Repeat Dose Study of Fluticasone Propionate/Salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-28

Study Completion Date

2005-04-13

Brief Summary

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A new formulation of Fluticasone propionate/Salmeterol comparing a lower dose of fluticasone propionate and salmeterol was compared with concurrent administration of fluticasone propionate and salmeterol. Administration occurred over 14 days and tolerability, PK (pharmacokinetic) and PD (pharmacodynamic) measurements were performed.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

investigational drug

Group Type EXPERIMENTAL

fluticasone propionate/salmeterol

Intervention Type DRUG

investigational drug

Interventions

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fluticasone propionate/salmeterol

investigational drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Documented history of mild or intermittent asthma
* Have PEF and FEV1\>80% predicted
* Not a smoker
* BMI of 19 - 29

Exclusion Criteria

* Have had a life threatening episode of asthma
* Have had a respiratory tract infection in the last four weeks
* Have other respiratory disease
* Have taken certain medications within restricted time periods

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Berlin, , Germany

Site Status

Countries

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Germany

References

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This study has not been published in the scientific literature.

Reference Type BACKGROUND

Study Documents

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