Effect of loteprednol etabonate nasal spray suspension on seasonal allergic rhinitis assessed by allergen challenge in an environmental exposure unit

Krug, Norbert; Hohlfeld, Jens M.; Geldmacher, Henning; Larbig, Michael; Heermann, R.; LaVallee, Nicole; Nguyễn, Duc Tung; Petzold, U.; Hermann, Róbert

doi:10.1111/j.1398-9995.2005.00703.x

Cited by 24 publications

(13 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Recent studies conducted in the exposure chambers in Austria [16] and Germany [17] have also mainly used TNSS to evaluate patient symptoms before and after treatment with antihistamines. Our TSS and TNSS levels were lower than those in reports on the efficacy of antihistamines for allergic rhinitis.…”

Section: Discussionmentioning

confidence: 99%

Validation Study of the OHIO Chamber in Patients with Japanese Cedar Pollinosis

Hashiguchi

Tang²,

Fujita³

et al. 2009

Int Arch Allergy Immunol

View full text Add to dashboard Cite

Background: An artificial exposure chamber (OHIO Chamber), which allows dispersal of a fixed concentration of Japanese cedar (JC) pollen under stable conditions, was constructed. This study was conducted to identify the exposure conditions assuring validity of the clinical tests conducted using this chamber. Methods: Twenty-four adult patients with JC pollinosis were exposed to different concentrations of JC pollen: 0 (only during the summer period), 4,000, 8,000 and 12,000 grains/m³, and the nasal and ocular symptoms were self-assessed during a 4-hour period of exposure. The amount of nasal discharge was measured and the sneezing frequency was recorded. This study was conducted twice during the summer and winter periods, i.e. non-pollen seasons. The reproducibility of the symptoms between the two seasons was assessed. Results: None of the subjects developed any symptom at the pollen concentration of 0 grains/m³. No significant differences in the time to the onset of symptoms were found between the summer and winter study, regardless of the pollen concentration. There were no significant differences between the summer and winter study in the total symptom score and total nasal symptom score at any pollen concentration, suggesting the very favorable reproducibility of symptoms. Conclusions: Efficient and reproducible results are obtained in patients exposed to JC pollen in the OHIO Chamber. The results suggest the conditions of JC pollen exposure have scientific validity and the OHIO Chamber has the potential to contribute significantly to basic and clinical studies of JC pollinosis.

show abstract

Section: Discussionmentioning

confidence: 99%

Validation Study of the OHIO Chamber in Patients with Japanese Cedar Pollinosis

Hashiguchi

Tang²,

Fujita³

et al. 2009

Int Arch Allergy Immunol

View full text Add to dashboard Cite

show abstract

“…15) [187,188]. A large (n ¼ 165) environmental exposure unit (EEU) study in patients with seasonal allergic rhinitis (SAR) also confirmed that LE 400 mg once daily is effective and superior to placebo: after 14 days of treatment, patient in this LE group had significantly lower total nasal symptom scores (TNSS) than those receiving placebo (p ¼ 0.007) [189]. Cortienic Acid-Based Soft Steroids: Second Generation (Etiprednol Dicloacetate and Analogs) More recently, a new, second generation of soft steroids with a unique 17a-dichloroester substituent has been identified (44, Fig.…”

Section: Softmentioning

confidence: 99%

Retrometabolism‐Based Drug Design and Targeting

Bodor

Buchwald

2010

Burger's Medicinal Chemistry and Drug Discovery

View full text Add to dashboard Cite

Retrometabolic drug design (RMDD) approaches are systematic methodologies aimed to design safe compounds with an improved therapeutic index. RMDDs thoroughly integrate structure– activity and structure‐metabolism considerations into the entire design process and incorporate two major concepts aimed to design soft drugs and chemical delivery systems, respectively. Soft drugs (SDs) are new, active therapeutic agents designed to undergo predictable metabolism resulting in inactive metabolites after exerting their desired therapeutic effect(s). Chemical delivery systems (CDSs) are biologically inert molecules that provide enhanced and targeted delivery of an active drug to a particular organ or site through a designed sequential metabolism that involves several steps. Here, we present a comprehensive review including a general overview of the RMDD principles and a large number of specific examples from various pharmacological areas, including many recent developments, to illustrate RMDD concepts. Whenever possible, the rationale for the design as well as the pharmacokinetic and pharmacodynamic properties of the new therapeutic agents are briefly summarized and compared to those of the other compounds used in the same field.

show abstract

“…In most research on nasal drug absorption so far, liquid formulations such as solution, emulsion, and suspension have been used [9–12]. As compared to liquid formulations, there are many advantages of the powder formulation, such as the better stability of the solid drug, application of larger dose, and the higher concentration of the drug in the nasal mucosa [13–16].…”

Section: Introductionmentioning

confidence: 99%

Nasal Absorption of Macromolecules from Powder Formulations and Effects of Sodium Carboxymethyl Cellulose on Their Absorption

et al. 2016

View full text Add to dashboard Cite

The nasal absorption of macromolecules from powder formulations and the effect of sodium carboxymethyl cellulose (CMC-Na) as a pharmaceutical excipient on their absorption were studied. Model macromolecules were fluorescein isothiocyanate-labeled dextran (average molecular weight of 4.4kDa, FD4) and insulin. The plasma concentration of FD4 after application of the powder containing 50% starch (control) was higher than that after application of the solution, and the absorption from 50% starch powder was enhanced by the substitution of starch with CMC-Na. The fractional absorption of FD4 after administration of the CMC-Na powder formulation was 30% and 40% higher than that after administration from the solution and the starch powder, respectively. The nasal absorption of insulin from the powder and the effect of CMC-Na were similar with those of FD4. The effective absorption of FD4 and insulin after application of powder with CMC-Na could be due to the increase in the nasal residence of FD4 and insulin. No damage in the nasal mucosa or dysfunction of the mucociliary clearance was observed after application of the drug powder and CMC-Na. The present findings indicate that nasal delivery of powder formulations with the addition of CMC-Na as an excipient is a promising approach for improving the nasal absorption of macromolecules.

show abstract

Effect of loteprednol etabonate nasal spray suspension on seasonal allergic rhinitis assessed by allergen challenge in an environmental exposure unit

Abstract: Loteprednol 400 microg once daily is superior to placebo and the only effective dose tested in improving nasal symptoms and objective parameters in patients with SAR.

Cited by 24 publications

References 22 publications

Validation Study of the OHIO Chamber in Patients with Japanese Cedar Pollinosis

Validation Study of the OHIO Chamber in Patients with Japanese Cedar Pollinosis

Retrometabolism‐Based Drug Design and Targeting

Nasal Absorption of Macromolecules from Powder Formulations and Effects of Sodium Carboxymethyl Cellulose on Their Absorption

Contact Info

Product

Resources

About