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Kenneth B. Newman - One of the best experts on this subject based on the ideXlab platform.

  • Linear growth and bone maturation are unaffected by 1 year of therapy with inhaled Flunisolide hydrofluoroalkane in prepubescent children with mild persistent asthma: a randomized, double-blind, placebo-controlled trial.
    Annals of allergy asthma & immunology : official publication of the American College of Allergy Asthma & Immunology, 2011
    Co-Authors: George W. Bensch, Leon S. Greos, Sandra Gawchik, Euloge Kpamegan, Kenneth B. Newman
    Abstract:

    Background Inhaled corticosteroids (ICS) are the preferred long-term therapy for subjects with persistent asthma. However, concerns remain about potential effects of long-term ICS use on growth in children. Objective To determine the effect of 1 year of inhalation therapy with Flunisolide hydrofluoroalkane (HFA) on growth velocity and bone maturation in children with mild persistent asthma. Methods In this double-blind, placebo-controlled study, 218 prepubescent (Tanner Stage 1) children with mild persistent asthma ranging in age from 4 to 10 years were evaluated. After a 2-week run-in period, subjects were randomized (1:1) to 2 puffs Flunisolide HFA twice daily (85 μg/puff) or placebo for 52 weeks. Height was assessed by stadiometry at each visit. Growth velocity (cm/52 weeks) was estimated by the slope of the linear regression of height over time. An independent assessor scored hand and wrist radiographs for bone development pretreatment and at week 52. Analysis of covariance was used for all efficacy endpoints. Results The 2 treatment groups were similar at baseline for sex, race, age, weight, and height. At the end of double-blind treatment, mean growth velocity was 6.01 ± 1.84 cm/52 weeks for Flunisolide HFA ( n = 106) and 6.19 ± 1.30 cm/52 weeks for placebo ( n = 112) ( P = .425). Mean advancement in bone age during the 1-year study was similar for the 2 groups: 0.93 ± 0.46 years for Flunisolide HFA ( n = 70) and 1.01 ± 0.41 years for placebo ( n = 75) ( P = .128). Conclusions In this study, Flunisolide HFA did not suppress growth or bone maturation at the highest approved dose for children with persistent asthma.

  • Effect of HFA-Flunisolide on peripheral lung inflammation in asthma.
    The Journal of allergy and clinical immunology, 2003
    Co-Authors: Hans-peter Hauber, Kenneth B. Newman, Mark H. Gotfried, Rahul Danda, Ronald J. Servi, Pota Christodoulopoulos, Qutayba Hamid
    Abstract:

    Background: New hydrofluoroalkane (HFA) formulations of glucocorticoids have been shown to effectively control asthma. HFA glucocorticoids are deposited across all sizes of airways, including the small ones. However, it is not clear whether they can suppress peripheral airway inflammation. Objective: We sought to determine whether HFA-Flunisolide could suppress peripheral inflammation in asthma. Methods: Twelve patients with mild to moderate asthma received HFA-Flunisolide for 6 weeks. Transbronchial and endobronchial biopsy specimens were obtained before and after treatment, and spirometry was performed. Changes in inflammatory cells (eosinophils, neutrophils, lymphocytes, macrophages, basophils) and IL-5 and eotaxin were measured by using immunocytochemistry and in situ hybridization. Results: Lung function significantly improved after treatment (P < .05). HFA-Flunisolide significantly reduced eosinophils, IL-5, and eotaxin in both peripheral and central airways (P < .01). Neutrophils significantly increased after treatment in peripheral and central airways (P < .05). The numbers of lymphocytes remained unchanged. Conclusions: These results show that HFA-Flunisolide effectively suppressed eosinophilic inflammation in peripheral and central airways. These changes were accompanied by improvement in lung function. (J Allergy Clin Immunol 2003;112:58-63.)

