Clinical trial to confirm the efficacy and safety of tiotropium 5 microgram administered via Respimat device, in patients with cystic fibrosis.

• Conditions: Cystic Fibrosis; MedDRA version: 14.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2010-019802-17-DE
• Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-04
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 372

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 between 1 and less than 12 years and adolescents = 12 years and adults).
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.
• adult (>18 years) predicted equations from: Knudson RJ et al. Changes in normal maximal expiratory flow-volume curve with growth.
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 pre-bronchodilator 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: 252
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
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
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified