- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00785083
A Study of the Effect of FTY720 on Pulmonary Function in Patients With Moderate Asthma
November 16, 2016 updated by: Novartis
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
This study will evaluate the effect of FTY720 on the lung function of patients with moderate asthma
Study Overview
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Manchester, United Kingdom
- Novartis Investigator Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: 2
|
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EXPERIMENTAL: 1
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in Pulmonary function tests (particularly Forced Expiratory Volume at 1 sec (FEV1) at Day 10
Time Frame: 10 days
|
10 days
|
Safety of FTY720
Time Frame: 10 days
|
10 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Use of short acting beta agonists during treatment compared to pre-treatment
Time Frame: 10 days
|
10 days
|
Pharmacokinetics of FTY720 and FTY720-P
Time Frame: 10 days
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Izquierdo 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (ACTUAL)
February 1, 2009
Study Registration Dates
First Submitted
November 4, 2008
First Submitted That Met QC Criteria
November 4, 2008
First Posted (ESTIMATE)
November 5, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
November 18, 2016
Last Update Submitted That Met QC Criteria
November 16, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Immunosuppressive Agents
- Immunologic Factors
- Sphingosine 1 Phosphate Receptor Modulators
- Fingolimod Hydrochloride
Other Study ID Numbers
- CFTY720D2102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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