  • One-Year Trial on Safety and Normal Linear Growth with Flunisolide HFA in Children with Asthma
    Clinical pediatrics, 2002
    Co-Authors: Sherwin A. Gillman, Robert Anolik, Eric J. Schenkel, Kenneth B. Newman
    Abstract:

    Flunisolide hydrofluoroalkane (HFA) has efficacy equivalent to that of Flunisolide chlorofluorocarbon (CFC) at one third the dose of the CFC formulation, a reduction from 250 pg/puff for Flunisolide CFC to 85 pg/puff for Flunisolide HFA. Flunisolide HFA delivers a smaller particle size (1.2 pim) in solution, resulting in improved lung deposition as compared with Flunisolide CFC (3.8 pm), which is delivered in suspension. An added built-in spacer has reduced oropharyngeal deposition that may result in fewer adverse events and make it easier to use. The objective of this study was to compare the year-long safety of Flunisolide HFA (daily dosage 340 pg) with that of CFC beclomethasone dipropionate (BDP) (daily dosage 336 pg) and cromolyn sodium (daily dosage 6,400 pg) in children 4-11 years old with mild-to-moderate asthma. The effects of these drugs on linear growth and growth velocity were also compared. The study was a 1-year open-label, parallel-group trial. Changes in physical examinations (including gr...

  • Effective control of asthma with hydrofluoroalkane Flunisolide delivered as an extrafine aerosol in asthma patients.
    Annals of allergy asthma & immunology : official publication of the American College of Allergy Asthma & Immunology, 2001
    Co-Authors: Jonathan Corren, George W. Bensch, Leon S. Greos, Harold S. Nelson, Marc F. Goldstein, Shanshan Wang, Kenneth B. Newman
    Abstract:

    Background Inhaled corticosteroids are established as maintenance therapy for persistent asthma. A new aerosol formulation of Flunisolide delivers a small particle size by using a hydrofluoroalkane (HFA) propellant with a built-in spacer. Objective To compare efficacy and safety of two different Flunisolide formulations, HFA and chlorofluorocarbon (CFC), with placebo treatment over a range of doses. Methods The multicenter, randomized, double-blind, placebo-controlled trial consisted of a 2-week, active run-in phase with CFC Flunisolide 500 μg, twice daily, followed by 12 weeks of double-blind treatment with placebo, HFA Flunisolide (85, 170, or 340 μg, twice daily), or CFC Flunisolide (250, 500, or 1,000 μg, twice daily). Patients (N = 669) were nonsmokers, at least 12 years of age, with mild to moderate asthma who were being treated with inhaled corticosteroids. Outcome measures were change from baseline in forced expiratory volume in 1 second (FEV 1 ), peak expiratory flow rate, as needed albuterol use, nocturnal awakenings, and asthma symptoms. Results After 12 weeks of treatment, patients receiving 170 μg, twice daily, and 340 μg, twice daily, of HFA Flunisolide showed a significant ( P 1 (12.22% at 170 μg, twice daily, and 14.69% at 340 μg, twice daily) compared with the placebo group (5.35%). At one-third the dose of CFC Flunisolide, HFA Flunisolide provided similar improvement in pulmonary function versus placebo. Both formulations demonstrated comparable linear dose dependency for the change from baseline in FEV 1 without any evidence of cortisol suppression. Outcome values for all seven secondary efficacy measures were numerically superior in patients receiving HFA Flunisolide compared with the CFC formulation. Both formulations seemed to be safe and well tolerated. Conclusions HFA Flunisolide provides comparable efficacy and safety at one-third the dose of CFC Flunisolide.

