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Study on the Effects of an AMP Challenge on Asthmatic Patients Following Treatment With Fluticasone Propionate

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

New Zealand

Study Type

Interventional

Intervention

Fluticasone propionate

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, AMP challenge

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Female of non-childbearing potential
Using appropriate contraception.
Mild asthmatic, non (or ex) smokers.
Has inflammatory response to AMP.
Otherwise healthy, not using any steroids.

Exclusion Criteria:

Have a history of life-threatening asthma, defined as an asthma episode, which required intubation and/or was associated with either hypercapnea, respiratory arrest or hypoxia seizures.
Have a known sensitivity to corticosteroids.
Have a history of milk protein allergy.
Test positive at the screening visit for hepatitis B or C or HIV

Sites / Locations

GSK Investigational Site
GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

study drug

Outcomes

Primary Outcome Measures

To characterise the dose response curve following repeat inhaled doses of FP for 5 days in the AMP challenge model.

Secondary Outcome Measures

Safety following multiple AMP challenges: Adverse events

Plasma concentrations of FP and derived pharmacokinetic parameters

Exhaled nitric oxide concentrations

Full Information

NCT ID

NCT00400855

First Posted

November 15, 2006

Last Updated

September 13, 2016

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00400855

Brief Title

Study on the Effects of an AMP Challenge on Asthmatic Patients Following Treatment With Fluticasone Propionate

Official Title

A Randomised, Double-blind, Placebo-controlled, Incomplete Block, 4-period Crossover, Study to Investigate the Effects of 5-day Repeat Inhaled Doses of Fluticasone Propionate (BID, 50-2000 mcg) on Airway Responsiveness to Adenosine 5-monophosphate (AMP) Challenge When Delivered After the Last Dose in Mild Asthmatic Subjects.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

August 2005 (Actual)

Study Completion Date

August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

Inhaling AMP causes an inflammatory response in the lung. This study will investigate whether 5-days of treatment with fluticasone propionate protects the lung from responding to the AMP in this way.

Detailed Description

A randomised, double-blind, placebo-controlled, incomplete block, 4-period crossover study to investigate the effects of 5-day repeat inhaled doses of fluticasone propionate (BID, 50-2000 mcg) on airway responsiveness to adenosine-5'-monophosphate (AMP) challenge when delivered after the last dose in mild asthmatic subjects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, AMP challenge

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

study drug

Intervention Type

Drug

Intervention Name(s)

Fluticasone propionate

Intervention Description

Study drug

Primary Outcome Measure Information:

Title

To characterise the dose response curve following repeat inhaled doses of FP for 5 days in the AMP challenge model.

Time Frame

5 days

Secondary Outcome Measure Information:

Title

Safety following multiple AMP challenges: Adverse events

Time Frame

5 days

Title

Plasma concentrations of FP and derived pharmacokinetic parameters

Time Frame

5 days

Title

Exhaled nitric oxide concentrations

Time Frame

5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female of non-childbearing potential Using appropriate contraception. Mild asthmatic, non (or ex) smokers. Has inflammatory response to AMP. Otherwise healthy, not using any steroids. Exclusion Criteria: Have a history of life-threatening asthma, defined as an asthma episode, which required intubation and/or was associated with either hypercapnea, respiratory arrest or hypoxia seizures. Have a known sensitivity to corticosteroids. Have a history of milk protein allergy. Test positive at the screening visit for hepatitis B or C or HIV

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Christchurch

ZIP/Postal Code

8011

Country

New Zealand

Facility Name

GSK Investigational Site

City

Wellington

ZIP/Postal Code

6035

Country

New Zealand

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

SIG103337

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

SIG103337

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

SIG103337

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

SIG103337

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

SIG103337

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

SIG103337

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

SIG103337

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Study on the Effects of an AMP Challenge on Asthmatic Patients Following Treatment With Fluticasone Propionate

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