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Investigation Of A New Medication (GW642444) In Asthmatic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00354874
First received: July 18, 2006
Last updated: March 15, 2012
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Asthma
 Drug: GW642444
Drug: Placebo
Drug: salmeterol 50mcg
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma Potassium
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • FEV1 at 24 hours after a single dose. [ Time Frame: 24 hours on 4 separate occasions ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FEV1 - Days 1 and 7 [ Time Frame: Days 1 and 7 on 4 separate occasions ] [ Designated as safety issue: No ]
  • Mean morning/evening PEFR [ Time Frame: Days 3-8 on 4 separate occasions ] [ Designated as safety issue: No ]
  • BP, HR & QTc on Days 1 and 7 [ Time Frame: Days 1 and 7 on 4 separate occasions ] [ Designated as safety issue: No ]
  • Potassium and glucose on Days 1 and 7 [ Time Frame: Days 1 and 7 on 4 separate occasions ] [ Designated as safety issue: No ]
  • safety & tolerability as measured by AEs, laboratory safety tests, cardiac monitoring, VS & ECG [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • PK parameters [ Time Frame: Days 1, 4 and 7 on 4 separate occasions ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: January 2005
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GW642444 50mcg Drug: GW642444
drug
Other Name: GW642444
Experimental: GW642444 100mcg Drug: GW642444
drug
Other Name: GW642444
Experimental: GW642444 200mcg Drug: GW642444
drug
Other Name: GW642444
Active Comparator: salmeterol 50mcg Drug: salmeterol 50mcg
salmeterol
Placebo Comparator: placebo Drug: Placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354874

Locations
Germany
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65187
GSK Investigational Site
Grosshansdorf, Schleswig-holstein, Germany, 22927
Sweden
GSK Investigational Site
Göteborg, Sweden, SE-413 45
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00354874     History of Changes
Other Study ID Numbers: B2C101762
Study First Received: July 18, 2006
Last Updated: March 15, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency

Keywords provided by GlaxoSmithKline:
GW642444 asthmatic subjects safety tolerability PD and PK

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
 Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013