  • Suppression of hypothalamic-pituitary-adrenal axis activity with inhaled Flunisolide and fluticasone propionate in adult asthma patients.
    Annals of allergy asthma & immunology : official publication of the American College of Allergy Asthma & Immunology, 2001
    Co-Authors: Thomas B. Casale, Harold S. Nelson, William E. Stricker, Hershel Raff, Kenneth B. Newman
    Abstract:

    Background Suppression of the hypothalamic-pituitary-adrenal (HPA) axis, a potential systemic effect of inhaled corticosteroid therapy, can be quantified by monitoring serum, urinary, and salivary cortisol levels. Objectives 1) Compare the effects on HPA axis of the inhaled corticosteroids Flunisolide and fluticasone propionate versus placebo and oral prednisone. 2) Estimate dose-potency ratio for HPA-axis suppression. Methods Multicenter, randomized, placebo-controlled, open-label, 21-day trial. Active regimens were Flunisolide 500 and 1,000 μg, twice daily; fluticasone propionate 110, 220, 330, and 440 μg, twice daily; and prednisone, 7.5 mg daily. Enrolled patients were nonsmokers, 18 to 50 years of age, with persistent mild-to-moderate asthma and had not used oral, nasal, or inhaled corticosteroids for 6 months before study. Main outcome measures were area under serum cortisol concentration curve for 22 hours (AUC 0–22h ); 24-hour urinary cortisol level; and 8 am salivary cortisol level. Results One hundred fifty-three patients were randomly assigned to active treatment or placebo; 125 patients completed the study and were at least 80% compliant with their regimens. Both fluticasone propionate and Flunisolide caused dose-dependent suppression of HPA axis, which was statistically greater for fluticasone propionate ( P = 0.0003). Dose-potency ratio showed 4.4 times more serum-cortisol suppression/microgram increase in dose with fluticasone propionate than with Flunisolide. Diurnal pattern of serum cortisol suppression was persistent with fluticasone propionate and "remitting" with Flunisolide. Salivary and urinary cortisol data were qualitatively similar to serum cortisol results. Conclusions Fluticasone caused significantly more suppression of HPA axis than Flunisolide. Flunisolide may provide a safe option for patients with asthma requiring long-term inhaled corticosteroid therapy.

Grace Ryu - One of the best experts on this subject based on the ideXlab platform.

  • Six-week trial of nebulized Flunisolide nasal spray: efficacy in young children with moderately severe asthma.
    Pediatric pulmonology, 1997
    Co-Authors: Elizabeth D. Allen, Elizabeth R. Whitaker, Grace Ryu
    Abstract:

    This study evaluated the clinical efficacy of nebulized Flunisolide nasal solution (Nasalide) in young children with moderately severe asthma. Twenty-two asthmatic children, ages 12-72 months, completed this double-blind placebo-controlled study. After a 6-week observation period, 18 patients were paired according to asthma severity. One child from each pair was randomized to Flunisolide, the other to placebo; 4 patients were independently randomized. Placebo or drug was then administered for 6 weeks. Throughout the study, symptoms, drug usage, and analog scales reflecting asthma severity and family disruption were recorded in a diary. Multiple regression analysis was used to compare the Flunisolide and placebo groups in regard to the amount of improvement demonstrated from the observation to the active periods of the study. Analog scores of asthma severity and family disruption, albuterol aerosol use, and systemic corticosteroid use fell roughly 40% from baseline in the Flunisolide group. This improvement was significant compared to the placebo group. We conclude that 1 ml (250 microg) of nebulized Flunisolide nasal spray solution, administered three times daily, reduced the severity of asthma symptoms, and the need for both albuterol aerosol and systemic corticosteroid therapy in young children with moderately severe asthma during a 6-week trial. Longer term studies are warranted.

Ahmad Kantar - One of the best experts on this subject based on the ideXlab platform.

  • What makes Flunisolide different among inhaled corticosteroids used for nebulization: a close look at the role of aqueous solubility.
    Multidisciplinary respiratory medicine, 2021
    Co-Authors: Ahmad Kantar
    Abstract:

