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Mometasone furoate dry powder inhaler for the treatment of asthma -
Mometasone furoate dry powder inhaler for the treatment of asthma
This is a randomized, multi-center, parallel-group, active-controlled, double-blind study evaluating the effects of mometasone furoate MF dry powder inhaler DPI on bone mineral density BMD in subjects with asthma. The mean percent change in lumbar spine BMD from the averaged baseline value the average of the two scan results prior to treatment to the endpoint of treatment time point the average of the last two valid post-baseline scan results during treatment for the comparison of MF DPI mcg daily in the evening versus montelukast ML 10 mg daily in the evening.
Drug Information available for: Fluticasone propionate Mometasone furoate Fluticasone Mometasone Mometasone furoate monohydrate Montelukast Fluticasone furoate. FDA Resources.
Arms and Interventions. Outcome Measures. The averaged baseline value is the average of the two scan results prior to treatment.
Mean percent change from Baseline the last non-missing value prior to treatment in pulmonary function test FEV1 from in-office visits and at Endpoint last non-missing postbaseline value carried forward.
Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Informed consent, adhere to schedules. Inform usual treating medical doctor MD of study participation. Female 18 to 40, male 18 to 50, any race. Women of childbearing potential must use birth control. Includes: hormonal contraceptive, intra-uterine device IUD ; condom in combination with spermicide; monogamous relationship with male who had vasectomy or is using condom.
Females must have negative serum pregnancy test at Screening. Treated with methotrexate, cyclosporin, gold, or other cytotoxic agents, for asthma or concurrent condition within last 3 months.
Can be rescheduled. Ever required ventilator support for respiratory failure secondary to asthma. Chronic bronchitis, bronchiectasis, emphysema or cystic fibrosis. Participated in study within last 30 days. Condition that might affect ability to ambulate normally, ie major surgical procedure. Condition that may interfere with BMD measurement. History of renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, respiratory, gastrointestinal, cerebrovascular, or other which could interfere with study or require treatment which might interfere eg calcium urolithiasis or absorptive hypercalcuria, insulin dependent diabetes, cancer within last 10 years except basal cell carcinoma , active hepatitis, coronary artery disease, stroke, rheumatoid arthritis, human immunodeficiency virus HIV , or respiratory conditions such as chronic obstructive pulmonary disease COPD , chronic bronchitis, cystic fibrosis.
The subject has undergone incisional or intraocular surgery in which the natural lens is still present in the eye. The subject has a history of penetrating trauma to both eyes. Pregnant, breast-feeding, or postmenopausal women.
Bilateral oophorectomy excluded. Relevant abnormal Baseline vital sign. HIV positive testing not performed. Alcoholic or illicit drug abuser.
Evidence of oropharyngeal candidiasis at Baseline with or without treatment. Taken restricted medications prior to Screening. No subject may participate in this same study at another site or simultaneously in any other study. No person directly associated with administration of study may participate. Contacts and Locations. More Information. Limitations: Only one study evaluated both morning and evening administration of once-daily doses, and one of the comparative clinical trials was an open-label study.
Conclusion: Once-daily administration of MF-DPI microg in patients with mild to moderate persistent asthma effectively improved lung function and asthma control. In patients with severe persistent asthma dependent on oral corticosteroids, treatment with MF-DPI microg BID permitted substantial reduction of oral corticosteroid use.
Abstract Background: Mometasone furoate MF , a potent synthetic inhaled corticosteroid ICS with a high affinity for the glucocorticoid receptor, is approved for use in the treatment of asthma.
Publication types Research Support, Non-U. Gov't Review.
❾-50%}Particles 5 mm, which frequently deposit in the mouth and oropharynx, where they can cause adverse events, such as oral candidiasis. In vitro studies utilizing the multiple plate method Andersen cascade impactor , which simulates the various anatomical regions of the respiratory tree, are a reliable and reproducible way to measure and compare inhaled dry powder formulations, since the low concentrations of the active principle inhaled make it difficult to detect in vivo in serum.
Patient preference for a given inhalation device should be considered, although this was not evaluated in the present study. References 1. Suissa S, Ernst P. Inhaled corticosteroids: impact on asthma morbidity and mortality. J Allergy Clin Immunol. Designing corticosteroid drugs for pulmonary selectivity. Proc Am Thorac Soc. Sharpe M, Jarvis B Inhaled mometasone furoate: a review of its use in adults and adolescents with persistent asthma.
