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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: FTY720

• Registration Number: NCT00785083
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-11-04
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Primary Completion: 2009-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	FTY720	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Novartis Investigator Site; 🇬🇧 Manchester, United Kingdom