    Evidence-based management of bronchial asthma and wheezing in children and adults recommends the employment of inhaled corticosteroids (ICSs). Difficulty in using some inhalation devices for ICS delivery, such as pressurized metered-dose and dry-powder inhalers, is common among young children and in the elderly, and for that reason, they are replaced with nebulizers. We reviewed comparative studies that evaluated funisolide with other ICSs currently available on the market, including beclomethasone dipropionate, fluticasone propionate, and budesonide. Moreover, we assessed the physicochemical properties of these ICSs in determining drug fate in the lung. Data indicate that the Flunisolide output in respirable particles by any type of pneumatic nebulizer (traditional, open breath or breathenhanced) is superior to the output of other ICSs. This is principally attributed to the higher water solubility of Flunisolide. Furthermore, in vivo simulation studies demonstrate that the intersubject variability of the inhaled dose among asthmatic children was much greater for suspensions of fluticasone propionate and beclomethasone dipropionate than for those of Flunisolide. The physicochemical properties and pharmacokinetic profile of Flunisolide favor its employment in nebulization.

  • what makes Flunisolide different among inhaled corticosteroids used for nebulization
    2020
    Co-Authors: Ahmad Kantar
    Abstract:

    Objective: Evidence-based management of bronchial asthma and wheezing in children and adults recommend the employment of inhaled corticosteroids (ICS). Difficulty in using some inhalation devices for ICS delivery such as pressurized metered-dose and dry-powder inhalers are common in young children and in the elderly, and for that reason they are replaced with nebulizers. Methods: We reviewed literature with comparative studies that evaluated funisolide with other ICS currently available on the market, including beclomethasone dipropionate, fluticasone propionate, and budesonide. Moreover, we assessed the role physico-chemical properties of these ICS in determining the drug fate in lung. Results: Data indicate that Flunisolide output in respirable particles by any type of pneumatic nebulizer (traditional, open breath or breath-enhanced) is superior to other ICS. This is principally attributed to the higher water solubility of Flunisolide. Furthermore, in vivo simulation studies demonstrate that the inter-subject variability of the inhaled dose by asthmatic children was much greater for suspensions of fluticasone propionate and beclomethasone dipropionate than for that of Flunisolide. Conclusion: The physicochemical properties and pharmacokinetic profile of Flunisolide favor its employment in nebulization.

  • Flunisolide attenuates nitric oxide-induced DNA damage in rat trachea epithelial cells.
    Treatments in respiratory medicine, 2006
    Co-Authors: Ahmad Kantar, Filippo Porcelli, Alessandro Fiocchi, Donatella Fedeli, Antonella Marconi, Giancarlo Falcioni
    Abstract:

    In asthma the bronchial epithelium is highly abnormal, with various structural changes. As a consequence, the epithelium becomes an important source of inflammatory mediators that contribute to the ongoing inflammation and remodeling responses occurring in asthma. Compared with normal individuals, the fraction of exhaled nitric oxide (NO) is elevated in patients with asthma, and these levels have been shown to vary with disease activity. Thus, in asthma, epithelial cells may be exposed to large amounts of NO. Increased NO production is associated with the formation of various nitrosating species capable of promoting DNA damage. In this study we investigated the effect of NO on DNA of rat trachea epithelial cells in the presence or absence of Flunisolide. Rat airway epithelial cells were prepared and incubated with the NO donor S-nitroso-L-glutathione monoethyl ester (GSNO-MEE). DNA damage was evaluated using single cell gel electrophoresis ‘comet assay.’ The parameters used as an index of DNA damage were tail length, tail intensity, and tail moment. Results of our study demonstrated that NO induced significant DNA damage in rat airway epithelial cells. Flunisolide in amounts of 11–110 μmol/L significantly reduced all the considered parameters indicating DNA damage. These data indicate that Flunisolide may protect epithelial cells from the NO-mediated DNA damage. NO overproduction could contribute to epithelial injury in asthma, and Flunisolide seems to attenuate this damage.

  • The output of Flunisolide from different nebulisers.
    The Journal of pharmacy and pharmacology, 2002
    Co-Authors: Christopher O'callaghan, Judy A. White, Judith M. Jackson, Peter H. Barry, Ahmad Kantar
    Abstract:

    The objective of this study was to determine the output, in-vitro, solution of a concentrated solution of Flunisolide from two different nebulisers under simulated breathing conditions. The BimboNeb and Nebula nebulisers were used to nebulise 2.6 mL of Flunisolide solution (600 microg). Particle size was determined by inertial impaction and the total output of drug from the nebulisers under simulated breathing conditions was measured using a sinus flow pump. Two different breathing patterns were used, simulating nebuliser use by a child and an adult. The mass median aerodynamic diameter of Flunisolide particles from the BimboNeb and Nebula were both 3.9 microm. With the simulated paediatric breathing pattern, both nebulisers delivered similar amounts of Flunisolide (56.4 microg (s.d. 1.4 microg) and 56.1 microg (5 microg) over 5 min from the BimboNeb and Nebula, respectively). With the adult breathing pattern, Flunisolide delivery from the BimboNeb was increased to 88.9 microg (3.3 microg), but delivery from the Nebula was only slightly increased to 64.6 microg (1.4 microg). With both nebulisers, little drug was released after 5 min of nebulisation. Both nebulisers delivered 9-15% of the nominal dose of Flunisolide to the breathing simulator, a similar percentage to previous studies with budesonide and more than previous studies with beclometasone. Drug delivery from the BimboNeb, but not the Nebula, was affected by the simulated breathing pattern. This study suggests that drug delivery from nebulisers is dependent upon the interaction between the nebuliser, the drug and the patient.

  • BONE METABOLISM IN CHILDREN WITH ASTHMA TREATED WITH NEBULIZED Flunisolide: A MULTICENTER ITALIAN STUDY
    Current Therapeutic Research, 1998
    Co-Authors: N. Oggiano, Ahmad Kantar, Giovanni V. Coppa, Roberto Ricciotti, Felice Arena, Filippo Bernardi, Maria L. Colombo, Maurizio Fano, Alberto Flores D’arcais
    Abstract:

    Abstract This multicenter, parallel-group, open-label, randomized study was conducted in prepubertal children with mild asthma to investigate the efficacy and influence on bone and collagen turnover of a daily regimen of Flunisolide 1200 μg alone (group A, n=14), Flunisolide 600 μg in combination with sodium cromoglycate (SCG) 60 mg (group B, n=15), or SCG 60 mg alone (group C, n=15) for 4 months. All medications were administered by means of a jet nebulizer using a mouthpiece. Serum osteocalcin (OC), bone alkaline phosphate (B-ALP), and procollagen type I carboxyterminal propeptide (PICP) were measured as markers of bone formation, and type I collagen telopeptide (ICTP) was measured as a marker of bone resorption before and after treatment. The efficacy of the treatment schedules was assessed measuring forced expiratory volume in 1 second (FEV 1 ) and the use of rescue medication. No significant differences were found in the concentration of OC, B-ALP, PICP, or ICTP between the three treatment groups before the treatment period. In addition, no significant changes were found after the treatment period, although a wide variation in individual response was observed in all markers. In the group treated with Flunisolide 1200 μg/d, FEV 1 improved significantly after treatment; no significant improvement in FEV 1 , was observed in the other two groups. The number of children who needed rescue medication was reduced to 14.3% in group A, 20.0% in group B, and 53.3% in group C. The results of the present study suggest that a 4-month regimen of nebulized Flunisolide 1200 μg/d is effective in patients with mild asthma and does not alter bone or collagen turnover markers. However, the differences in individual response to therapy make it necessary to examine further the issues of bone metabolism in Flunisolide-treated children with asthma.

Günther Hochhaus - One of the best experts on this subject based on the ideXlab platform.

