Efficacy and Safety of 4 Weeks of Treatment With Inhaled BI 1744 CL in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: BI 1744 CL
Intervention MeSH terms: Olodaterol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Enrollment: 296.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL
      inhalation solution delivered by the Respimat® inhaler for four weeks in patients with
      asthma. The selection of the optimum dose(s) will be based on bronchodilator efficacy (how
      well it helps your breathing), safety evaluations and pharmacokinetic evaluations (the amount
      of the medication found in your blood).
    

Eligibility criteria:

        Inclusion Criteria:

          1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to
             participation in the trial, which includes medication washout and restrictions

          2. Male or female patients, 18 years of age or older

          3. Diagnosis of asthma (GINA)

          4. Pre-bronchodilator FEV1 greater than or equal to 60% predicted and <90% predicted
             (ECSC);

          5. Increase in FEV1 greater than or equal to 12% and 200 ml 15 minutes after 400µg
             salbutamol (albuterol) at Visit 1

          6. Patient must have been taking Inhaled Corticosteroids for at least 12 weeks prior to
             screening, and must have been receiving a stable low/moderate dose for at least 6
             weeks prior to screening.

          7. Patients must be able to perform technically acceptable pulmonary function tests and
             PEF measurements, and must be able to maintain records (Patient Daily e-Diary) during
             the study period as required in the protocol

          8. Patients must be able to inhale medication in a competent manner from the Respimat®
             inhaler and from a metered dose inhaler (MDI).

        Exclusion Criteria:

          1. Patients with a smoking history of more than 10 pack years

          2. Patients with any of the following conditions: a diagnosis of thyrotoxicosis, a
             diagnosis of paroxysmal tachycardia (>100 beats per minute), a marked baseline
             prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450
             ms), a history of additional risk factors for Torsade de Pointes (TdP) (e.g., heart
             failure, hypokalemia, family history of Long QT Syndrome)

          3. Patients with any of the following conditions: a history of myocardial infarction
             within 1 year of screening visit (Visit 1), a diagnosis of clinically relevant cardiac
             arrhythmia, a history of cor pulmonale, known active tuberculosis, a malignancy for
             which patient has undergone resection, radiation therapy or chemotherapy within last
             five years (patients with treated basal cell carcinoma are allowed), a history of
             life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically
             evident bronchiectasis, a history of significant alcohol or drug abuse

          4. Patients who have undergone thoracotomy with pulmonary resection

          5. Patients who have taken an investigational drug within one month or six half lives
             (whichever is greater) prior to Screening Visit (Visit 1)

          6. Pregnant or nursing women

          7. Women of childbearing potential not using a highly effective method of birth control.
             Female patients will be considered to be of childbearing potential unless surgically
             sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at
             least 2 years

          8. Patients who have previously been randomized in this study or are currently
             participating in another study

          9. Patients who are unable to comply with pulmonary medication restrictions prior to
             randomization