NCT01962467 is a Phase 1 clinical trial of FF/LEV FDC in Rhinitis, Allergic, Perennial and Seasonal, sponsored by GlaxoSmithKline.

Who is sponsoring NCT01962467?

NCT01962467 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01962467?

Interventions in NCT01962467: FF/LEV FDC, FF, LEV.

What condition does NCT01962467 study?

NCT01962467 studies Rhinitis, Allergic, Perennial and Seasonal.

Is NCT01962467 still recruiting?

NCT01962467 is currently completed. Last updated 15 May 2017.

Last reviewed 2017-05-15 · How we verify

NCT01962467

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Relative Bioavailability Study of Fluticasone Furoate and Levocabastine

Completed Phase 1 Last updated 15 May 2017

What this trial tests

Phase 1 trial testing FF/LEV FDC in Rhinitis, Allergic, Perennial and Seasonal in 30 participants. Completed in 27 February 2014.

Timeline

11 October 2013

Primary endpoint
27 February 2014

27 February 2014

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	11 October 2013
Primary completion	27 February 2014
Estimated completion	27 February 2014
Sites	1 location across Australia

Drugs / interventions tested

FF/LEV FDC — full drug profile →
FF — full drug profile →
LEV — full drug profile →

Conditions studied

Rhinitis, Allergic, Perennial and Seasonal — all drugs for Rhinitis, Allergic, Perennial and Seasonal →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Rhinitis, Allergic, Perennial and Seasonal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open label, randomized, 3-way cross-over, and repeat administration study in healthy male and female subjects. The purpose of the study is to determine the relative bioavailability of Fluticasone Furoate (FF) and Levocabastine (LEV), when each is administered alone and as FF/LEV Fixed Dose Combination (FDC).This study consists of Part A (in which 30 subjects including 12 Korean subjects will be enrolled) and Part B (in which 18 subjects will be enrolled). Each part will consist of three treatment periods separated by a minimum washout period of 14 days. In each treatment period, subjects will receive seven daily doses of one of the 3 treatments: FF, LEV or FF/LEV FDC, via an intranasal spray according to one of the 6 possible randomization sequences. The study will use an adaptive design with an interim review following Part A to confirm whether Part B is required.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01962467 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 15 May 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01962467.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing