Dosage Regimens of Intranasal Aerosolized Surfactant on Otitis Media with Effusion in an Animal Model

Venkatayan, Natarajan; Connelly, Patricia E.; Mautone, Alan J.; Troublefield, Yolanda L.; Chandrasekhar, Sujana S.

doi:10.1067/mhn.2001.114310

Cited by 11 publications

(8 citation statements)

References 22 publications

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“…These reductions were statistically significant ( p < .05). In ears with artificially induced OME, intranasal surfactant treatment significantly reduced time of middle ear effusion, from an average of 16 to 10.6 days when given once daily, and 16-8.6 days when administered twice daily ( p < .05) [12]. Both the healthy ear animal study and the OME animal study proved the efficacy of anterior intranasal surfactant treatment at the nasopharyngeal ET orifice.…”

Section: Introductionmentioning

confidence: 83%

Intranasal phenylephrine-surfactant treatment is not beneficial in otitis media with effusion

Johnson

Chandrasekhar

Mautone

2008

International Journal of Pediatric Otorhinolaryngology

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Section: Introductionmentioning

confidence: 83%

Intranasal phenylephrine-surfactant treatment is not beneficial in otitis media with effusion

Johnson

Chandrasekhar

Mautone

2008

International Journal of Pediatric Otorhinolaryngology

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“…Seventy adult M unguiculatus gerbils with experimental OME were divided into nine treatment groups as follows: control, placebo delivered once daily (QD) and twice daily (BID), SURF delivered QD and BID, SURF+BETA delivered QD and BID, and SURF+PHENYL delivered QD and BID 28 Five animals were excluded, three for anesthetic complications and 2 for cholesteatoma. Experimental therapies were given either QD or BID, depending on the assigned group.…”

Section: Methodsmentioning

confidence: 99%

Otitis Media: Treatment With Intranasal Aerosolized Surfactant

Chandrasekhar

Mautone

2004

The Laryngoscope

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“…4,9 Animal studies related to this product have been previously described. 4,10,11 OP0201 is administered intranasally via a metered dose inhaler. It is supplied in mechanical packaging parts that include a pressurized canister with a securely attached metering valve where the drug product is contained, an actuator into which the canister is seated, the valve that connects with the device body, and a tip to deliver the drug to the nostril.…”

Section: Introductionmentioning

confidence: 99%

A Randomized Phase 1 Safety Study of Repeated Doses of Intranasal OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adults: A Potential Treatment for Otitis Media

Sirimanne¹,

Patel²,

Kankam³

et al. 2020

Preprint

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Background OP0201 Nasal Aerosol is a novel drug-device surfactant product being developed for treatment and prevention of otitis media. The active ingredients in OP0201, dipalmitoylphosphatidylcholine (DPPC) and cholesteryl palmitate (CP), are endogenous to the human nasal and respiratory systems. This phase 1 study evaluated the safety and tolerability of OP0201 in healthy adults. Methods This was a randomized, double-blind, placebo-controlled, parallel-group study with a dose-escalation cohort design to evaluate 30 mg/day (Cohort A) and 60 mg/day (Cohort B) of OP0201. Subjects were randomized 4:1 to receive either OP0201 or placebo 3 times per day for 14 consecutive days. Treatment was administered via a metered dose inhaler and sprayed directly backwards into each nostril. Primary endpoints were adverse events, otoscopy, tympanometry, nasal and epipharynx endoscopy, University of Pennsylvania Smell Identification Test (UPSIT), audiology pure-tone hearing test, 12-lead electrocardiography, physical examination, vital signs, and clinical laboratory tests. Exploratory endpoints included baseline-adjusted maximum serum concentration (Cmax) and time to maximum concentration (tmax) of DPPC and CP on Day 14 in Cohort B. Results 101 participants were screened, and 30 were randomized (15 per cohort; n=12 OP0201, n=3 placebo). No deaths, serious adverse events, or treatment-emergent adverse events leading to study discontinuation were reported. No clinically significant deviations from baseline were found in any of the primary endpoints. Serum DPPC and CP concentrations on Day 14 were comparable to baseline in the OP0201 group and numerically higher in the placebo group. Mean baseline-corrected serum DPPC Cmax on Day 14 was 0.82 µg/mL with OP0201 and 4.51 µg/mL with placebo, with a median tmax observed at 0.05 hours for both groups. Mean baseline-corrected serum CP Cmax on Day 14 was 14.89 µM with OP0201 and 89.50 µM with placebo, with a median tmax observed at 0.05 and 0.22 hours for OP0201 and placebo, respectively. Conclusions OP0201 was safe and well tolerated in healthy adults. There were no supraphysiologic systemic concentrations of DPPC or CP after local intranasal administration of a 60 mg/day dose of OP0201. These outcomes support continued development of OP0201 with future studies in a patient population.

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Dosage Regimens of Intranasal Aerosolized Surfactant on Otitis Media with Effusion in an Animal Model

Abstract: This study reiterates the effectiveness of OME treatment with an aerosolized synthetic surfactant with and without steroids and establishes a superior twice-daily dosage schedule.

Cited by 11 publications

References 22 publications

Intranasal phenylephrine-surfactant treatment is not beneficial in otitis media with effusion

Intranasal phenylephrine-surfactant treatment is not beneficial in otitis media with effusion

Otitis Media: Treatment With Intranasal Aerosolized Surfactant

A Randomized Phase 1 Safety Study of Repeated Doses of Intranasal OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adults: A Potential Treatment for Otitis Media

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