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 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 Health-Related Effects of Home Nebulization With Glycopyrronium on Difficult-to-Treat Asthma: Post-Hoc Analyses of an Observational Study (Preprint)

2020 ◽  
Author(s):  
Deepak Talwar ◽  
Salil Bendre
Keyword(s):  
Adverse Events ◽  
Asthma Control ◽  
Inhaled Corticosteroids ◽  
Moderate Intensity ◽  
Serious Adverse Events ◽  
Female Ratio ◽  
Mean Values ◽  
Control Score ◽  
Long Acting ◽  
Post Hoc

BACKGROUND Bronchial asthma remains a clinical enigma with poorly controlled symptoms or exacerbations despite regular use of inhaled corticosteroids. Home nebulization offers a simplified solution for the delivery of rescue and maintenance bronchodilators, which is especially true for patients with frequent exacerbations during management of uncontrolled or difficult-to-treat asthma. OBJECTIVE We aimed to assess the clinical impact and outcomes associated with home nebulization—delivered long-acting bronchodilators for uncontrolled or difficult-to-treat asthma. METHODS This observational, concurrent study was conducted with 60 patients at 2 centers during November 2018. Statistical analyses for prebronchodilator forced expiratory volume in one second (FEV1) and Global Initiative for Asthma (GINA) asthma control score in patients on long-acting bronchodilators and corticosteroids were conducted, with two-tailed <i>P</i> values &lt;.05 considered statistically significant. RESULTS Per protocol analyses (53/60) for consecutive cases receiving home nebulization with long-acting bronchodilators and corticosteroids were conducted. The baseline demographics included a male-to-female ratio of 30:23 and mean values of the following: age, 60.3 years (SD 11.8 years); weight, 64 kg (SD 16.8 kg); FEV1, 43% (SD 16%); GINA asthma control score, 3.0 points (SD 0.8 points); serum eosinophil level, 4% (SD 3%); fractional exhaled nitric oxide (FeNO), 12.1 ppb (SD 6 ppb). Of the patients, 100% (53/53) had uncontrolled symptoms, 69.8% (37/53) had prior exacerbations, 100% (53/53) used formoterol/budesonide, and 75.5% (40/53) used glycopyrronium. The per protocol group (n=53) had significantly improved mean prebronchodilator FEV1 (23.7%, SD 29.8%; 0.46 L, SD 0.58 L; <i>P</i>&lt;.001) and GINA asthma control score (2.1 points, SD 0.8 points, <i>P</i>&lt;.001). At baseline, patients (n=40) receiving glycopyrronium/formoterol/budesonide (25/20/500 mcg) nebulization admixture had the following mean values: prebronchodilator FEV1, 38% (SD 15%); GINA asthma control score, 3.0 points (SD 0.8 points); reversibility, 12% (SD 6%); peripheral eosinophil level, 4% (SD 3%); FeNO, 12 ppb (SD 5.7 ppb). In the post hoc analyses, these patients had significantly improved mean prebronchodilator FEV1 of 27.7% (SD 26.2%; 0.54 L, SD 0.51 L; <i>P</i>&lt;.001) at 8 weeks compared with baseline. At baseline, patients (n=13) receiving formoterol/budesonide (20/500 mcg) nebulization had the following mean values: FEV1, 55% (SD 12%); GINA asthma control score, 3.0 points (SD 1.2 points); reversibility, 14% (SD 7%); serum eosinophil level, 4% (SD 3%); FeNO, 13.3 ppb (SD 6.8 ppb). In the post hoc analyses, these patients showed a significant improvement in prebronchodilator FEV1 of 11.2% (SD 13.1%; 0.22 L, SD 0.25 L; <i>P</i>&lt;.001) from baseline. Breathlessness of mild to moderate intensity was reported by 10 cases (10/53, 18.9%), with no other treatment-emergent adverse events or serious adverse events. CONCLUSIONS Home nebulization remains a viable option for symptomatic difficult-to-treat asthma cases with frequent use of rescue medications. Glycopyrronium as add-on therapy offers a synergistic response in patients on corticosteroids with difficult-to-treat asthma. CLINICALTRIAL Clinical Trial Registry of India CTRI/2018/11/016319; https://tinyurl.com/y78cctm3

