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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Disease, Chronic Obstructive

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

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Mean change from baseline in trough FEV1

Secondary outcome:

Mean change from baseline in trough FEV1

Mean change from baseline in trough FEV1

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

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

GSK Investigational Site, Berlin 14057, Germany

GSK Investigational Site, Utrecht 3584 CJ, Netherlands

GSK Investigational Site, Moscow 115446, Russian Federation

GSK Investigational Site, Lund SE-221 85, Sweden

GSK Investigational Site, Manchester M23 9LT, United Kingdom

GSK Investigational Site, Wiesbaden, Hessen 65187, Germany

Additional Information

Starting date: April 2006
Last updated: November 7, 2013

Page last updated: August 23, 2015

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