Formoterol In Patients Research Articles

Influence of Leukotriene Pathway Polymorphism on Responsiveness to Montelukast, Budesonide Plus Formoterol in Patients with Asthma

Variability between patients in response to montelukast, and budesonide / formoterol inhalation powder may be related to genetic variation and non-genetic factors. this paper aims to determine association between polymorphism in leukotriene pathway candidate gene with lung function outcomes in Iraqi patients with asthma receiving montelukast, budesonide plus formoterol inhaler in comparison with healthy control. This research was done on a study group of 80 Baghdad-based Iraqi patients. 40 asthmatic patients receiving montelukast were in the first group, while 40 asthmatic patients on budesonide / formoterol inhalation powder (160/4.5mcg/dose) were in the second group. Screening for the presence of ALOX5 rs2115819, LTA4H rs2660845 and CysLTR1 rs320995 SNPs allelic variants genes were determined using conventional PCR technique and sequencing. In montelukast group, the % change in FEV1 in patients with the GG genotype for ALOX5 (rs2115819) SNP were significantly improved after montelukast intake compared with those carrying AA or AG genotypes. For budesonide / formoterol inhalation powder patients group, the included polymorphism had no significant association with the %change in FEV1. As a conclusion Asthmatic patients carrying AA genotype for ALOX5 rs2115819 may not achieved the optimal response to montelukast treatment. Budesonide / formoterol inhalation powder cannot be used effectively in patients with ALOX5 rs2115819 polymorphism.

Safety and Effectiveness of As-Needed Formoterol in Asthma Patients Taking Inhaled Corticosteroid (ICS)-Formoterol or ICS-Salmeterol Maintenance Therapy.

As-needed low-dose inhaled corticosteroid (ICS)-formoterol reliever is recommended in patients with asthma prescribed maintenance ICS-formoterol. Clinicians often ask whether ICS-formoterol reliever can be used with other maintenance ICS-long-acting β2-agonists. To evaluate the safety and effectiveness of as-needed formoterol in patients taking maintenance ICS-formoterol or ICS-salmeterol from the RELIEF study. RELIEF (SD-037-0699) was a 6-month, open-label study that randomized 18,124 patients with asthma to as-needed formoterol 4.5 μg or salbutamol 200 μg on top of maintenance therapy. This post hoc analysis included patients on maintenance ICS-formoterol or ICS-salmeterol (n= 5436). The primary safety outcome was a composite of serious adverse events (SAEs) and/or adverse events leading to discontinuation (DAEs); the primary effectiveness outcome was time-to-first exacerbation. For both maintenance groups and both relievers, similar numbers of patients had ≥1 SAE and/or DAE. In patients taking maintenance ICS-salmeterol, but not ICS-formoterol, significantly more non-asthma-related and nonserious DAEs occurred with as-needed formoterol versus as-needed salbutamol (P= .0066 and P= .0034, respectively). In patients taking maintenance ICS-formoterol, there was a significantly lower risk in time-to-first exacerbation with as-needed formoterol versus as-needed salbutamol (hazard ratio [HR]: 0.82, 95% confidence interval [CI]: 0.70, 0.95; P= .007). In patients taking ICS-salmeterol maintenance, time-to-first exacerbation was not significantly different between treatment arms (HR: 0.95, 95% CI: 0.84, 1.06; P= .35). As-needed formoterol significantly reduced exacerbation risk compared with as-needed salbutamol when added to maintenance ICS-formoterol, but not to maintenance ICS-salmeterol. More DAEs were seen with ICS-salmeterol maintenance therapy plus as-needed formoterol. Further research is needed to assess whether this is relevant to as-needed combination ICS-formoterol.

A randomized prospective study to compare the efficacy and safety of budesonide plus formoterol and tiotropium plus formoterol in patients having mild to moderate chronic obstructive pulmonary disease

Background: Chronic obstructive pulmonary disease (COPD) is a leading respiratory illness affecting the quality of lives around the world. The present study aims to compare the efficacy and safety of combination of inhaled corticosteroid (ICS) and long acting β2 agonist (LABA) with long acting β2 agonist and long acting muscarinic antagonist (LAMA) in treatment of mild to moderate COPD in a tertiary care hospital.Methods: Total 132 patients with COPD were recruited on the basis of inclusion and exclusion criteria for 8 weeks study from outpatient clinic. A complete pulmonary examination including spirometry examination was done to rule out severe and very severe forms of COPD. Spirometry was performed at the time of recruitment for evaluation of forced expiratory volume in one second (FEV1) and measurement of SpO2 at the time of recruitment at 2 weeks and 8 weeks. Appropriate statistical methods were used to compare the qualitative and quantitative primary and secondary efficacy end points, p value <0.05 was considered significant.Results: On analysis, there was a significant difference (p<0.05) was observed in FEV1 and SpO2 from baseline in ICS plus LABA group (n=66). A similarly significant difference (p<0.05) was observed in LABA and LAMA group (n=66). On comparison between ICS plus LABA and LABA plus LAMA no significant difference in FEV1 and SpO2 was observed between the two groups. More adverse drug reactions were observed in ICS plus LABA group than LAMA plus LABA group.Conclusions: Combination of ICS and LABA combination is as effective as combination of LABA and LAMA in patients having mild to moderate COPD. However, LABA and LAMA combination is preferable because it is associated with fewer side effects.

Efficacy and safety of CHF6001, a novel inhaled PDE4 inhibitor in COPD: the PIONEER study

BackgroundThis study evaluated the efficacy, safety and tolerability of the novel inhaled phosphodiesterase-4 inhibitor CHF6001 added-on to formoterol in patients with chronic obstructive pulmonary disease (COPD).MethodsRandomised, double-blind, placebo- and active-controlled, parallel-group study. Eligible patients had symptomatic COPD, post-bronchodilator forced expiratory volume in 1 s (FEV1) 30–70% predicted, and history of ≥1 moderate/severe exacerbation. Patients were randomised to extrafine CHF6001 400, 800, 1200 or 1600 μg twice daily (BID), budesonide, or placebo for 24 weeks. Primary objectives: To investigate CHF6001 dose-response for pre-dose FEV1 after 12 weeks, and to identify the optimal dose. Moderate-to-severe exacerbations were a secondary endpoint.ResultsOf 1130 patients randomised, 91.9% completed. Changes from baseline in pre-dose FEV1 at Week 12 were small in all groups (including budesonide), with no CHF6001 dose-response, and no significant treatment–placebo differences. For moderate-to-severe exacerbations, CHF6001 rate reductions versus placebo were 13–28% (non-significant). In post-hoc analyses, CHF6001 effects were larger in patients with a chronic bronchitis phenotype (rate reductions versus placebo 24–37%; non-significant), and were further increased in patients with chronic bronchitis and eosinophil count ≥150 cells/μL (49–73%, statistically significant for CHF6001 800 and 1600 μg BID). CHF6001 was well tolerated with no safety signal (including in terms of gastrointestinal adverse events).ConclusionsCHF6001 had no effect in the primary lung function analysis, although was well-tolerated with no gastrointestinal adverse event signal. Post-hoc analyses focused on exacerbation risk indicate specific patient subgroups who may receive particular benefit from CHF6001.Trial registrationClinicalTrials.gov (NCT02986321). Registered 8 Dec 2016.