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.

scholarly journals Montelukast as an Alternative to Low-Dose Inhaled Corticosteroids in the Management of Mild Asthma (The SIMPLE Trial): An Open-Label Effectiveness Trial

2009 ◽  
Vol 16 (suppl a) ◽  
pp. 11A-16A ◽  
Author(s):  
R Andrew McIvor ◽  
Alan Kaplan ◽  
Caroline Koch ◽  
John S Sampalis
Keyword(s):  
Asthma Control ◽  
Outcome Measures ◽  
Low Dose ◽  
Inhaled Corticosteroids ◽  
Symptom Control ◽  
Physician Satisfaction ◽  
Mild Asthma ◽  
Secondary Outcome ◽  
Open Label ◽  
Number Of Patients

OBJECTIVE: To evaluate the effectiveness of montelukast as monotherapy for patients with mild asthma who remain uncontrolled or unsatisfied while on inhaled corticosteroid (ICS) monotherapy.DESIGN: A multicentre, open-label study. Patients (six years of age or older) had ICS therapy discontinued and were treated with orally administered montelukast once daily for six weeks.MAIN OUTCOME MEASURES: The primary outcome measure was the rate at which asthma symptom control was achieved or maintained after six weeks of treatment. The secondary outcome measures were to compare compliance and physician satisfaction, and to further assess the safety and tolerability of montelukast.RESULTS: Of the 534 patients enrolled, 481 (90.1%) completed the study. Mean (± SD) age was 27.8±19.0 years. The number of patients with uncontrolled symptoms decreased from 455 (85.2%) at baseline to 143 (26.8%) at week 6 (P<0.001), and mean Asthma Control Questionnaire score decreased from 1.4±0.8 to 0.6±0.6 (P<0.001), representing a clinically significant improvement. Of the 79 patients with controlled asthma symptoms at baseline, 73.4% maintained asthma control at week 6. Compliance to asthma therapy increased from 41% at baseline for ICS to 88% at week 6 for montelukast (P<0.001). Physician satisfaction with treatment increased from 43% to 85% (P<0.001) and patient satisfaction increased from 45% at baseline to 94% at week 6. No serious adverse events were reported over the course of the study.CONCLUSION: Montelukast is an effective and well-tolerated alternative to ICS treatment in patients with mild asthma who are uncontrolled or unsatisfied with low-dose ICS therapy.

scholarly journals Long-term adherence to inhaled corticosteroids and asthma control in adult-onset asthma

2021 ◽  
Vol 7 (1) ◽  
pp. 00715-2020
Author(s):  
Iida Vähätalo ◽  
Hannu Kankaanranta ◽  
Leena E. Tuomisto ◽  
Onni Niemelä ◽  
Lauri Lehtimäki ◽  
...  
Keyword(s):  
Asthma Control ◽  
Inhaled Corticosteroids ◽  
Early Recognition ◽  
Forced Expiratory Volume ◽  
Rapid Decline ◽  
Adult Onset ◽  
Lung Function Decline ◽  
Adult Asthma ◽  
Asthma Patients

