Randomised clinical trial: the safety and tolerability of fluticasone propionate orally disintegrating tablets versus placebo for eosinophilic oesophagitis.

Hirano, Ikuo; Safroneeva, Ekaterina; Roumet, Marie C.; Comer, Gail M; Eagle, Gina; Schoepfer, Alain; Falk, Gary 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), pp. 750-759. Wiley-Blackwell 10.1111/apt.15670

[img] Text
Hirano AlimentPharmacolTher 2020.pdf - Published Version
Restricted to registered users only
Available under License Publisher holds Copyright.

Download (610kB) | Request a copy
[img] Text
Hirano AlimentPharmacolTher 2020_AAM.pdf - Accepted Version
Restricted to registered users only until 10 March 2021.
Available under License Publisher holds Copyright.

Download (647kB) | Request a copy

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).

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > CTU Bern
04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine (ISPM)

UniBE Contributor:

Safroneeva, Ekaterina and Roumet, Marie Camille

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

0269-2813

Publisher:

Wiley-Blackwell

Language:

English

Submitter:

Andrea Flükiger-Flückiger

Date Deposited:

18 Mar 2020 12:21

Last Modified:

27 May 2020 05:18

Publisher DOI:

10.1111/apt.15670

PubMed ID:

32149424

Additional Information:

Hirano and Safroneeva contributed equally to this work.

BORIS DOI:

10.7892/boris.141939

URI:

https://boris.unibe.ch/id/eprint/141939

Actions (login required)

Edit item Edit item
Provide Feedback