Acute effects of indacaterol on lung hyperinflation in moderate COPD: A comparison with tiotropium (original) (raw)
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Respiratory Medicine, 2013
Aim: In this randomized, double-blind, crossover study, we explored the acute effects on respiratory function and safety of an additional dose of indacaterol 150 mg in stable COPD patients regularly treated with a conventional dose of indacaterol 150 mg. Methods: On two non-consecutive days, patients inhaled indacaterol 150 mg. After 180 min, they inhaled an additional dose of indacaterol 150 mg or placebo. Lung function, oxygen saturation by pulse oximetry (SpO 2 ) and heart rate were measured before the first drug administration and up to 360 min thereafter. Results: In both treatment groups, indacaterol induced a significant (P < 0.05) bronchodilation during all the study time. The difference between the FEV 1 AUCs 0e180 min was not statistically significant (P Z 0.971). On the contrary, the difference between the FEV 1 AUCs 180e360 min was significant (P < 0.0001). However, only 8 out of 20 patients showed a further increase of at least 100 ml from the peak obtained after the first administration of indacaterol 150 mg with the second dose of 150 mg. Indacaterol 150 mg induced a modest but significant decrease in SpO 2 up to 60 min and a second dose of indacaterol 150 mg significantly decreased the SpO 2 mean value up to 360 min. Conclusion: This study suggests that it is reasonable and safe to increase the dose of indacaterol in those stable COPD patients who are under regular therapy with indacaterol 150 mg from which they do not draw the maximum benefit because they are unable to perceive bronchodilation. However, only a minority of patients seem to benefit from this dose escalation, at least in terms of spirometric improvement. ª
The effect of indacaterol during an acute exacerbation of COPD
Pulmonary Pharmacology & Therapeutics, 2013
Some clinical trials have suggested that the inhaled long-acting b 2 -agonists (LABAs) may be effective in the treatment of acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Since indacaterol, the first once-daily LABA to be developed for the regular treatment of COPD, exhibits fast onset of action and 24-h duration of bronchodilation, we have investigated its effects in patients with AECOPD managed in the emergency department.
The Lancet. Respiratory medicine, 2013
We compared the efficacy and safety of indacaterol and tiotropium in patients with severe chronic obstructive pulmonary disease (COPD) and a history of at least one moderate to severe exacerbation in the previous 12 months. In this multicentre, randomised, blinded, double-dummy, parallel group study, we enrolled patients aged 40 years or older with severe COPD and at least one exacerbation within the previous year. We used a computer-generated sequence to randomly allocate patients (1:1; stratified by baseline inhaled corticosteroid use, with the balance of treatments maintained at country level) to receive either indacaterol (150 μg) or tiotropium (18 μg) once-daily for 52 weeks. Our primary and key secondary objectives were to investigate whether indacaterol was non-inferior to tiotropium for trough forced expiratory volume in 1 s (FEV1) at week 12 (primary endpoint), and for rate of exacerbations at week 52 (secondary endpoint). Analysis populations for the primary and key second...
Comparative efficacy of indacaterol in chronic obstructive pulmonary disease
International journal of chronic obstructive pulmonary disease, 2012
Long-acting bronchodilators have been shown to improve multiple clinical outcomes in chronic obstructive pulmonary disease (COPD) including lung function, symptoms, dyspnea, quality of life, and exacerbations. Indacaterol is a novel, inhaled, long-acting β2-agonist providing 24-hour bronchodilation with once-daily dosing. It is currently approved for the maintenance treatment of COPD to be administered as 150 or 300 μg once-daily doses as licensed in many countries and 75 μg as licensed in the US by means of a single-dose dry powder inhaler. The data from clinical development support a favorable safety and tolerability profile within the β2-agonist drug class, with no relevant issues identified. Current evidence indicates that indacaterol is suitable for use as first-line monotherapy in COPD patients with moderate disease (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage II) and beyond that do not require an inhaled corticosteroid (ICS) as per GOLD guidelines, or ...
