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A Study in Patients With Moderate Asthma to Compare Pharmacokinetics and Pharmacodynamic Effects of Fluticasone Propionate and Salmeterol Delivered Via the ROTAHALER® Inhaler Relative to the DISKUS® Inhaler

NCT02218762 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2015-02-11

No results posted yet for this study

Summary

The Fluticasone Propionate/Salmeterol combination (FSC) at a dose of 100/50 micrograms (mcg) twice daily in DISKUS inhaler (also known as ACCUHALER®, Ddpi) inhaler is a recognised and licensed therapy for the treatment of asthma. GlaxoSmithKline (GSK) is developing the ROTAHALER/ ROTACAPS® (Rdpi) inhaler as an alternative treatment option for asthmatic patients. This study is a Phase I, randomised, double-blind, double-dummy, two- treatment, four-way cross-over (replicate design), two sequence, repeat dose, two centre study in mild to moderate asthmatics to compare the pharmacokinetics and pharmacodynamics of fluticasone proprionate/salmeterol (100/50 mcg) delivered via the Rdpi versus the Ddpi. A total of 58 subjects will be enrolled to ensure 52 subjects complete all dosing occasions. Each subject will be allocated to one of two treatment sequences and will participate in four treatment periods, receiving each of the treatments twice.

DISKUS, ACCUHALER, ROTAHALER and ROTACAPS are registered trademarks of GSK groups of companies.

Conditions

Interventions

DRUG

Fluticasone Propionate/Salmeterol Xinafoate DISKUS

A blister strip contained within the DISKUS inhaler. Each blister contains a small quantity of powder comprising of a blend of fluticasone propionate (micronized)(100 mcg), salmeterol xinafoate (micronized) (50 mcg) and excipient(s). One blister to be administered twice daily via DISKUS inhaler

DRUG

Placebo to Match DISKUS

A blister strip contained within the DISKUS inhaler. Each blister contains a small quantity of lactose and powder comprising of excipient(s). One blister to be administered twice daily via DISKUS inhaler

DRUG

Fluticasone Propionate/Salmeterol Xinafoate ROTACAPS

A capsule containing a small quantity of powder comprising of a blend of fluticasone propionate (micronized) (100 mcg), salmeterol xinafoate (micronized) (50 mcg) and excipient(s). One capsule to be administered twice daily via ROTAHALER inhaler

DRUG

Placebo to Match ROTACAPS

A capsule containing a small quantity of lactose and powder comprising of excipient(s). One capsule to be administered twice daily via ROTAHALER inhaler

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-06-30
Completion
2015-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02218762 on ClinicalTrials.gov