Formoterol in patients with chronic obstructive pulmonary disease: a randomized, controlled, 3-month trial

Aalbers, Rick; Ayres, Jon G.; Backer, Vibeke; Decramer, Marc; Lier, Per Arve; Magyar, P.; Małolepszy, J; Ruffin, Richard E.; Sybrecht, Gerhard W.

doi:10.1183/09031936.02.00240902

Cited by 137 publications

(96 citation statements)

References 25 publications

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“…Tashkin et al [2008] reported that FFIS was well tolerated when combined with tiotropium maintenance therapy for twelve weeks. Other controlled studies of formoterol dry powder inhaler treatment for COPD of 12 to 26-week duration reported similar safety results [Campbell et al 2005;Aalbers et al 2002;Dahl et al 2001].…”

Section: Discussionsupporting

confidence: 57%

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Long-term safety of nebulized formoterol: Results of a twelve-month open-label clinical trial

Donohue

Hanania

Fogarty

et al. 2008

Ther Adv Respir Dis

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Formoterol fumarate is a long-acting β 2 -agonist that is an effective bronchodilator for the maintenance management of patients with chronic obstructive pulmonary disease. The safety profile of the newly developed nebulized formoterol was evaluated over a twelve-month period in an open-label, active-control study. After completing a twelve-week double-blind doubledummy period, 569 subjects with chronic obstructive pulmonary disease entered an open-label extension study and received twice-daily 20 µg formoterol fumarate inhalation solution for nebulization (FFIS) or 12 µg formoterol fumarate dry powder inhalation (FA) for 52 weeks. Most of the FFIS-treated subjects (86%) completed at least six months of open-label treatment with over 90% compliance, comparable to the FA group (88%). Results of safety monitoring for adverse events, laboratory values, and cardiac changes were similar between treatment groups. Three hundred forty (73%) of FFIS-treated subjects and 83 (78%) of FA-treated subjects experienced an adverse event over the course of the study, the majority of which were mild to moderate and considered unrelated to treatment. COPD exacerbation occurred in 15.8% of FFIS-treated and 17.9% of FA-treated subjects. Deaths, serious adverse events, and discontinuations for adverse events occurred in 1.3, 16.2, and 5.4% of the nebulized group versus 1.9, 17.9, and 7.5% of the inhaled group, respectively. There were no clinically important changes from baseline in laboratory tests, including serum potassium and glucose, or vital signs and no treatment-related increases in cardiac arrhythmias, heart rate, or QTc prolongation. We conclude that nebulized formoterol fumarate twice daily is well tolerated over long-term treatment in moderate-to-severe COPD subjects and has a similar safety profile to the DPI formulation.

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Section: Discussionsupporting

confidence: 57%

“…At a range of doses, formoterol improves airflow obstruction in subjects with COPD [Campbell et al 2005;Aalbers et al 2002;Cheer and Scott, 2002;Rossi et al 2002;Dahl et al 2001]. Formoterol dry powder inhaler (DPI) provides more effective bronchodilation than theophylline [Rossi et al 2002] or ipratropium bromide [Dahl et al 2001].…”

Section: Introductionmentioning

confidence: 99%

Long-term safety of nebulized formoterol: Results of a twelve-month open-label clinical trial

Donohue

Hanania

Fogarty

et al. 2008

Ther Adv Respir Dis

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“…Similarly, formoterol, another LABA, provided a consistent reduction in rescue medication use [25][26][27]. However, formoterol 6 or 12 mg failed to show an effect on dyspnoea, and all doses failed to improve exercise tolerance [25].…”

Section: Labasmentioning

confidence: 99%

Tiotropium as essential maintenance therapy in COPD

Decramer¹

2006

European Respiratory Review

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Over the past decade, several large-scale clinical trials have been performed to assess the impact of pharmacological treatments on patient-centred outcomes such as dyspnoea, exercise tolerance, exacerbations and health-related quality of life (HRQoL) in patients with chronic obstructive pulmonary disease (COPD).Tiotropium, a once-daily inhaled anticholinergic agent that works through prolonged muscarinic M 3 receptor blockade, has consistently been shown to provide sustained improvements in lung function parameters. Furthermore, several prospective trials have shown that tiotropium improves exercise tolerance and augments the beneficial effects of pulmonary rehabilitation. Beyond these important physiological outcomes, tiotropium has been shown to reduce dyspnoea, decrease the frequency of exacerbations and improve HRQoL in studies of f1 yr in duration. Such improvements in patient-centred outcomes may allow patients to increase their activity levels, thereby interrupting the downward spiral of chronic inactivity that leads to physical deconditioning and further reductions in exercise tolerance.Recently, combination therapies of two long-acting bronchodilators have been examined more closely regarding their potential to provide patients with superior symptom relief compared with that provided by single-agent therapy.Because maintenance treatment with tiotropium provides consistent and sustained improvements in many relevant clinical outcomes of chronic obstructive pulmonary disease, it may reduce the progression of the disease. This hypothesis is being tested in the ongoing Understanding the Potential Long-term Impacts on Function with Tiotropium (UPLIFT) trial.