Effects of treatment with mometasone furoate dry powder inhaler in children with persistent asthma. Ann Allergy Asthma Immunol. Bioavailability and metabolism of mometasone furoate following administration by metered-dose and dry-powder inhalers in healthy human volunteers.
J Clin Pharmacol. Inhaled mometasone furoate reduces oral prednisone requirements while improving respiratory function and health-related quality of life in patients with severe persistent asthma. Dose-ranging study of a new steroid for asthma: mometasone furoate dry powder inhaler. Respir Med. Once-daily mometasone furoate dry powder inhaler in the treatment of patients with persistent asthma.
Mometasone furoate administered once daily is as effective as twice-daily administration for treatment of mild-to-moderate persistent asthma. Expiratory peak flow rate. Standard values for normal subjects. Use as a clinical test of ventilatory function. Am Rev Respir Dis. Influence of formulation excipients and physical characteristics of inhalation dry powders on their aerosolization performance.
J Control Release. Efficacy and safety overview of a new inhaled corticosteroid, QVAR hydrofluoroalkane-beclomethasone extrafine inhalation aerosol , in asthma. Relevance of pharmacokinetics and pharmacodynamics of inhaled corticosteroids to asthma. Eur Respir J. Modeling and algebraic formulation of regional aerosol deposition in man.
J Aerosol Sci ; 21 suppl 1 : In vitro comparison of two delivery devices for administering formoterol: Foradil P and formoterol ratiopharm single-dose capsule inhaler. FDA Resources. Arms and Interventions. Outcome Measures. The averaged baseline value is the average of the two scan results prior to treatment. Mean percent change from Baseline the last non-missing value prior to treatment in pulmonary function test FEV1 from in-office visits and at Endpoint last non-missing postbaseline value carried forward.
Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Informed consent, adhere to schedules. Inform usual treating medical doctor MD of study participation. Female 18 to 40, male 18 to 50, any race. Women of childbearing potential must use birth control. Includes: hormonal contraceptive, intra-uterine device IUD ; condom in combination with spermicide; monogamous relationship with male who had vasectomy or is using condom.
Females must have negative serum pregnancy test at Screening. Treated with methotrexate, cyclosporin, gold, or other cytotoxic agents, for asthma or concurrent condition within last 3 months. Can be rescheduled. Ever required ventilator support for respiratory failure secondary to asthma. Chronic bronchitis, bronchiectasis, emphysema or cystic fibrosis. Participated in study within last 30 days.
Condition that might affect ability to ambulate normally, ie major surgical procedure. Condition that may interfere with BMD measurement. History of renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, respiratory, gastrointestinal, cerebrovascular, or other which could interfere with study or require treatment which might interfere eg calcium urolithiasis or absorptive hypercalcuria, insulin dependent diabetes, cancer within last 10 years except basal cell carcinoma , active hepatitis, coronary artery disease, stroke, rheumatoid arthritis, human immunodeficiency virus HIV , or respiratory conditions such as chronic obstructive pulmonary disease COPD , chronic bronchitis, cystic fibrosis.
The subject has undergone incisional or intraocular surgery in which the natural lens is still present in the eye. The subject has a history of penetrating trauma to both eyes. Pregnant, breast-feeding, or postmenopausal women.
Conclusion: Once-daily administration of MF-DPI microg in patients with mild to moderate persistent asthma effectively improved lung function and asthma control. In patients with severe persistent asthma dependent on oral corticosteroids, treatment with MF-DPI microg BID permitted substantial reduction of oral corticosteroid use.
Abstract Background: Mometasone furoate MF , a potent synthetic inhaled corticosteroid ICS with a high affinity for the glucocorticoid receptor, is approved for use in the treatment of asthma. Publication types Research Support, Non-U.
Cadastre seu e-mail abaixo e receba a nossa newsletter Enviar. Objective: Mometasone furoate MF is a new potent synthetic inhaled corticosteroid.
Internationally, MF is administered via a dry-powder inhaler that contains multiple doses. As a preparation that would be more cost-effective, single-dose MF capsules were developed in Brazil. The objective of the present study was to evaluate the efficacy and safety of the two inhalers for MF administration in patients with asthma. Results: No significant differences were observed between the two groups regarding the primary endpoints FEV1 and rescue medication use or the secondary endpoints morning PEF, tolerability, and safety, the last as assessed on the basis of hypothalamic-pituitary-adrenal axis function.
