Tiotropium Bromide in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: tiotropium Respimat® inhaler; Placebo Respimat® inhaler
Intervention description: to evaluate safety and efficacy tiotropium delivered with Respimat® inhaler compared to placebo.; patient to receive placebo matching active drug once daily
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 464.0
Sex: All
Healthy volunteers: No

Summary:

      To date, there have been no formal clinical studies completed using tiotropium in CF
      patients. While there is a large body of evidence demonstrating the efficacy and safety of
      tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD), relatively little
      is known about its efficacy and safety in patients with a diagnosis of cystic fibrosis.
      Therefore, Boehringer Ingelheim proposed to profile the long acting anticholinergic
      tiotropium and to generate adequate clinical data for use as a bronchodilator in paediatric
      and adult CF. The phase III trial (205.438) is a part of the approved Paediatric
      Investigation Plan (PIP) agreed for Spiriva® Respimat® in Cystic Fibrosis.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients with a documented diagnosis of Cystic Fibrosis (CF) (positive sweat chloride
             >=60 mEq/liter, by pilocarpine iontophoresis) and/or a genotype with two identifiable
             mutations.

          2. Male or female patients (children less than 12 years and adolescents >12 years).

          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 Forced Expiratory Volume in One Second (FEV1) >25% of predicted
             values.

          5. Pre-bronchodilator FEV1 at Visit 2 must be within 15% of FEV1 at Visit 1.

          6. No evidence of respiratory tract infection and no pulmonary exacerbation requiring use
             of intravenous/oral/inhaled antibiotics, or oral corticosteroids within 2 weeks of
             screening.

          7. The patient or the patient's legally acceptable representative must be able to give
             informed consent.

          8. 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.

          9. Patients who are on daily inhaled antibiotic use must be stabilized for at least 6
             weeks prior to Visit 1 (screening).

         10. Patients having previously participated in study 205.339 can also be selected.

        Exclusion criteria:

          1. Patients with a known hypersensitivity to study drug

          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.

          5. Adolescent and adult female patients who are pregnant or lactating, including females
             who have a positive serum pregnancy test at screening.

          6. Female patients of child bearing potential who are not using a medically approved form
             of contraception.

          7. 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. Patients with diabetes may participate if
             their disease is under good control prior to screening.