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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00785083

Enrollment

Registered

2008-11-05

Start date

2008-09-30

Completion date

Unknown

Last updated

2016-11-18

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

Conditions

Asthma

Keywords

Asthma, adrenergic beta agonists, multiple sclerosis, pulmonary function tests, forced expiratory volume

Brief summary

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

Interventions

DRUGFTY720

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Change from baseline in Pulmonary function tests (particularly Forced Expiratory Volume at 1 sec (FEV1) at Day 10	10 days
Safety of FTY720	10 days

Secondary

Measure	Time frame
Use of short acting beta agonists during treatment compared to pre-treatment	10 days
Pharmacokinetics of FTY720 and FTY720-P	10 days

Countries

United Kingdom

Outcome results

None listed

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