Safety and efficacy of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with perennial allergic rhinitis

Meltzer, Eli O.; Jacobs, Robert L.; LaForce, Craig; Kelley, C.L.; Dunbar, Stephanie; Tantry, Sudeesh K.

doi:10.2500/aap.2012.33.3571

Cited by 33 publications

(24 citation statements)

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“…While no standardized minimum clinically important difference has been established for TNSS, these results are of a similar or greater magnitude to i.n. corticosteroid studies where the effects are present over a 24‐hour dosing period . Here, the probability of a sustained treatment effect on TNSS for both doses was modest to high, about 90%, at 1 week and 84% at 3 weeks after treatment.…”

Section: Discussionmentioning

confidence: 80%

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Safety and pharmacodynamics of intranasal GSK2245035, a TLR7 agonist for allergic rhinitis: A randomized trial

Ellis

Tsitoura

Quint

et al. 2017

Clin Experimental Allergy

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Section: Discussionmentioning

confidence: 80%

“…corticosteroid studies where the effects are present over a 24-hour dosing period. [34][35][36][37][38] Here, the probability of a sustained treatment effect on TNSS for both doses was modest to high, about 90%, at 1 week and 84% at 3 weeks after treatment. GSK2245035 is yet to be determined, and Th1/regulatory responses were not detected, the i.n.…”

Section: 84mentioning

confidence: 88%

Safety and pharmacodynamics of intranasal GSK2245035, a TLR7 agonist for allergic rhinitis: A randomized trial

Ellis

Tsitoura

Quint

et al. 2017

Clin Experimental Allergy

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show abstract

“…The issues related to the high particle speed and “cold Freon effect” have been reduced with the recently introduced hydrofluoroalkane (HFA)-based pMDI for nasal use offering lower particle speeds [60]. Recently, the first nasal pMDI using HFA as propellant to deliver the first generation topical steroid beclomethasone dipropionate (BDP) was approved for allergic rhinitis in the USA [62]. Like spray pumps, nasal pMDIs produce a localized deposition on the anterior non-ciliated epithelium of the nasal vestibule and in the anterior parts of the narrow nasal valve, but due to quick evaporation of the spray delivered with a pMDI, noticeable “drip-out” may be less of an issue [63].…”

Section: Nasal Drug Delivery Devicesmentioning

confidence: 99%

Nasal drug delivery devices: characteristics and performance in a clinical perspective—a review

Djupesland

2012

Drug Deliv. and Transl. Res.

399

334

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Nasal delivery is the logical choice for topical treatment of local diseases in the nose and paranasal sinuses such as allergic and non-allergic rhinitis and sinusitis. The nose is also considered an attractive route for needle-free vaccination and for systemic drug delivery, especially when rapid absorption and effect are desired. In addition, nasal delivery may help address issues related to poor bioavailability, slow absorption, drug degradation, and adverse events in the gastrointestinal tract and avoids the first-pass metabolism in the liver. However, when considering nasal delivery devices and mechanisms, it is important to keep in mind that the prime purpose of the nasal airway is to protect the delicate lungs from hazardous exposures, not to serve as a delivery route for drugs and vaccines. The narrow nasal valve and the complex convoluted nasal geometry with its dynamic cyclic physiological changes provide efficient filtration and conditioning of the inspired air, enhance olfaction, and optimize gas exchange and fluid retention during exhalation. However, the potential hurdles these functional features impose on efficient nasal drug delivery are often ignored. With this background, the advantages and limitations of existing and emerging nasal delivery devices and dispersion technologies are reviewed with focus on their clinical performance. The role and limitations of the in vitro testing in the FDA guidance for nasal spray pumps and pressurized aerosols (pressurized metered-dose inhalers) with local action are discussed. Moreover, the predictive value and clinical utility of nasal cast studies and computer simulations of nasal airflow and deposition with computer fluid dynamics software are briefly discussed. New and emerging delivery technologies and devices with emphasis on Bi-Directional™ delivery, a novel concept for nasal delivery that can be adapted to a variety of dispersion technologies, are described in more depth.

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“…), the only other nasal HFA aerosol, would help discern potential differences between these two nasal HFA aerosol sprays. 22,23 In this study, both INS formulations were generally well tolerated, and most AEs were mild or moderate in intensity.…”

mentioning

confidence: 94%

A patient preference and satisfaction study of ciclesonide nasal aerosol and mometasone furoate aqueous nasal spray in patients with perennial allergic rhinitis

Berger

Prenner²,

Turner³

et al. 2013

allergy asthma proc

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Patients' preference and satisfaction with their nasal allergy medications may be influenced by their sensory attributes. This study evaluates patient preference and satisfaction with ciclesonide hydrofluoroalkane nasal aerosol (CIC-HFA) compared with mometasone furoate aqueous nasal spray (MFNS). Symptomatic subjects with perennial allergic rhinitis (PAR) were randomized to CIC-HFA at 74 micrograms or MFNS at 200 micrograms q.d. in an open-label, two-period, crossover study. Subject preference was recorded as total preference score (TPS; average of 17 individual preference items) at the end of treatment period 2, and satisfaction was assessed with a 76-item, self-administered instrument at baseline and at the end of each 2-week treatment period. The primary assessments were TPS and regimen attributes composite satisfaction score composed of two of nine satisfaction subscales: sensory impact (including medication running out of the nose, medication running down the throat, and impact on smell and taste) and regimen management (comprised of issues relating to dosing and ability to remember to take medication). Two hundred ninety-four subjects completed the study. A total of 68.1% of subjects preferred CIC-HFA (p < 0.0001 versus MFNS), with a mean TPS of 68.3 versus 31.7 for the MFNS group. The regimen attributes composite satisfaction score significantly (p < 0.0001 for each treatment period) favored CIC-HFA versus MFNS at the end of treatment period 1 (85.5 vs 77.6) and treatment period 2 (83.0 versus 73.5), respectively. In this study, subjects reported higher preference for and satisfaction with CIC-HFA compared with MFNS, suggesting significant differences in patient perception of attributes in favor of CIC-HFA. Clinical trial registration URL and registration number: www.clinicaltrials.gov/ct2/show/NCT01401465.

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Safety and efficacy of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with perennial allergic rhinitis

Cited by 33 publications

References 0 publications

Safety and pharmacodynamics of intranasal GSK2245035, a TLR7 agonist for allergic rhinitis: A randomized trial

Safety and pharmacodynamics of intranasal GSK2245035, a TLR7 agonist for allergic rhinitis: A randomized trial

Nasal drug delivery devices: characteristics and performance in a clinical perspective—a review

A patient preference and satisfaction study of ciclesonide nasal aerosol and mometasone furoate aqueous nasal spray in patients with perennial allergic rhinitis

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