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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
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study will evaluate the effect of FTY720 on the lung function of patients with moderate asthma

Condition or disease Intervention/treatment Phase
Asthma Drug: FTY720 Drug: Placebo Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: FTY720
Placebo Comparator: 2 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in Pulmonary function tests (particularly Forced Expiratory Volume at 1 sec (FEV1) at Day 10 [ Time Frame: 10 days ]
  2. Safety of FTY720 [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Use of short acting beta agonists during treatment compared to pre-treatment [ Time Frame: 10 days ]
  2. Pharmacokinetics of FTY720 and FTY720-P [ Time Frame: 10 days ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United Kingdom
Novartis Investigator Site
Manchester, United Kingdom
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Novartis Investigator Site
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Results for CFTY720D2102 from the Novartis Clinical Trials website  This link exits the ClinicalTrials.gov site

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