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
1 other identifier
interventional
36
1 country
1
Brief Summary
This study will evaluate the effect of FTY720 on the lung function of patients with moderate asthma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 4, 2008
CompletedFirst Posted
Study publicly available on registry
November 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedNovember 18, 2016
November 1, 2016
5 months
November 4, 2008
November 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Use of short acting beta agonists during treatment compared to pre-treatment
10 days
Pharmacokinetics of FTY720 and FTY720-P
10 days
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Novartis Investigator Site
Manchester, United Kingdom
Related Publications (2)
Boulton C, David OJ, Meiser K, Schmouder R. Tolerability and Pulmonary Pharmacodynamic Effects During Treatment Initiation of Once-Daily Oral Fingolimod in Subjects With Moderate Asthma. Clin Pharmacol Drug Dev. 2013 Jan;2(1):2-10. doi: 10.1002/cpdd.4. Epub 2013 Mar 4.
PMID: 27121555RESULTIzquierdo G, O'Connor P, Montalban X, von Rosenstiel P, Cremer M, de Vera A, Sfikas N, Francis G, Radue EW, Kappos L. Five-year results from a phase 2 study of oral fingolimod in relapsing multiple sclerosis. Mult Scler. 2014 Jun;20(7):877-81. doi: 10.1177/1352458513513059. Epub 2013 Nov 30.
PMID: 24293455DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Novartis
Novartis Investigator Site
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2008
First Posted
November 5, 2008
Study Start
September 1, 2008
Primary Completion
February 1, 2009
Last Updated
November 18, 2016
Record last verified: 2016-11