  • pharmacokinetic pharmacodynamic evaluation of systemic effects of Flunisolide after inhalation
    The Journal of Clinical Pharmacology, 1997
    Co-Authors: Helmut Möllmann, Hartmut Derendorf, Jürgen Barth, Bernd Meibohm, M. Wagner, Michael Krieg, Heike Weisser, Jürgen Knöller, A.c. Möllmann, Günther Hochhaus
    Abstract:

    The pharmacokinetics and pharmacodynamics of Flunisolide were studied in healthy volunteers after inhalation. In the morning on the day the study began, volunteers inhaled 0.5 mg of Flunisolide with and without oral administration of charcoal, or 1 mg, 2 mg, and 3 mg of Flunisolide with concomitant administration of charcoal. A placebo group was used to assess the endogenous cortisol, granulocyte, and lymphocyte baseline levels. Flunisolide plasma levels were determined by high-performance liquid chromatography using a tandem mass spectrometer as detector (HPLC/MS/MS). Cortisol plasma levels and differential white blood cell counts were obtained over 12 hours. An integrated pharmacokinetic/pharmacodynamic (PK/PD) model was applied to link the Flunisolide plasma concentrations with the effects on lymphocytes, granulocytes, and cortisol. Maximum concentration levels of 3 to 9 ng/mL of Flunisolide were observed after 0.2 to 0.3 hours for all of the investigated doses. The terminal half-life ranged from 1.3 to 1.7 hours. There was no statistical difference between treatments in the presence or absence of orally administered charcoal. The pharmacokinetic/pharmacodynamic (PK/PD) models satisfactorily described the time-courses of the effects on granulocytes, lymphocytes, and cortisol suppression. The resulting E50-values (concentrations to induce 50% of the maximum effect) concurred with the reported values of in vitro receptor binding affinities. The duration of the systemic effects were short because of the short half-life of the drug. Cumulative cortisol suppression increased with dose administration and ranged from 20% to 36%. The PK/PD simulations resulted in a smaller degree of cortisol suppression for the drug administered at 10 pm. The cumulative change from baseline was slightly smaller for the effects on granulocytes and lymphocytes than those on cortisol. This information promotes the comparison with other inhaled glucocorticoids. J Clin Pharmacol 1997;37:893–903.

  • Pharmacokinetic/Pharmacodynamic Evaluation of Systemic Effects of Flunisolide after Inhalation
    Journal of clinical pharmacology, 1997
    Co-Authors: Helmut Möllmann, Hartmut Derendorf, Jürgen Barth, Bernd Meibohm, M. Wagner, Michael Krieg, Heike Weisser, Jürgen Knöller, A.c. Möllmann, Günther Hochhaus
    Abstract:

    The pharmacokinetics and pharmacodynamics of Flunisolide were studied in healthy volunteers after inhalation. In the morning on the day the study began, volunteers inhaled 0.5 mg of Flunisolide with and without oral administration of charcoal, or 1 mg, 2 mg, and 3 mg of Flunisolide with concomitant administration of charcoal. A placebo group was used to assess the endogenous cortisol, granulocyte, and lymphocyte baseline levels. Flunisolide plasma levels were determined by high-performance liquid chromatography using a tandem mass spectrometer as detector (HPLC/MS/MS). Cortisol plasma levels and differential white blood cell counts were obtained over 12 hours. An integrated pharmacokinetic/pharmacodynamic (PK/PD) model was applied to link the Flunisolide plasma concentrations with the effects on lymphocytes, granulocytes, and cortisol. Maximum concentration levels of 3 to 9 ng/mL of Flunisolide were observed after 0.2 to 0.3 hours for all of the investigated doses. The terminal half-life ranged from 1.3 to 1.7 hours. There was no statistical difference between treatments in the presence or absence of orally administered charcoal. The pharmacokinetic/pharmacodynamic (PK/PD) models satisfactorily described the time-courses of the effects on granulocytes, lymphocytes, and cortisol suppression. The resulting E50-values (concentrations to induce 50% of the maximum effect) concurred with the reported values of in vitro receptor binding affinities. The duration of the systemic effects were short because of the short half-life of the drug. Cumulative cortisol suppression increased with dose administration and ranged from 20% to 36%. The PK/PD simulations resulted in a smaller degree of cortisol suppression for the drug administered at 10 pm. The cumulative change from baseline was slightly smaller for the effects on granulocytes and lymphocytes than those on cortisol. This information promotes the comparison with other inhaled glucocorticoids. J Clin Pharmacol 1997;37:893–903.

