scholarly journals Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD

2021 ◽  
Vol 31 (1) ◽  
Author(s):  
Sandeep Bansal ◽  
Martin Anderson ◽  
Antonio Anzueto ◽  
Nicola Brown ◽  
Chris Compton ◽  
...  
Keyword(s):  
Health Status ◽  
Triple Therapy ◽  
Treatment Guidelines ◽  
Forced Expiratory Volume ◽  
Chronic Obstructive ◽  
Fluticasone Furoate ◽  
Double Blind ◽  
Once Daily ◽  
Copd Patients ◽  
Severe Copd

AbstractChronic obstructive pulmonary disease (COPD) treatment guidelines do not currently include recommendations for escalation directly from monotherapy to triple therapy. This 12-week, double-blind, double-dummy study randomized 800 symptomatic moderate-to-very-severe COPD patients receiving tiotropium (TIO) for ≥3 months to once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 mcg via ELLIPTA (n = 400) or TIO 18 mcg via HandiHaler (n = 400) plus matched placebo. Study endpoints included change from baseline in trough forced expiratory volume in 1 s (FEV1) at Days 85 (primary), 28 and 84 (secondary), health status (St George’s Respiratory Questionnaire [SGRQ] and COPD Assessment Test [CAT]) and safety. FF/UMEC/VI significantly improved trough FEV1 at all timepoints (Day 85 treatment difference [95% CI] 95 mL [62–128]; P < 0.001), and significantly improved SGRQ and CAT versus TIO. Treatment safety profiles were similar. Once-daily single-inhaler FF/UMEC/VI significantly improved lung function and health status versus once-daily TIO in symptomatic moderate-to-very-severe COPD patients, with a similar safety profile.

scholarly journals Single Inhaler Triple Therapy (FF/UMEC/VI) Versus FF/VI and UMEC/VI in Patients with COPD: Subgroup Analysis of the China Cohort in the IMPACT Trial

2019 ◽  
Author(s):  
Jinping Zheng ◽  
Nanshan Zhong ◽  
Changzheng Wang ◽  
Li Ping Wei ◽  
Xiang Dong Zhou ◽  
...  
Keyword(s):  
Triple Therapy ◽  
Dual Therapy ◽  
Multicenter Trial ◽  
Forced Expiratory Volume ◽  
Phase Iii ◽  
Chronic Obstructive ◽  
Severe Exacerbation ◽  
Double Blind ◽  
Treatment Difference ◽  
The Impact

Abstract Background In the Phase III InforMing the PAthway of COPD Treatment (IMPACT) trial, fluticasone furoate [FF]/umeclidinium [UMEC]/vilanterol [VI] single-inhaler triple therapy resulted in lower rates of moderate/severe exacerbations than dual therapy with FF/VI or UMEC/VI in patients with symptomatic chronic obstructive pulmonary disease (COPD) and a history of exacerbations. Here we present the result in the subpopulation of patients enrolled in China. Methods The IMPACT trial was a 52-week, randomized, double-blind, parallel-group, multicenter trial. Patients (≥40 years of age) with COPD and ≥1 moderate/severe exacerbations in the prior year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25 µg, FF/VI 100/25 µg, or UMEC/VI 62.5/25 µg administered via the Ellipta inhaler. Endpoints, assessed in the overall intent-to-treat (ITT) population and in patients from China, included annual rates of exacerbations, time-to-first on-treatment moderate/severe exacerbation, and change from baseline in trough forced expiratory volume in 1 second (FEV1) at Week 52. Results Of the 10,355 patients randomized, 535 (5.2%) were from China. In the China cohort, the rate of on-treatment moderate/severe exacerbations was 0.81 per year with FF/UMEC/VI versus 0.96 with FF/VI (rate ratio [RR]: 0.84; 95% confidence interval [CI]: 0.64, 1.11; p=0.227) and 0.80 with UMEC/VI (RR: 1.02; 95% CI: 0.72, 1.44; p=0.929). Hazard ratio for time-to-first moderate/severe exacerbation was 0.84 (95% CI: 0.63, 1.11; p=0.218) for FF/UMEC/VI versus FF/VI, and 0.89 (95% CI: 0.62, 1.27; p=0.516) for FF/UMEC/VI versus UMEC/VI. Improvements in mean change from baseline in trough FEV1 were observed for FF/UMEC/VI versus FF/VI (treatment difference 137 mL; 95% CI: 86, 188; p<0.001) and FF/UMEC/VI versus UMEC/VI (treatment difference 63 mL; 95% CI: 0, 125; p=0.0.050) in China. Health status was also improved with FF/UMEC/VI versus both dual therapies. Broadly, these results were in the same direction as those seen in the overall ITT population. No new safety signals were identified. Conclusions In the China cohort of the IMPACT trial, single-inhaler triple therapy with FF/UMEC/VI versus dual therapy with FF/VI or UMEC/VI reduced the rate and risk of exacerbations, and improved lung function and quality of life similar to the overall ITT population. Trial registration: NCT02164513 (GSK study number CTT116855).

