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Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects

NCT ID: NCT00517634

Last Updated: 2016-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-07-31

Brief Summary

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The aim of the present study is to investigate whether the effects of salmeterol in combination with fluticasone propionate on blood markers of airway inflammation are maintained after chronic dosing and whether the effect is influenced by the time of allergen challenge relative to the time of dosing.

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Detailed Description

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A 12-week, randomised, double-blind, placebo-controlled, three-period, cross-over pilot study comparing the effect of salmeterol/fluticasone propionate, fluticasone propionate and placebo on perpheral blood eosinophils and serum IL-5 in response to allergen challenge in asthma subjects when allergen challenge is administered at 1 hour or 11-12 hours post-dose of the dosing interval

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sequence 1: FP, SFC, Placebo

Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period

Group Type EXPERIMENTAL

FP

Intervention Type DRUG

Fluticasone Propionate 100 mcg BD

SFC

Intervention Type DRUG

Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD

Placebo

Intervention Type DRUG

Matching Placebo

Sequence 2: Placebo, SFC, FP

Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period

Group Type EXPERIMENTAL

FP

Intervention Type DRUG

Fluticasone Propionate 100 mcg BD

SFC

Intervention Type DRUG

Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD

Placebo

Intervention Type DRUG

Matching Placebo

Sequence 3: SFC, FP, Placebo

Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period

Group Type EXPERIMENTAL

FP

Intervention Type DRUG

Fluticasone Propionate 100 mcg BD

SFC

Intervention Type DRUG

Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD

Placebo

Intervention Type DRUG

Matching Placebo

Sequence 4: SFC, Placebo, FP

Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period

Group Type EXPERIMENTAL

FP

Intervention Type DRUG

Fluticasone Propionate 100 mcg BD

SFC

Intervention Type DRUG

Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD

Placebo

Intervention Type DRUG

Matching Placebo

Sequence 5: FP, Placebo, SFC

Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period

Group Type EXPERIMENTAL

FP

Intervention Type DRUG

Fluticasone Propionate 100 mcg BD

SFC

Intervention Type DRUG

Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD

Placebo

Intervention Type DRUG

Matching Placebo

Sequence 6: Placebo, FP, SFC

Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period

Group Type EXPERIMENTAL

FP

Intervention Type DRUG

Fluticasone Propionate 100 mcg BD

SFC

Intervention Type DRUG

Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD

Placebo

Intervention Type DRUG

Matching Placebo

Interventions

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FP

Fluticasone Propionate 100 mcg BD

Intervention Type DRUG

SFC

Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD

Intervention Type DRUG

Placebo

Matching Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent.
* Outpatient.
* Male or non-pregnant/non-lactating female.
* Aged 18-55.
* Diagnosis of asthma.
* Pre-bronchodilatory FEV1 \> 75% predicted.
* Using inhaled short-acting beta-2-agonists (SABA) with no inhaled corticosteroids.
* Judged capable of withholding SABA for at least 6 hours prior to visits.
* Reversibility of \>12% and 200mL or PC20 of \<8mg/mL.
* Demonstration of atopy

Exclusion Criteria

* History of life-threatening asthma.
* Use of proscribed asthma medications.
* Use of anti-histamines or potent inhibitors of CYP3A4.
* Respiratory tract infection.
* Asthma exacerbation with 4 weeks of Visit 1.
* Subjects with exercise induced asthma only.
* Concurrent respiratory disease.
* Other clinically significant, uncontrolled condition or disease.
* Use of any investigational drug within 30 days.
* Allergic to beta-2-agonists, inhaled corticosteroids or excipients.
* Positive pregnancy test.
* Using immunosuppressive medications.
* Milk protein allergy.
* Factors likely to interfere with attendance.
* Current smokers or ex-smokers with a history of \>10 pack years.
* Affiliation wih Investigator site.
* Medications that may affect the course of asthma or interact with sympathomimetic amines.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Madison, Wisconsin, United States

Site Status

GSK Investigational Site

Manchester, , United Kingdom

Site Status

Countries

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United States United Kingdom

Study Documents

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Document Type: Individual Participant Data Set

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

View Document

Document Type: Annotated Case Report Form

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

View Document

Document Type: Study Protocol

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

View Document

Document Type: Statistical Analysis Plan

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

View Document

Document Type: Clinical Study Report

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

View Document

Document Type: Dataset Specification

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

View Document

Document Type: Informed Consent Form

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

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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HZA109912

Identifier Type: -

Identifier Source: org_study_id

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