scholarly journals Effects of a Short Course of Inhaled Corticosteroids in Noneosinophilic Asthmatic Subjects

2011 ◽  
Vol 18 (5) ◽  
pp. 278-282 ◽  
Author(s):  
Catherine Lemière ◽  
Caroline Tremblay ◽  
Mark FitzGerald ◽  
Shawn D Aaron ◽  
Richard Leigh ◽  
...  
Keyword(s):  
Placebo Group ◽  
Fluticasone Propionate ◽  
Asthma Control ◽  
Inhaled Corticosteroids ◽  
Poor Response ◽  
Treated Group ◽  
Forced Expiratory Volume ◽  
Open Label ◽  
Double Blind ◽  
Asthma Control Questionnaire

BACKGROUND: Noneosinophilic asthma has been regarded as a distinct phenotype characterized by a poor response to inhaled corticosteroids (ICS).OBJECTIVE: To determine whether noneosinophilic, steroid-naive asthmatic subjects show an improvement in asthma control, asthma symptoms and spirometry after four weeks of treatment with ICS, and whether they further benefit from the addition of a long-acting beta-2 agonists to ICS.METHODS: A randomized, double-blind, placebo-controlled, multicentre study comparing the efficacy of placebo versus inhaled fluticasone propionate 250 μg twice daily for four weeks in mildly uncontrolled, steroid-naive asthmatic subjects with a sputum eosinophil count ≤2%. This was followed by an open-label, four-week treatment period with fluticasone propionate 250 μg/salmeterol 50 μg, twice daily for all subjects.RESULTS: After four weeks of double-blind treatment, there was a statistically significant and clinically relevant improvement in the mean (± SD) Asthma Control Questionnaire score in the ICS-treated group (n=6) (decrease of 1.0±0.5) compared with the placebo group (n=6) (decrease of 0.09±0.4) (P=0.008). Forced expiratory volume in 1 s declined in the placebo group (−0.2±0.2 L) and did not change in the ICS group (0.04±0.1 L) after four weeks of treatment (P=0.02). The open-label treatment with fluticasone propionate 250 μg/salmeterol 50 μg did not produce additional improvements in those who were previously treated for four weeks with inhaled fluticasone alone.CONCLUSION: A clinically important and statistically significant response to ICS was observed in mildly uncontrolled noneosinophilic asthmatic subjects.

scholarly journals Maintained therapeutic effect of revefenacin over 52 weeks in moderate to very severe Chronic Obstructive Pulmonary Disease (COPD)

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
James F. Donohue ◽  
Edward Kerwin ◽  
Sanjay Sethi ◽  
Brett Haumann ◽  
Srikanth Pendyala ◽  
...  
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Health Outcomes ◽  
Pulmonary Disease ◽  
Inhaled Corticosteroids ◽  
Forced Expiratory Volume ◽  
Chronic Obstructive ◽  
Open Label ◽  
Double Blind ◽  
Obstructive Pulmonary Disease ◽  
Long Acting

Abstract Background Revefenacin is a long-acting muscarinic antagonist that was recently approved for the nebulized treatment of chronic obstructive pulmonary disease (COPD). Although shorter duration studies have documented the efficacy of revefenacin in COPD, longer-term efficacy has not been described. In a recent 52-week safety trial, revefenacin was well tolerated and had a favorable benefit-risk profile. Here we report exploratory efficacy and health outcomes in patients receiving revefenacin 175 μg or 88 μg daily during the 52-week trial. Methods In this randomized, parallel-group, 52-week trial (NCT02518139), 1055 participants with moderate to very severe COPD received revefenacin 175 μg or 88 μg in a double-blind manner, or open-label active control tiotropium. Results Over the 52-week treatment period, both doses of revefenacin, as well as tiotropium, elicited significant (all p < 0.0003) improvements from baseline in trough forced expiratory volume in 1 s (FEV1). The trough FEV1 profile (least squares mean change from baseline) for revefenacin 175 μg ranged from 52.3–124.3 mL and the trough FEV1 profile for tiotropium ranged from 79.7–112.8 mL. In subgroup comparisons, the effect of revefenacin on trough FEV1 was comparable in patients taking concomitant long-acting β-agonists, with or without inhaled corticosteroids, with patients who were not taking these medications. There were statistically significant (p < 0.05) improvements in all measured health status outcomes (evaluated using St. George’s Respiratory Questionnaire, COPD Assessment Test, Clinical COPD Questionnaire and Baseline and Transition Dyspnea Index) from 3 months onward, in all treatment arms. Conclusions Significant sustained improvements from baseline in trough FEV1 and respiratory health outcomes were demonstrated for 175-μg revefenacin over 52 weeks, further supporting its use as a once-daily bronchodilator for the nebulized treatment of patients with COPD. Trial registration NCT02518139; Registered 5 August 2015.

Fluticasone versus Salmeterol/Low-Dose Fluticasone for Long-Term Asthma Control

2002 ◽  
Vol 36 (12) ◽  
pp. 1944-1949 ◽  
Author(s):  
Catherine A Heyneman ◽  
Rachel Crafts ◽  
Jerry Holland ◽  
Aaron D Arnold
Keyword(s):  
Fluticasone Propionate ◽  
Asthma Control ◽  
Low Dose ◽  
Inhaled Corticosteroids ◽  
Symptom Control ◽  
Persistent Asthma ◽  
Forced Expiratory Volume ◽  
Combination Drug ◽  
Medium Dose

OBJECTIVE: To evaluate the relative clinical superiority of increasing the dose of fluticasone propionate versus the addition of salmeterol to low-dose fluticasone propionate for long-term asthma control. DATA SOURCES: Literature was identified by a MEDLINE search (1966–October 2002). Key search terms included asthma, inhalation, corticosteroid, β-adrenergic agonist, and combination drug therapy. DATA SYNTHESIS: Current guidelines for long-term control of asthma include treatment with either inhaled corticosteroids (medium dose) or inhaled corticosteroids (low to medium dose) in combination with a long-acting bronchodilator. Previous studies evaluating salmeterol or formoterol combination therapy with beclomethasone or budesonide have generally produced superior results compared with increasing the dose of the inhaled corticosteroid. Four recent controlled clinical trials have compared the clinical utility of fluticasone propionate monotherapy versus salmeterol/low-dose fluticasone propionate for long-term asthma control in patients with moderate to severe persistent asthma. Based on spirometry data, rescue albuterol use, and symptom scores, the addition of salmeterol to low-dose fluticasone propionate was superior to increasing the dose of fluticasone propionate. CONCLUSIONS: Based on improvements in forced expiratory volume in 1 second, peak expiratory flow, and symptom control, the addition of salmeterol to low-dose fluticasone propionate provides better control of asthma than increasing the dose of fluticasone propionate.

scholarly journals Comparison of Once- with Twice-Daily Dosing of Fluticasone Propionate in Mild and Moderate Asthma

2000 ◽  
Vol 7 (3) ◽  
pp. 239-247 ◽  
Author(s):  
Louis-Philippe Boulet ◽  
Robert L Cowie ◽  
Roberto Dal Negro ◽  
Wade Brett ◽  
Milton Gold ◽  
...  
Keyword(s):  
Fluticasone Propionate ◽  
Asthma Control ◽  
Treatment Guidelines ◽  
Group Versus ◽  
Forced Expiratory Volume ◽  
Double Blind ◽  
Once Daily ◽  
Daily Group ◽  
Moderate Asthma ◽  
The Mean