scholarly journals Effects of umeclidinium/vilanterol on exercise endurance in COPD: a randomised study

2018 ◽  
Vol 4 (1) ◽  
pp. 00073-2017 ◽  
Author(s):  
John H. Riley ◽  
Chris J. Kalberg ◽  
Alison Donald ◽  
David A. Lipson ◽  
Muhammad Shoaib ◽  
...  
Keyword(s):  
Forced Expiratory Volume ◽  
Chronic Obstructive ◽  
Post Dose ◽  
Double Blind ◽  
Endurance Time ◽  
Obstructive Pulmonary Disease ◽  
Once Daily ◽  
Randomised Study ◽  
Residual Capacity ◽  
Exercise Endurance

This multicentre, randomised, double-blind, placebo-controlled, two-period crossover study assessed the effect of umeclidinium/vilanterol (UMEC/VI) on exercise capacity in patients with chronic obstructive pulmonary disease (COPD) using the endurance shuttle walk test (ESWT).Patients were randomised 1:1 to one of two treatment sequences: 1) UMEC/VI 62.5/25 µg followed by placebo or 2) placebo followed by UMEC/VI 62.5/25 µg. Each treatment was taken once daily for 12 weeks. The primary end-point was 3-h post-dose exercise endurance time (EET) at week 12. Secondary end-points included trough forced expiratory volume in 1 s (FEV1) and 3-h post-dose functional residual capacity (FRC), both at week 12. COPD Assessment Test (CAT) score at week 12 was also assessed.UMEC/VI treatment did not result in a statistically significant improvement in EET change from baseline at week 12 versus placebo (p=0.790). However, improvements were observed in trough FEV1 (206 mL, 95% CI 167–246), 3-h post-dose FRC (−346 mL, 95% CI −487 to −204) and CAT score (−1.07 units, 95% CI −2.09 to −0.05) versus placebo at week 12.UMEC/VI did not result in improvements in EET at week 12 versus placebo, despite improvements in measures of lung function, hyperinflation and health status.

scholarly journals Efficacy of umeclidinium/vilanterol versus umeclidinium and salmeterol monotherapies in symptomatic patients with COPD not receiving inhaled corticosteroids: the EMAX randomised trial

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
François Maltais ◽  
Leif Bjermer ◽  
Edward M. Kerwin ◽  
Paul W. Jones ◽  
Michael L. Watkins ◽  
...  
Keyword(s):  
Treatment Failure ◽  
Inhaled Corticosteroids ◽  
Randomised Trial ◽  
Forced Expiratory Volume ◽  
Chronic Obstructive ◽  
Short Term ◽  
Double Blind ◽  
Once Daily ◽  
Clinically Important Deterioration ◽  
Exacerbation Risk

