung function. Improvement in symptoms and rescue medication use with aclidinium bromide in patients with chronic obstructive pulmonary disease: Twice-daily aclidinium bromide in COPD patients: Reduced COPD exacerbations associated with aclidinium bromide versus placebo: Preference, satisfaction and errors with two dry powder inhalers in patients with COPD.

Expert Opin Drug Deliv. Safety and tolerability of aclidinium bromide in patients with COPD: Food and Drug Administration Tudorza Pressair: Summary review of regulatory action.

COPD Efficacy Study | TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder)

Inhaler mishandling remains common in real life and is associated with reduced disease control. Support Center Support Center. Please review our privacy policy. Adverse events reported aclidinuum seven patients receiving aclidinium, eight receiving placebo, and three receiving tiotropium Most common AE was COPD exacerbation three patients all receiving placebo.

The safety profile of aclidinium was comparable to placebo.