A Study of the Effect of FTY720 on Pulmonary Function in Patients With Moderate Asthma
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ClinicalTrials.gov Identifier: NCT00785083 |
Recruitment Status
:
Completed
First Posted
: November 5, 2008
Last Update Posted
: November 18, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: FTY720 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | February 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 | Drug: FTY720 |
Placebo Comparator: 2 | Drug: Placebo |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785083
United Kingdom | |
Novartis Investigator Site | |
Manchester, United Kingdom |
Principal Investigator: | Novartis | Novartis Investigator Site |
Additional Information:
Publications of Results:
Responsible Party: | Novartis |
ClinicalTrials.gov Identifier: | NCT00785083 History of Changes |
Other Study ID Numbers: |
CFTY720D2102 |
First Posted: | November 5, 2008 Key Record Dates |
Last Update Posted: | November 18, 2016 |
Last Verified: | November 2016 |
Keywords provided by Novartis:
Asthma, adrenergic beta agonists, multiple sclerosis, pulmonary function tests, forced expiratory volume |
Additional relevant MeSH terms:
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Fingolimod Hydrochloride Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |