|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
25 November 2019 |
|
Main ID: |
EUCTR2007-001714-16-GB |
|
Date of registration:
|
07/03/2008 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public 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.
|
|
Scientific 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. |
|
Date of first enrolment:
|
01/05/2008 |
|
Target sample size:
|
36 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001714-16 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: Time-lagged, ascending multiple-dose study.
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
|
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
1. Male and female patients aged 18-65 years.
2. Moderate asthmatics; a history of asthma of at least 6 months.
3. Pre-treatment FEV1 before the start of treatment on Day 1 must be i) within 15% of the actual Screening vale (litres) and ii) = 60% of normal predicted FEV1.
4. No exacerbation of asthma within 3 months.
5. Male subjects must be sterile or willing to use a clinically-approved method of
contraception from the time of study entry until at least 3 months after the last dose of study medication.
6. All female patients must have a negative serum pregnancy test at Screening and Baseline and must be:
a) of non-child bearing potential (i.e. physiologically incapable of becoming pregnant)
b) of child bearing potential and agree to using two or more of the following acceptable methods of contraception.
7. At Screening, and Baseline (Day -2), vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed after the subject has rested for at least three (3) minutes, and again when required after three (3) minutes in the standing position.
8. Otherwise healthy having passed Screening examinations.
9. Subjects must weigh at least 50kg to participate in the study, and must have a body mass index (BMI) within the range of 18 to 33 kg/m2.
10. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
Please refer to the enclosed protocol for further details.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Patients who have smoked tobacco products within the 6 month period prior to Screening, or who have a smoking history of greater than 10 packs years, (defined as the number of packs of cigarettes smoked per day (20 cigarettes/pack) multiplied by the number of years that the patient has smoked). Urine cotinine levels will be measured during screening. A CO Breath Test may be used at Baseline. Smokers will be defined as any subject who reports tobacco use and/or who has a urine cotinine = 500 ng/mL.
2. Use of any inhaled corticosteroid at dose > 500 µg Fluticasone (or equivalent comparative daily dosage Budesonide-DPI 1000µg) per day or oral or injected corticosteroid, leukotriene receptor antagonist, theophylline or oral ß2-agonist within 1 month prior to Screening. Changes to asthma therapy, other than the use of inhaled short-acting ß2 agonists, are not allowed between Screening and Baseline (Day -1) or during the treatment phase of the study.
3. A history of pulmonary disorder other than asthma.
4. A respiratory tract infection within 1 month prior to Screening. Patients with upper
respiratory tract infections during the screening period must discontinue from the trial, but can re-enter the screening period one month after the infection has resolved. Patients who develop a respiratory tract infection during the treatment period should be withdrawn and replaced.
5. History of clinically significant drug allergy, or a known hypersensitivity to the study
drug, any drug similar to the study drug, or any of its excipients.
6. Participation in any clinical research trial in which the patient received investigational product within three (3) months or 5 half lives, whichever is longer, prior to initial dosing (or longer if required by local regulations, and for any other limitation of participation based on local regulations).
7. Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulation.
8. Significant illness within two (2) weeks prior to dosing.
9. A past medical history of clinically significant ECG abnormalities, or a known family
history (grandparents, parents, siblings) of a prolonged QT-interval syndrome
10. An abnormal ECG defined as QTcB> 470 msec females; QTcB> >450 msec males
11. History of autonomic dysfunction (e.g., recurrent episodes of fainting, orthostatic
hypotension, sinus arrhythmia).
12. Any surgical or medical condition which might significantly alter the absorption,
distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
13. History of immunodeficiency diseases, including a positive HIV test result.
14. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
15. History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening and/or at baseline.
Please refer to the enclosed protocol for further details.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
|
Moderate asthma.
|
|
Intervention(s)
|
Product Name: FTY720
Product Code: FTY720D
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fingolimod
CAS Number: 162359-56-0
Current Sponsor code: FTY720D
Other descriptive name: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: FTY720
Product Code: FTY720D
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fingolimod
CAS Number: 162359-56-0
Current Sponsor code: FTY720D
Other descriptive name: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
|
|
Primary Outcome(s)
|
Main Objective: • 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.
• To assess the safety and tolerability of once daily dosing of FTY720 in patients with moderate asthma.
|
Primary end point(s): The magnitude of the FTY720-induced bronchoconstriction will be primarily assessed by the baseline adjusted FEV1 AUC(0-6h) on Day 1.
Please refer to the enclosed protocol for further details.
|
Secondary Objective: • To assess the effect of FTY720 with once daily dosing of 0.5 mg, 1.25 mg and 2.5 mg for 10 days on the use of short-acting ß2 agonists in patients with moderate asthma.
• To assess the pharmacokinetics (PK) of FTY720 and FTY720-phosphate (FTY720-P) after administration of once daily doses of FTY720 in patients with moderate asthma.
|
|
Secondary ID(s)
|
|
CFTY720D2102
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
|
|