One-Year Safety and Efficacy Study of Arformoterol Tartrate in Patients With Moderate to Severe COPD

Donohue, James F.; Hanania, Nicola A.; Make, Barry J.; Miles, Matthew; Mahler, Donald A.; Curry, Lisa; Tosiello, Robert; Wheeler, Alistair; Tashkin, Donald P.

doi:10.1378/chest.14-0117

Cited by 22 publications

(18 citation statements)

References 30 publications

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“…A fixed-dose combination of indacaterol and glycopyrronium similarly offered a significant and clinically meaningful improvement in FEV 1 AUC 0–12 at week 26 compared with that achieved with a combination of salmeterol and fluticasone. 95 Similar findings with respect to lung-function improvements over LABA-ICS combinations have been observed with other dual-bronchodilator combinations, such as umeclidinium–vilanterol 96 and aclidinium–formoterol. 93 , 97 …”

Section: The Effect Of Bronchodilators On Exacerbation Rates In Copdsupporting

confidence: 64%

Inhaled therapies in patients with moderate COPD in clinical practice: current thinking

Ariel¹,

Altraja²,

Белевский³

et al. 2017

COPD

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COPD is a complex, heterogeneous condition. Even in the early clinical stages, COPD carries a significant burden, with breathlessness frequently leading to a reduction in exercise capacity and changes that correlate with long-term patient outcomes and mortality. Implementation of an effective management strategy is required to reduce symptoms, preserve lung function, quality of life, and exercise capacity, and prevent exacerbations. However, current clinical practice frequently differs from published guidelines on the management of COPD. This review focuses on the current scientific evidence and expert opinion on the management of moderate COPD: the symptoms arising from moderate airflow obstruction and the burden these symptoms impose, how physical activity can improve disease outcomes, the benefits of dual bronchodilation in COPD, and the limited evidence for the benefits of inhaled corticosteroids in this disease. We emphasize the importance of maximizing bronchodilation in COPD with inhaled dual-bronchodilator treatment, enhancing patient-related outcomes, and enabling the withdrawal of inhaled corticosteroids in COPD in well-defined patient groups.

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Section: The Effect Of Bronchodilators On Exacerbation Rates In Copdsupporting

confidence: 64%

Inhaled therapies in patients with moderate COPD in clinical practice: current thinking

Ariel¹,

Altraja²,

Белевский³

et al. 2017

COPD

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“…A 12-month Phase 4 trial found no increased risk of respiratory death or COPD exacerbation-related hospitalizations with nebulized arformoterol treatment. 41 Being a single enantiomer of formoterol, arformoterol may have hypothetically more potent bronchodilator properties, microgram per microgram, than racemic formoterol fumarate, but no major clinical differences between the two drugs have been observed in patients with COPD. 42 Maintenance therapy with nebulized arformoterol or formoterol demonstrated a 37% reduction and a 42% reduction in rescue albuterol use, respectively.…”

Section: Nebulized Pharmacologic Therapymentioning

confidence: 99%

A review of nebulized drug delivery in COPD

Tashkin¹

2016

COPD

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Current guidelines recommend inhaled pharmacologic therapy as the preferred route of administration for treating COPD. Bronchodilators (β2-agonists and antimuscarinics) are the mainstay of pharmacologic therapy in patients with COPD, with long-acting agents recommended for patients with moderate to severe symptoms or those who are at a higher risk for COPD exacerbations. Dry powder inhalers and pressurized metered dose inhalers are the most commonly used drug delivery devices, but they may be inadequate in various clinical scenarios (eg, the elderly, the cognitively impaired, and hospitalized patients). As more drugs become available in solution formulations, patients with COPD and their caregivers are becoming increasingly satisfied with nebulized drug delivery, which provides benefits similar to drugs delivered by handheld inhalers in both symptom relief and improved quality of life. This article reviews recent innovations in nebulized drug delivery and the important role of nebulized therapy in the treatment of COPD.

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“…Some long-term COPD trials have reported up to 45% of patients discontinue study treatment [22]. In the current trial, there were fewer withdrawals by patients in the TIO group (12%) compared with the revefenacin groups (revefenacin 88 μg, 19%; 175 μg, 24%).…”

Section: Discussionmentioning

confidence: 47%

Revefenacin, a once-daily, lung-selective, long-acting muscarinic antagonist for nebulized therapy: Safety and tolerability results of a 52-week phase 3 trial in moderate to very severe chronic obstructive pulmonary disease

Donohue

Kerwin

Sethi

et al. 2019

Respiratory Medicine

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A B S T R A C TBackground: Prior replicate 12-week phase 3 trials demonstrated that once-daily doses of revefenacin inhalation solution at 88 μg and 175 μg produced significant bronchodilation over 24 h post dose in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). The objective was to characterize the safety profile of revefenacin 88 μg and 175 μg over 52 weeks of treatment. Methods: In this randomized, parallel-group, 52-week trial (NCT02518139), 1055 participants with moderate to very severe COPD received revefenacin 88 μg or 175 μg in a double-blind manner, or open-label active control tiotropium. Results: Treatment-emergent adverse events (AEs) were comparable across all treatment groups (n [%] patients; revefenacin 88 μg, 272 [74.7%]; 175 μg, 242 [72.2%]; tiotropium, 275 [77.2%]). Numerically fewer COPD exacerbations (n [%] patients) were observed with revefenacin 175 μg (73 [21.8%]) than with 88 μg (107 [29.4%]) or tiotropium (100 [28.1%]). Serious AEs were comparable with revefenacin 88 μg (58 [15.9%] and tiotropium (58 [16.3%]), but were lower with revefenacin 175 μg (43 [12.8%]), and mortality was low. In patients using revefenacin 88 μg or tiotropium with a concurrent long-acting β-agonist (LABA) product, the incidence of AEs was slightly higher than without concurrent LABA. LABA did not affect the incidence of AEs for patients who received revefenacin 175 μg. Conclusions: Revefenacin was generally well tolerated over 52 weeks of treatment, and had a safety profile that supports its use as a long-term once-daily bronchodilator for the nebulized treatment of COPD.

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One-Year Safety and Efficacy Study of Arformoterol Tartrate in Patients With Moderate to Severe COPD

Cited by 22 publications

References 30 publications

Inhaled therapies in patients with moderate COPD in clinical practice: current thinking

Inhaled therapies in patients with moderate COPD in clinical practice: current thinking

A review of nebulized drug delivery in COPD

Revefenacin, a once-daily, lung-selective, long-acting muscarinic antagonist for nebulized therapy: Safety and tolerability results of a 52-week phase 3 trial in moderate to very severe chronic obstructive pulmonary disease

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