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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A Multi-enter, Randomized, 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 (10, 15, and 20 mcg) of GSK159797

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358488
• Other study ID #: B2E106359
• Status: Completed
• Phase: Phase 2
• First received: July 27, 2006
• Last updated: October 26, 2016
• Start date: April 2006
• Est. completion date: January 2007

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

• 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

Exclusion criteria:

• 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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• GSK159797 (10, 15, and 20mcg)
GSK159797 (10, 15, and 20mcg)
• salbutamol
salbutamol
• salmeterol 50mcg
salmeterol 50mcg
• placebo
placebo

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Wiesbaden	Hessen
Netherlands	GSK Investigational Site	Utrecht
Russian Federation	GSK Investigational Site	Moscow
Sweden	GSK Investigational Site	Lund
United Kingdom	GSK Investigational Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Germany,  Netherlands,  Russian Federation,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in trough FEV1		after 14 day repeat doses
Secondary	Mean change from baseline in trough FEV1		after a single dose
Secondary	Mean change from baseline in trough FEV1		after 7 days repeat dosing
Secondary	Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours		Day 1 and Day 14

External Links

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