Effect of long-acting β2-agonists olodaterol and formoterol on heart rate and blood pressure in chronic obstructive pulmonary disease patients

BackgroundCardiovascular comorbidities are common in chronic obstructive pulmonary disease (COPD), and elevated heart rate reflects increased cardiovascular risk over time, which is associated with unfavourable neurohumoral activation. Long-acting β2-agonists (LABAs) are established treatments in COPD, but potentially increase heart rate. We report a post hoc pooled analysis of the effect of olodaterol (5 or 10 μg) or formoterol (12 μg) on heart rate and blood pressure (BP) in Global Initiative for Chronic Obstructive Lung Disease Stage 2–4 COPD patients. MethodsFour randomised, double-blind, placebo-controlled, Phase III studies were analysed. Changes in heart rate and systolic/diastolic BP were measured before and after dosing with the study medication at each visit. ResultsAt each study visit, the increase in pre-dose heart rate was numerically lower with both LABAs compared with placebo. Systolic and diastolic BP were decreased with all treatments. Short-term (pre-dose to 40 min post-dose) effects of drug administration on heart rate were small and similar for all treatment arms (between −3 and +1 beats per minute). ConclusionHeart rate and BP were not adversely influenced in this study involving long-term administration of olodaterol or formoterol in patients with moderate-to-severe COPD. This supports the cardiovascular safety of LABAs in COPD maintenance treatment.

The 24-h FEV1 time profile of olodaterol once daily via Respimat® and formoterol twice daily via Aerolizer® in patients with GOLD 2-4 COPD: results from two 6-week crossover studies.

These studies evaluated the 24-h forced expiratory volume in 1 sec (FEV1) profile of once-daily (QD) olodaterol compared to placebo and twice-daily (BID) formoterol in patients with moderate to very severe chronic obstructive pulmonary disease. In two replicate, randomized, double-blind, double-dummy, four-way crossover studies, patients received olodaterol 5 and 10 μg QD, formoterol 12 μg BID, or placebo for 6 weeks in addition to usual-care background maintenance therapy. Co-primary end points were FEV1 area under the curve from 0–12 h (AUC0–12) response (change from baseline) and FEV1 AUC from 12–24 h (AUC12–24) response after 6 weeks, with FEV1 AUC from 0–24 h response identified as a key secondary end point. Other secondary end points included FEV1 AUC from 0–3 h and trough FEV1 responses, as well as corresponding forced vital capacity responses. With both olodaterol doses, FEV1 increased to near-maximal 30 min post-morning dose, which was sustained over 24 h. FEV1 also increased within 30 min post-morning dose of formoterol and was sustained over 12 h; the second formoterol dose resulted in a further increase, sustained for an additional 12 h. FEV1 AUC0–12 and AUC12–24 responses with both QD olodaterol doses and BID formoterol were significantly greater than placebo at 6 weeks (P < .0001). Secondary end-point outcomes were consistent with those of the co-primary end points. These data, together with those from the wider phase III clinical program, provide evidence for the 24-h bronchodilator efficacy of olodaterol QD in this patient population.Trial registryClinicalTrials.gov; NCT00931385 and NCT00932646.Electronic supplementary materialThe online version of this article (doi:10.1186/2193-1801-3-419) contains supplementary material, which is available to authorized users.

Dose-Ranging Study of 2 Fixed-Dose Combinations of Twice-Daily Aclidinium Bromide Plus Formoterol in Patients With Moderate to Severe COPD

Dose-Ranging Study of 2 Fixed-Dose Combinations of Twice-Daily Aclidinium Bromide Plus Formoterol in Patients With Moderate to Severe COPD

Comparison of the bronchodilator and systemic effects of AZD3199, an inhaled ultra-long-acting β2-adrenoceptor agonist, with formoterol in patients with asthma

