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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:
ClinicalTrials.gov Identifier:
NCT00785083
First Posted: November 5, 2008
Last Update Posted: November 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  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

Information from the National Library of Medicine

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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
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

Additional Information:
Publications:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00785083     History of Changes
Other Study ID Numbers: CFTY720D2102
First Submitted: November 4, 2008
First Posted: November 5, 2008
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