Use Of Salbutamol Research Articles

Beta2-adrenergic agonist use and the risk of multiple sclerosis: a total population-based case-control study

Objective: The aim of this study was to investigate whether the use of fenoterol, a beta2-adrenergic agonist, was associated with multiple sclerosis (MS) risk by conducting a total population-based case-control study in Taiwan. Methods: A total of 578 patients with newly diagnosed MS who had a severely disabling disease (SDD) certificate between January 1, 2002 and December 1, 2008 comprised the case group. These cases were compared with 2890 gender-, age-, residence-, and insurance premium-matched controls. Fenoterol use was analyzed using a conditional logistic regression model that controlled for asthma, chronic obstructive pulmonary disease (COPD), salbutamol and steroid use. Results: Compared with the group of people who did not use fenoterol, the adjusted odds ratios were 0.67 (95% confidence interval (CI) = 0.48–0.93, p = 0.016) for the group prescribed fenoterol below 2.25 cumulative defined daily dose (cDDD) and 0.49 (95% CI = 0.33–0.71, p < 0.001) for the group with a cumulative fenoterol use of more than 2.25 cDDD. The dose-response relationship was similar within the non-asthma patients. The associations were similar between males and females, but differences between age groups were observed. Conclusions: The results of this study suggest that fenoterol use may reduce the risk of MS.

Metrics of salbutamol use as predictors of future adverse outcomes in asthma

Beta-agonist overuse is associated with adverse outcomes in asthma, however, the relationships between different metrics of salbutamol use and future risk are uncertain. To investigate the relationship between metrics of salbutamol use and adverse outcome. In a 24-week randomized controlled trial of 303 asthma patients at risk of severe exacerbations which compared the efficacy and safety of combination budesonide/formoterol inhaler according to a single inhaler regimen (SMART) with a fixed-dose regimen with salbutamol as reliever ('Standard'), actual medication use was measured by electronic monitoring (Australian New Zealand Clinical Trials Registry Number ACTRN12610000515099). A nested cohort study explored the relationship between metrics of baseline salbutamol use over 2weeks and future severe asthma exacerbations, poor asthma control (ACQ-5≥1.5) or 'extreme' salbutamol overuse (>32 salbutamol actuations/24-h period). Higher mean daily salbutamol use (per two actuations/day) [Odds ratio (OR) (95% CI) 1.24 (1.06-1.46)], higher days of salbutamol use (per 2days in 2weeks) [OR 1.15 (1.00-1.31)] and higher maximal 24-h use (per two actuations/day) [OR 1.09 (1.02-1.16)] were associated with future severe exacerbations. Higher mean daily salbutamol use was associated with future poor asthma control [OR 1.13 (1.02-1.26)]. Higher mean daily salbutamol use [OR 2.73 (1.84-4.07)], number of days of use [OR 1.46 (1.24-1.71)], and maximal daily use [OR 1.57 (1.31-1.89)] were associated with an increased risk of future extreme salbutamol overuse. Electronically recorded frequency of current salbutamol use is a strong predictor of risk of future adverse outcomes in asthma, with average daily use performing the best. These findings provide new information for clinicians considering metrics of salbutamol as predictors of future adverse outcomes in asthma.

Proof-of-concept evaluation of trough airway hyper-responsiveness following regular racemic or levosalbutamol in genotype-stratified steroid-treated persistent asthmatic patients

Asthmatic patients receiving ICSs (inhaled corticosteroids) may take frequent add-on therapy with salbutamol despite on-demand prescription. Frequent salbutamol use can be detrimental in asthma. The isomeric formulation of salbutamol and the B2ADR (β2 adrenoceptor) 16 genotype may also influence this phenomenon. We performed a randomized, double-blind, placebo-controlled, triple crossover, proof of concept trial comparing 2weeks of regular therapy with inhaled racemic salbutamol [200μg q.i.d. (four times daily)], levosalbutamol (100μg q.i.d.) or placebo on trough methacholine PC20 [provocative concentration causing 20% fall in FEV1 (forced expiratory volume in 1s)] 6h post-dose (the primary outcome) in 30 persistent asthmatic patients (15 who were Arg16 homozygous and 15 who were Gly16 homozygous) all receiving ICSs. There was no worsening of AHR (airway hyper-responsiveness) at trough to methacholine after 2weeks regular exposure to either racemic (P=0.53) or levosalbutamol (P=0.84) compared with placebo, nor between genotypes-as dd (doubling dilution) difference in methacholine PC20 from placebo [salbutamol/Arg16=0.36 dd [95% CI (confidence interval), -0.43, 1.15]; salbutamol/Gly16=0.01 dd (95% CI, -0.47, 0.49); levosalbutamol/Arg16=-0.01 dd (95% CI, -0.89, 0.87); and levosalbutamol/Gly16=0.28 dd (95% CI, -0.22, 0.77)]. Both active treatments improved morning PEF (peak expiratory flow) in Gly16 (P=0.04 overall) but not Arg16 (P=0.50 overall) patients, whereas evening PEF improved in both Gly16 (P<0.001 overall) and Arg16 (P=0.006 overall) patients. In conclusion, the regular exposure to either racemic or levosalbutamol for 2weeks added to ICSs did not cause worsening of AHR at trough compared with placebo; with no difference seen between B2ADR 16 genotypes.

