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

Phase 2CompletedNCT00785083

Novartis36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Asthma

Interventions

FTY720DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Investigator Site

Manchester, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 10 days

Safety of FTY720

Time frame: 10 days

Secondary Outcomes

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

Time frame: 10 days

Pharmacokinetics of FTY720 and FTY720-P

Time frame: 10 days

Data from ClinicalTrials.gov

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