Abstract Background Prospective evidence is lacking regarding incremental benefits of long-acting dual- versus mono-bronchodilation in improving symptoms and preventing short-term disease worsening/treatment failure in low exacerbation risk patients with chronic obstructive pulmonary disease (COPD) not receiving inhaled corticosteroids. Methods The 24-week, double-blind, double-dummy, parallel-group Early MAXimisation of bronchodilation for improving COPD stability (EMAX) trial randomised patients at low exacerbation risk not receiving inhaled corticosteroids, to umeclidinium/vilanterol 62.5/25 μg once-daily, umeclidinium 62.5 μg once-daily or salmeterol 50 μg twice-daily. The primary endpoint was trough forced expiratory volume in 1 s (FEV1) at Week 24. The study was also powered for the secondary endpoint of Transition Dyspnoea Index at Week 24. Other efficacy assessments included spirometry, symptoms, heath status and short-term disease worsening measured by the composite endpoint of clinically important deterioration using three definitions. Results Change from baseline in trough FEV1 at Week 24 was 66 mL (95% confidence interval [CI]: 43, 89) and 141 mL (95% CI: 118, 164) greater with umeclidinium/vilanterol versus umeclidinium and salmeterol, respectively (both p < 0.001). Umeclidinium/vilanterol demonstrated consistent improvements in Transition Dyspnoea Index versus both monotherapies at Week 24 (vs umeclidinium: 0.37 [95% CI: 0.06, 0.68], p = 0.018; vs salmeterol: 0.45 [95% CI: 0.15, 0.76], p = 0.004) and all other symptom measures at all time points. Regardless of the clinically important deterioration definition considered, umeclidinium/vilanterol significantly reduced the risk of a first clinically important deterioration compared with umeclidinium (by 16–25% [p < 0.01]) and salmeterol (by 26–41% [p < 0.001]). Safety profiles were similar between treatments. Conclusions Umeclidinium/vilanterol consistently provides early and sustained improvements in lung function and symptoms and reduces the risk of deterioration/treatment failure versus umeclidinium or salmeterol in symptomatic patients with low exacerbation risk not receiving inhaled corticosteroids. These findings suggest a potential for early use of dual bronchodilators to help optimise therapy in this patient group.

scholarly journals Tiotropium and olodaterol fixed-dose combinationversusmono-components in COPD (GOLD 2–4)

2015 ◽  
Vol 45 (4) ◽  
pp. 969-979 ◽  
Author(s):  
Roland Buhl ◽  
François Maltais ◽  
Roger Abrahams ◽  
Leif Bjermer ◽  
Eric Derom ◽  
...  
Keyword(s):  
Area Under The Curve ◽  
Forced Expiratory Volume ◽  
Phase Iii ◽  
Fixed Dose ◽  
Chronic Obstructive ◽  
Double Blind ◽  
Obstructive Pulmonary Disease ◽  
Once Daily ◽  
Multicentre Phase ◽  
St George's Respiratory Questionnaire

Efficacy and safety of tiotropium+olodaterol fixed-dose combination (FDC) compared with the mono-components was evaluated in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) in two replicate, randomised, double-blind, parallel-group, multicentre, phase III trials.Patients received tiotropium+olodaterol FDC 2.5/5 μg or 5/5 μg, tiotropium 2.5 μg or 5 μg, or olodaterol 5 μg delivered once-dailyviaRespimat inhaler over 52 weeks. Primary end points were forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h (AUC0–3) response, trough FEV1 response and St George's Respiratory Questionnaire (SGRQ) total score at 24 weeks.In total, 5162 patients (2624 in Study 1237.5 and 2538 in Study 1237.6) received treatment. Both FDCs significantly improved FEV1 AUC0–3 and trough FEV1 responseversusthe mono-components in both studies. Statistically significant improvements in SGRQ total scoreversusthe mono-components were only seen for tiotropium+olodaterol FDC 5/5 μg. Incidence of adverse events was comparable between the FDCs and the mono-components.These studies demonstrated significant improvements in lung function and health-related quality of life with once-daily tiotropium+olodaterol FDCversusmono-components over 1 year in patients with moderate to very severe COPD.

scholarly journals Lung function, pharmacokinetics, and tolerability of inhaled indacaterol maleate and acetate in asthma patients

