Single Dose GW685698X Magnesium Stearate Study In Asthmatic Patients.

NCT00444509 | Completed Phase 1

• 1 other identifier: HZA108799
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthmatic Patients

Outcome Measures

Primary Outcomes (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 Outcomes (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.

Study Arms (2)

Treatment 1

EXPERIMENTAL

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; Drug: GW685698X containing magnesium stearate

Treatment 2

EXPERIMENTAL

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; Drug: GW685698X containing magnesium stearate

Interventions

GW685698X DRUG

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

Treatment 1; Treatment 2

GW685698X containing magnesium stearate DRUG

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

Treatment 1; Treatment 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Wellington, 6035, New Zealand

Location

Related Publications (1)

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

  BACKGROUND

Related 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.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2007
• First Posted: March 7, 2007
• Study Start: February 17, 2007
• Primary Completion: April 9, 2007
• Study Completion: April 9, 2007
• Last Updated: August 4, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

NZ (1)