Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00347139
First received: June 29, 2006
Last updated: May 31, 2012
Last verified: March 2011
  Purpose

In order to obtain information on a wider range of doses of GW642444 (a possible new medication to treat asthma) than has been previously examined in asthmatic patients, this current study will be conducted at doses of 25 100 and 400 mcg of GW642444 and will be compared with salmeterol (50 mcg twice daily). This study will be conducted in a similar manner to a study that has already been completed (study number B2C101762) which examined repeat doses of 50, 100 and 200 mcg of GW642444. The data obtained will compliment the data from study B2C101762 and will provide confidence (or not) that the desired bronchodilation can be achieved and maintained without undesirable side effects.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Asthma
Drug: GW642444 (25, 100 & 400 mcg/day)
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, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Multi-centre, Randomised, Double-blind, Placebo-controlled, Four-way Incomplete Block Crossover Study, to Examine Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Administration of Three Inhaled Doses (25, 100 and 400 Mcg Once Daily) of GW642444

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean change from baseline in trough FEV1 after repeat dosing [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • Mean change in FEV1 [ Time Frame: after a single dose ]
  • Mean change in FEV1 after dosing [ Time Frame: 7 days ]
  • Weighted Mean FEV1 0-2, 0-4 and 0-24h [ Time Frame: on Day 1, Day 7, Day 14 ]
  • AM PEFRAM FEV1 [ Time Frame: over Days 2-15 ]
  • PM PEFRPM FEV1 [ Time Frame: over Days 1-14 ]

Enrollment: 56
Study Start Date: May 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GW642444
N/A
Drug: GW642444 (25, 100 & 400 mcg/day)
25, 100 and 400mcg/dose
Active Comparator: Salmeterol Drug: Salmeterol 50mcg
Salmeterol 50mcg

  Eligibility

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

Inclusion criteria:

  • Subjects with a documented history of persistent asthma.
  • Current non-smokers.
  • Clinically stable persistent asthma FEV1 between 60 and 90% of predicted values.
  • Inhaled corticosteroid therapy at a total daily dose between 200-500mcg of fluticasone or equivalent.

Exclusion criteria:

  • Subjects with significant past or present disease which which may affect their safety.
  • Upper or lower respiratory tract infection within 4 weeks of screening.
  • History of life threatening asthma, or asthma requiring treatment with oral corticosteroids within 3 months of study.
  • Patients taking doses of inhaled corticosteroid >500mcg/day and patients who have changed therapy within 8 weeks of the study.
  • Patients weighing less than 50kg.
  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: NCT00347139

Locations
Germany
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65187
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
New Zealand
GSK Investigational Site
Wellington, New Zealand, 6035
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 105 077
Sweden
GSK Investigational Site
Göteborg, Sweden, SE-413 45
United Kingdom
GSK Investigational Site
London, United Kingdom, SE5 9RJ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00347139     History of Changes
Other Study ID Numbers: B2C106093
Study First Received: June 29, 2006
Last Updated: May 31, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
New Zealand: Health Research Council
Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency

Keywords provided by GlaxoSmithKline:
Tolerability
Pharmacodynamics
Safety
Pharmacokinetics
GW642444
Asthmatic patients
Efficacy

Additional relevant MeSH terms:
Asthma
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes
Salmeterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
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 August 28, 2014