Correlation between nitrites in induced sputum and asthma symptoms in asthmatic schoolchildren

To determine if nitrites (nitric oxide metabolites) measured in induced sputum decrease and correlate with improvement of clinical asthma symptoms after treatment, we performed a prospective longitudinal study in a tertiary care hospital in Arequipa, Peru. In 95 schoolchildren with mild and moderate persistent asthma we determined nitrites in induced sputum samples (measured using the Griess assay). Clinical parameters and exercise bronchial challenge (EBC) test were performed twice, at baseline and after 3 months of beclomethasone-dipropionate treatment (median doses: 300 mcg/day, IQR: 300-450). Sixty out of 95 children completed the study (median age of 9-year [IQR: 7-13]). A significant change in sputum nitrites levels between admission and the end of the study was observed (34.4 nmol/ml [IQR:18.2-58.4] and 11.2 nmol/ml [6-20.1], respectively, P = < 0.0001). Also a significant correlation between decrease of sputum nitrites levels and improvement of clinical parameters (acute exacerbations [r = 0.361, P = 0.005]; use of salbutamol [r = 0.322, P = 0.013]; emergency visits [r = 0.275, P = 0.033]; and school absence [r = 0.41, P = 0.001]) from admission to the end of the study was found. However, sputum nitrites levels did not correlated with peripherical blood eosinophils or serum IgE levels or with EBC test at any point of the study. The decrease of sputum nitrites levels after the treatment was significant in each asthma group (mild and moderate), but not between groups. This study showed that measured nitrite in induced sputum (a simple and cheap non-invasive method) is a good alternative for monitoring asthmatic treatment in schoolchildren.

Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD

To examine the efficacy and safety of the once-daily, inhaled, long-acting muscarinic antagonist/β2-agonist combination umeclidinium/vilanterol (UMEC/VI) compared with UMEC and VI monotherapies in patients with chronic obstructive pulmonary disease (COPD). In this 24-week, double-blind, placebo-controlled, parallel-group study (ClinicalTrials.gov: NCT01313650) eligible patients were randomised 3:3:3:2 to treatment with UMEC/VI 62.5/25mcg, UMEC 62.5mcg, VI 25mcg or placebo administered once daily via dry powder inhaler (N=1532; intent-to-treat population). Primary endpoint was trough forced expiratory volume in one second (FEV1) on Day 169 (23-24h post-dose). Additional lung-function, symptomatic, and health-related quality-of-life endpoints were assessed, including 0-6h weighted-mean FEV1, rescue salbutamol use, Transition Dyspnoea Index (TDI), Shortness Of Breath With Daily Activity (SOBDA) and St. George's Respiratory Questionnaire (SGRQ) scores. Safety evaluations included adverse events (AEs), vital signs, 12-lead/24-h Holter electrocardiography parameters and clinical laboratory/haematology measurements. All active treatments produced statistically significant improvements in trough FEV1 compared with placebo on Day 169 (0.072-0.167L, all p<0.001); increases with UMEC/VI 62.5/25mcg were significantly greater than monotherapies (0.052-0.095L, p≤0.004). Improvements were observed for UMEC/VI 62.5/25mcg vs placebo for weighted-mean FEV1 on Day 168 (0.242L, p<0.001), rescue salbutamol use during Weeks 1-24 (-0.8 puffs/day, p=0.001), TDI (1.2 units, p<0.001), SOBDA (-0.17 units, p<0.001) and SGRQ (-5.51 units, p<0.001) scores. No clinically-significant changes in vital signs, electrocardiography, or laboratory parameters were observed. Once-daily UMEC/VI 62.5/25mcg was well tolerated and provided clinically-significant improvements in lung function and symptoms in patients with COPD.

