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 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 Effectiveness and Quality of Life with Montelukast in Asthma – A double-blind randomized control trial

2019 ◽  
Vol 35 (3) ◽  
Author(s):  
Mirza Saif Ullah Baig ◽  
Rashid Ahmed Khan ◽  
Kamran Khan ◽  
Nadeem Rizvi
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Asthma Control ◽  
Persistent Asthma ◽  
Double Blind ◽  
Once Daily ◽  
The Mean ◽  
Moderate Persistent Asthma

Objective: To determine the role of montelukast – a leukotriene receptor antagonist (LTRA) – in improving the quality of life (QOL) and asthma control of adult patients with mild to moderate persistent asthma. Methods: Randomized, double-blind, placebo-controlled, non-crossover trial was conducted from March 2017 till November 2018 in three hospitals of Karachi and Hyderabad. Adults of age 15 years or more with mild to moderate persistent asthma. Treatment group was administered tablet montelukast 10mg once daily; the other group was given a similar looking placebo; as an adjuvant to the current medication. QOL was assessed with Asthma Quality of Life Questionnaire – Standard (AQLQ-S) before and after the treatment. Asthma control was monitored via Asthma Control Test (ACT). Results: After 4 weeks, the mean ± SD of overall QOL on AQLQ-S improved from 3.74±0.88 to 5.06±0.89 for montelukast group and from 3.58±0.92 to 4.71±0.97 for placebo group (p=0.02). The improvement in sub-domains of symptoms, activity, and emotional functions was not significant; however, the sub-domain “environmental stimuli” significantly improved with 5.06±0.89 for montelukast group and 4.71±0.97 for placebo group (p=0.02). The mean ± SD of ACT, after four weeks, for montelukast group was 18.19±2.91 and for placebo group 17.28±3.36. Only on ACT, Montelukast did not show any statistically insignificant results. Conclusion: The role of montelukast in improving QOL of adult patients with mild to moderate persistent asthma is quite beneficial. It improves patient quality of life. It has the ease of once daily oral administration and also eradicates side effects associated with long-term adherence to steroids. doi: https://doi.org/10.12669/pjms.35.3.42 How to cite this:Baig S, Khan RA, Khan K, Rizvi N. Effectiveness and Quality of Life with Montelukast in Asthma – A double-blind randomized control trial. Pak J Med Sci. 2019;35(3):---------. doi: https://doi.org/10.12669/pjms.35.3.42 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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 Fluticasone furoate/vilanterol 92/22 µg once a day: a 12-month study on outcomes in mild to moderate asthma

2018 ◽  
Vol 12 ◽  
pp. 175346661878989 ◽  
Author(s):  
Roberto W. Dal Negro ◽  
Luca Bonadiman ◽  
Paola Turco
Keyword(s):  
Forced Expiratory Volume ◽  
Time Dependent ◽  
Adherence To Treatment ◽  
Fluticasone Furoate ◽  
Exacerbation Rate ◽  
Once Daily ◽  
Moderate Asthma ◽  
Hospitalization Rates ◽  
The Mean ◽  
Over Time

Background: Fluticasone furoate/vilanterol (FF/V) is an effective long-acting β2 agonist/inhaled corticosteroid combination for managing persistent bronchial asthma. The aim of the study was to assess the outcomes achievable in patients with mild to moderate asthma receiving FF/V 92/22 µg once daily for 12 months. Methods: Data were automatically and anonymously obtained from the institutional database: forced expiratory volume in 1 s predicted values; the exacerbation and hospitalization rates; days of hospitalization; general practitioner (GP) or specialist visits; days of inactivity; courses of systemic steroids or antibiotics were recorded at baseline and after 3, 6 and 12 months of treatment. The overall adherence to treatment was also calculated. Analysis of variance was used for checking the trends of variables. The improvement in lung function was significant ( p < 0.001) and time dependent. The mean (±standard error) exacerbation rate per patient changed from 1.05 (±0.16) at baseline to 0.28 (±0.07) after 3 months, 0.33 (±0.08) after 6 months and 0.18 (±0.08) after 12 months ( p < 0.001). The mean hospitalization rate per patient changed from 0.30 (±0.07) at baseline to 0.08 (±0.04) after 3 months, 0.10 (±0.05) after 6 months and 0.03 (±0.03) after 12 months ( p < 0.001). Also mean duration of hospitalization and days of inactivity were reduced over time ( p < 0.001). GP visits were also reduced, together with specialist visits (both p < 0.001). Steroid and antibiotic courses dropped significantly ( p < 0.001 and p < 0.001, respectively). Moreover, changes in all outcomes considered proved time dependent, particularly over the second semester. Finally, over time, adherence to treatment was high. Conclusions: The once-daily inhalation of combined FF/V 92/22 µg optimized systematically the exacerbation and hospitalization rates in mild to moderate asthma, together with all other outcomes over time. The effectiveness of FF/V 92/22 µg once daily proved to be time dependent over the period of the study.

