Efficacy (Bronchoprotection) and Safety of Orally Inhaled BI 1744 CL in Patients With Intermittent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Placebo; Olodaterol (BI1744CL); Olodaterol (BI1744CL); Olodaterol (BI1744CL); Olodaterol (BI1744CL)
Intervention description: Placebo device for comparison; Olodaterol comparison of low, medium low, medium high and high doses; Olodaterol comparison of low, medium low, medium high and high doses; Olodaterol comparison of low, medium low, medium high and high doses; Olodaterol comparison of low, medium low, medium high and high doses
Intervention MeSH terms: Olodaterol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to assess the efficacy (bronchoprotection) and safety
      of single doses of BI 1744 CL inhalation solution (2, 5, 10 and 20 mcg) delivered via the
      Respimat® inhaler, in patients with intermittent asthma.
    

Eligibility criteria:

        Inclusion criteria

          1. Diagnosis of intermittent asthma according to Global Initiative for Asthma criteria

          2. Non-smokers or ex-smokers who have not smoked for at least 1 year and have a smoking
             history of less than 5 pack-years

          3. Forced Expiratory Volume in 1second greater than or equal to 80% predicted normal
             (Visit 1).

          4. Bronchial hyperresponsiveness to inhaled methacholine with a provocative concentration
             of a methacholine causing a 20% fall in Forced Expiratory Volume in one second less
             than or equal to 8 mg/mL (Visit 1).

          5. Be able to perform technically acceptable pulmonary function tests

          6. Be able to inhale medication in a competent manner from the Respimat® inhaler

          7. Must sign and date an informed consent consistent with International Conference on
             Harmonisation-Good Clinical Practice guidelines prior to participation in the trial,
             which includes medication washout and restrictions.

        Exclusion criteria

          1. Patients with a significant disease other than asthma

          2. Patients with seasonal asthma or allergies whose participation in the trial will occur
             during the season for which they are allergic.

          3. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or
             urinalysis; all patients with a serum glutamic oxaloacetic transaminase > 80 IU/L,
             serum glutamic pyruvic transaminase > 80 IU/L, bilirubin >2.0 mg/dL or creatinine >
             2.0 mg/dL will be excluded regardless of clinical condition

          4. Patients with any of the following conditions: a diagnosis of hyperthyrosis or
             paroxysmal tachycardia (>100 beats per minute), a marked baseline prolongation of
             QT/QTc interval, a history of additional risk factors for Torsade de Pointes, a
             history of myocardial infarction, a diagnosis of clinically relevant cardiac
             arrhythmia, a history of cor pulmonale, known active tuberculosis, a malignancy for
             which the patient has undergone resection, radiation therapy or chemotherapy within
             the 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, or a history of significant alcohol or drug abuse.

          5. Patients who have undergone thoracotomy with pulmonary resection

          6. Patients who are being treated with any of the following concomitant medications:
             medications that prolong the QT/QTc interval, oral beta-adrenergics, beta-blockers or
             monoamine oxidase inhibitors or tricyclic antidepressants.

          7. Patients who have been treated with any respiratory medications (excluding
             short-acting beta-agonists) for control of their asthma symptoms within 3 months of
             the Screening Visit (Visit 1).

          8. Patients who have taken an investigational drug within one month or six half lives
             (whichever is greater) prior to Screening Visit (Visit 1).

          9. Pregnant or nursing women, or women of childbearing potential not using a highly
             effective method of birth control.