Study on the Effects of an AMP Challenge on Asthmatic Pat... | NCT00400855

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

NCT00400855

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Sep 15, 2016Estimated

Enrollment

49Actual

Phase

Phase 2

Conditions

Asthma

Interventions

Fluticasone propionate

Countries

New Zealand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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.

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Aug 2005Actual

Completion Date

Aug 2005Actual

First Submitted Date

Nov 15, 2006

First Submission Date that Met QC Criteria

Nov 15, 2006

First Posted Date

Nov 17, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2016

Last Update Posted Date

Sep 15, 2016Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	study drug	Drug: Fluticasone propionate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluticasone propionate	Drug	Study drug	Arm 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Safety following multiple AMP challenges: Adverse events		5 days
Plasma concentrations of FP and derived pharmacokinetic parameters		5 days
Exhaled nitric oxide concentrations

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Christchurch		8011	New Zealand
GSK Investigational Site

References Module

Citations

Not provided

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

ID	Term
D000730	Androstadienes
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473