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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: September 13, 2016
Last verified: September 2016
  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:


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
Experimental: GW642444 100mcg Drug: GW642444
drug
Experimental: GW642444 200mcg Drug: GW642444
drug
Active Comparator: salmeterol 50mcg Drug: salmeterol 50mcg
salmeterol
Placebo Comparator: placebo Drug: Placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: B2C101762
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: B2C101762
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: B2C101762
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: B2C101762
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: B2C101762
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: B2C101762
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: B2C101762
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00354874     History of Changes
Other Study ID Numbers: B2C101762 
Study First Received: July 18, 2006
Last Updated: September 13, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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

Additional relevant MeSH terms:
Salmeterol Xinafoate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 26, 2016