A Study on Whether Patients Prefer the Spiriva® Respimat® or the Spiriva® Handihaler® for Treating Their Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Tiotropium Respimat® (T1); Tiotropium Handihaler® (T2)
Intervention description: inhalation solution; Inhalation Powder
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The objective of this study is to investigate the patient acceptability/preference of
      Respimat® compared with Handihaler® in patients with moderate to very severe chronic
      obstructive pulmonary disease (COPD) to demonstrate the superiority of Respimat®.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients must have a diagnosis of COPD and must meet the following spirometric
             criteria at Visit 1 (Screening).

               -  Relatively stable, moderate to very severe airway obstruction with a
                  post-bronchodilator FEV1 <80% of predicted normal and FEV1/FVC <70%. Spirometry
                  should be done at baseline and approximately 1/2 hour following 4 inhalations of
                  albuterol.

               -  Male = exp [-10.61669 + 2.27078 × ln (- in cm) + 0.06622 × ln (age in year) +
                  Mspline] Female = exp [-9.69716 + 2.09385 × ln (- in cm) + 0.02006 × ln (age in
                  year) + Mspline]

               -  Historical data from spirometry measurements within the past 6 either at the site
                  or at the other hospital may be used. If the measurements are not performed at
                  the trial site a referral letter and signed copies of the measurement printouts
                  must be provided to the trial site for source data verification. In case several
                  qualifying spirometry measurements are available, the most recent one should be
                  referred to as long as it was not performed during an exacerbation. Patients may
                  not be randomised to the study without the availability of spirometry data at the
                  actual study site.

          -  Male or female, age: ≥40 years of age

          -  Patients must be current or ex-smokers with a smoking history of ≥ 10 pack years.
             (Patients who have never smoked cigarettes must be excluded).

          -  Signed and dated written informed consent in accordance with International Council on
             Harmonization (ICH) ICH-GCP and local legislation prior to admission to the trial

          -  Patients must be able to inhale medication from the Tiotropium Respimat® and
             Tiotropium HandiHaler®

          -  Patients must be able to perform all study related procedures, and must be able to
             maintain records (patient diary) during the study period as required by the protocol

        Exclusion Criteria:

          -  Had visual, cognitive, or motor impairment that, as judged by the investigator, did
             not allow the patient to independently read and complete the PASAPQ questionnaire

          -  Patients have had used both Respimat® and HandiHaler® (including generic HandiHaler®)
             within one year prior to screening.

          -  Patients with significant diseases other than COPD will be excluded. A significant
             disease is defined as a disease or condition which, in the opinion of the
             investigator, may put the patients at risk because of participation in the study or
             may influence either the results of the study or the patient's ability to participate
             in the study.

          -  All patients with an Aspartate Transaminase (AST) (serum glutamic-oxaloacetic
             transaminase, SGOT) >80 IU/L, Alanine Aminotransferase (ALT) (Serum Glutamic-pyruvic
             Transaminase, SGPT) >80 IU/L, Bilirubin >2.0 mg/dL or Creatinine >2.0 mg/dL will be
             excluded regardless of the clinical condition. Repeat laboratory evaluation will not
             be conducted in these subjects.

          -  Patients with a recent history (i.e., one year or less) of myocardial infarction.

          -  Patients who have been hospitalized or being treated for heart failure within the past
             year.

          -  Patients with any unstable or life-threatening cardiac arrhythmia requiring
             intervention or change in drug therapy during the last year.

          -  Patients with a malignancy for which patient has undergone resection, radiation
             therapy or chemotherapy within last five years (patients with treated basal cell
             carcinoma are allowed).

          -  Known active tuberculosis.

          -  Patients with a history of asthma, cystic fibrosis, clinically not well-controlled
             bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease

          -  History of thoracotomy with pulmonary resection. Patients with a history of
             thoracotomy for other reasons should be evaluated.

          -  Patients with any respiratory tract infection or COPD exacerbation in the 6 weeks
             prior to the initial screening visit (Visit 1).

          -  Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
             Patients whose symptoms are controlled on treatment may be included.

          -  Patients with known narrow-angle glaucoma

          -  Use of systemic corticosteroid medication at unstable doses (i.e., less than six weeks
             on stable dose) or at doses in excess of the equivalent of 10 milligrams (mg)
             prednisolone per day.

          -  Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in
             the investigator's opinion will be unable to abstain from the use of oxygen therapy.

          -  Pregnant or nursing women or women of childbearing potential not using a medically
             approved means of contraception (i.e., oral or injectable contraceptives, intrauterine
             devices (IUD) or diaphragm with spermicide, or Norplant®).

          -  Significant alcohol or drug abuse within the past 12 months

          -  Known hypersensitivity to anticholinergic drugs, lactose, benzalkonium chloride (BAC),
             ethylenediaminetetraacetic acid (EDTA) or any other components of the HandiHaler® or
             Respimat® inhalation solution delivery system.

          -  Patients currently in any pulmonary rehabilitation program or scheduled to participate
             in any such program during the study period.

          -  Previous participation in this study. (The patient cannot re-enroll into this study.)

          -  Patients who are currently participating in another interventional study.