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 Nebulized fluticasone propionate, a viable alternative to systemic route in the management of childhood moderate asthma attack: A double-blind, double-dummy study

2015 ◽  
Vol 109 (9) ◽  
pp. 1120-1125 ◽  
Author(s):  
Beyza Poplata Demirca ◽  
Hasret Cagan ◽  
Ayca Kiykim ◽  
Ulku Arig ◽  
Medeni Arpa ◽  
...  
Keyword(s):  
Fluticasone Propionate ◽  
Viable Alternative ◽  
Double Blind ◽  
Moderate Asthma ◽  
Asthma Attack

scholarly journals Comparative Efficacy and Safety of Moxifloxacin and Clindamycin in the Treatment of Odontogenic Abscesses and Inflammatory Infiltrates: a Phase II, Double-Blind, Randomized Trial

2010 ◽  
Vol 55 (3) ◽  
pp. 1142-1147 ◽  
Author(s):  
Georg Cachovan ◽  
Rainer H. Böger ◽  
Ina Giersdorf ◽  
Olaf Hallier ◽  
Thomas Streichert ◽  
...  
Keyword(s):  
Comparative Efficacy ◽  
Primary Analysis ◽  
Double Blind ◽  
Once Daily ◽  
Odontogenic Infections ◽  
Perceived Pain ◽  
Clinical Responses ◽  
Efficacy Assessment ◽  
The Mean ◽  
Inflammatory Infiltrates

ABSTRACTMoxifloxacin penetrates well into oromaxillary tissue and covers the causative pathogens that show an increasing resistance to standard antibiotics. Clinical reports suggest that moxifloxacin may be effective for the treatment of odontogenic infections that can lead to serious complications. The objective of this prospective, randomized, double-blind, multicenter study was to compare the efficacies and safeties of moxifloxacin and clindamycin for the medical treatment of patients with gingival inflammatory infiltrates and as an adjuvant therapy for patients with odontogenic abscesses requiring surgical treatment. Patients received either 400 mg moxifloxacinper osonce daily or 300 mg clindamycinper osfour times daily for 5 days consecutively. The primary efficacy endpoint was the percent reduction in patients' perceived pain on a visual analogue scale at days 2 to 3 from baseline. Primary analysis included 21 moxifloxacin- and 19 clindamycin-treated patients with infiltrates and 15 moxifloxacin- and 16 clindamycin-treated patients with abscesses. The mean pain reductions were 61.0% (standard deviation [SD], 46.9%) with moxifloxacin versus 23.4% (SD, 32.1%) with clindamycin (P= 0.006) for patients with infiltrates and 55.8% (SD, 24.8%) with moxifloxacin versus 42.7% (SD, 48.5%) with clindamycin (P= 0.358) for patients with abscesses. A global efficacy assessment at days 2 to 3 and 5 to 7 showed faster clinical responses with moxifloxacin in both abscess and infiltrate patients. Rates of adverse events were lower in moxifloxacin- than in clindamycin-treated patients. In patients with inflammatory infiltrates, moxifloxacin was significantly more effective in reducing pain at days 2 to 3 of therapy than clindamycin. No significant differences between groups were found for patients with odontogenic abscesses.

A Comparative Study of a New Food Supplement, ViviScal®, with Fish Extract for the Treatment of Hereditary Androgenic Alopecia in Young Males

1992 ◽  
Vol 20 (6) ◽  
pp. 445-453 ◽  
Author(s):  
A Lassus ◽  
E Eskelinen
Keyword(s):  
Treatment Group ◽  
Food Supplement ◽  
Androgenic Alopecia ◽  
Double Blind ◽  
Once Daily ◽  
Young Males ◽  
Highly Active ◽  
Parallel Group ◽  
The Mean

A controlled, randomized, double-blind, parallel-group study compared the effects of ViviScal® (a new food supplement incorporating special marine extracts and a silica compound) with those of a fish extract in the treatment of young males with hereditary androgenic alopecia. The pretreatment histological diagnosis was alopecia with a mild to moderate perifollicular inflammation zone. The study consisted of 20 subjects who received two tablets of ViviScal® once daily and 20 who received two tablets of fish extract once daily for 6 months. The mean patient age and mean duration and severity of baldness compared well between the two groups. Most patients had been treated with long-term topical 2% minoxidil for 1 year or more prior to the study. At baseline and after 6 months' treatment, a biopsy was taken for histological examination. A non-vellus hair count was performed at baseline and after 2, 4 and 6 months. In the fish extract treatment group three patients withdrew from the study before the fourth month due to lack of therapeutic effect. After 6 months' treatment, patients receiving ViviScal® showed a mean increase in non-vellus hair of 38% compared with a 2% increase in the fish extract treatment group (P < 0.0001). In the ViviScal® group, 19 (95%) subjects showed both clinical and histological cure, whereas none treated with fish extract showed any clinical or histological difference after 6 months' treatment ( P < 0.0001). In both groups, a minimal decrease in the erythemal index was observed. In conclusion, ViviScal® appears to be the first highly active treatment for androgenic alopecia in young males.

A Parallel-Group Comparison of Astemizole and Loratadine for the Treatment of Perennial Allergic Rhinitis

1997 ◽  
Vol 25 (4) ◽  
pp. 175-181 ◽  
Author(s):  
H Al-Muhaimeed
Keyword(s):  
Allergic Rhinitis ◽  
Statistical Significance ◽  
Double Blind Study ◽  
Perennial Allergic Rhinitis ◽  
Double Blind ◽  
Once Daily ◽  
Runny Nose ◽  
Parallel Group ◽  
The Mean ◽  
To Receive

The efficacy and safety of the two antihistamines, astemizole and loratadine, were compared in a double-blind study of 84 patients with perennial allergic rhinitis. Patients were randomized to receive orally either astemizole 10 mg once daily ( n = 40) or loratadine 10 mg once daily ( n = 44) for 1 week. No other antirhinitis medication was allowed during the study. By day 7 the mean daily symptom scores, recorded on diary cards, were lower in patients receiving astemizole than in those receiving loratadine for runny nose, itchy nose and sneezing, although not for blocked nose, and treatment differences only reached statistical significance for runny nose. After 7 days, 53.75% of patients on astemizole and 38.6% on loratadine were free of symptoms, and 87% of patients on astemizole described the treatment as good or excellent compared with 62% on loratadine. The present results suggest that astemizole may be more effective than loratadine in controlling symptoms of perennial allergic rhinitis.

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.

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