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

NCT00347139 | Completed Phase 2

• 1 other identifier: B2C106093
• Study Type: interventional
• Target: 55
• Locations: 5 countries
• Sites: 7

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Tolerability; Pharmacodynamics; Safety; Pharmacokinetics; GW642444; Asthmatic patients; Efficacy

Outcome Measures

Primary Outcomes (1)

• Mean change from Baseline (pre-dose on Day 1) in the mean of 23 and 24 hour (h) visit (pre-bronchodilator and pre-dose) trough FEV1 after repeat dosing over 14 days

  The forced expiratory volume in one second (FEV1) is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was defined as the value recorded pre-dose (before dosing) on Day 1. Least square mean change along with standard error has been presented.

  From Baseline (pre-dose on Day 1) and up to 14 days

Secondary Outcomes (7)

• Mean change from Baseline (pre-dose on Day 1) in weighted mean clinic FEV1 on Day 1 and Day 14

  From Baseline (pre-dose on Day 1) and at 0-2 h, 0-4, and 0-24 h Days 1 and 14

• Mean change from Baseline (pre-dose on Day 1) in morning (AM) Peak expiratory flow rate (PEFR) from electronic flow meter over Days 2-15

  Baseline (pre-dose on Day 1) and up to 15 days

• Mean change from Baseline (pre-dose on Day 1) in the evening (PM) PEFR from electronic flow meter over Days 1-14

  Baseline (pre-dose on Day 1) and up to 14 days

• Mean change from Baseline (pre-dose on Day 1) in AM FEV1 from electronic flow meter over Days 2-15

  Baseline (pre-dose on Day 1), Day 2, and Day 15

• Mean change from Baseline (pre-dose on Day 1) in PM FEV1 from electronic flow meter over 14 days

  Baseline (pre-dose on Day 1) and up to Day 14

Study Arms (2)

GW642444

EXPERIMENTAL

Drug: GW642444 (25, 100 & 400 mcg/day)

Salmeterol

ACTIVE COMPARATOR

Drug: Salmeterol 50mcg

Interventions

GW642444 (25, 100 & 400 mcg/day) DRUG

25, 100 and 400mcg/dose

GW642444

Salmeterol 50mcg DRUG

Salmeterol 50mcg

Salmeterol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (7)

GSK Investigational Site

Wiesbaden, Hesse, 65187, Germany

Location

GSK Investigational Site

Großhansdorf, Schleswig-Holstein, 22927, Germany

Location

GSK Investigational Site

Wellington, 6035, New Zealand

Location

GSK Investigational Site

Moscow, 105 077, Russia

Location

GSK Investigational Site

Gothenburg, SE-413 45, Sweden

Location

GSK Investigational Site

Stockholm, SE-141 86, Sweden

Location

GSK Investigational Site

London, SE5 9RJ, United Kingdom

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2006
• First Posted: July 4, 2006
• Study Start: May 23, 2006
• Primary Completion: January 10, 2007
• Study Completion: January 10, 2007
• Last Updated: September 14, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

SE (2); NZ (1); DE (2); RU (1); GB (1)