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
David Miller ◽  
Soniya Vaidya ◽  
Juergen Jauernig ◽  
Brian Ethell ◽  
Kristina Wagner ◽  
...  
Keyword(s):  
Lung Function ◽  
Systemic Exposure ◽  
Forced Expiratory Volume ◽  
Fixed Dose ◽  
Chronic Obstructive ◽  
Electronic Diary ◽  
Double Blind ◽  
Once Daily ◽  
Long Acting ◽  
Salt Forms

Abstract Background Indacaterol maleate delivered with the Breezhaler® inhalation device is a long-acting β2-agonist approved for chronic obstructive pulmonary disease. In the development of a once daily, inhaled fixed dose combination (FDC) of indacaterol, glycopyrronium bromide (a long-acting muscarinic antagonist), and mometasone furoate (an inhaled corticosteroid [ICS]) for the treatment of patients with asthma, the acetate salt of indacaterol is used instead of the maleate salt. Here, we investigated the lung function, pharmacokinetics (PK) and safety of indacaterol maleate 150 μg once daily (o.d.) and indacaterol acetate 150 μg o.d. in comparison with placebo. Methods This was a randomised, double-blind, three-period crossover study (ClinicalTrials.gov identifier, NCT03257995) in patients with asthma on background ICS therapy. Patients with percent predicted pre-bronchodilator forced expiratory volume per second (FEV1) ≥50% and ≤ 90% were included in the study. Patients received indacaterol maleate 150 μg o.d., indacaterol acetate 150 μg o.d., or placebo on top of stable background ICS in randomised sequence. Trough FEV1 was assessed after 14 days of treatment. PK of indacaterol salts were assessed at steady state after 14 days of treatment; peak expiratory flow (PEF) rate and rescue medication use were collected with a combined PEF-meter/electronic diary throughout the study. Results Of the 54 adult patients (median age of 48 years), 51 patients completed the study. Both indacaterol salts demonstrated statistically significant improvements in trough FEV1 of 186 mL (maleate) and 146 mL (acetate) compared with placebo (both P < 0.001). FEV1 AUC0-4h improved by 248 mL (maleate) and 245 mL (acetate), and PEF by 33 L/min (maleate) and 30.8 L/min (acetate) versus placebo. Systemic exposure of indacaterol (AUC0-24h,ss and Cmax,ss on Day 14) was comparable after administration of both salt forms. Both salt forms demonstrated a good safety profile and were well tolerated, with a difference in the reporting frequency of AEs of coughing (maleate, 23.5%; acetate, 0%). Conclusions In patients with asthma, indacaterol maleate and acetate elicited comparable and significant improvements in lung function compared with placebo and achieved comparable systemic exposure. Both indacaterol salts were safe and well tolerated. Trial registration ClinicalTrials.gov NCT03257995 June 06, 2017

scholarly journals Efficacy and safety of single-inhaler triple therapy of glycopyrronium, formoterol, and fluticasone in patients with chronic obstructive pulmonary disease: a double-blind, randomised controlled trial

2021 ◽  
pp. 00255-2021
Author(s):  
Sundeep Salvi ◽  
Akash Balki ◽  
Srikanth Krishnamurthy ◽  
Sagar Panchal ◽  
Saiprasad Patil ◽  
...  
Keyword(s):  
Triple Therapy ◽  
Controlled Trial ◽  
Dual Therapy ◽  
Fixed Dose ◽  
Comparable Efficacy ◽  
Chronic Obstructive ◽  
Double Blind ◽  
Obstructive Pulmonary Disease ◽  
Copd Patients ◽  
The Difference

BackgroundInvestigating the safety and efficacy of single-inhaler triple therapy with glycopyrronium (GB) 12.5 μg/formoterol fumarate (FF) 12 μg/fluticasone propionate (FP) 250 μg, compared to GB 50 μg co-administered with a fixed dose of FF 12 μg/FP 250 μg in subjects with COPD.MethodsA phase 3, randomised, double-blind, active-control, parallel-group, noninferiority study conducted at 20 sites across India. COPD patients aged ≥40 to ≤75 years, with FEV1/FVC <0.70, using mono/dual therapy with ICS, LAMA, or LABA for ≥1 month, were included. Subjects were randomised 1:1 to GB/FF/FP or GB+FF/FP for 12 weeks. Primary efficacy endpoint was the change from baseline in trough FEV1 at the end of 12 weeks. The study is registered with the Clinical Trials Registry of India (CTRI Reg No: CTRI/2019/01/017156).ResultsBetween March 23, 2019 and February 14, 2020, 396 subjects were enrolled, 198 patients each in the fixed-triple (GB/FF/FP) and open-triple (GB+FF/FP) groups. The difference in LSM changes in predose FEV1 from baseline at 12 weeks was noninferior between the groups (p<0.05). The LSM change from baseline in postdose FEV1 was comparable (p=0.38). Superiority test showed comparable efficacy (p =0.12) for the difference in mean change from baseline in trough FEV1 between the groups. Adverse events (mild or moderate) were recorded in 25.3% and 24.9% of subjects in the GB/FF/FP and GB+FF/FP groups.ConclusionsFixed triple therapy with GB/FF/FP provides comparable bronchodilation and lung function improvement like open triple therapy. It is safe and well-tolerated in symptomatic COPD patients with a history of exacerbations.

scholarly journals Clinical effectiveness of once-daily fluticasone furoate/umeclidinium/vilanterol in usual practice: the COPD INTREPID study design

2019 ◽  
Vol 5 (4) ◽  
pp. 00061-2019
Author(s):  
Sally Worsley ◽  
Neil Snowise ◽  
David M.G. Halpin ◽  
Dawn Midwinter ◽  
Afisi S. Ismaila ◽  
...  
Keyword(s):  
Clinical Effectiveness ◽  
Healthcare Systems ◽  
Forced Expiratory Volume ◽  
Chronic Obstructive ◽  
Fluticasone Furoate ◽  
Open Label ◽  
Meaningful Improvement ◽  
Holistic View ◽  
Usual Practice ◽  
Once Daily

Effectiveness studies complement conventional randomised controlled trials by providing a holistic view of treatments in the setting of usual clinical practice. We present the protocol for the ongoing INTREPID (INvestigation of TRelegy Effectiveness: usual PractIce Design; ClinicalTrials.gov identifier: NCT03467425) study, a randomised, open-label, 24-week effectiveness study of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI; Trelegy) delivered by the ELLIPTA inhaler versus non-ELLIPTA multiple-inhaler triple therapy in patients with chronic obstructive pulmonary disease (COPD) in usual practice settings. INTREPID was designed to provide evidence of FF/UMEC/VI effectiveness in patients with COPD managed in routine healthcare systems across multiple European countries. Between study initiation and end-of-study visits, patients will receive their medication and care as they would ordinarily receive it, from their usual healthcare provider at their usual healthcare centre. Study-specific intervention will be minimal. The primary end-point will be the proportion of COPD assessment test (CAT) responders, defined as a clinically meaningful improvement from baseline of ≥2 units, at week 24. The CAT was chosen as it provides health status information relevant to patients, physicians, health technology agencies and payers. Lung function (forced expiratory volume in 1 s) and critical inhaler errors will also be assessed in a subgroup of patients. The strengths and weaknesses of the protocol and some of the challenges associated with conducting this multicountry study, such as differences in healthcare systems and treatment practices across sites, will also be discussed.

Real-Life Clinical and Functional Effects of Fluticasone Furoate/Umeclidinium/Vilanterol-Combined Triple Therapy in Patients with Chronic Obstructive Pulmonary Disease

Respiration ◽  
2020 ◽  
pp. 1-8
Author(s):  
Corrado Pelaia ◽  
Giada Procopio ◽  
Maria Rosaria Deodato ◽  
Olivia Florio ◽  
Angelantonio Maglio ◽  
...  
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Triple Therapy ◽  
Real Life ◽  
Chronic Obstructive ◽  
Fluticasone Furoate ◽  
Obstructive Pulmonary Disease ◽  
Copd Exacerbations ◽  
Copd Patients ◽  
Inhaled Therapy ◽  
Long Acting

<b><i>Background:</i></b> Triple therapy consisting of a drug association including an inhaled corticosteroid, a long-acting muscarinic receptor antagonist and a long-acting β<sub>2</sub>-adrenergic agonist, delivered via a single device, can be a valuable treatment for chronic obstructive pulmonary disease (COPD) patients experiencing frequent disease exacerbations. <b><i>Objectives:</i></b> The aim of this real-life, single-center, observational study was to evaluate, in 44 COPD patients with recurrent exacerbations, the effects of the triple inhaled therapy combining fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI). <b><i>Methods:</i></b> Within such a therapeutic context, several clinical and lung functional parameters were considered at baseline and after 24 weeks of treatment with combined inhaled triple therapy. <b><i>Results:</i></b> With respect to baseline, after 24 weeks of treatment with FF/UMEC/VI, significant changes were recorded with regard to Modified British Medical Research Council (<i>p</i> &#x3c; 0.0001) and COPD Assessment Test (<i>p</i> &#x3c; 0.0001) scores, COPD exacerbations (<i>p</i> &#x3c; 0.001), forced expiratory volume in the first second (<i>p</i> &#x3c; 0.001), residual volume (<i>p</i> &#x3c; 0.01), forced mid-expiratory flow between 25 and 75% of FVC (<i>p</i> &#x3c; 0.0001), inspiratory capacity (<i>p</i> &#x3c; 0.01), forced vital capacity (<i>p</i> &#x3c; 0.05), and peak expiratory flow (<i>p</i> &#x3c; 0.0001). Moreover, in a subgroup of 28 patients, a significant increase of diffusion lung capacity (<i>p</i> &#x3c; 0.01) was also detected. <b><i>Conclusions:</i></b> In conclusion, our real-life results suggest that triple inhaled therapy with FF/UMEC/VI, when given to COPD patients with frequent exacerbations, is able to positively impact on dyspnea and global health status as well as to significantly decrease COPD exacerbations and improve airflow limitation and lung hyperinflation.

scholarly journals The minimal important difference for the St George's Respiratory Questionnaire in patients with severe COPD

2015 ◽  
Vol 46 (6) ◽  
pp. 1598-1604 ◽  
Author(s):  
Jorrit B.A. Welling ◽  
Jorine E. Hartman ◽  
Nick H.T. Ten Hacken ◽  
Karin Klooster ◽  
Dirk-Jan Slebos
Keyword(s):  
Clinical Trials ◽  
Minimal Important Difference ◽  
Forced Expiratory Volume ◽  
Sample Size Determination ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Copd Patients ◽  
St George's Respiratory Questionnaire ◽  
Severe Copd

The St George's Respiratory Questionnaire (SGRQ) is a validated, commonly used questionnaire for measuring quality of life in patients with chronic obstructive pulmonary disease (COPD). The current established minimal important difference (MID) for SGRQ scores in an average COPD population is −4 units. However, for patients with severe COPD, the MID has not been thoroughly validated. We re-determined the SGRQ MID for this patient group.115 severe COPD patients (forced expiratory volume in 1 s (FEV1) 26±9% of predicted, SGRQ score 62±11 units; mean±sd,) who participated in seven different bronchoscopic lung volume reduction clinical trials were included in the analysis. Anchor- and distribution-based methods were used to define the MID for SGRQ scores. FEV1, 6-min walk distance and residual volume were used as anchors.Combining both anchor- and distribution-based methods, we identified a SGRQ MID of −8.3 units at 1 month and −7.1 units at 6 months.This study proposes an alternative SGRQ MID for patients with severe COPD of −8.3 units at 1 month and −7.1 units at 6 months follow-up after intervention. Our new MID estimates could be applied for both interpreting SGRQ outcomes as well as sample size determination in future clinical trials investigating interventions in severe COPD patients.

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.

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