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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00358488

Enrollment

Registered

2006-07-31

Start date

2006-04-30

Completion date

2007-01-31

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Safety, Asthmatic patients, GSK159797, Efficacy

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.

Interventions

DRUGGSK159797 (10, 15, and 20mcg)

GSK159797 (10, 15, and 20mcg)

DRUGsalbutamol

salbutamol

DRUGsalmeterol 50mcg

salmeterol 50mcg

DRUGplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mean change from baseline in trough FEV1	after 14 day repeat doses

Secondary

Measure	Time frame
Mean change from baseline in trough FEV1	after a single dose
Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours	Day 1 and Day 14

Countries

Germany, Netherlands, Russia, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026