Pharmacologically mediated bronchodilation is important in the management of asthma, and is primarily achieved with β₂-agonists. Novel compounds should preferably have a longer duration of action and a better systemic side effect profile than established alternatives at comparable peak bronchodilation. This single-dose crossover study was conducted to investigate and compare with formoterol the bronchodilatory and systemic effects, tolerability and safety of AZD3199, a novel ultra-long-acting β₂-agonist (uLABA). Patients with asthma (n = 37) were randomized to receive AZD3199 (120, 480, 1920 µg), formoterol (9, 36 µg) or placebo inhaled via a Turbuhaler™. Bronchodilation was evaluated by maximum (E(max)) and average 22-26 h (E₂₂₋₂₆) forced expiratory volume in 1 second (FEV1). Serum potassium was evaluated by minimum (E(min)) and 0-4 h average (E(av)) determined from serial measurements. AZD3199 and formoterol were compared on the basis of relative dose potency. Adverse events, clinical laboratory tests and physical examinations were markers for safety and tolerability, with plasma AZD3199 as the indicator of drug exposure. All active treatments dose-dependently increased E(max) and AZD3199 (480 and 1920 µg) and formoterol (36 µg) significantly increased E(₂₂₋₂₆) versus placebo. Relative dose potency between AZD3199 and formoterol was 50-fold on the microgram scale with respect to E max and 11-fold with respect to E(₂₂₋₂₆). Small, dose-dependent effects on potassium, heart rate and QTc were seen after administration of AZD3199 compared with placebo. These well-known dose-related class effects of β₂-agonists were mild. Notably, serum potassium suppression was less pronounced after AZD3199 compared with formoterol at similar bronchodilation. Overall, AZD3199 was well tolerated. AZD3199 480 µg and 1920 µg produced 24-hour bronchodilation. At comparable peak bronchodilator effect, AZD3199 was associated with a lower level of systemic side effects than formoterol. AZD3199 was well tolerated, with no safety concerns identified to preclude further investigation. ClinicalTrials.gov study identifier: NCT00736489.

Budesonide/formoterol via Turbuhaler® versus formoterol via Turbuhaler® in patients with moderate to severe chronic obstructive pulmonary disease: Phase III multinational study results

The efficacy and tolerability of budesonide/formoterol versus formoterol in patients with moderate to severe chronic obstructive pulmonary disease (COPD) was evaluated. In this randomized, double-blind, parallel-group, phase III study (NCT01069289), patients with moderate to severe COPD for ≥2 years received either budesonide/formoterol 160/4.5 μg two inhalations twice daily via Turbuhaler® or formoterol 4.5 μg two inhalations twice daily via Turbuhaler® for 12 weeks. Salbutamol was available as reliever medication. Primary outcome variable: change from baseline to average during treatment in pre-dose forced expiratory volume in 1 s (FEV1 ). One thousand two hundred ninety-three patients were randomized (budesonide/formoterol n = 636; formoterol n = 657). Both budesonide/formoterol and formoterol increased pre-dose FEV1 versus baseline (improvements of 4.6% and 1.5% over baseline, respectively), with the increase from baseline being significantly greater with budesonide/formoterol versus formoterol (budesonide/formoterol:formoterol ratio 1.032; 95% confidence interval: 1.013-1.052; P = 0.0011). The budesonide/formoterol group had a significantly prolonged time to first exacerbation versus the formoterol group (hazard ratio: 0.679; 95% confidence interval: 0.507-0.909; P = 0.0094) and significantly greater improvements in many secondary outcome measures. Both treatments were well tolerated; the incidence and type of adverse events were similar: most commonly reported (budesonide/formoterol vs formoterol): COPD (8.0% vs 9.4%) and nasopharyngitis (5.5% vs 4.9%). Budesonide/formoterol 160/4.5 μg two inhalations twice daily was effective and well tolerated in patients with moderate to severe COPD, offering benefits over formoterol alone in terms of improved lung function and reduced risk of exacerbation.

Comparison of the systemic bioavailability of mometasone furoate after oral inhalation from a mometasone furoate/formoterol fumarate metered-dose inhaler versus a mometasone furoate dry-powder inhaler in patients with chronic obstructive pulmonary disease

