Tiotropium+olodaterol FDC in COPD and the effect on exercise tolerance.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 280

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 pulmonarydisease and must meet the following spirometric criteria:
Patients must have relatively stable airway obstruction with a postbronchodilator FEV1 <80% of predicted normal (ECSC) ; GOLD II - IV and a postbronchodilator FEV1/FVC <70% at Visit 1 (ECSC predicted normal
equations)
3. Male or female patients, between 40 and 75 years of age (inclusive)
on day of signing informed consent.
4. Patients must be current or ex-smokers with a smoking history of
more than 10 pack years.
Patients who have never smoked cigarettes must be excluded.
5. Patients must be able to perform technically acceptable pulmonary
function tests (spirometry), must be able to complete multiple symptom limited cycle ergometry tests during the study period as required in the
protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 280

Exclusion Criteria

1. Patients with a significant disease other than COPD; a significant
disease is defined as a disease which, in the opinion of the investigator,
may (i) put the patient at risk because of participation in the study, (ii)
influence the results of the study, or (iii) cause concern regarding the
patient's ability to participate in the study
2. Patients with clinically relevant abnormal baseline haematology,
blood chemistry, or urinalysis; all patients with an SGOT >x2 ULN, SGPT
>x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN will be excluded
regardless of clinical condition (a repeat laboratory evaluation will not
be conducted in these patients)
3. Patients with a history of asthma. For patients with allergic rhinitis or
atopy, source documentation is required to verify that the patient does
not have asthma. If a patient has a total blood eosinophil count greater
than or equal to 600/mm3, source documentation is required to verify
that the increased eosinophil count is related to a non-asthmatic
condition.
Patients with any of the following conditions:
4. A diagnosis of thyrotoxicosis (due to the known class side effect
profile of
ß2-agonists)
5. A diagnosis of paroxysmal tachycardia (>100 beats per minute) (due
to the known class side effect profile of ß2-agonists)
6. A history of myocardial infarction within 1 year of screening visit
(Visit 1)
7. Unstable or life-threatening cardiac arrhythmia
8. Hospitalized for heart failure within the past year
9. Known active tuberculosis
10. A malignancy for which patient has undergone resection, radiation
therapy or chemotherapy within last five years (patients with treated
basal cell carcinoma are allowed)
11. A history of life-threatening pulmonary obstruction
12. A history of cystic fibrosis
13. Clinically evident bronchiectasis
14. A history of significant alcohol or drug abuse
15. Any contraindications for exercise testing as outlined in protocol
16. Patients who have undergone thoracotomy with pulmonary
resection (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1)
17. Patients being treated with any oral ß-adrenergics
18. Patients being treated with oral corticosteroid medication at
unstable doses (i.e., less than six weeks on a stable dose) or at doses in
excess of the equivalent of 10 mg of prednisone per day or 20 mg every
other day
19. 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
20. Patients who have completed a pulmonary rehabilitation program in
the six weeks prior to the screening visit (Visit 1) or patients who are
currently in a pulmonary rehabilitation program
21. Patients who have a limitation of exercise performance as a result of
factors other than fatigue or exertional dyspnoea, such as arthritis in the
leg, angina pectoris or claudication or morbid obesity.
22. Patients with an endurance time greater than 25 minutes during the
training (Visit 1) or baseline constant work rate cycle ergometry at Visit
2
23. Patients who have taken an investigational drug within one month
or six half lives (whichever is greater) prior to screening visit (Visit 1)
24. Patients with known hypersensitivity to ß-adrenergics drugs,
anticholinergic drugs, BAC, EDTA or any other component of the
Respimat® inhalation solution delivery syste