Abundant neutrophil extracellular traps in thrombus of patient with microscopic polyangiitis

The Asthma Severity Scoring System (ASSESS) quantifies asthma severity in adolescents and adults. Scale performance in children < 12 years is unknown.To validate the ASSESS score in the All Age Asthma Cohort (ALLIANCE) and explore its use in children <12 years.Scale properties, responsiveness, and known-group validity were assessed in 247 children (median age 11 years, IQR: 8-13 years) and 206 adults (median age 52 years, IQR: 43-63 years).Overall, measures of internal test consistency and test-retest reliability were similar to the original data of the Severe Asthma Research Program (SARP). Cronbach’s α was 0.59 in children 12–18 years and 0.73 in adults, reflecting the inclusion of multiple and not always congruent dimensions to the ASSESS score especially in children. Analysis of known-group validity confirmed the discriminatory power, as the ASSESS score was significantly worse in patients with poor asthma control, exacerbations and increased salbutamol use. In children between 6–11 years test reliability was inferior compared to adults and adolescents (Cronbach’s α 0.27) mostly due to a less lung function impairment in asthmatic children of this age group. Known-group validity however confirmed good discriminative power regarding severity-associated variables similar to adolescents and adults.Test reliability and validity of the ASSESS score was confirmed in the ALLIANCE cohort. In children aged 6-11 years internal consistency was inferior compared to older asthma patients, however test validity was good and encourages age-spanning usage of the ASSESS score in all asthma patients ≥ 6 years.

Chronic treatment with indacaterol and airway response to salbutamol in stable COPD

Tolerance to both the bronchoprotective effect, and, to a lesser extent, the bronchodilator activity, occurs with all inhaled β2-agonists. Assumed the importance of this topic and the lack of a clinical evaluation specifically designed to assess the impact of chronic administration of indacaterol on the response to salbutamol, we sought to compare the effect of 4-week treatment with indacaterol 150μg once-daily versus formoterol 12μg twice-daily on the dose-response curve to inhaled salbutamol (total cumulative dose of 800μg) in a non-double-blinded, crossover, randomised, and controlled pilot trial that enrolled 20 outpatients with moderate to severe COPD. At the end of 4-week treatments, there was not a statistically significant difference between the two trough FEV1 (p=0.16), and both indacaterol and formoterol were able to produce a significant (p<0.001) increase in FEV1 mean differences (L)=indacaterol 0.15 (95% confidence interval (CI) 0.12-0.18); formoterol 0.10, (95% CI 0.08-0.12) 2h after their inhalation. Salbutamol elicited an evident dose-dependent increase in FEV1 and this occurred also after regular treatment with indacaterol and formoterol with a further mean maximum increase of 0.10L (95% CI 0.05-0.14) and 0.05L (95% CI 0.02-0.08), respectively. The differences between indacaterol and formoterol in FEV1 increases after salbutamol were never statistically significant. The results of thisstudy support the use of salbutamol as rescue medication for rapid relief of bronchospasm in patients suffering from COPD, even when they are under regular treatment with indacaterol.

Safety and Efficacy of 12-Week or Longer Indacaterol Treatment in Moderate-to-Severe COPD Patients: A Systematic Review

This is a meta-analysis of the safety and efficacy of indacaterol in chronic obstructive pulmonary disease (COPD) with treatment duration of ≥12weeks. Randomized controlled trials (RCTs) reported in English (to September 30, 2012) were identified from PubMed, the Cochrane Library, Embase, websites, reference lists, and manual searches. Two reviewers independently assessed the quality of the trials and extracted information. Five RCTs were eligible. Five involved indacaterol, two salmeterol, one formoterol, and one tiotropium. Four studies had placebos. Using trough forced expiratory volume in 1s as a measure of therapeutic effect, indacaterol was superior to the other β2-agonists, tiotropium, and placebo at weeks 12, 26, and 52. Indacaterol had a greater effect on the transition dyspnoea index compared with placebo, formoterol, and salmeterol, but not open-label tiotropium. In reducing the as-needed use of salbutamol, indacaterol were superior to placebo, tiotropium, and formoterol, but not salmeterol (5, 95% confidence interval (CI), -2.15, 12.15). Indacaterol improved St George's Respiratory Questionnaire scores more than placebo and open-label tiotropium, but not formoterol. Indacaterol seemed to cause more adverse events than placebo only at a dose of 600μg daily and a duration of 52weeks (risk ratio 1.15; 95% CI, 1.04, 1.26). The total and serious adverse events and adverse events leading to discontinuation were comparable with open-label tiotropium and the β2-agonists. Indacaterol is effective and well-tolerated as a bronchodilator for the maintenance of moderate to severe COPD.