OBJECTIVES:Two 12-week, randomized, double-blind, parallel-group studies were performed to compare the efficacy and safety of once- and twice-daily dosing of fluticasone propionate (FP) in the treatment of mild to moderate asthma, considered to require the equivalent of either 200 or 500 µg of FP daily.PATIENTS AND METHODS:In study A, 461 patients with asthma received FP either 200 µg once daily or 100 µg twice daily. In study B, 443 patients with asthma received FP, either 500 µg once daily or 250 µg twice daily.RESULTS:In both studies, regardless of the treatment regimen to which patients were randomly assigned, small improvements over baseline were observed in morning peak expiratory flows (PEF) and forced expiratory volume in 1 s (FEV1) following 12 weeks of treatment. In study A, the mean morning PEF improved by 2.4% and 4.3% (once daily versus twice daily, P=0.008).  In study B, the mean morning PEF improvement was 0.2% and 3.7% (once daily versus twice daily, PÃ0.001). For both studies, the increases observed in FEV1were not significantly different between the two groups (P = not significant). The incidence of exacerbations of asthma and related events was 13% and 5%, respectively, in the patients with mild asthma for the once-daily group versus the twice-daily group; these exacerbations were 12% and 10%, respectively, in patients with moderate asthma. Otherwise, the incidence and types of adverse events were comparable for the two treatment regimens. Although twice-daily dosing demonstrated small but statistically significant improvements over once-daily dosing, patients of both groups generally maintained a good level of asthma control on both regimens according to current treatment guidelines.CONCLUSIONS:Twice-daily dosing of FP is more effective than once-daily dosing, although the latter can maintain asthma control in most patients.

scholarly journals Montelukast as Add-On Therapy to Inhaled Corticosteroids in the Management of Asthma (the SAS trial)

2009 ◽  
Vol 16 (suppl a) ◽  
pp. 5A-10A ◽  
Author(s):  
J Mark Fitzgerald ◽  
Sylvain Foucart ◽  
Stephen Coyle ◽  
John Sampalis ◽  
Denis Haine ◽  
...  
Keyword(s):  
Asthma Control ◽  
Inhaled Corticosteroids ◽  
Inhaled Corticosteroid ◽  
Uncontrolled Asthma ◽  
Open Label ◽  
Asthma Control Questionnaire ◽  
Asthmatic Patients ◽  
The Mean ◽  
Clinically Significant ◽  
High Doses

AIM: To evaluate the effectiveness of montelukast as add-on therapy for asthmatic patients who remain uncontrolled with low, moderate or high doses of inhaled corticosteroid monotherapy.DESIGN: An eight-week, multicentre, open-label, observational study.RESULTS: Of 320 patients enrolled, 288 (90.0%) completed the study. Of patients who had uncontrolled asthma symptoms (Canadian Asthma Consensus Guidelines Update, 2003) but were controlled according to the Asthma Control Questionnaire (ACQ score of less than 1.5), 93.9% maintained asthma control at week 8. Of patients with uncontrolled asthma at baseline for both definitions, 63.5% achieved asthma control by week 8. The mean ± SD ACQ score decreased from 1.13±0.28 to 0.57±0.50 (P<0.001) for controlled patients at baseline and from 2.38±0.73 to 1.03±0.80 (P<0.001) for patients who were uncontrolled at baseline, each representing a clinically significant improvement.CONCLUSION: Montelukast add-on therapy is an effective alternative to inhaled corticosteroid monotherapy.

scholarly journals A randomised controlled trial of tiotropium in adolescents with severe symptomatic asthma

2016 ◽  
Vol 49 (1) ◽  
pp. 1601100 ◽  
Author(s):  
Eckard Hamelmann ◽  
Jonathan A. Bernstein ◽  
Mark Vandewalker ◽  
Petra Moroni-Zentgraf ◽  
Daniela Verri ◽  
...  
Keyword(s):  
Asthma Control ◽  
Inhaled Corticosteroids ◽  
Controlled Trial ◽  
Forced Expiratory Volume ◽  
Phase Iii ◽  
Double Blind ◽  
Once Daily ◽  
Symptomatic Asthma ◽  
Baseline Response ◽  
Randomised Controlled

