Skip to main content
OpenTrials
Completed

NCT Number: NCT00354874

Investigation Of A New Medication (GW642444) In Asthmatic Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Wiesbaden, Hesse, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GW642444

Drug

drug

Placebo

Drug

placebo

Salmeterol 50mcg

Drug

salmeterol

Primary outcomes

  1. FEV1 at 24 hours after a single dose.

    Time frame: 24 hours on 4 separate occasions

Secondary outcomes

  1. FEV1 - Days 1 and 7

    Time frame: Days 1 and 7 on 4 separate occasions

  2. Mean morning/evening PEFR

    Time frame: Days 3-8 on 4 separate occasions

  3. BP, HR & QTc on Days 1 and 7

    Time frame: Days 1 and 7 on 4 separate occasions

  4. Potassium and glucose on Days 1 and 7

    Time frame: Days 1 and 7 on 4 separate occasions

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

    Time frame: throughout study

  6. PK parameters

    Time frame: Days 1, 4 and 7 on 4 separate occasions

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Jul 20, 2006
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.