Safety of indacaterol in the treatment of patients with COPD
International Journal of Chronic Obstructive Pulmonary Disease, 2011
Pooled data were analyzed to evaluate the safety and tolerability of indacaterol, a once-daily inhaled long-acting β 2-agonist for chronic obstructive pulmonary disease (COPD). Patients and methods: Data were pooled from clinical studies of 3-12 months' duration in patients with moderate-to-severe COPD receiving double-blind indacaterol 75 µg (n = 449), 150 µg (n = 2611), 300 µg (n = 1157), or 600 µg once daily (n = 547); formoterol 12 µg twice daily (n = 556); salmeterol 50 µg twice daily (n = 895); placebo (n = 2012); or tiotropium 18 µg once daily, given open label or blinded (n = 1214). Outcomes were adverse events, serious adverse events and deaths, plasma potassium, blood glucose, and QTc interval and vital signs. Results: The commonest adverse events with indacaterol were COPD worsening, nasopharyngitis, and headache; most cases were mild or moderate and incidence was generally similar to placebo and other active treatments. The risk of acute respiratory serious adverse events (leading to hospitalization, intubation, or death) was not significantly increased with any of the active treatments compared with placebo. COPD exacerbation rates (analyzed in the intent-to-treat population) were significantly reduced with all active treatments versus placebo. Hazard ratios versus placebo for major cardiovascular adverse events were ,1 for all indacaterol doses. Notable values for vital signs and measures of systemic β 2-adrenoceptor activity were rare with indacaterol. The number of deaths adjusted per patient-year was lower with indacaterol (all doses combined) than with placebo (relative risk 0.21 [95% confidence interval 0.07-0.660], P = 0.008). Conclusion: Indacaterol has a good profile of safety and tolerability that is appropriate for the maintenance treatment of patients with COPD.
Role of indacaterol, a once-daily bronchodilator, in chronic obstructive pulmonary disease
Journal of thoracic disease, 2013
Chronic obstructive pulmonary disease (COPD) is characterized by progressive airflow obstruction that can lead to lung destruction and dyspnea. Although there has been a slight reduction in mortality in recent decades, COPD is still a serious health problem that has enormous costs and utilizes significant medical resources. There have been a number of pharmacologic interventions that have been developed for the treatment of COPD. Current guidelines recommend the use of long-acting bronchodilators for the treatment of moderate and severe stage COPD, since they have been shown to improve lung function, respiratory symptoms, and quality of life. Indacaterol is a once-daily beta2-agonist (β2-agonist) delivered by a single-dose dry powder inhaler used for the treatment of COPD. It is currently approved at a dose of 75 μg in the United States and a dose of 150 μg with a maximal dose of 300 μg in Europe and other countries. Several studies show that indacaterol was statistically superior t...
Pulmonary pharmacology & therapeutics, 2015
Indacaterol is an inhaled, once-daily, ultra-long-acting β2-agonist for the treatment of chronic obstructive pulmonary disease (COPD). We report on the effectiveness of indacaterol and other bronchodilators compared with placebo in patients across the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011 categories A to D. A post-hoc, subgroup pooled analysis of 6-month efficacy data from three randomized, placebo-controlled, parallel-group studies involving 3862 patients was performed across GOLD 2011 categories A to D, according to baseline forced expiratory volume in 1 s (FEV1) % predicted, modified Medical Research Council (mMRC) dyspnea scale, and exacerbation history in the 12 months prior to entry. Efficacy of once-daily indacaterol 150 and 300 μg, open-label tiotropium 18 μg, twice-daily salmeterol 50 μg, and formoterol 12 μg was compared with placebo. End points analysed were trough FEV1, transition dyspnea index (TDI), and St George's Respiratory Questionn...
