Single Dose GW685698X Magnesium Stearate Study In Asthmatic Patients.

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00444509
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.7
• Patients Per Site Per Month: 11.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: GW685698X; Drug: GW685698X containing magnesium stearate	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Primary Purpose: Treatment
• Official Title: A Double-blind, Placebo-controlled, Crossover Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Dose Dry Powder GW685698X Containing Magnesium Stearate in Subjects With Mild to Moderate Asthmatic Patients
• Actual Study Start Date: Feb 17, 2007
• Actual Primary Completion Date: Apr 9, 2007
• Actual Study Completion Date: Apr 9, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: GW685698X; GW685698X will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS; 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
Experimental: 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.	Drug: GW685698X; GW685698X will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS; 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

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability: Vital signs: for 48 hours 12-lead ECG including QT, QTc, PR and QRS intervals for 48 hours PEFR, FEV1 for 48 hours Laboratory safety tests (clinical chemistry, haematology, urinalysis) at predose Adverse events for 46 days [Vital signs: for 48 hours]

Secondary Outcome Measures

1. Plasma GW685698X concentrations and pharmacokinetic parameters (AUC, Cmax, t1/2, tmax) following single inhaled doses in mild/moderate asthmatic patients for 48 hours. Weighted mean serum cortisol (0-24 h) on Day 1. [following single inhaled doses in mild/moderate asthmatic patients for 48 hours.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Wellington		New Zealand	6035

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

• This study has not been published in the scientific literature.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00444509
• Other Study ID Numbers: HZA108799
• First Posted: Mar 7, 2007
• Last Update Posted: Aug 4, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Asthmatic Patients
• Additional relevant MeSH terms: Asthma

Study Results

No Results Posted as of Aug 4, 2017