BackgroundIn short-term studies, poor adherence to inhaled corticosteroids (ICS) has been associated with worse asthma control, but the association of long-term adherence and disease control remains unclear.ObjectiveTo assess the relationship between 12-year adherence to ICS and asthma control in patients with adult-onset asthma.MethodsAs part of the Seinäjoki Adult Asthma Study, 181 patients with clinically confirmed new-onset adult asthma and regular ICS medication were followed-up for 12 years. Adherence (%) to ICS was assessed individually ((µg dispensed/µg prescribed)×100) during the follow-up. Asthma control was evaluated after 12 years of treatment according to the Global Initiative for Asthma 2010 guideline.ResultsAsthma was controlled in 31% and not controlled (partly controlled or uncontrolled) in 69% of the patients. Patients with not-controlled asthma were more often male, older, nonatopic and used higher doses of ICS than those with controlled disease. The mean±sd 12-year adherence to ICS was 63±38% in patients with controlled asthma and 76±40% in patients with not-controlled disease (p=0.042). Among patients with not-controlled asthma, those with lower 12-year adherence (<80%) had more rapid decline in forced expiratory volume in 1 s (−47 mL·year−1) compared to patients with better adherence (≥80%) (−40 mL·year−1) (p=0.024). In contrast, this relationship was not seen in patients with controlled asthma.ConclusionsIn adult-onset asthma, patients with not-controlled disease showed better 12-year adherence to ICS treatment than those with controlled asthma. In not-controlled disease, adherence <80% was associated with more rapid lung function decline, underscoring the importance of early recognition of such patients in routine clinical practice.

scholarly journals Is there an association between the value of forced expiratory volume in the 1st second, the Asthma Control Test and a Control Framework by Global Initiative for asthma in asthmatic children and adolescents treated with inhaled corticosteroids?

2019 ◽  
Vol 29 (3) ◽  
pp. 346-353
Author(s):  
Karla Delevedove Taglia-Ferre ◽  
Sandra Lisboa ◽  
Luanda Dias da S. Salviano ◽  
Ana Carolina Carioca da Costa ◽  
Shandra Lisboa Monteiro ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Asthma Control ◽  
Control Method ◽  
Inhaled Corticosteroids ◽  
Forced Expiratory Volume ◽  
Control Test ◽  
Asthma Control Test ◽  
Asthmatic Children ◽  
Global Initiative For Asthma ◽  
Global Initiative

Objective: Evaluate the presence of association between the classification of the level of asthma control, using the method proposed by the Global Initiative for Asthma (GINA), the Asthma Control Test (ACT)/Childhood-ACT and the forced expiratory volume in the 1st second (FEV1), in asthmatic children and adolescents treated with inhaled corticosteroids, followed up at the National Institute of Women's, Children's and Adolescents' Health FernandesFigueira of the Oswaldo Cruz Foundation (IFF / FIOCRUZ). Method: A cross-sectional study was carried out with a review of the medical records of all children between 7 and 17 years of age followed up at the Asthma Outpatient Clinic and referred to the Respiratory Insertion Test (PFR) sector between March 2013 and September 2014. In the same day were applied the C-ACT/ACT questionnaires, an asthma control method proposed by the GINA and the FEV1 value in a spirometrictest. Results: From the total number of records evaluated (72), 16 children were excluded because they did not meet the required criteria for performing spirometry. The sample studied (56 children) was predominantly male (58.9%) and median age was 12 (7-17) years. It was observed an association between FEV1 and GINA values ??(p <0.01). Conclusion: The results found in this study indicate that FEV1 measurement is a useful component among the instruments for assessing clinical control of asthma by GINA.

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 Predictors of Loss of Asthma Control Induced by Corticosteroid Withdrawal

2006 ◽  
Vol 13 (3) ◽  
pp. 129-133 ◽  
Author(s):  
Jose Belda ◽  
Krishnan Parameswaran ◽  
Catherine Lemière ◽  
Dennis Kamada ◽  
Paul M O'Byrne ◽  
...  
Keyword(s):  
Nitric Oxide ◽  
Asthma Control ◽  
Eosinophil Count ◽  
Inhaled Corticosteroids ◽  
Forced Expiratory Volume ◽  
Exhaled Nitric Oxide ◽  
Baseline Risk ◽  
Blood Eosinophil ◽  
Inhaled Corticosteroid ◽  
Sputum Eosinophil

