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Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients Suffering From Chronic Obstructive Pulmonary Disease

NCT ID: NCT01559116

Last Updated: 2015-07-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-08-31

Brief Summary

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The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks of treatment.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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tiotropium+olodaterol FDC low dose

tiotropium+olodaterol FDC low dose; 2 inhalations once daily (a.m. dosing)

Group Type EXPERIMENTAL

tiotropium + olodaterol

Intervention Type DRUG

low dose + one dose only

Respimat

Intervention Type DEVICE

Respimat inhaler

tiotropium+olodaterol FDC high dose

tiotropium+olodaterol FDC high dose; 2 inhalations once daily (a.m. dosing)

Group Type EXPERIMENTAL

tiotropium + olodaterol

Intervention Type DRUG

low dose + one dose only

Respimat

Intervention Type DEVICE

Respimat inhaler

tiotropium low dose

tiotropium low dose; 2 inhalations once daily (a.m. dosing)

Group Type ACTIVE_COMPARATOR

tiotropium

Intervention Type DRUG

low dose

Respimat

Intervention Type DEVICE

Respimat inhaler

tiotropium high dose

tiotropium high dose; 2 inhalations once daily (a.m. dosing)

Group Type ACTIVE_COMPARATOR

tiotropium

Intervention Type DRUG

high dose

Respimat

Intervention Type DEVICE

Respimat inhaler

olodaterol

one dose only; 2 inhalations once daily (a.m. dosing)

Group Type ACTIVE_COMPARATOR

olodaterol

Intervention Type DRUG

one dose only

Respimat

Intervention Type DEVICE

Respimat inhaler

placebo

2 inhalations once daily (a.m. dosing)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo matching tiotropium+olodaterol FDC

Respimat

Intervention Type DEVICE

Respimat inhaler

Interventions

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tiotropium + olodaterol

low dose + one dose only

Intervention Type DRUG

tiotropium

low dose

Intervention Type DRUG

olodaterol

one dose only

Intervention Type DRUG

tiotropium

high dose

Intervention Type DRUG

tiotropium + olodaterol

low dose + one dose only

Intervention Type DRUG

Placebo

placebo matching tiotropium+olodaterol FDC

Intervention Type DRUG

Respimat

Respimat inhaler

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of chronic obstructive pulmonary disease
2. Relatively stable airway obstruction with a post-bronchodilator FEV1\< 80% of predicted normal and a post-bronchodilator FEV1/FVC \<70%
3. Male or female patients, 40 years of age or older
4. Smoking history of more than 10 pack years
5. Ability to perform technically acceptable pulmonary function tests and maintain records
6. Ability to inhale medication in a competent manner from the RESPIMAT Inhaler and from a metered dose inhaler (MDI)

Exclusion Criteria

1. significant disease other than COPD
2. clinically relevant abnormal lab values
3. history of asthma
4. diagnosis of thyrotoxicosis
5. diagnosis of paroxysmal tachycardia
6. history of myocardial infarction
7. unstable or life-threatening cardiac arrhythmia
8. Hospitalization for heart failure within the past year
9. known active tuberculosis
10. malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
11. history of life-threatening pulmonary obstruction
12. history of cystic fibrosis
13. clinically evident bronchiectasis
14. history of significant alcohol or drug abuse
15. history of thoracotomy with pulmonary resection
16. oral or patch ß-adrenergics
17. oral corticosteroid medication at unstable doses
18. regular use daytime oxygen therapy for more than one hour per day
19. Pulmonary rehabilitation program in the six weeks prior to the screening visit
20. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
21. Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA
22. Pregnant or nursing women
23. Women of childbearing potential not using a highly effective method of birth control
24. Patients who have previously been randomised in this study or are currently participating in another study
25. Patients who are unable to comply with pulmonary medication restrictions prior to randomisation
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1237.20.1204 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Site Status

1237.20.1203 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

Site Status

1237.20.1201 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Site Status

1237.20.1202 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Site Status

1237.20.32203 Boehringer Ingelheim Investigational Site

Genk, , Belgium

Site Status

1237.20.32201 Boehringer Ingelheim Investigational Site

Ghent, , Belgium

Site Status

1237.20.32204 Boehringer Ingelheim Investigational Site

Jambes, , Belgium

Site Status

1237.20.02202 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Site Status

1237.20.02201 Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

Site Status

1237.20.45002 Boehringer Ingelheim Investigational Site

Hvidovre, , Denmark

Site Status

1237.20.45003 Boehringer Ingelheim Investigational Site

Odense C, , Denmark

Site Status

1237.20.45001 Boehringer Ingelheim Investigational Site

Silkeborg, , Denmark

Site Status

1237.20.49205 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1237.20.49204 Boehringer Ingelheim Investigational Site

Großhansdorf, , Germany

Site Status

1237.20.49203 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1237.20.49206 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1237.20.49201 Boehringer Ingelheim Investigational Site

Mannheim, , Germany

Site Status

1237.20.49207 Boehringer Ingelheim Investigational Site

Mönchengladbach, , Germany

Site Status

1237.20.49202 Boehringer Ingelheim Investigational Site

Wiesbaden, , Germany

Site Status

1237.20.36202 Boehringer Ingelheim Investigational Site

Gödöllö, , Hungary

Site Status

1237.20.36204 Boehringer Ingelheim Investigational Site

Komárom, , Hungary

Site Status

1237.20.36203 Boehringer Ingelheim Investigational Site

Pécs, , Hungary

Site Status

1237.20.36201 Boehringer Ingelheim Investigational Site

Szarvas, , Hungary

Site Status

1237.20.36205 Boehringer Ingelheim Investigational Site

Százhalombatta, , Hungary

Site Status

1237.20.31205 Boehringer Ingelheim Investigational Site

Almelo, , Netherlands

Site Status

1237.20.31202 Boehringer Ingelheim Investigational Site

Breda, , Netherlands

Site Status

1237.20.31201 Boehringer Ingelheim Investigational Site

Heerlen, , Netherlands

Site Status

1237.20.31204 Boehringer Ingelheim Investigational Site

Hengelo, , Netherlands

Site Status

1237.20.31203 Boehringer Ingelheim Investigational Site

Zutphen, , Netherlands

Site Status

Countries

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United States Belgium Canada Denmark Germany Hungary Netherlands

References

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Beeh KM, Westerman J, Kirsten AM, Hebert J, Gronke L, Hamilton A, Tetzlaff K, Derom E. The 24-h lung-function profile of once-daily tiotropium and olodaterol fixed-dose combination in chronic obstructive pulmonary disease. Pulm Pharmacol Ther. 2015 Jun;32:53-9. doi: 10.1016/j.pupt.2015.04.002. Epub 2015 May 6.

Reference Type DERIVED
PMID: 25956072 (View on PubMed)

Other Identifiers

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2011-004710-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1237.20

Identifier Type: -

Identifier Source: org_study_id

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