Single Dose GW685698X Magnesium Stearate Study In Asthmatic Patients.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: GW685698X; Drug: GW685698X containing magnesium stearate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00444509

HZA108799

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Treatment 1

Experimental group

Description:

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.

Treatment:

Drug: GW685698X

Drug: GW685698X containing magnesium stearate

Treatment 2

Experimental group

Description:

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.

Treatment:

Drug: GW685698X

Drug: GW685698X containing magnesium stearate