Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients

NCT00358488 | Completed Phase 2

• 1 other identifier: B2E106359
• Study Type: interventional
• Target: 54
• Locations: 5 countries
• Sites: 6

Brief Summary

This study is designed to determine the efficacy and safety of a new long-acting beta-agonist for asthma patients (GSK159797) following dosing for 14 days.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Safety; Asthmatic patients; GSK159797; Efficacy

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in trough FEV1

  after 14 day repeat doses

Secondary Outcomes (3)

• Mean change from baseline in trough FEV1

  after a single dose

• Mean change from baseline in trough FEV1

  after 7 days repeat dosing

• Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours

  Day 1 and Day 14

Study Arms (4)

GSK159797 (10, 15, and 20mcg)

EXPERIMENTAL

GSK159797 (10, 15, and 20mcg)

Drug: GSK159797 (10, 15, and 20mcg)

salbutamol

EXPERIMENTAL

salbutamol

Drug: salbutamol

salmeterol 50mcg

EXPERIMENTAL

salmeterol 50mcg

Drug: salmeterol 50mcg

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

GSK159797 (10, 15, and 20mcg) DRUG

GSK159797 (10, 15, and 20mcg)

GSK159797 (10, 15, and 20mcg)

salbutamol DRUG

salbutamol

salbutamol

salmeterol 50mcg DRUG

salmeterol 50mcg

salmeterol 50mcg

placebo DRUG

placebo

Also known as: GSK159797 (10, 15, and 20mcg), salbutamol, salmeterol 50mcg

placebo

Eligibility Criteria

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

You may qualify if:

• Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid
• Female subjects only using acceptable birth control method
• Non-smokers
• FEV1 between 60 and 90% predicted
• Increase in FEV1 12% or greater and 300mL and greater after salbutamol use

You may not qualify if:

• Past or present disease conditions
• Normal screening Holter ECG
• Respiratory tract infection within 4 weeks of screening
• History of life threatening asthma
• Previous use of COA

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Wiesbaden, Hesse, 65187, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 14057, Germany

Location

GSK Investigational Site

Utrecht, 3584 CJ, Netherlands

Location

GSK Investigational Site

Moscow, 115446, Russia

Location

GSK Investigational Site

Lund, SE-221 85, Sweden

Location

GSK Investigational Site

Manchester, M23 9LT, 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

Albuterol; 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)

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2006
• First Posted: July 31, 2006
• Study Start: April 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: October 28, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

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