BackgroundCoadministration of mometasone furoate (MF) and formoterol fumarate (F) produces additive effects for improving symptoms and lung function and reduces exacerbations in patients with asthma and chronic obstructive pulmonary disease (COPD). The present study assessed the relative systemic exposure to MF and characterized the pharmacokinetics of MF and formoterol in patients with COPD.MethodsThis was a single-center, randomized, open-label, multiple-dose, three-period, three-treatment crossover study. The following three treatments were self-administered by patients (n = 14) with moderate-to-severe COPD: MF 400 μg/F 10 μg via a metered-dose inhaler (MF/F MDI; DULERA®/ZENHALE®) without a spacer device, MF/F MDI with a spacer, or MF 400 μg via a dry-powder inhaler (DPI; ASMANEX® TWISTHALER®) twice daily for 5 days. Plasma samples for MF and formoterol assay were obtained predose and at prespecified time points after the last (morning) dose on day 5 of each period of the crossover. The geometric mean ratio (GMR) as a percent and the corresponding 90% confidence intervals (CI) were calculated for treatment comparisons.ResultsSystemic MF exposure was lower (GMR 77%; 90% CI 58, 102) following administration by MF/F MDI compared to MF DPI. Additionally, least squares geometric mean systemic exposures of MF and formoterol were lower (GMR 72%; 90% CI 61, 84) and (GMR 62%; 90% CI 52, 74), respectively, following administration by MF/F MDI in conjunction with a spacer compared to MF/F MDI without a spacer. MF/F MDI had a similar adverse experience profile as that seen with MF DPI. All adverse experiences were either mild or moderate in severity; no serious adverse experience was reported.ConclusionSystemic MF exposures were lower following administration by MF/F MDI compared with MF DPI. Additionally, systemic MF and formoterol exposures were lower following administration by MF/F MDI with a spacer versus without a spacer. The magnitude of these differences with respect to systemic exposure was not clinically relevant.

A Comparison of the Local and Systemic Effects of AZD3199, an Inhaled Ultra-long-acting β2-adrenoceptor Agonist (uLABA), With Formoterol in Patients With Asthma

To compare the local and systemic effects, tolerability, and safety of single doses of inhaled AZD3199, a novel, ultra-long-acting β2-adrenoceptor agonist, with formoterol in patients with mild-to-moderate asthma.

Clinical Efficacy and Safety of Combined Mometasone Furoate and Formoterol in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Clinical studies have shown that combining inhaled corticosteroids with long-acting β2-agonists can be effective in COPD. We evaluated the combination mometasone furoate/formoterol (MF/F), administered via metered-dose inhaler, as treatment for moderate-very severe COPD.

Combined Mometasone Furoate and Formoterol in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD): Phase 3 Efficacy and Safety Study

Combined Mometasone Furoate and Formoterol in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD): Phase 3 Efficacy and Safety Study

Efficacy and safety of inhaled formoterol 4.5 and 9 μg twice daily in Japanese and European COPD patients: Phase III study results

BackgroundThis study evaluated the efficacy and safety of the long-acting β2-agonist formoterol in patients with moderate-to-severe COPD.MethodsThis double-blind, placebo-controlled, parallel-group, multinational phase III study randomized patients ≥ 40 years of age with moderate-to-severe COPD to inhaled formoterol 4.5 or 9 μg twice daily (bid) via Turbuhaler® or placebo for 12 weeks. Salbutamol 100 μg/actuation via pMDI was permitted as reliever medication. The primary outcome variable was change (ratio) from baseline to treatment period in FEV1 60-min post-dose.Results613 patients received treatment (formoterol 4.5 μg n = 206; 9 μg n = 199; placebo n = 208); 539 (87.9%) male; 324 (52.9%) Japanese and 289 (47.1%) European. End of study increases in FEV1 60-min post-dose were significantly greater (p < 0.001 for both) with formoterol 4.5 and 9 μg bid (113% of baseline for both) than with placebo, as were all secondary outcome measures. The proportion of patients with an improvement in St George's Respiratory Questionnaire score of ≥ 4 was 50.2% for formoterol 4.5 μg (p = 0.0682 vs. placebo), 59.2% (p = 0.0004) for 9 μg, and 41.3% for placebo. Reduction in reliever medication use was significantly greater with formoterol vs. placebo (9 μg: -0.548, p < 0.001; 4.5 μg: -0.274, p = 0.027), with 9 μg being significantly superior to 4.5 μg (-0.274, p = 0.029). Formoterol was well tolerated with the incidence and type of adverse events not being different for the three groups.ConclusionsFormoterol 4.5 μg and 9 μg bid was effective and well tolerated in patients with COPD; there was no difference between formoterol doses for the primary endpoint; however, an added value of formoterol 9 μg over 4.5 μg bid was observed for some secondary endpoints.Trial registrationNCT00628862 (ClinicalTrials.gov); D5122C00001 (AstraZeneca Study code).

P137 Efficacy and safety of once-daily aclidinium bromide 200 μg in combination with formoterol in patients with COPD

IntroductionCombinations of different classes of medication used in the management of chronic obstructive pulmonary disease (COPD) may provide additional improvements compared with monotherapy. This study assessed the efficacy and safety...

Safety of formoterol in patients with asthma: Combined analysis of data from double-blind, randomized controlled trials

Concerns exist that regular long-acting beta(2)-adrenergic agonist (LABA) therapy may increase the risk of serious asthma-related events. To assess risks of formoterol-containing versus non-LABA treatment by using a large asthma database. This analysis included all blind, parallel-arm, randomized, active-controlled and/or placebo-controlled AstraZeneca-sponsored asthma studies with formoterol-containing and non-LABA comparator arms. Serious adverse events were assessed for inclusion in all-cause death, asthma-related death, asthma-related intubation, and asthma-related hospitalization categories by using blind adjudication. Data were combined across trials; relative risk (RR) was assessed by using Mantel-Haenszel methods. Data were from 13,542 formoterol-randomized and 9968 non-LABA patients 4 years or older (42 trials), of whom 93% and 89%, respectively, received inhaled corticosteroid as part of randomized treatment or allowed medication. Incidence of all-cause death was low (n=3 and n=4, respectively), with numerically lower all-cause deaths/1000 patient-treatment years in the formoterol-treated group (0.53) versus the non-LABA group (0.82) (RR, 0.64; 95% confidence interval [CI], 0.14-2.92). No asthma-related deaths and 1 asthma-related intubation (formoterol-treated group) occurred. Asthma-related hospitalizations/1000 patient-treatment years were lower numerically in the formoterol-treated group (12.1) versus the non-LABA group (16.4) (RR, 0.73; 95% CI, 0.54-1.01), with fewer study discontinuations in the formoterol-treated group (12.7% vs 15.4%, respectively; RR, 0.79; 95% CI, 0.74-0.85). Relative to non-LABA, increasing daily formoterol dose (>/=4.5, 9, 18, 36 mug) did not increase the rate or incidence of asthma-related hospitalization. No evidence of increased risk of asthma-related hospitalization, no asthma-related deaths, and a low incidence of all-cause death and asthma-related intubation were seen with formoterol-containing versus non-LABA treatment.

Bronchodilator effects of indacaterol and formoterol in patients with COPD

Background Resting inspiratory capacity (IC) reflects static hyperinflation in chronic obstructive pulmonary disease (COPD). This study compared the effects of formoterol and indacaterol, a novel once-daily ultra-long-acting β 2-agonist (or ultra-LABA), on resting IC and forced expiratory volume in 1 s (FEV 1). Methods Thirty patients with COPD (mean FEV 1/FVC 0.49, mean FEV 1 56% predicted) each inhaled three treatments (two in randomized sequence followed by open-label formoterol) on separate study days: a single dose of indacaterol 300 μg, matching placebo, and two doses of formoterol 12 μg 12 h apart. Results Indacaterol and formoterol increased FEV 1 and IC at all time points relative to placebo ( p < 0.001). Peak effects on FEV 1 were similar, while indacaterol had a greater effect on peak IC (31% vs 23% from pre-dose; p = 0.034). Indacaterol had a greater effect than formoterol on FEV 1 at 8 h (1.47 vs 1.39 L; p = 0.014) and 24 h (1.44 vs 1.35 L; p = 0.003), and on IC from 4 to 24 h (differences of 0.13–0.19 L; p < 0.05). At 24 h, indacaterol and formoterol increased FEV 1 by 17.7% and 7.5%, respectively, from pre-dose. Conclusions This study discriminated between the effects on IC and FEV 1 of once daily indacaterol and twice daily formoterol. The greater effect of indacaterol on IC may translate into improved long-term clinical outcomes.