Tailored second-line therapy in asthmatic children with the Arg16 genotype

The Arg(16) β(2) receptor genotype confers increased susceptibility to exacerbations in asthmatic children taking regular LABA (long-acting β(2) agonists). We therefore evaluated using montelukast as an alternative to salmeterol as tailored second-line asthma controller therapy in children expressing this susceptible genotype. A total of 62 persistent asthmatic children with the homozygous Arg16 genotype were randomized to receive salmeterol (50 μg, b.i.d.) or montelukast (5 or 10 mg, once daily) as an add-on to inhaled fluticasone for 1 year. School absences (the primary outcome) were reduced with montelukast compared with salmeterol {difference in score=-0.40 [95% CI (confidence interval), -0.22 to -0.58]; P=0.005}. Salbutamol use was also reduced with montelukast compared with salmeterol [difference in score=-0.47 (95% CI, -0.16 to -0.79); P<0.0001]. Greater improvements occurred in both symptom and quality of life scores with montelukast against salmeterol, whereas there was no difference in FEV(1) (forced expiratory volume in 1 s). In conclusion, montelukast may be suitable as tailored second-line controller therapy instead of salmeterol in asthmatic children expressing the susceptible Arg(16) genotype, a move towards a personalized medicine approach to management.

Bronchodilation of umeclidinium, a new long-acting muscarinic antagonist, in COPD patients

BackgroundThis study evaluated the dose–response of the new long-acting muscarinic antagonist umeclidinium (GSK573719) in patients with COPD. MethodsThis randomized, double-blind, placebo-controlled, parallel-group study evaluated three once-daily doses of umeclidinium (125, 250 and 500μg) for 28days in 285 patients with COPD having FEV1 of 35–70% predicted (mean (SD) age=61.4 (8.41); mean (SD) post-bronchodilator FEV1=1.577 (0.450)). The primary endpoint was morning trough FEV1 at Day 29. Secondary endpoints included 0–6h weighted mean FEV1 and serial FEV1 measured over 6h post-dose and at trough. Safety and pharmacokinetics were also assessed. ResultsAll doses of umeclidinium significantly increased trough FEV1 over placebo from 150 to 168mL (p<0.001), 0–6h weighted mean FEV1 from 113 to 211mL (p<0.001), and serial FEV1 at each point in time over 24h. Reductions in salbutamol use and improvements in FVC were noted for all doses. Umeclidinium was well tolerated with no apparent treatment-related changes in vital signs. ConclusionOnce-daily umeclidinium provides clinically significant, sustained improvement in lung function and is well tolerated.

Salbutamol tolerance to bronchoprotection: course of onset

BackgroundRegular use of inhaled β-agonist leads to tolerance to its bronchoprotective effect. This occurs within 12 hours with salmeterol and has been documented at 1 week for salbutamol. The course of onset after introduction of salbutamol has not been investigated. ObjectiveTo determine the course of onset of tolerance to the bronchoprotective effect of salbutamol against methacholine. MethodsThirteen individuals with mild asthma completed a randomized, double-blind, placebo-controlled, cross-over study. Each treatment period consisted of 7 twice-daily doses (2 puffs of 100 μg of salbutamol or placebo). Methacholine challenges were conducted 24 hours apart on 4 consecutive days, 10 minutes after the first, third, fifth, and seventh doses. The 2 treatment periods were separated by at least 14 days. ResultsMethacholine provocation concentration that caused a decrease in forced expiratory volume in 1 second of 20% (PC20) values during the 4 days of placebo treatment did not significantly differ (analysis of variance P = .79). A single dose of salbutamol shifted the methacholine PC20 approximately 5-fold from a geometric mean of 2.1 mg/mL to a geometric mean of 10.7 mg/mL. Maximal bronchoprotection after the active treatment occurred on day 2 after the third dose, which was significantly higher than on day 1 after the first dose (P = .04). After the fifth dose the methacholine PC20 was trending downward, and on day 4 the bronchoprotective effect of salbutamol had significantly decreased from its peak protection (P = .001). ConclusionThe detrimental effects on bronchoprotection after regular use of salbutamol manifest after 5 doses and are significantly reduced from peak protection after 7 doses. Trial Registrationclinicaltrials.gov Identifier: NCT01338311

