Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients
NCT ID: NCT01533922
Last Updated: 2015-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
295 participants
INTERVENTIONAL
2012-03-31
2013-11-30
Brief Summary
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Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Tiotropium + olodaterol High dose QD
patient will receive tiotropium 5 mcg + olodaterol 5 mcg in a fixed dose combination once daily
tiotropium + olodaterol
tiotropium + olodaterol 5 mcg once daily
Respimat
Respimat inhaler
Tiotropium + olodaterol Low dose QD
patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in a fixed dose combination once daily
Tiotropium + Olodaterol
Tiotropium 2.5 mcg + Olodaterol 5 mcg once daily
Respimat
Respimat inhaler
Tiotropium 5 mcg QD
patient will receive tiotropium 5 mcg once daily
Tiotropium
Tiotropium 5 mcg once daily
Respimat
Respimat inhaler
Olodaterol 5 mcg QD
patient will receive olodaterol 5 mcg once daily
Olodaterol
Olodaterol 5 mcg once daily
Respimat
Respimat inhaler
Placebo QD
Placebo
placebo matching tiotropium + olodaterol FDC
Respimat
Respimat inhaler
Interventions
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Placebo
placebo matching tiotropium + olodaterol FDC
Tiotropium
Tiotropium 5 mcg once daily
Olodaterol
Olodaterol 5 mcg once daily
tiotropium + olodaterol
tiotropium + olodaterol 5 mcg once daily
Tiotropium + Olodaterol
Tiotropium 2.5 mcg + Olodaterol 5 mcg once daily
Respimat
Respimat inhaler
Eligibility Criteria
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Inclusion Criteria
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 \<80% of predicted normal and a post-bronchodilator FEV1/FVC \<70% at Visit 1.
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.
Exclusion Criteria
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
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.
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.
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
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 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 who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit
23. Patients with known hypersensitivity to ß-adrenergics drugs, anticholinergic drugs, BAC, EDTA or any other component of the Respimat® inhalation solution delivery system
24. Pregnant or nursing women
25. Women of childbearing potential not using highly effective methods of birth control.
40 Years
75 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1237.13.01302 Boehringer Ingelheim Investigational Site
Torrance, California, United States
1237.13.01308 Boehringer Ingelheim Investigational Site
Hartford, Connecticut, United States
1237.13.01304 Boehringer Ingelheim Investigational Site
Livonia, Michigan, United States
1237.13.01307 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania, United States
1237.13.01305 Boehringer Ingelheim Investigational Site
Easley, South Carolina, United States
1237.13.01301 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
1237.13.01303 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
1237.13.01306 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
1237.13.54301 Boehringer Ingelheim Investigational Site
Capital Federal, , Argentina
1237.13.54302 Boehringer Ingelheim Investigational Site
Mar del Plata, , Argentina
1237.13.61306 Boehringer Ingelheim Investigational Site
Concord, New South Wales, Australia
1237.13.61301 Boehringer Ingelheim Investigational Site
Daw Park, South Australia, Australia
1237.13.61305 Boehringer Ingelheim Investigational Site
Toorak Gardens, South Australia, Australia
1237.13.61304 Boehringer Ingelheim Investigational Site
Footscray, Victoria, Australia
1237.13.61302 Boehringer Ingelheim Investigational Site
Prahran, Victoria, Australia
1237.13.43303 Boehringer Ingelheim Investigational Site
Linz, , Austria
1237.13.43301 Boehringer Ingelheim Investigational Site
Thalheim bei Wels, , Austria
1237.13.32302 Boehringer Ingelheim Investigational Site
Brussels, , Belgium
1237.13.32303 Boehringer Ingelheim Investigational Site
Edegem, , Belgium
1237.13.32305 Boehringer Ingelheim Investigational Site
Jambes, , Belgium
1237.13.32304 Boehringer Ingelheim Investigational Site
Lanaken, , Belgium
1237.13.32301 Boehringer Ingelheim Investigational Site
Leuven, , Belgium
1237.13.11302 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1237.13.11303 Boehringer Ingelheim Investigational Site
Kingston, Ontario, Canada
1237.13.11304 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
1237.13.56301 Boehringer Ingelheim Investigational Site
Chile, , Chile
1237.13.56302 Boehringer Ingelheim Investigational Site
Santiago, , Chile
1237.13.49302 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1237.13.49307 Boehringer Ingelheim Investigational Site
Dortmund, , Germany
1237.13.49304 Boehringer Ingelheim Investigational Site
Frankfurt, , Germany
1237.13.49301 Boehringer Ingelheim Investigational Site
Halle, , Germany
1237.13.49303 Boehringer Ingelheim Investigational Site
Hanover, , Germany
1237.13.49305 Boehringer Ingelheim Investigational Site
Lübeck, , Germany
1237.13.39302 Boehringer Ingelheim Investigational Site
Genova, , Italy
1237.13.39304 Boehringer Ingelheim Investigational Site
Parma, , Italy
1237.13.39303 Boehringer Ingelheim Investigational Site
Pavia, , Italy
1237.13.39305 Boehringer Ingelheim Investigational Site
Pavullo Nel Frignano (mo), , Italy
1237.13.39301 Boehringer Ingelheim Investigational Site
Pisa, , Italy
1237.13.39312 Boehringer Ingelheim Investigational Site
Pisa, , Italy
1237.13.39310 Boehringer Ingelheim Investigational Site
Roma, , Italy
1237.13.39308 Boehringer Ingelheim Investigational Site
Sesto S. Giovanni (mi), , Italy
1237.13.39306 Boehringer Ingelheim Investigational Site
Trieste, , Italy
1237.13.64302 Boehringer Ingelheim Investigational Site
Christchurch, , New Zealand
1237.13.64301 Boehringer Ingelheim Investigational Site
Greenlane East Auckland NZ, , New Zealand
Countries
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References
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O'Donnell DE, Casaburi R, Frith P, Kirsten A, De Sousa D, Hamilton A, Xue W, Maltais F. Effects of combined tiotropium/olodaterol on inspiratory capacity and exercise endurance in COPD. Eur Respir J. 2017 Apr 19;49(4):1601348. doi: 10.1183/13993003.01348-2016. Print 2017 Apr.
Other Identifiers
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2011-004659-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1237.13
Identifier Type: -
Identifier Source: org_study_id
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