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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
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
  • Safety of FTY720 [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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
Genders Eligible for Study:   Both
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
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

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00785083     History of Changes
Other Study ID Numbers: CFTY720D2102
Study First Received: November 4, 2008
Last Updated: May 8, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
Adrenergic beta-Agonists
 Fingolimod
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 19, 2013