The safety of formoterol among patients with asthma using inhaled corticosteroids. Systematic review and meta‑analysis

It has been postulated that inhaled long acting beta-agonists (LABAs) when used as monotherapy in asthma may increase the incidence of asthma related deaths, intubations and hospitalizations, but concomitant use of inhaled corticosteroids (ICS) may modify this effect. To assess the safety of formoterol in patients with asthma using ICS. We conducted a systematic review and meta-analysis of parallel group, blinded, randomized controlled trials with at least 12 weeks of treatment examining the impact of twice a day formoterol on asthma-related and total morbidity and mortality in patients concurrently using ICS. Our main analysis considering impact of LABAs (salmeterol and formoterol) has already been published. In this report we present detailed information from studies investigating use of twice daily formoterol among patients receiving ICS. The search yielded 16 relevant studies included in this analysis. Among over 10,000 participants (5,996 taking formoterol with over 4,000 patient-years observation in formoterol groups) there were 2 asthma-related deaths (both in formoterol groups) and no asthma-related non-fatal intubations. The risk of asthma-related hospitalizations (odds ratio [OR] 0.59, 95% CI 0.37-0.93) and asthma-related serious adverse events (mostly hospitalizations) [OR 0.58, 95% CI 0.37-0.91] were significantly lower in patients on formoterol and ICS compared to patients on ICS alone. The OR for total mortality was 1.22, 95% CI 0.38-3.90, reflecting 7 deaths in formoterol groups and 3 deaths in control groups respectively. In patients with asthma using inhaled corticosteroids formoterol decreased the risk of asthma-related hospitalizations. There were too few asthma-related deaths and intubations to establish formoterol's relative impact on these outcomes.

Efficacy of formoterol Turbuhaler in the emergency treatment of patients with obstructive airway diseases

Dry powder devices are rarely used in the emergency room (ER) treatment of acute and severe bronchoconstriction due to hesitations with respect to clinical efficacy. This study investigated the effects of two inhalers with formoterol in patients visiting the ER Department for acute and severe dyspnoea, mainly exacerbations of chronic obstructive pulmonary disease. Two doses of 12mug formoterol were given at enrolment, either via Turbuhaler or via pressurised metered dose inhaler, connected to a spacer device (pMDI+S) in a double-blind way and parallel design. Another two doses of 12 microg formoterol were given after 30 min. Forced expiratory volume in the 1s (FEV(1)) and Borg dyspnoea score were assessed until 60 min. The study was designed to test non-inferiority in effects on FEV(1). Seventy-seven patients were enrolled with a mean age of 66 years and a FEV(1) of 1.03 L (39% of predicted). The effects of the two treatments were almost identical. The mean improvement in FEV(1) at 60 min after formoterol Turbuhaler was 94% of the improvement after formoterol pMDI+S. A statistically significant non-inferiority was shown (p=0.037) at 60 min (primary endpoint) as well as at 5 and 30 min (secondary endpoints, p=0.0043 and 0.013, respectively). Improvements in the Borg dyspnoea score and other lung-function parameters did not differ significantly between the two devices. In conclusion, formoterol Turbuhaler was equally effective as formoterol pMDI+S in the treatment of acute bronchoconstriction within the ER.

Randomised trial comparing as-needed versus regular treatment with formoterol in patients with persistent asthma

Randomised trial comparing as-needed versus regular treatment with formoterol in patients with persistent asthma