Efficacy and Safety of 4 Weeks of Treatment With Orally Inhaled BI1744/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: BI 1744 CL plus tiotropium bromide; Respimat® Inhaler
Intervention description: BI 1744 CL plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
Intervention MeSH terms: Bromides; Tiotropium Bromide; Olodaterol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 141.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL
      administered with 5 microgram tiotropium bromide solution for inhalation, delivered by the
      Respimat® inhaler, once daily for four weeks in patients with chronic obstructive pulmonary
      disease (COPD).
    

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. All patients must have a diagnosis of chronic obstructive pulmonary disease and must
             meet the following spirometric criteria:

             Patients must have relatively stable airway obstruction with a post-bronchodilator
             FEV1 >= 30% of predicted normal and <80% of predicted normal and a post-bronchodilator
             FEV1 / FVC <70% at Visit 1

          3. Male or female patients, 40 years of age or older

          4. Patients must be current or ex-smokers with a smoking history of more than 10 pack
             years

          5. 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

          6. Patients must be able to inhale medication in a competent manner from the Respimat
             inhaler and from a metered dose inhaler (MDI).

          7. additional inclusion criteria apply.

        Exclusion Criteria:

          1. Patients with a significant disease other than COPD

          2. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or
             urinalysis;

          3. Patients with a history of asthma or a total blood eosinophil count >= 600/mm3.

          4. 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 QTcF* 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)

          5. 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, known active tuberculosis, a malignancy for which patient has undergone
             resection, radiation therapy or chemotherapy within last five years, a history of
             life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically
             evident bronchiectasis, a history of significant alcohol or drug abuse

          6. Patients who have undergone thoracotomy with pulmonary resection

          7. Patients who regularly use daytime oxygen therapy for more than one hour per day and
             in the investigator's opinion will be unable to abstain from the use of oxygen therapy
             during clinic visits.

          8. Pregnant or nursing women

          9. Women of childbearing potential not using two effective method of birth control (one
             barrier and one non-barrier). 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 two years

         10. Patients who have previously been randomized in this study or are currently
             participating in another study

         11. Patients who are unable to comply with pulmonary medication restrictions prior to
             randomization

         12. Patients who have taken an investigational drug within one month or six half lives
             (whichever is greater) prior to Screening Visit

         13. additional exclusion criteria apply.