Conclusions: The use of the single-dose inhaler developed in Brazil for MF administration is as effective and safe as is that of a standard inhaler in the treatment of patients with asthma.
Keywords: Anti-asthmatic agents; Pregnadienediols; Metered dose inhalers. Desenvolvido por:. Its in vitro affinity for glucocorticoid receptors is 12 times greater than is that of dexamethasone and 5 times greater than is that of budesonide.
In addition, MF has significantly lower oral bioavailability than do budesonide and beclomethasone, which translates to a lower risk of adverse effects from systemic exposure to glucocorticoids. Methods This was a randomized, multicenter, open-label, parallel-group clinical trial approved by the ethics committees of the five centers involved and conducted in accordance with the principles of the Declaration of Helsinki.
Ninety-seven patients with symptomatic, moderate persistent asthma that was classified as stable diagnosed at least six months priorand aged 18 or older, were randomized. Women of childbearing age were included only if they were using contraception. Patients were asked to avoid using asthma medications prior to the tests, for a period consistent with the duration of action of the medication used.
After the screening visit, designated visit 1 V1the patients were evaluated on days 7 V215 V330 V445 V5 and 60 V6. The primary objective of this study was to evaluate efficacy by determining the difference between the FEV1 values obtained at V1 and those obtained at the subsequent visits after therapy with MF administered either via a multiple-dose DPI or a single-dose DPI. In addition, the two groups were compared in terms of daily PEF values, as determined by a domestic peak flow meter, and in terms of treatment response, as assessed by the investigator and by the patients themselves.
The number of daily applications of rescue medication albuterol used by the patients throughout the study period was also determined.
The secondary objective was to assess the safety and tolerability of both treatments on the basis of hypothalamic-pituitary-adrenal axis function, as determined through application of the cosyntropin test and determination of plasma cortisol levels prior to and 60 min after administration of mg of i. All patients gave written informed consent. The Kruskal-Wallis test was used to analyze the differences between the baseline and post-stimulus values, including plasma concentrations of cortisol cosyntropin test results and other nonparametric variables.
The level of significance was set at 0. Results A total of 97 patients were included. Of those 97 patients, 23 were excluded: 15 because they were ineligible; 5 because they experienced treatment failure 3 cases in the multiple-dose group and 2 cases in the single-dose group ; and 3 because they were lost to follow-up. Therefore, the number of patients who completed the treatment evaluable population was 74 40 in the single-dose group and 34 in the multiple-dose group.
All randomized patients who received at least one dose of medication were considered in the tolerability analysis. The two treatment groups were comparable regarding baseline demographic and asthma-related characteristics Table 1. The comparison of the baseline values with the values obtained in the subsequent visits revealed a statistically significant difference between V1 and all the subsequent visits, for the multiple-dose group and the single-dose group.
The comparison of the groups regarding the frequency of use of albuterol revealed no significant difference, as evidenced by the median range for the number of puffs used in each of the five weeks of the study by the patients in the single-dose and multiple-dose groups, respectively: week and 4 ; week and 1 ; week and 4 ; week and 0 ; and week and 1 There was no difference between the two treatment groups regarding the morning PEF values, as measured by the patients on a daily basis Figure 2.
The assessment of hypothalamic-pituitary-adrenal axis function revealed no statistically significant differences in plasma cortisol concentrations baseline values or values obtained after stimulation with ACTH between the pre-treatment and the post-treatment period in either of the two groups that received MF, demonstrating that the administration of this corticosteroid via either of the DPIs tested did not affect the integrity of hypothalamic-pituitary-adrenal axis function Figure 3.
There were no significant differences between the two treatment groups regarding the biochemical profile, vital signs, or adverse event profile after 60 days of exposure to MF-DPI. We observed only a few treatment-related adverse effects, all of which were considered mild to moderate in intensity, and the most common were headache and pharyngitis None of the patients had or developed oral candidiasis.
Figure 4 shows the treatment response, as evaluated by the investigator, at each follow-up visit in comparison with the baseline visit.
The proportion of patients considered to have gotten "much better" or "better" from V2 to V6 was similar in the two treatment groups The treatment response, as evaluated by the patient, at each follow-up visit in relation to the baseline visit, was also similar in the two groups, and the proportion of patients who reported having gotten "much better" or "better" from V2 to V6 was, respectively, Discussion The present study has demonstrated that the use of a multiple-dose inhaler is as effective as is that of a single-dose inhaler for MF administration in patients with moderate persistent asthma, which supports the use of the MF administration system available in Brazil.
