Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00347139
First received: June 29, 2006
Last updated: May 31, 2012
Last verified: March 2011
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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
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 Respiration Disorders 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 |
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