We present results from the first phase III trial of once-daily tiotropium add-on to inhaled corticosteroids (ICS) plus one or more controller therapies in adolescents with severe symptomatic asthma.In this double-blind, parallel-group trial (NCT01277523), 392 patients aged 12–17 years were randomised to receive once-daily tiotropium 5 µg or 2.5 µg, or placebo, as an add-on to ICS plus other controller therapies over 12 weeks. The primary and key secondary end-points were change from baseline (response) in peak forced expiratory volume in 1 s (FEV1) within 3 h post-dosing (FEV1(0–3h)) and trough FEV1, respectively, after 12 weeks of treatment.Tiotropium 5 µg provided numerical improvements in peak FEV1(0–3h) response, compared with placebo (90 mL; p=0.104), and significant improvements were observed with tiotropium 2.5 µg (111 mL; p=0.046). Numerical improvements in trough FEV1 response and asthma control were observed with both tiotropium doses, compared with placebo. The safety and tolerability of tiotropium were comparable with those of placebo.Once-daily tiotropium Respimat add-on to ICS plus one or more controller therapies in adolescents with severe symptomatic asthma was well tolerated. The primary end-point of efficacy was not met, although positive trends for improvements in lung function and asthma control were observed.

scholarly journals Adjustable Maintenance Dosing with Budesonide/Formoterol Reduces Asthma Exacerbations Compared with Traditional Fixed Dosing: A Five-Month Multicentre Canadian Study

2003 ◽  
Vol 10 (8) ◽  
pp. 427-434 ◽  
Author(s):  
J Mark FitzGerlad ◽  
Malcolm R Sears ◽  
Louis-Philippe Boulet ◽  
Allan B Becker ◽  
Andrew R McIvor ◽  
...  
Keyword(s):  
Asthma Control ◽  
Inhaled Corticosteroids ◽  
Drug Dose ◽  
Forced Expiratory Volume ◽  
Number Needed To Treat ◽  
Canadian Study ◽  
Open Label ◽  
Serious Adverse Events ◽  
Blood Institute ◽  
Dosing Regimens

BACKGROUND: Adjustable maintenance dosing with budesonide/formoterol in a single inhaler (Symbicort, AstraZeneca, Lund, Sweden) may provide a convenient means of maintaining asthma control with the minimum effective medication level.Objectives: To compare adjustable and fixed maintenance dosing regimens of budesonide/formoterol in asthma.METHODS: This was an open-label, randomized, parallel-group, multicentre, Canadian study of asthma patients (aged 12 years or older, postbronchodilator forced expiratory volume in 1 s 70% or greater of predicted normal). Following a one-month run-in on budesonide/formoterol (100/6 µg or 200/6 µg metered doses, two inhalations twice daily), 995 patients were randomly assigned either to continue on this fixed dosing regimen or to receive budesonide/formoterol adjustable dosing (step down to one inhalation twice daily if symptoms were controlled or temporarily step up to four inhalations twice daily for seven or 14 days if asthma worsened). The primary efficacy variable was the occurrence of exacerbations (requiring oral or inhaled corticosteroids, emergency department treatment, serious adverse events or added maintenance therapy because of asthma).RESULTS: With adjustable dosing, significantly fewer patients experienced exacerbations compared with fixed dosing (4.0% versus 8.9%, P=0.002; number needed to treat=21 [95% CI 13 to 59]). Patients required 36% fewer overall doses of budesonide/formoterol (2.5 versus 3.9 inhalations/day, P<0.001), and total costs per patient were lower (difference over five months CDN$-141 [95% CI -$162 to -$116]). Asthma symptom severity (modified National Heart, Lung, and Blood Institute stage) was maintained or improved in 97% or greater of patients in both groups (pre-run-in to end of treatment). Both treatments were well tolerated.CONCLUSIONS: Budesonide/formoterol adjustable maintenance dosing provided more effective asthma control than fixed dosing, with a lower overall drug dose and reduced total cost.

scholarly journals Effects of fluticasone propionate on arachidonic acid metabolites in BAL-fluid and methacholine dose-response curves in non-smoking atopic asthmatics

1996 ◽  
Vol 5 (3) ◽  
pp. 224-229 ◽  
Author(s):  
S. E. Overbeek ◽  
J. M. Bogaard ◽  
I. M. Garrelds ◽  
F. J. Zijlstra ◽  
P. G. H. Mulder ◽  
...  
Keyword(s):  
Arachidonic Acid ◽  
Fluticasone Propionate ◽  
Dose Response ◽  
Treated Group ◽  
Forced Expiratory Volume ◽  
The Other ◽  
Inflammatory Factors ◽  
Response Curves ◽  
Double Blind ◽  
The One

