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This study will evaluate the effect of FTY720 on the lung function of patients with moderate asthma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FTY720 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Use of short acting beta agonists during treatment compared to pre-treatment | 10 days | |
| Pharmacokinetics of FTY720 and FTY720-P | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis Investigator Site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Manchester | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27121555 | Result | 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. | |
| 24293455 | Derived | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D011409 |
| Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |