Single Dose GW685698X Magnesium Stearate Study In Asthmatic Patients.

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-17

Study Completion Date

2007-04-09

Brief Summary

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This is a single centre, randomised, double blind, two-way crossover study, to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dry powder GW685698X (800?g) containing magnesium stearate. Magnesium stearate is an excipient added to improve the physical stability of inhaled dry powder formulations. Male and female patients with mild/moderate asthma will be randomised to determine which order they receive a single inhaled administration of GW685698X (800?g) with and without magnesium stearate. There will be a wash-out period of at least 5 days between doses.

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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

Study Groups

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Treatment 1

Subjects will receive GW685698X 800 microgram (mcg) single inhaled dose via a DISKUS inhaler. There will be a wash-out period of at least 5 days between doses.

Group Type EXPERIMENTAL

GW685698X

Intervention Type DRUG

GW685698X will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS

GW685698X containing magnesium stearate

Intervention Type DRUG

GW685698X containing magnesium stearate will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS

Treatment 2

Subjects will receive GW685698X 800 mcg containing magnesium stearate inhaled dose via a DISKUS inhaler. There will be a wash-out period of at least 5 days between doses.

Group Type EXPERIMENTAL

GW685698X

Intervention Type DRUG

GW685698X will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS

GW685698X containing magnesium stearate

Intervention Type DRUG

GW685698X containing magnesium stearate will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS

Interventions

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GW685698X

GW685698X will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS

Intervention Type DRUG

GW685698X containing magnesium stearate

GW685698X containing magnesium stearate will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinically stable persistent mild/moderate asthma within the 4 weeks preceding the screening visit,
* screening pre-bronchodilator FEV1 \>or=60 % predicted,demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of \>or= 12.0% over the max of the three screening measures and an absolute change of

\>or= 200 mL within 30 minutes following a single 400 mcg salbutamol dose, male or female (of non child bearing potential or meet the contraception criteria),
* BMI 19-31 kg/m2,
* Non-smoker,
* refrains from use of prohibited medication within the specified timeframes

Exclusion Criteria

* Pregnant or nursing females
* History of life threatening asthma
* Subjects who are unable to stop taking protocol defined prohibited medication

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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

Wellington, , New Zealand

Site Status

Countries

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New Zealand

References

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This study has not been published in the scientific literature.

Reference Type BACKGROUND

Study Documents

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