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A Study of the Effect of FTY720 on Pulmonary Function in Patients With Moderate Asthma
This study has been completed.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00785083
First received: November 4, 2008
Last updated: November 16, 2016
Last verified: November 2016
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Purpose
This study will evaluate the effect of FTY720 on the lung function of patients with moderate asthma
| Condition | Intervention | Phase |
|---|---|---|
| Asthma | Drug: FTY720 Drug: Placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 36 |
| Study Start Date: | September 2008 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 | Drug: FTY720 |
| Placebo Comparator: 2 | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785083
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785083
Locations
| United Kingdom | |
| Novartis Investigator Site | |
| Manchester, United Kingdom | |
Sponsors and Collaborators
Novartis
Investigators
| Principal Investigator: | Novartis | Novartis Investigator Site |
More Information
Additional Information:
Publications:
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00785083 History of Changes |
| Other Study ID Numbers: |
CFTY720D2102 |
| Study First Received: | November 4, 2008 |
| Last Updated: | November 16, 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 |
ClinicalTrials.gov processed this record on September 19, 2017