Spacer Comparison In Adult Asthmatics - Tabular View

Tracking Information

First Received Date ^ICMJE

August 28, 2006

Last Updated Date

October 9, 2008

Start Date ^ICMJE

March 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The pharmacokinetic profile of fluticasone propionate (in particular the area under the curve to time t and the maximum concentration)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00369993 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The pharmacokinetic profile of salmeterol and the time to maximum concentration of fluticasone propionate

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Spacer Comparison In Adult Asthmatics

Official Title ^ICMJE

See Detailed Description

Brief Summary

Spacers are used by people with respiratory diseases who have problems using MDIs (metered dose inhalers). This study used fluticasone propionate/salmeterol to look at the pharmacokinetic profiles produced by different spacers in their washed and un-washed states.

Detailed Description

A randomised, open label, five-way crossover study to assess the systemic exposure of fluticasone propionate and salmeterol from SERETIDE™/ADVAIR™ 250 HFA MDI without spacer and with AeroChamber-Max spacer and VOLUMATIC™ both in their washed and unwashed states in adult subjects with mild or intermittent asthma.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: fluticasone propionate/salmeterol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion criteria:

Non-smoking with a BMI of 19 - 30
Diagnosed with mild or intermittent asthma and taking medication for it.

Exclusion criteria:

Taking oral corticosteroids or inhaled fluticasone propionate
Have certain medical conditions or are not otherwise healthy.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

New Zealand

Administrative Information

NCT ID ^ICMJE

NCT00369993

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

SAS104449

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, BA, MB, BS, PhD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP