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Be Part of Research - Trial Details - An Investigation of the Pharmacokinetics of GSK961081 and Fluticasone Propionate in Healthy Volunteers
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An Investigation of the Pharmacokinetics of GSK961081 and Fluticasone Propionate in Healthy Volunteers

Completed

Open to: ALL

Age: 18.0 - 50.0

London

Medical Conditions

Pulmonary Disease, Chronic Obstructive

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


In the current study GSK961081 and fluticasone propionate will be administered in a blended formulation from a single device and compared with GSK961081 and fluticasone propionate administered alone and concurrently. This is a single centre, randomized, double-blind, double dummy, single dose, four way cross-over study investigating the pharmacokinetics and pharmacodynamics of GSK961081 and fluticasone propionate when administered alone, concurrently and as a combination blend in healthy subjects.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jul 2011 Sep 2011

Publications

"Norris V, Ambery C, Riley T. Pharmacokinetics and pharmacodynamics of GSK961081, a novel inhaled muscarinic antagonist beta2 -agonist, and fluticasone propionate administered alone, concurrently and as a combination blend formulation in healthy volunteers. Clin Pharmacol Drug Dev. 2014 Jul;3(4):305-13. doi: 10.1002/cpdd.105. Epub 2014 Feb 20."; "27128837"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : To be provided via a combination of 4 inhalers - one 400 micrograms GSK961081 Diskus inhalation, a second 400 microgram GSK961081 Diskus inhalation and one inhalation each from two separate placebo Diskus inhalers

Intervention Arm Group : Sequence 1;Sequence 2;Sequence 3;Sequence 4;

Intervention Type : DRUG
Intervention Description : To be provided via a combination of 4 inhalers - one 250 microgram fluticasone propionate Diskus inhalation, a second 250 microgram fluticasone proopionate Diskus inhalation, and one inhalation each from two separate placebo Diskus inhalers

Intervention Arm Group : Sequence 1;Sequence 2;Sequence 3;Sequence 4;

Intervention Type : DRUG
Intervention Description : To be provided via a combination of 4 inhalers - one 400 microgram GSK961081 Diskus inhalation, a second 400 microgram GSK961081 Diskus inhalation, one 250 microgram fluticasone propionate Diskus inhalation, and a second fluticasone propionate 250 microgram Diskus inhalation

Intervention Arm Group : Sequence 1;Sequence 2;Sequence 3;Sequence 4;

Intervention Type : DRUG
Intervention Description : To be provided via a combination of 4 inhalers - one inhalation of a Diskus inhaler containing a blend of 400 microgram of GSK961081 and 250 microgram of fluticasone propionate per inhalation, a second inhalation of a Diskus inhaler containing a blend of 400 microgram of GSK961081 and 250 microgram of fluticasone propionate per inhalation, and one inhalation each from two separate placebo inhalers

Intervention Arm Group : Sequence 1;Sequence 2;Sequence 3;Sequence 4;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • GSK Investigational Site
    London
    NW10 7EW


The study is sponsored by GlaxoSmithKline



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Read full details for Trial ID: NCT01449799
Last updated 26 July 2017

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