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Main
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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. |
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Register:
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EUCTR |
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Last refreshed on:
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9 October 2012 |
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Main ID: |
EUCTR2010-019802-17-AT |
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Date of registration:
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09/09/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Scientific title:
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A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. -
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Date of first enrolment:
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20/10/2010 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019802-17 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Austria
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Czech Republic
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France
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Germany
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Hungary
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Ireland
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Italy
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Portugal
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Spain
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1.Patients with a documented diagnosis of CF (positive sweat chloride =60 mEq/liter,
by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations
consistent with CF accompanied by one or more clinical features with the CF
phenotype.
2. Male or female patients (children less than 12 years and adolescents = 12 years).
Patients below 1 year of age, if eligible, can be included in the trial only for safety
assessment.
3. Patients = 5 years of age must be able to perform acceptable spirometric maneuvers,
according to the American Thoracic Society (ATS) standards.
4. Pre-bronchodilator FEV1 >25% of predicted values:
• pediatric/adolescent (= 5 years up to 18 years of age, inclusive) predicted
equations from: Wang X et al. Pulmonary function between 6 and 18 years of
age. Pediatr Pulmonol 1993;15:75-88.
• adult (>18 years) predicted equations from: Knudson RJ et al. Changes in
normal maximal expiratory flow-volume curve with growth. Am Rev Respir
Dis 1983;127:725-734 [R98-1298]
5. Patients must be able to inhale medication in a reproducible manner from the
Respimat® inhaler and from a metered dose inhaler (MDI) for children of 5 years and
above. For children below 5 years, patients must be able to inhale medication in a
reproducible manner from the Respimat® inhaler with spacer (the Aerochamber
plus® holding chamber with facemask).
6. Pre-bronchodilator FEV1 at Visit 2 must be within 15% of FEV1 at Visit 1. If prebronchodilator
FEV1 at Visit 2 is not within 15% of FEV1 at Visit 1, Visit 2 can be
repeated within 7 days and rescheduled once.
7. Investigator should also ascertain that the patient is symptomatically stable as defined
by:
• no evidence of acute upper or lower respiratory tract infection within 2 weeks
of screening (Visit 1).
• no pulmonary exacerbation requiring use of i.v./oral/inhaled antibiotics, or oral
corticosteroids within 2 weeks of screening (Visit 1).
8. The patient or the patient’s legally acceptable representative must be able to give
informed consent in accordance with International Conference on Harmonization
(ICH) Good Clinical Practice (GCP) guidelines and local regulation prior to
participation in the trial (i.e. prior to any study procedures, including any pre-study
washout of medication and medication restrictions for pulmonary function test at
Visit1).
9. Patients who are on a cycling TOBI® regimen must have completed at least 2 cycles
every other month TOBI® administration prior to the screening visit. The last TOBI®
cycle should have been completed 2 weeks before randomisation visit (visit 2). For
other inhaled antibiotics (e.g., colistin, aztreonam), please contact the local clinical
monitor (CML) for guidance.
10. Patients who are on daily inhaled antibiotic use must be stabilized for at least 6 weeks
prior to Visit 1 (screening).
11. Patients having previously participated in study 205.339 can also be selected.
Are the trial subjects under 18? yes
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 with a known hypersensitivity to study drug or its components or known
medication allergy that is deemed relevant to the trial as judged by the Investigator.
“Relevance” in this context refers to any increased risk of hypersensitivity reaction to
trial medication.
2. Patients who have participated in another study with an Investigational drug within
one month preceding the screening visit.
3. Patients who are currently participating in another trial. Observational studies are
allowed. Permission should be obtained from sponsor of other study.
4. Patients with known relevant substance abuse, including alcohol or drug abuse. The
intention of this criterion is to exclude patients who are considered to be at risk of not
complying with or abusing the trial medication administration directives.
5. Adolescent and adult female patients who are pregnant or lactating, including females
who have a positive serum pregnancy test at screening (pregnancy tests will be
performed for all adolescent and adult females of child bearing potential).
6. Female patients of child bearing potential who are not using a medically approved
form of contraception. The ICH (M3) defined highly effective methods of birth
control as those, alone or in combination, that result in a low failure rate (i.e. less than
1% per year) when used consistently and correctly. For patients using a hormonal
contraceptive method, information regarding the product under evaluation and its
potential effect on the contraceptive should be addressed. Barrier contraceptives (e.g.
male condom or diaphragm) are acceptable if used in combination with spermicides
(e.g. foam gel).Refer to ICH Topic M3 provided in the ISF..
7. Patients who have started a new chronic medication for CF within 2 weeks before the
screening visit (Visit 1).
8. Clinically significant disease or medical condition other than CF or CF-related
conditions that, in the opinion of the Investigator, would compromise the safety of the
patient or the quality of the data. This includes but is not limited to significant
haematological, hepatic, renal, cardiovascular, and neurologic disease. Patients with
diabetes may participate if their disease is under good control prior to screening. This
criterion provides an opportunity for the investigator to exclude patients based on
clinical judgment, even if other eligibility criteria are satisfied.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
MedDRA version: 12.1
Level: LLT
Classification code 10011762
Term: Cystic fibrosis
MedDRA version: 12.1
Level: PT
Classification code 10011762
Term: Cystic fibrosis
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Intervention(s)
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Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
Pharmaceutical Form: Inhalation vapour, solution
CAS Number: 411207313
Current Sponsor code: Ba 679 Br
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 3.124-
Pharmaceutical form of the placebo: Inhalation vapour*
Route of administration of the placebo: Inhalation use
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Primary Outcome(s)
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Main Objective: Efficacy and safety of tiotropium bromide, Spiriva, in patients with cystic fibrosis administered once daily via the Respimat device.
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Secondary Objective: NA
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Primary end point(s): Primary endpoints: FEV1 percent predicted AUC0-4H (first) and trough FEV1 percent
predicted (second) at week 12.
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Secondary ID(s)
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205.438
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2010-019802-17-PT
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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