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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:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00785083
First received: November 4, 2008
Last updated: May 8, 2009
Last verified: May 2009
History of Changes

November 4, 2008
May 8, 2009
September 2008
February 2009   (final data collection date for primary outcome measure)
  • Change from baseline in Pulmonary function tests (particularly Forced Expiratory Volume at 1 sec (FEV1) at Day 10 [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
  • Safety of FTY720 [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00785083 on ClinicalTrials.gov Archive Site
  • Use of short acting beta agonists during treatment compared to pre-treatment [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics of FTY720 and FTY720-P [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of the Effect of FTY720 on Pulmonary Function in Patients With Moderate Asthma
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

This study will evaluate the effect of FTY720 on the lung function of patients with moderate asthma
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: FTY720
  • Drug: Placebo
  • Experimental: 1
    Intervention: Drug: FTY720
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
Not Provided
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00785083
CFTY720D2102
No
External Affairs, Novartis
Novartis
Not Provided
Principal Investigator: Novartis Novartis Investigator Site
Novartis
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP