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OpenTrials
Completed

NCT Number: NCT00358488

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Wiesbaden, Hesse, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GSK159797 (10, 15, and 20mcg)

Drug

GSK159797 (10, 15, and 20mcg)

Salbutamol

Drug

salbutamol

Salmeterol 50mcg

Drug

salmeterol 50mcg

Placebo

Drug

placebo

Other names: GSK159797 (10, 15, and 20mcg), salbutamol, salmeterol 50mcg

Primary outcomes

  1. Mean change from baseline in trough FEV1

    Time frame: after 14 day repeat doses

Secondary outcomes

  1. Mean change from baseline in trough FEV1

    Time frame: after a single dose

  2. Mean change from baseline in trough FEV1

    Time frame: after 7 days repeat dosing

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

    Time frame: Day 1 and Day 14

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 31, 2006
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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