Hyperresponsiveness of the airways to nonspecific stimuli is a characteristic feature of asthma. Airway responsiveness is usually characterized in terms of the position and shape of the dose–response curve to methacholine (MDR). In the study we have investigated the influence of fluticasone propionate (FP), a topically active glucocorticoid, on arachidonic acid (AA) metabolites in broncho-alveolar lavage (BAL) fluid (i.e. TxB2, PGE2, PGD2, 6kPGF1αand LTC4) on the one hand and MDR curves on the other hand. The effect of FP was studied in a randomized, double-blind, placebo-controlled design in 33 stable nonsmoking asthmatics; 16 patients received FP (500 μg b.i.d.) whereas 17 patients were treated with placebo. We found that the forced expiratory volume in 1s (FEV1% predicted) increased, the log2PC20methacholine increased and the plateau value (% fall in FEV1) decreased after a 12 week treatment period. No changes in AA-metabolites could be determined after treatment except for PGD2which decreased nearly significantly (p = 0.058) within the FP treated group, whereas the change of PGD2differed significantly (p= 0.05) in the FP treated group from placebo. The levels of the other AA metabolites (i.e. TxB2, PGE2, 6kPGF1αand LTC4) remained unchanged after treatment and were not significantly different from the placebo group. Our results support the hypothesis that although FP strongly influences the position, the shape and also the maximum response plateau of the MDR curve, this effect is not mainly achieved by influence on the level of AA metabolites. Other pro-inflammatory factors may be of more importance for the shape of the MDR curve. It is suggested that these pro-inflammatory factors are downregulated by FP.

scholarly journals Salmeterol and Fluticasone Propionate (50/250 μg) Administered via Combination Diskus Inhaler: As Effective as When Given via Separate Diskus Inhalers

1999 ◽  
Vol 6 (1) ◽  
pp. 45-51 ◽  
Author(s):  
Kenneth R Chapman ◽  
Nils Ringdal ◽  
Vibeke Backer ◽  
Mona Palmqvist ◽  
Seppo Saarelainen ◽  
...  
Keyword(s):  
Fluticasone Propionate ◽  
Inhaled Corticosteroids ◽  
Safety Data ◽  
Serum Cortisol ◽  
Forced Expiratory Volume ◽  
New Combination ◽  
Double Blind ◽  
Asthma Patients ◽  
Symptomatic Asthma ◽  
The Difference

OBJECTIVE: To compare the efficacy and safety of a new combination Diskus inhaler containing both salmeterol 50 μg and fluticasone propionate 250 μg (Seretide) with the two drugs delivered via separate Diskus inhalers.DESIGN: A multicentre, double-blind, double-dummy study. Three hundred and seventy-one symptomatic asthma patients (age range 13 to 75 years, mean 42 years) receiving inhaled corticosteroids were randomly assigned to two treatement groups: 28 weeks’ treatment with either salmeterol/fluticasone propionate (50/250 μg bid) via a single Diskus inhaler (combination) and placebo bid via another Diskus inhaler, or salmeterol 50 μg bid via one Diskus inhaler and fluticasone propionate 250 μg bid via another (concurrent). Morning peak expiratory flow rate (PEFR) and symptoms were measured for the first 12 weeks and safety data were collected throughout the study.RESULTS: Over weeks 1 to 12, adjusted mean improvements in morning PEFR were 43 and 36 L/min for combination and concurrent therapies, respectively. The difference between the two treatment arms was 6 L/min (90% CI –13 to 0 L/min; P=0.114), which was within the predefined criteria for clinical equivalence. Adjusted mean improvements in forced expiratory volume in 1 s from baseline for week 28 were also similar between the two therapies. Thirty-five per cent of patients receiving combination inhaler and 31% of those receiving concurrent therapy had a mean daytime symptom score of zero over weeks 1 to 12 compared with 1% and 2%, respectively, at baseline. There was no difference in the incidence of adverse events between the two treatment arms. Mean serum cortisol levels were similar, and no differences in frequency of abnormal results were noted between the two groups.CONCLUSIONS: This study shows that the combination of salmeterol and fluticasone propionate in a single inhaler is as efficacious in achieving asthma control and as well tolerated over a 28-week period as the two drugs administered individually.