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“…[1] The goals of COPD therapy include QOL). [2][3][4][5][6] Inhaled corticosteroids (ICSs) reduce the (i) improvements in airflow, exercise tolerance, frequency of exacerbations, [7][8][9] but have shown inhealth status and COPD symptoms (e.g. dyspnoea); consistent results in terms of reduction in mortality (ii) prevention of disease progression and exacerba-and modest effects with respect to improvement in tions; and (iii) a reduction in mortality.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Budesonide and Formoterol in One Pressurized Metered-Dose Inhaler in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Tashkin

Rennard

Martin

et al. 2008

Drugs

180

219

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Abstractacting bronchodilator is recommended in the treatment of patients with chronic obstructive pulmonary disease (COPD) who have frequent exacerbations. Budesonide/formoterol dry powder inhaler (DPI) has demonstrated efficacy and tolerability in patients with COPD. Objective: To evaluate the efficacy and tolerability of budesonide/formoterol administered via one hydrofluoroalkane pressurized metered-dose inhaler (pMDI) in patients with COPD. Methods: This was a 6-month, randomized, double-blind, double-dummy, placebo-controlled, parallel-group, multicentre study (NCT00206154) of 1704 patients aged ≥40 years with moderate to very severe COPD conducted in 194 centres in the US, Czech Republic, the Netherlands, Poland and South Africa. After 2 weeks of treatment based on previous therapy (ICSs and short-acting bronchodilators allowed during the run-in period), patients received one of the following treatments administered twice daily: budesonide/formoterol pMDI 160/4.5 μg × two inhalations (320/9 μg); budesonide/formoterol pMDI 80/4.5 μg × two inhalations (160/9 μg); budesonide pMDI 160 μg × two inhalations (320 μg) plus formoterol DPI 4.5 μg × two inhalations (9 μg); budesonide pMDI 160 μg × two inhalations (320 μg); formoterol DPI 4.5 μg × two inhalations (9 μg); or placebo. Main outcome measures:The co-primary efficacy variables were pre-dose forced expiratory volume in 1 second (FEV1) and 1-hour post-dose FEV1. Results: Budesonide/formoterol 320/9 μg demonstrated significantly greater improvements in pre-dose FEV1 versus formoterol (p = 0.026; pre-specified primary comparator) and 1-hour post-dose FEV1 versus budesonide (p < 0.001; pre-specified primary comparator); budesonide/formoterol 160/9 μg demonstrated significantly greater improvements versus budesonide (p < 0.001) for 1-hour post-dose FEV1 but not versus formoterol for pre-dose FEV1. Dyspnoea (measured using the Breathlessness Diary) and health-related quality-of-life (HR-QOL) scores (based on the St George's Respiratory Questionnaire total score) were significantly improved with both dosage strengths of budesonide/formoterol compared with budesonide, formoterol and placebo (p ≤ 0.044 for all). Although not powered a priori for comparisons, the number of exacerbations per patienttreatment year requiring treatment with oral corticosteroids and/or hospitalization was numerically (20-25%) lower with the budesonide-containing treatments (0.710-0.884) versus formoterol (1.098) and placebo (1.110). This result was driven by the exacerbations requiring treatment with oral corticosteroids (79-120 events). The number of exacerbations resulting in hospitalization was very low across treatment groups (11-22); the number per patient-treatment year was significantly different for budesonide/formoterol 320/9 μg (0.158) versus other treatment groups (0.081-0.108) except budesonide/formoterol 160/9 μg (0.139), and for budesonide/formoterol 160/9 μg versus formoterol (0.081) [p ≤ 0.05]. All treatments were generally well tolerated. The incidence of individual non-f...

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Formoterol in patients with chronic obstructive pulmonary disease: a randomized, controlled, 3-month trial

Cited by 137 publications

References 25 publications

Long-term safety of nebulized formoterol: Results of a twelve-month open-label clinical trial

Long-term safety of nebulized formoterol: Results of a twelve-month open-label clinical trial

Tiotropium as essential maintenance therapy in COPD

Efficacy and Safety of Budesonide and Formoterol in One Pressurized Metered-Dose Inhaler in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

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