Investigation Of A New Medication (GW642444) In Asthmatic Patients

NCT00354874 | Completed Phase 2

• 1 other identifier: B2C101762
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 3

Brief Summary

This study will evaluate efficacy (FEV1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat inhaled doses of GW642444. This will be a multi-centre, double-blind, placebo controlled, dose ascending, four way cross-over study in approximately 28 mild to moderate asthmatic subjects. Key assessments: Efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics will be assessed by measurement of FEV1, blood pressure, heart rate, 12-lead ECGs, clinical laboratory tests, collection of adverse events (AE) information and blood samples.

Conditions

Asthma

Keywords

GW642444 asthmatic subjects safety tolerability PD and PK

Outcome Measures

Primary Outcomes (1)

• FEV1 at 24 hours after a single dose.

  24 hours on 4 separate occasions

Secondary Outcomes (6)

• FEV1 - Days 1 and 7

  Days 1 and 7 on 4 separate occasions

• Mean morning/evening PEFR

  Days 3-8 on 4 separate occasions

• BP, HR & QTc on Days 1 and 7

  Days 1 and 7 on 4 separate occasions

• Potassium and glucose on Days 1 and 7

  Days 1 and 7 on 4 separate occasions

• safety & tolerability as measured by AEs, laboratory safety tests, cardiac monitoring, VS & ECG

  throughout study

Study Arms (5)

GW642444 50mcg

EXPERIMENTAL

Drug: GW642444

GW642444 100mcg

EXPERIMENTAL

Drug: GW642444

GW642444 200mcg

EXPERIMENTAL

Drug: GW642444

salmeterol 50mcg

ACTIVE COMPARATOR

Drug: salmeterol 50mcg

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

GW642444 DRUG

drug

GW642444 100mcg; GW642444 200mcg; GW642444 50mcg

Placebo DRUG

placebo

placebo

salmeterol 50mcg DRUG

salmeterol

salmeterol 50mcg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects must be non-childbearing (i.e., surgically sterilised or post-menopausal).
• Non-smokers for at least 6 months.
• Stable asthma.

You may not qualify if:

• Abnormal findings on heart monitoring assessment.
• Lower respiratory tract infection within 4 weeks, upper respiratory tract within 2 weeks of study.
• Currently taking doses of fluticasone propionate over 500mcg/day.
• Unstable asthma medication.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Wiesbaden, Hesse, 65187, Germany

Location

GSK Investigational Site

Großhansdorf, Schleswig-Holstein, 22927, Germany

Location

GSK Investigational Site

Gothenburg, SE-413 45, Sweden

Location

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.

MeSH Terms

Conditions

Asthma

Interventions

Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2006
• First Posted: July 20, 2006
• Study Start: January 1, 2005
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: September 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (2); SE (1)