Allergic rhinitis and non‐allergic rhinitis in children in the tropics: Prevalence and risk associations

The age-related comparative prevalence of allergic rhinitis (AR) and non-allergic rhinitis (NAR) in children is poorly defined. We aimed to characterize AR and NAR in children. This study enrolled children with chronic rhinitis who presented to a tertiary paediatric center for a diagnostic skin prick test (SPT). Parents completed a medical history questionnaire for their child, including disease activity for asthma and rhinitis. Sociodemographic data was obtained and all participants underwent a common inhalant SPT panel. A positive SPT indicated AR. From March 2001 to March 2009, 6,660 children (64% male) were enrolled (aged 6 months to 19 years, mean 7.82 years). Only 3.7% (249) of the children were <2 years old, and almost 30% of these had AR. Most children with AR (73%) presented after age 6. Males were more likely to have AR (vs. NAR) (OR 1.5; CI 1.39-1.77). Antihistamine and salbutamol use did not differ between children with AR and NAR. Children with AR were more likely to require adjunct therapy with inhaled corticosteroids (51.2% vs. 43.2%, P < 0.001), have drug hypersensitivity (especially antipyretic drugs) (2.5% vs. 1.3%, P = 0.384) or an asthma admission (9.1% vs. 6.0%, P < 0.001). AR is more common in male children, is relatively rare below the age of 2 years, and accounts for two-thirds of all childhood chronic rhinitis and 73.3% of all chronic rhinitis in school-aged children (≥6 years old). Children with AR have more severe rhinitis symptoms and more often suffer from asthma-related events and admissions.

An algorithm for the use of intravenous salbutamol in children

An algorithm for the use of intravenous salbutamol in children

An algorithm for the use of intravenous salbutamol in children

the evidence base for the management of severe or life-threathening exacerbations of asthma is not as strong as that for mild or moderate exacerbations. Despite this information deficit, intravenous (IV) salbutamol has become an accepted treatment option for children not responding to inhaled bronchodilator and corticosteroid therapy. Studies have shown that it is used in many centres in the UK replacing IV aminophylline, however, there is wide variation in dosing regimens and inconsistencies in practice. The authors audited their own prescribing practice and developed an algorithm-based approach to the use of IV salbutamol that includes patient selection and all aspects of prescribing, preparation, administration, monitoring and the requirements of the environment where care is delivered. It includes details of the IV salbutamol bolus and the infusion process, incorporating all available evidence. The algorithm provides guidance on IV salbutamol usage in children up to and including 18 years. The authors hope it will promote standardised practice, limit the opportunity for prescribing errors and highlight the need for a national paediatric study comparing IV salbutamol and IV aminophylline. It may also stimulate discussion on the IV salbutamol dosage used in adult practice.

Impact of fluctuating patterns of bronchiolitis epidemics in infants

To the Editor, Walker and coauthors [5] recently reported on the effects of introducing a new clinical care pathway in the management of bronchiolitis in infants aged below 6 months. They observed a significant reduction in the use of salbutamol and ipratropium bromide, and an overall reduction in the duration of hospital stay while the prescription rate of antibiotics

Prediction and course of symptoms and lung function around an exacerbation in chronic obstructive pulmonary disease

BackgroundFrequent exacerbations induce a high burden to Chronic Obstructive Pulmonary Disease (COPD). We investigated the course of exacerbations in the published COSMIC study that investigated the effects of 1-year withdrawal of fluticasone after a 3-month run-in treatment period with salmeterol/fluticasone in patients with COPD.MethodsIn 373 patients, we evaluated diary cards for symptoms, Peak Expiratory Flow (PEF), and salbutamol use and assessed their course during exacerbations.ResultsThere were 492 exacerbations in 224 patients. The level of symptoms of cough, sputum, dyspnea and nocturnal awakening steadily increased from 2 weeks prior to exacerbation, with a sharp rise during the last week. Symptoms of cough, sputum, and dyspnea reverted to baseline values at different rates (after 4, 4, and 7 weeks respectively), whereas symptoms of nocturnal awakening were still increased after eight weeks. The course of symptoms was similar around a first and second exacerbation. Increases in symptoms and salbutamol use and decreases in PEF were associated with a higher risk to develop an exacerbation, but with moderate predictive values, the areas under the receiver operating curves ranging from 0.63 to 0.70.ConclusionsExacerbations of COPD are associated with increased symptoms that persist for weeks and the course is very similar between a first and second exacerbation. COPD exacerbations are preceded by increased symptoms and salbutamol use and lower PEF, yet predictive values are too low to warrant daily use in clinical practice.