Donald P. Tashkin - One of the best experts on this subject based on the ideXlab platform.

  • Flunisolide hydrofluoroalkane with integrated spacer for treating asthma: an updated review.
    Allergy and asthma proceedings, 2015
    Co-Authors: William E. Berger, Donald P. Tashkin
    Abstract:

    Flunisolide hydrofluoroalkane (HFA) with integrated spacer is the most recent reformulated inhaled corticosteroid (ICS) for asthma available in the United States. It is the only product that combines a corticosteroid extrafine aerosol with a built-in spacer. The potential clinical benefit of the Flunisolide HFA formulation and its integrated spacer for treating persistent asthma was assessed through a comprehensive review of the published literature and data from the past 10 years focusing on (1) Flunisolide, the molecule, and the impact of the HFA reformulation; (2) updated information on the anti-inflammatory response to Flunisolide HFA, particularly in the distal airways; and (3) the usefulness of an integrated spacer. Flunisolide HFA was found effective and safe in clinical studies and comparable with the chlorofluorocarbon (CFC) formulation, but at about one-third the dose of Flunisolide CFC, likely reflecting both the device and the particle size of the reformulated product. Compared with the CFC formulation, the extrafine aerosol and smaller particle size of Flunisolide HFA substantially increased pulmonary deposition and decreased oropharyngeal deposition. The integrated spacer further enhanced the pulmonary/oropharyngeal deposition ratio. Examination of lung biopsy specimens indicated a favorable anti-inflammatory response to Flunisolide HFA in peripheral airways. Pediatric studies showed no significant effects on growth. The data indicate that Flunisolide HFA is a safe and effective maintenance therapy for asthma patients. The integrated spacer may provide an added advantage for patients, especially those who may be more likely to experience adverse effects of ICSs, both local and systemic, including children susceptible to adverse effects on growth.

  • Evaluation of efficacy and safety of Flunisolide hydrofluoroalkane for the treatment of asthma.
    Clinical therapeutics, 2003
    Co-Authors: Jonathan Corren, Donald P. Tashkin
    Abstract:

    Abstract Background: Inhaled corticosteroids are currently recommended as first-line therapy for the long-term control and management of persistent asthma. Flunisolide hydrofluoroalkane (HFA) is a new formulation of the corticosteroid Flunisolide that is delivered by a metered-dose inhaler containing an HFA propellant. HFA replaces the chlorofluorocarbon (CFC) propellant of the previous formulation, producing aerosols of smaller average particle size. Objective: This article reviews the physical and pharmacologic properties, deposition profile, and potential clinical benefits of Flunisolide HFA for the treatment of asthma. Methods: Data included in this review were found via MEDLINE (search term, Flunisolide HFA ). Results: Flunisolide HFA has a mass median aerodynamic diameter (MMAD) of 1.2 μm, smaller than the 3.8 μm MMAD of the CFC formulation. Compared with Flunisolide CFC, more of each Flunisolide HFA dose reaches the lungs and less is deposited in the oropharynx. In addition, scintigraphic studies have found that the extra-fine particle size of Flunisolide HFA gives it better access to small airways. In short- and long-term clinical studies, Flunisolide HFA has been found to significantly increase pulmonary function relative to placebo. Although not statistically superior to the previous CFC formulation, Flunisolide HFA exhibited small improvements in secondary efficacy measures, such as as-needed albuterol use and asthma symptoms, relative to Flunisolide CFC. Furthermore, research suggests that the new HFA formulation has a low risk of systemic corticosteroid effects (eg, hypothalamic-pituitary-adrenal axis suppression, growth inhibition in children). Also, lower levels of oropharyngeal deposition, such as those seen with Flunisolide HFA, are associated with lower incidence of local effects (eg, candidiasis). Conclusion: Flunisolide HFA offers effective asthma control with a high level of tolerability in an extra-fine particle formulation that distributes corticosteroid to all areas of the lung, including small airways.