Single Dose GW685698X Magnesium Stearate Study In Asthmatic Patients.

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00444509
• Other study ID #: HZA108799
• Status: Completed
• Phase: Phase 1
• First received: March 6, 2007
• Last updated: August 3, 2017
• Start date: February 17, 2007
• Est. completion date: April 9, 2007

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 9, 2007
• Est. primary completion date: April 9, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
New Zealand	GSK Investigational Site	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

New Zealand, 

References & Publications (1)

This study has not been published in the scientific literature.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study HZA108799 can be found on the GSK Clinical Study Register.