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NCT00785083 Clinical Trial

A Study of the Effect of FTY720 on Pulmonary Function in Patients With Moderate Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00785083
Other study ID # CFTY720D2102
Secondary ID
Status Completed
Phase Phase 2
First received November 4, 2008
Last updated November 16, 2016
Start date September 2008

Study information
Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

This study will evaluate the effect of FTY720 on the lung function of patients with moderate asthma

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• FTY720

• Placebo

Locations
Country Name City State
United Kingdom Novartis Investigator Site Manchester

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Boulton C, David OJ, Meiser K, Schmouder R. Tolerability and Pulmonary Pharmacodynamic Effects During Treatment Initiation of Once-Daily Oral Fingolimod in Subjects With Moderate Asthma. Clin Pharmacol Drug Dev. 2013 Jan;2(1):2-10. doi: 10.1002/cpdd.4. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in Pulmonary function tests (particularly Forced Expiratory Volume at 1 sec (FEV1) at Day 10 10 days Yes
Primary Safety of FTY720 10 days Yes
Secondary Use of short acting beta agonists during treatment compared to pre-treatment 10 days No
Secondary Pharmacokinetics of FTY720 and FTY720-P 10 days No
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