BACKGROUND: Asthma guidelines recommend reducing the dose of inhaled corticosteroids after establishing control.OBJECTIVE: To identify predictors of loss of control and the kinetics of symptoms, and inflammatory and physiological measurements when inhaled corticosteroids are reduced in patients with stable asthma.PATIENTS AND METHODS: In a single-blind study, the daily dose of inhaled corticosteroid was reduced by one-half at intervals of 20±2 days in 17 adults with controlled asthma until loss of asthma control occurred or until the corticosteroid was replaced with placebo for 20 days. The patients recorded symptoms and peak expiratory flow each day, and forced expiratory volume in 1 s (FEV1), the provocative concentration of methacholine causing a 20% fall in FEV1(PC20), exhaled nitric oxide, and eosinophils in sputum and blood were measured every 10 days. A loss of asthma control was defined as a worsening of the symptoms score of at least 20%, and either a decrease in FEV1of at least 15% or a decrease in PC20of at least fourfold.RESULTS: Two patients had a respiratory infection and were withdrawn from the study. In eight patients, asthma became uncontrolled after a mean of 33 days (range 13 to 48 days). This was accurately reflected by a worsening of all parameters. The first parameter to change was the sputum eosinophil percentage (20 days before the loss of asthma control). Significant changes in exhaled nitric oxide, FEV1and methacholine PC20were observed only when the symptoms became uncontrolled. A high blood eosinophil count at baseline (risk ratio of 2.5, 95% CI 1.0 to 6.5) and an increase in sputum eosinophil count after the reduction of corticosteroids were predictors of loss of asthma control.CONCLUSION: In patients whose asthma is controlled on inhaled corticosteroid, it is prudent not to reduce the dose further if the blood eosinophils are increased or if the sputum eosinophils increase by as little as 1% after the reduction of corticosteroids.

scholarly journals INTREPID: single- versus multiple-inhaler triple therapy for COPD in usual clinical practice

2021 ◽  
pp. 00950-2020
Author(s):  
David M. G. Halpin ◽  
Sally Worsley ◽  
Afisi S. Ismaila ◽  
Kai-Michael Beeh ◽  
Dawn Midwinter ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Triple Therapy ◽  
Clinical Care ◽  
Forced Expiratory Volume ◽  
Inhalation Technique ◽  
Open Label ◽  
Serious Adverse Events ◽  
Once Daily ◽  
Open Label Phase ◽  
Critical Error

IntroductionReal-world trial data comparing single- with multiple-inhaler triple therapy (MITT) in COPD patients are currently lacking. The effectiveness of once-daily single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) and MITT were compared in usual clinical care.MethodsINTREPID was a multicentre, randomised, open-label, phase IV effectiveness study comparing FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA inhaler with a clinician's choice of any approved non-ELLIPTA MITT in usual COPD clinical practice in five European countries. Primary endpoint was proportion of COPD Assessment Test (CAT) responders (≥2-unit decrease in CAT score from baseline) at Week 24. Secondary endpoints in a subpopulation included change from baseline in forced expiratory volume in 1 s (FEV1) and percentage of patients making ≥1 critical error in inhalation technique at Week 24. Safety was also assessed.Results3092 patients were included (FF/UMEC/VI N=1545; MITT N=1547). The proportion of CAT responders at Week 24 was significantly greater with FF/UMEC/VI versus non-ELLIPTA MITT (odds ratio: 1.31; 95% confidence interval [CI]: 1.13, 1.51; p<0.001) and mean change from baseline in FEV1 was significantly greater with FF/UMEC/VI (77 mL versus 28 mL; treatment difference [95% CI] 50 mL [26, 73]; p<0.001). The percentage of patients with ≥1 critical error in inhalation technique was low in both groups (FF/UMEC/VI 6%, non-ELLIPTA MITT 3%). Safety profiles, including incidence of pneumonia serious adverse events, were similar between treatments.ConclusionsIn a usual clinical care setting, treatment with once-daily single-inhaler FF/UMEC/VI resulted in significantly more patients gaining health status improvement and greater lung function improvement versus non-ELLIPTA MITT.

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