One limitation of the present study was that the magnitude of the increase in FEV1 was reflected in the perception of symptom improvement by the patients. However, taken together, our results demonstrate that the improvement was not substantial, which might be due to the fact that most of the patients evaluated had mild asthma or that the power of the study sample was sufficient to reveal clinical differences among patients with mild symptoms.
Studies employing longer follow-up periods of several months would allow the assessment of other endpoints, such as the number of exacerbations. However, exacerbations, which were uncommon, occurred at a similar frequency in the two groups. Inhaled dry-powder glucocorticoid is a pharmaceutical formulation that is effective in the treatment of asthma patients and ensures that this medication is delivered directly to the airways.
Among aerosol delivery systems, DPIs have advantages, such as requiring no propellant, greater stability of the formulation, and lower cost. Particles 5 mm, which frequently deposit in the mouth and oropharynx, where they can cause adverse events, such as oral candidiasis. In vitro studies utilizing the multiple plate method Andersen cascade impactorwhich simulates the various anatomical regions of the respiratory tree, are a reliable and reproducible way to measure and compare inhaled dry powder formulations, since the low concentrations of the active principle inhaled make it difficult to detect in vivo in serum.
Patient preference for a given inhalation device should be considered, although this was not evaluated in the present study. References 1. Suissa S, Ernst P. Inhaled corticosteroids: impact on asthma morbidity and mortality. J Allergy Clin Immunol. Designing corticosteroid drugs for pulmonary selectivity.
Proc Am Thorac Soc. Sharpe M, Jarvis B Inhaled mometasone furoate: a review of its use in adults and adolescents with persistent asthma. Effects of treatment with mometasone furoate dry powder inhaler in children with persistent asthma.
Ann Allergy Asthma Immunol. Bioavailability and metabolism of mometasone furoate following administration by metered-dose and dry-powder inhalers in healthy human volunteers. J Clin Pharmacol. Inhaled mometasone furoate reduces oral prednisone requirements while improving respiratory function and health-related quality of life in patients with severe persistent asthma. Dose-ranging study of a new steroid for asthma: mometasone furoate dry powder inhaler. Respir Med. Once-daily mometasone furoate dry powder inhaler in the treatment of patients with persistent asthma.
Mometasone furoate administered once daily is as effective as twice-daily administration for treatment of mild-to-moderate persistent asthma.
Expiratory peak flow rate. Standard values for normal subjects. Use as a clinical test of ventilatory function. Am Rev Respir Dis. Influence of formulation excipients and physical characteristics of inhalation dry powders on their aerosolization performance. J Control Release. Efficacy and safety overview of a new inhaled corticosteroid, QVAR hydrofluoroalkane-beclomethasone extrafine inhalation aerosolin asthma.
Relevance of pharmacokinetics and pharmacodynamics of inhaled corticosteroids to asthma. Eur Respir J. Modeling and algebraic formulation of regional aerosol deposition in man. J Aerosol Sci ; 21 suppl 1 : In vitro comparison of two delivery devices for administering formoterol: Foradil P and formoterol ratiopharm single-dose capsule inhaler.
J Aerosol Med. Peak inspiratory flow rates generated through the Novolizer and the Turbuhaler dry powder inhaler devices by children with stable asthma. Clinical equivalence trial on budesonide delivered either by the Novolizer multidose dry powder inhaler or the Turbuhaler in asthmatic patients. Comparison of the efficacy and safety of mometasone furoate dry powder inhaler to budesonide Turbuhaler. Use of dry powder inhalers in COPD. Int J Clin Pract.
Correspondence to: Carlos Alberto de Castro Pereira. Tel 55 11 E-mail: pereirac uol. Submitted: 19 November Accepted, after review: 24 March Alberto Cukier Tenured Professor of Pulmonology. Rafael Stelmach Adjunct Professor. Erich Vidal Carvalho Pulmonologist. Edimar Pedrosa Gomes Pulmonologist. Suzete Varela Mayo Pulmonologist.