Airway responses and inflammation in subjects with asthma after four days of repeated high-single-dose allergen challenge.

BackgroundBoth standard and low-dose allergen provocations are an established tool in asthma research to improve our understanding of the pathophysiological mechanism of allergic asthma. However, clinical symptoms are less likely to be induced. Therefore, we designed a protocol for repetitive high-dose bronchial allergen challenges to generate clinical symptoms and airway inflammation.MethodsA total of 27 patients aged 18 to 40 years with positive skin-prick tests and mild asthma underwent repetitive high-dose allergen challenges with household dust mites for four consecutive days. Pulmonary function and exhaled NO were measured at every visit. Induced sputum was analysed before and after the allergen challenges for cell counts, ECP, IL-5, INF-γ, IL-8, and the transcription factor Foxp3.ResultsWe found a significant decrease in pulmonary function, an increased use of salbutamol and the development of a late asthmatic response and bronchial hyperresponsiveness, as well as a significant induction of eNO, eosinophils, and Th-2 cytokines. Repeated provocation was feasible in the majority of patients. Two subjects had severe adverse events requiring prednisolone to cope with nocturnal asthma symptoms.ConclusionsRepeated high-dose bronchial allergen challenges resulted in severe asthma symptoms and marked Th-2-mediated allergic airway inflammation. The high-dose challenge model is suitable only in an attenuated form in diseased volunteers for proof-of-concept studies and in clinical settings to reduce the risk of severe asthma exacerbations.Trial registrationClinicalTrials.govNCT00677209

The effect of 800 μg and 1600 μg inhaled salbutamol on FEV1 in non-asthmatic football players

The World Anti-doping Agency stipulates that athletes who declare the use of salbutamol should not exceed 1600 μg over a 24 h period. Most studies investigating the effect of inhaled...

The physiological effect of 800 mcg and 1600 mcg inhaled salbutamol during a football specific treadmill run at high ambient temperatures

The World Anti-doping Agency stipulates that athletes who declare salbutamol use should not exceed 1600 μg over a 24 h period. No studies have investigated the physiological effect of 1600...

Comparison of the Effect of Low-Dose Ciclesonide and Fixed-Dose Fluticasone Propionate and Salmeterol Combination on Long-term Asthma Control

Patients with mild persistent asthma constitute about 70% of the asthma population; thus, it is important to know which first-line treatment is best for the management of mild asthma. We compared benefits of first-line treatment with ciclesonide and a combination of fluticasone and salmeterol in patients with mild asthma. Patients aged 12 to 75 years with mild persistent asthma were enrolled in a randomized, double-blind, placebo-controlled study. After run-in, patients were randomized to ciclesonide 160 μg once daily (CIC160), fluticasone propionate/salmeterol 100/50 μg bid (FP200/S100), or placebo for 52 weeks. The primary variable was time to first severe asthma exacerbation; the coprimary variable was the percentage of poorly controlled asthma days. Patients recorded asthma symptoms and salbutamol use in electronic diaries and completed a standardized version of the Asthma Quality of Life Questionnaire. Compared with placebo, the time to first severe asthma exacerbation was prolonged, and lung function was improved with FP200/S100 treatment (P = .0002) but not with CIC160. Both CIC160 and FP200/S100 provided significantly fewer poorly controlled asthma days than placebo (P ≤ .0016 for both active treatments). Moreover, both active treatments provided significantly more asthma symptom-free days (P ≤ .0001), rescue medication-free days (P = .0005, one-sided), and days with asthma control (P ≤ .0033). Overall Asthma Quality of Life Questionnaire scores were significantly higher in both active treatment groups than placebo (P ≤ .0017). In mild asthma, FP200/S100 prolonged time to first severe asthma exacerbation, and CIC160 and FP200/S100 were clinically equieffective for most measures of asthma control. ClinicalTrials.gov; No.: NCT00163358; URL: www.clinicaltrials.gov.