A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 micrograms administered once daily via the Respimat device in patients with cystic fibrosis. - ND
- Conditions
- MedDRA version: 9.1Level: LLTClassification code 10011762Patients with cystic fibrosis
- Registration Number
- EUCTR2010-019802-17-IT
- Lead Sponsor
- BOEHRINGER ING.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 440
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. 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. For TOBI cycling during the trial please refer to section 4.2.1.2. 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
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. 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. Thiscriterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method