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Once-daily administration of MF-DPI microg in patients with mild to moderate persistent asthma effectively improved lung function and asthma control. Mometasone furoate dry powder is an inhaled corticosteroid that is approved for once-daily treatment of asthma in both adults and children. Mometasone furoate dry-powder inhaler (MF-DPI) is an inhaled corticosteroid (ICS) used for the treatment of persistent asthma in patients aged ≥ 12 years. To evaluate the efficacy and safety of 2 dosing regimens of mometasone furoate DPI in the treatment of mild-to-moderate persistent asthma in children. Condition or disease, Intervention/treatment, Phase. Asthma, Drug: mometasone furoate dry powder inhaler Drug: fluticasone propionate hydrofluoroalkane. Once-daily dosing of MF-DPI was effective in patients with mild or moderate persistent asthma previously taking twice-daily regimens of inhaled corticosteroids ICSsand in patients taking only inhaled beta2-agonists for symptom relief. J Clin Pharmacol. In vitro studies utilizing the multiple plate method Andersen cascade impactorwhich simulates the various anatomical regions of the respiratory tree, are a reliable and reproducible way to measure and compare inhaled dry powder formulations, since the low concentrations of the active principle inhaled make it difficult to detect in vivo in serum. Suissa S, Ernst P. National Institutes of Health U. Introduction: Asthma is a chronic inflammatory disease that causes significant morbidity and mortality.Study record managers: refer to the Data Element Definitions if submitting registration or results information. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.
For general information, Learn About Clinical Studies. We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
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Results First Posted : March 7, Last Update Posted : February 22, Study Description. This is a randomized, multi-center, parallel-group, active-controlled, double-blind study evaluating the effects of mometasone furoate MF dry powder inhaler DPI on bone mineral density BMD in subjects with asthma. The mean percent change in lumbar spine BMD from the averaged baseline value the average of the two scan results prior to treatment to the endpoint of treatment time point the average of the last two valid post-baseline scan results during treatment for the comparison of MF DPI mcg daily in the evening versus montelukast ML 10 mg daily in the evening.
Drug Information available for: Fluticasone propionate Mometasone furoate Fluticasone Mometasone Mometasone furoate monohydrate Montelukast Fluticasone furoate. FDA Resources. Arms and Interventions. Outcome Measures. The averaged baseline value is the average of the two scan results prior to treatment. Mean percent change from Baseline the last non-missing value prior to treatment in pulmonary function test FEV1 from in-office visits and at Endpoint last non-missing postbaseline value carried forward.
Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Informed consent, adhere to schedules. Inform usual treating medical doctor MD of study participation. Female 18 to 40, male 18 to 50, any race. Women of childbearing potential must use birth control. Includes: hormonal contraceptive, intra-uterine device IUD ; condom in combination with spermicide; monogamous relationship with male who had vasectomy or is using condom.
Females must have negative serum pregnancy test at Screening. Treated with methotrexate, cyclosporin, gold, or other cytotoxic agents, for asthma or concurrent condition within last 3 months.
Can be rescheduled. Ever required ventilator support for respiratory failure secondary to asthma. Chronic bronchitis, bronchiectasis, emphysema or cystic fibrosis.
Participated in study within last 30 days. Condition that might affect ability to ambulate normally, ie major surgical procedure.
Condition that may interfere with BMD measurement. History of renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, respiratory, gastrointestinal, cerebrovascular, or other which could interfere with study or require treatment which might interfere eg calcium urolithiasis or absorptive hypercalcuria, insulin dependent diabetes, cancer within last 10 years except basal cell carcinoma , active hepatitis, coronary artery disease, stroke, rheumatoid arthritis, human immunodeficiency virus HIV , or respiratory conditions such as chronic obstructive pulmonary disease COPD , chronic bronchitis, cystic fibrosis.
The subject has undergone incisional or intraocular surgery in which the natural lens is still present in the eye. The subject has a history of penetrating trauma to both eyes. Pregnant, breast-feeding, or postmenopausal women. Bilateral oophorectomy excluded. Relevant abnormal Baseline vital sign. HIV positive testing not performed.
Alcoholic or illicit drug abuser. Evidence of oropharyngeal candidiasis at Baseline with or without treatment. Taken restricted medications prior to Screening. No subject may participate in this same study at another site or simultaneously in any other study. No person directly associated with administration of study may participate. Contacts and Locations. More Information. Effects of mometasone, fluticasone, and montelukast on bone mineral density in adults with asthma.
J Allergy Clin Immunol Pract. Epub Oct 8. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Drug: mometasone furoate dry powder inhaler Drug: fluticasone propionate hydrofluoroalkane HFA Drug: montelukast. Phase 4. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. Drug: mometasone furoate dry powder inhaler mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year.
Other Name: Asmanex. Drug: montelukast 10 mg given once daily in the evening by mouth for 1 year. Other Name: Singulair. November 1, Key Record Dates.
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