Clinical trial NCT02172534 (phase 1, status: completed)
Conditions: cystic fibrosis
ICD codes: E84.9, Z14.1, E84.0, E84.11, E84.8, E84.19, P09.4
Drugs: tiotropium bromide low, tiotropium bromide medium, tiotropium bromide high, placebo
SMILES: [H][C@]12O[C@@]1([H])[C@]1([H])C[C@@]([H])(C[C@@]2([H])[N+]1(C)C)OC(=O)C(O)(C1=CC=CS1)C1=CC=CS1, [H][C@]12O[C@@]1([H])[C@]1([H])C[C@@]([H])(C[C@@]2([H])[N+]1(C)C)OC(=O)C(O)(C1=CC=CS1)C1=CC=CS1, [H][C@]12O[C@@]1([H])[C@]1([H])C[C@@]([H])(C[C@@]2([H])[N+]1(C)C)OC(=O)C(O)(C1=CC=CS1)C1=CC=CS1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients (pediatric ≤11 years; adolescent / adult ≥12 years)

          -  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

          -  Able to perform acceptable spirometric maneuvers, according to ATS (American Thoracic
             Society) standards

          -  FEV1 >25% of predicted values

          -  Patients must be able to inhale medication in a reproducible manner from the Respimat®
             inhaler and from a metered dose inhaler (MDI)

          -  Clinical stability:

               -  no evidence of acute upper or lower respiratory tract infection within 4 weeks of
                  screening

               -  no pulmonary exacerbation requiring use of i.v./oral/inhaled antibiotics, or oral
                  corticosteroids within 4 weeks of screening

               -  FEV1 at Visit 2 must be within 10% of FEV1 at Visit 1. If FEV1 at Visit 2 is not
                  within 10% of FEV1 at Visit 1, Visit 2 may be re-scheduled once within 7 days

          -  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

          -  Patients taking a chronic medication must be willing to continue this therapy for the
             entire duration of the study

        Exclusion Criteria:

          -  Patients with a significant history of allergy / hypersensitivity (including
             medication allergy) which 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

          -  Patients with a known hypersensitivity to study drug or its components

          -  Patients who have participated in another study with an Investigational drug within
             one month or six half-lives (whichever is greater) preceding the screening visit

          -  Patients who are currently participating in another trial. Observational studies are
             allowed. Permission should be obtained from the sponsor of the study

          -  Patients with known relevant substance abuse, including alcohol or drug abuse. The
             intention of this criterion was to exclude patients who are considered to be at risk
             of not complying with or abusing the trial medication administration directives.

          -  Female patients who are pregnant or lactating, including females who have a positive
             urine pregnancy test at screening (pregnancy tests were performed for all females of
             child bearing potential)

          -  Female patients of child bearing potential who are not using a medically approved form
             of contraception.

          -  Patients with documented persistent colonization with B. cepacia (defined as more than
             one positive culture within the past year). The intention of this exclusion criterion
             is to be consistent with the current policy within the CF community for reducing the
             risk of B. cepacia cross infection.

          -  Patients who have started a new chronic medication for CF within four (4) weeks of
             screening. Patients who are on a cycling TOBI® (Tobramycin treatment) regimen must
             have completed at least three (3) cycles of every other month TOBI® administration
             prior to the screening visit. As there are other cycles used with TOBI®, the clinical
             monitor should be consulted before the patient was enrolled.

          -  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 included significant hematological,
             hepatic, renal, cardiovascular, and neurologic disease. Patients with diabetes could
             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.