Tags

Type your tag names separated by a space and hit enter

Randomised clinical trial: the safety and tolerability of fluticasone propionate orally disintegrating tablets versus placebo for eosinophilic oesophagitis.
Aliment Pharmacol Ther. 2020 04; 51(8):750-759.AP

Abstract

BACKGROUND

APT-1011, a fluticasone propionate orally disintegrating tablet formulation, is under investigation for the treatment of eosinophilic oesophagitis (EoE).

AIMS

To evaluate the safety and tolerability of APT-1011 administered to patients with EoE and to assess the effect on clinical symptoms of EoE, endoscopic appearance and oesophageal eosinophilia.

METHODS

A randomised, double-blind, placebo-controlled, multicentre, phase 1b/2a study was conducted at seven medical centres in the US to evaluate the safety and tolerability of APT-1011 over 8 weeks in adults and adolescents with EoE. Participants were randomised to placebo (n = 8), 1.5 mg APT-1011 BID (n = 8) or 3.0 mg APT-1011 QD (n = 8). Safety and tolerability were assessed as the primary outcome; histologic and endoscopic measures were assessed as exploratory outcomes.

RESULTS

There were no deaths, serious treatment-emergent adverse events (TEAEs), severe TEAEs or discontinuations from the study related to a TEAE. In one participant randomised to 1.5 mg APT-1011 BID, a reduction in cortisol was observed, but without evidence of adrenal insufficiency. Compared with placebo, treatment with APT-1011 resulted in greater reductions in oesophageal eosinophil counts, EoE Endoscopic Reference Score, patient global assessment and symptom-based EoE activity index from baseline to end of treatment (Week 8).

CONCLUSIONS

APT-1011 was safe and well tolerated in adolescents and adults with EoE. Exploratory efficacy outcomes demonstrated improvement in histologic and endoscopic findings as well evidence of symptom improvement. The results of this study support the continued development of APT-1011 for the treatment of EoE (NCT-01386112).

Authors+Show Affiliations

Department of Gastroenterology and Hepatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.Clinical Trials Unit, University of Bern, Bern, Switzerland.Adare Pharmaceuticals, Lawrenceville, NJ, USA.Adare Pharmaceuticals, Lawrenceville, NJ, USA.Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.Division of Gastroenterology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32149424

Citation

Hirano, Ikuo, et al. "Randomised Clinical Trial: the Safety and Tolerability of Fluticasone Propionate Orally Disintegrating Tablets Versus Placebo for Eosinophilic Oesophagitis." Alimentary Pharmacology & Therapeutics, vol. 51, no. 8, 2020, pp. 750-759.
Hirano I, Safroneeva E, Roumet MC, et al. Randomised clinical trial: the safety and tolerability of fluticasone propionate orally disintegrating tablets versus placebo for eosinophilic oesophagitis. Aliment Pharmacol Ther. 2020;51(8):750-759.
Hirano, I., Safroneeva, E., Roumet, M. C., Comer, G. M., Eagle, G., Schoepfer, A., & Falk, G. W. (2020). Randomised clinical trial: the safety and tolerability of fluticasone propionate orally disintegrating tablets versus placebo for eosinophilic oesophagitis. Alimentary Pharmacology & Therapeutics, 51(8), 750-759. https://doi.org/10.1111/apt.15670
Hirano I, et al. Randomised Clinical Trial: the Safety and Tolerability of Fluticasone Propionate Orally Disintegrating Tablets Versus Placebo for Eosinophilic Oesophagitis. Aliment Pharmacol Ther. 2020;51(8):750-759. PubMed PMID: 32149424.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomised clinical trial: the safety and tolerability of fluticasone propionate orally disintegrating tablets versus placebo for eosinophilic oesophagitis. AU - Hirano,Ikuo, AU - Safroneeva,Ekaterina, AU - Roumet,Marie C, AU - Comer,Gail M, AU - Eagle,Gina, AU - Schoepfer,Alain, AU - Falk,Gary W, Y1 - 2020/03/09/ PY - 2019/10/02/received PY - 2019/10/21/revised PY - 2020/02/03/accepted PY - 2020/3/10/pubmed PY - 2020/3/10/medline PY - 2020/3/10/entrez SP - 750 EP - 759 JF - Alimentary pharmacology & therapeutics JO - Aliment. Pharmacol. Ther. VL - 51 IS - 8 N2 - BACKGROUND: APT-1011, a fluticasone propionate orally disintegrating tablet formulation, is under investigation for the treatment of eosinophilic oesophagitis (EoE). AIMS: To evaluate the safety and tolerability of APT-1011 administered to patients with EoE and to assess the effect on clinical symptoms of EoE, endoscopic appearance and oesophageal eosinophilia. METHODS: A randomised, double-blind, placebo-controlled, multicentre, phase 1b/2a study was conducted at seven medical centres in the US to evaluate the safety and tolerability of APT-1011 over 8 weeks in adults and adolescents with EoE. Participants were randomised to placebo (n = 8), 1.5 mg APT-1011 BID (n = 8) or 3.0 mg APT-1011 QD (n = 8). Safety and tolerability were assessed as the primary outcome; histologic and endoscopic measures were assessed as exploratory outcomes. RESULTS: There were no deaths, serious treatment-emergent adverse events (TEAEs), severe TEAEs or discontinuations from the study related to a TEAE. In one participant randomised to 1.5 mg APT-1011 BID, a reduction in cortisol was observed, but without evidence of adrenal insufficiency. Compared with placebo, treatment with APT-1011 resulted in greater reductions in oesophageal eosinophil counts, EoE Endoscopic Reference Score, patient global assessment and symptom-based EoE activity index from baseline to end of treatment (Week 8). CONCLUSIONS: APT-1011 was safe and well tolerated in adolescents and adults with EoE. Exploratory efficacy outcomes demonstrated improvement in histologic and endoscopic findings as well evidence of symptom improvement. The results of this study support the continued development of APT-1011 for the treatment of EoE (NCT-01386112). SN - 1365-2036 UR - https://www.unboundmedicine.com/medline/citation/32149424/Randomised_clinical_trial:_the_safety_and_tolerability_of_fluticasone_propionate_orally_disintegrating_tablets_versus_placebo_for_eosinophilic_oesophagitis L2 - https://doi.org/10.1111/apt.15670 DB - PRIME DP - Unbound Medicine ER -
Try the Free App:
Prime PubMed app for iOS iPhone iPad
Prime PubMed app for Android
Prime PubMed is provided
free to individuals by:
Unbound Medicine.