scholarly journals Montelukast as Add-On Therapy to Inhaled Corticosteroids in the Management of Asthma (The SAS Trial)

2009 ◽  
Vol 16 (suppl a) ◽  
pp. 5A-10A ◽  
Author(s):  
J Mark FitzGerald ◽  
Sylvain Foucart ◽  
Stephen Coyle ◽  
John Sampalis ◽  
Denis Haine ◽  
...  
Keyword(s):  
Asthma Control ◽  
Inhaled Corticosteroids ◽  
Inhaled Corticosteroid ◽  
Uncontrolled Asthma ◽  
Open Label ◽  
Asthma Control Questionnaire ◽  
Asthmatic Patients ◽  
The Mean ◽  
Clinically Significant ◽  
High Doses

AIM: To evaluate the effectiveness of montelukast as add-on therapy for asthmatic patients who remain uncontrolled with low, moderate or high doses of inhaled corticosteroid monotherapy.DESIGN: An eight-week, multicentre, open-label, observational study.RESULTS: Of 320 patients enrolled, 288 (90.0%) completed the study. Of patients who had uncontrolled asthma symptoms (Canadian Asthma Consensus Guidelines Update, 2003) but were controlled according to the Asthma Control Questionnaire (ACQ score of less than 1.5), 93.9% maintained asthma control at week 8. Of patients with uncontrolled asthma at baseline for both definitions, 63.5% achieved asthma control by week 8. The mean ± SD ACQ score decreased from 1.13±0.28 to 0.57±0.50 (P<0.001) for controlled patients at baseline and from 2.38±0.73 to 1.03±0.80 (P<0.001) for patients who were uncontrolled at baseline, each representing a clinically significant improvement.CONCLUSION: Montelukast add-on therapy is an effective alternative to inhaled corticosteroid monotherapy.

scholarly journals Higher Omega-3 Index Is Associated with Better Asthma Control and Lower Medication Dose: A Cross-Sectional Study

Nutrients ◽  
2019 ◽  
Vol 12 (1) ◽  
pp. 74 ◽  
Author(s):  
Isobel Stoodley ◽  
Manohar Garg ◽  
Hayley Scott ◽  
Lesley Macdonald-Wicks ◽  
Bronwyn Berthon ◽  
...  
Keyword(s):  
Fatty Acids ◽  
Asthma Control ◽  
Inhaled Corticosteroids ◽  
Asthma Management ◽  
Airway Disease ◽  
Cross Sectional Study ◽  
Erythrocyte Membranes ◽  
Omega 3 ◽  
Asthma Control Questionnaire ◽  
Cross Sectional

Asthma is a chronic inflammatory airway disease, associated with systemic inflammation. Omega-3 polyunsaturated fatty acids (n-3 PUFA) have established anti-inflammatory effects, thus having potential as an adjunct therapy in asthma. This study aimed to compare erythrocyte n-3 PUFA in adults with (n = 255) and without (n = 137) asthma and determine the relationship between erythrocyte n-3 PUFA and clinical asthma outcomes. Subjects had blood collected, lung function measured and Juniper Asthma Control Questionnaire (ACQ) score calculated. Fatty acids were measured in erythrocyte membranes by gas chromatography, and the omega-3 index (O3I) was calculated (% eicosapentaenoic acid + % docosahexaenoic acid). O3I was similar in subjects with and without asthma (p = 0.089). A higher O3I was observed in subjects with controlled or partially controlled asthma (ACQ < 1.5) compared to subjects with uncontrolled asthma (ACQ ≥ 1.5) (6.0% (5.4–7.2) versus 5.6% (4.6–6.4) p = 0.033). Subjects with a high O3I (≥8%) had a lower maintenance dose of inhaled corticosteroids (ICS) compared to those with a low O3I (<8%) (1000 μg (400–1000) versus 1000 μg (500–2000) p = 0.019). This study demonstrates that a higher O3I is associated with better asthma control and with lower ICS dose, suggesting that a higher erythrocyte n-3 PUFA level may have a role in asthma management.

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