Effect of indacaterol on arterial blood gases in patients suffering from acute exacerbation of COPD
Respiratory Medicine, 2014
Aim: The administration of b 2 -agonists to patients with airways obstruction often results in transient decrease in PaO 2 despite concomitant bronchodilation. This effect is potentially dangerous for patients suffering from acute exacerbation of COPD (AECOPD). In this study, we investigated the effect of indacaterol 150 mg and 300 mg on the arterial blood gas tensions of hospitalised patients with AECOPD. Methods: We explored the acute effects on arterial blood gases and spirometry of two doses of indacaterol Breezhaler (150 and 300 mg) in 12 patients hospitalised because of an AECOPD in 2 non-consecutive days under open-label, randomized, crossover conditions, with blind evaluation. Blood specimens were taken just before the inhalation and at 15, 30, 60, 120, 240 and 360 min after inhalation of each treatment, and spirometry was performed at the same time points. Results: Both doses of indacaterol did not cause significant changes in blood gases, although some patients with relatively well-preserved PaO 2 presented transient episodes of oxygen desaturation that normalize spontaneously in a very short time. Moreover, they induced a significant mean increase in FEV 1 and FVC, although the improvement caused by indacaterol 300 mg was larger. Conclusions: Indacaterol up to 300 mg is a potent bronchodilator that may induce small, transient decrease in PaO 2 mainly in patients with relatively well-preserved PaO 2 . There appeared to be no clinical consequences of these PaO 2 abnormalities in patients suffering from AECOPD. ª
BACKGROUND: Indacaterol is an inhaled, long-acting beta(2)-agonist providing 24-h bronchodilation with once-daily dosing in patients with COPD. METHODS: Subjects with moderate to severe COPD who completed a 26-week, randomized, double-blind study were eligible for enrollment in an extension, during which treatment with double-blind indacaterol, 150 or 300 mug once daily, or placebo was continued for a further 26 weeks. The primary objective was to evaluate the long-term safety of indacaterol. Efficacy end points included trough (24 h postdose) FEV(1) at 52 weeks, exacerbations, and health status (St. George Respiratory Questionnaire [SGRQ]). RESULTS: Four hundred fifteen subjects participated in the extension. Adverse events, mostly mild or moderate, occurred in 76%, 77%, and 68% of subjects receiving indacaterol, 150 mug; indacaterol, 300 mug; and placebo, respectively. Serious adverse events occurred in 10.4%, 12.3%, and 10.5%, respectively. Indacaterol had no clinically significant effects on ECG findings (corrected QT interval) or on serum potassium or plasma glucose levels. Indacaterol increased trough FEV(1) relative to placebo throughout the study (difference of >/= 170 mL at week 52). No tolerance to its bronchodilator effect was detected. Indacaterol treatment was accompanied by significant reductions in COPD exacerbations (rate ratios compared with placebo, 0.62-0.64; P < .05) and as-needed albuterol use (1.2-1.4 puffs/d decrease, P < .001 compared with placebo). Health status improved with indacaterol treatment, with decreases from baseline in mean total SGRQ score generally > 4 units. CONCLUSIONS: During 1 year of treatment, indacaterol was well tolerated and provided significant and well-maintained bronchodilation that was accompanied by improved clinical outcomes. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00677807; URL: www.clinicaltrials.gov.
International journal of chronic obstructive pulmonary disease, 2013
Once-daily long-acting β2-agonists (LABAs) are an important treatment option, either alone or in combination with other inhaled long-acting bronchodilators in the management of chronic obstructive pulmonary disease (COPD). To audit the effectiveness of indacaterol as maintenance therapy in patients with moderate-to-severe COPD (Global initiative for chronic Obstructive Lung Disease [GOLD] stage II/III). This was a single-center audit of a primary care COPD cohort comprising all patients treated with indacaterol following treatment escalation (as per National Institute for Health and Care Excellence guidelines) or failure with other therapies. The sample was restricted to patients treated for a minimum of 12 months with indacaterol, for whom preswitching and follow-up spirometry as well as exacerbation frequency data were available (GOLD spirometry guidelines). Pulmonary function was assessed by spirometry (recorded as forced expiratory volume in 1 second [FEV1] expressed as percenta...