Spacer Comparison In Adult Asthmatics

October 13, 2016 updated by: GlaxoSmithKline

A Randomised, Open Label, Five-way Crossover Study to Assess the Systemic Exposure of Fluticasone Propionate and Salmeterol From SERETIDE/ADVAIR 250HFA MDI Alone and With AeroChamber-Max Spacer and VOLUMATIC Both in Their Washed and Unwashed States in Adult Subjects With Mild or Intermittent Asthma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Wellington, New Zealand, 6035
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • This study has not been published in the scientific literature.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

August 28, 2006

First Submitted That Met QC Criteria

August 29, 2006

First Posted (Estimate)

August 30, 2006

Study Record Updates

Last Update Posted (Estimate)

October 17, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAS104449

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Study Protocol
    Information identifier: SAS104449
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Dataset Specification
    Information identifier: SAS104449
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Informed Consent Form
    Information identifier: SAS104449
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Annotated Case Report Form
    Information identifier: SAS104449
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: SAS104449
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individual Participant Data Set
    Information identifier: SAS104449
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Statistical Analysis Plan
    Information identifier: SAS104449
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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