Investigation Of A New Medication (GW642444) In Asthmatic Patients

Asthma Clinical Trial

Official title:

A Multi-centre, Randomised, Double-blind, Placebo Controlled, Dose Ascending, Four Way Crossover Study to Examine Efficacy (FEV1), Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Doses of GW642444

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00354874
• Other study ID #: B2C101762
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2006
• Last updated: September 13, 2016
• Start date: January 2005
• Est. completion date: June 2005

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

• Female subjects must be non-childbearing (i.e., surgically sterilised or post-menopausal).

• Non-smokers for at least 6 months.

• Stable asthma.

Exclusion criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• GW642444
drug
• Placebo
placebo
• salmeterol 50mcg
salmeterol

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Grosshansdorf	Schleswig-Holstein
Germany	GSK Investigational Site	Wiesbaden	Hessen
Sweden	GSK Investigational Site	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 at 24 hours after a single dose.		24 hours on 4 separate occasions	No
Secondary	FEV1 - Days 1 and 7		Days 1 and 7 on 4 separate occasions	No
Secondary	Mean morning/evening PEFR		Days 3-8 on 4 separate occasions	No
Secondary	BP, HR & QTc on Days 1 and 7		Days 1 and 7 on 4 separate occasions	No
Secondary	Potassium and glucose on Days 1 and 7		Days 1 and 7 on 4 separate occasions	No
Secondary	safety & tolerability as measured by AEs, laboratory safety tests, cardiac monitoring, VS & ECG		throughout study	No
Secondary	PK parameters		Days 1, 4 and 7 on 4 separate occasions	No

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.