Skip to main content
OpenTrials
Completed

NCT Number: NCT00785083

A Study of the Effect of FTY720 on Pulmonary Function in Patients With Moderate Asthma

This study will evaluate the effect of FTY720 on the lung function of patients with moderate asthma

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Autoimmune Diseases Autoimmune Diseases of the Nervous System Bronchial Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Multiple Sclerosis Nervous System Diseases Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigator Site

Manchester, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Forced Expiratory Volume in 1 second of at least 60%
  • History of asthma for at least 6 months
  • Current use of short-acting beta agonists, inhaled long-acting beta agonists and inhaled corticosteroids (up to a specified dose)

Exclusion criteria

  • History of lung disease other than asthma
  • Smokers
  • Use of inhaled corticosteroid above specified dose
  • Use of oral beta agonists or corticosteroids or other asthma medications
  • Hypersensitivity to the drug
  • Respiratory tract infections within 1 month of the study

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

FTY720

Drug

Placebo

Drug

Primary outcomes

  1. Change from baseline in Pulmonary function tests (particularly Forced Expiratory Volume at 1 sec (FEV1) at Day 10

    Time frame: 10 days

  2. Safety of FTY720

    Time frame: 10 days

Secondary outcomes

  1. Use of short acting beta agonists during treatment compared to pre-treatment

    Time frame: 10 days

  2. Pharmacokinetics of FTY720 and FTY720-P

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Double-blind, Randomized, Placebo-controlled, Parallel, Time-lagged, Ascending, Multi-centre, Multiple-dose Study to Measure the Magnitude and Time Course of the Effect of FTY720 on FEV1 and Other Pulmonary Function Tests (FVC, FEF25-75%, and FEV1/FVC) in Patients With Moderate Asthma

Important dates

Study start
2008
Primary completion
2009
First posted
Nov 5, 2008
Registry last updated
Nov 18, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.