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Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients

NCT ID: NCT01969721

Last Updated: 2016-02-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-02-28

Brief Summary

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The objective of the trial is to compare the lung function profile of once daily treatment with tiotropium+olodaterol FDC \[2.5/ 5µg and 5/ 5µg\] delivered by the RESPIMAT with the lung function profile of twice daily treatment with fluticasone propionate+salmeterol FDC \[250/50µg and 500/50µg\] delivered by the Accuhaler® 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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T+O FDC dosage 1

Low dose

Group Type EXPERIMENTAL

olodaterol

Intervention Type DRUG

placebo

Intervention Type DRUG

placebo/dummy for blinding purposes

tiotropium

Intervention Type DRUG

tiotropium low dose

T+O FDC dosage 2

High dose

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

placebo/dummy for blinding purposes

tiotropium

Intervention Type DRUG

tiotropium high dose

olodaterol

Intervention Type DRUG

ICS/LABA FDC Dosage 1

Low dose

Group Type ACTIVE_COMPARATOR

fluticasone propionate

Intervention Type DRUG

low dose

salmeterol

Intervention Type DRUG

placebo

Intervention Type DRUG

placebo/dummy for blinding purposes

ICS/LABA FDC Dosage 2

High dose

Group Type ACTIVE_COMPARATOR

placebo

Intervention Type DRUG

placebo/dummy for blinding purposes

fluticasone propionate

Intervention Type DRUG

low dose

salmeterol

Intervention Type DRUG

Interventions

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fluticasone propionate

low dose

Intervention Type DRUG

salmeterol

Intervention Type DRUG

placebo

placebo/dummy for blinding purposes

Intervention Type DRUG

placebo

placebo/dummy for blinding purposes

Intervention Type DRUG

tiotropium

tiotropium high dose

Intervention Type DRUG

olodaterol

Intervention Type DRUG

olodaterol

Intervention Type DRUG

placebo

placebo/dummy for blinding purposes

Intervention Type DRUG

placebo

placebo/dummy for blinding purposes

Intervention Type DRUG

tiotropium

tiotropium low dose

Intervention Type DRUG

fluticasone propionate

low dose

Intervention Type DRUG

salmeterol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of chronic obstructive pulmonary disease
2. Relatively stable airway obstruction with a post-bronchodilator 30% \</= Forced Expiratory Volume in 1 second (FEV1)\<80% of predicted normal and a post-bronchodilator FEV1/(Forced Vital Capacity)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, Accuhaler and from a metered dose inhaler (MDI)

Exclusion Criteria

1. Significant disease other than COPD
2. COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or iv) or hospitalization in the last 3 months.
3. Clinically relevant abnormal lab values
4. History of asthma
5. Diagnosis of thyrotoxicosis
6. Diagnosis of paroxysmal tachycardia
7. History of myocardial infarction
8. Unstable or life-threatening cardiac arrhythmia
9. Hospitalization for heart failure within the past year
10. Known active tuberculosis
11. malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
12. History of life-threatening pulmonary obstruction
13. History of cystic fibrosis
14. Clinically evident bronchiectasis
15. History of significant alcohol or drug abuse
16. History of thoracotomy with pulmonary resection
17. oral or patch ß-adrenergics
18. Oral corticosteroid medication within 6 weeks prior to Visit 1
19. Regular use daytime oxygen therapy for more than one hour per day
20. Pulmonary rehabilitation program in the six weeks prior to the screening visit
21. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
22. Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA
23. Pregnant or nursing women
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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1237.11.32002 Boehringer Ingelheim Investigational Site

Genk, , Belgium

Site Status

1237.11.32001 Boehringer Ingelheim Investigational Site

Ghent, , Belgium

Site Status

1237.11.42003 Boehringer Ingelheim Investigational Site

Kyjov, , Czechia

Site Status

1237.11.42004 Boehringer Ingelheim Investigational Site

Rokycany, , Czechia

Site Status

1237.11.42002 Boehringer Ingelheim Investigational Site

Tábor, , Czechia

Site Status

1237.11.42001 Boehringer Ingelheim Investigational Site

Třebíč, , Czechia

Site Status

1237.11.45002 Boehringer Ingelheim Investigational Site

Hvidovre, , Denmark

Site Status

1237.11.45004 Boehringer Ingelheim Investigational Site

Kolding, , Denmark

Site Status

1237.11.45001 Boehringer Ingelheim Investigational Site

Odense C, , Denmark

Site Status

1237.11.45003 Boehringer Ingelheim Investigational Site

Silkeborg, , Denmark

Site Status

1237.11.49003 Boehringer Ingelheim Investigational Site

Großhansdorf, , Germany

Site Status

1237.11.49005 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1237.11.49001 Boehringer Ingelheim Investigational Site

Mannheim, , Germany

Site Status

1237.11.49004 Boehringer Ingelheim Investigational Site

Mönchengladbach, , Germany

Site Status

1237.11.49002 Boehringer Ingelheim Investigational Site

Wiesbaden, , Germany

Site Status

1237.11.36001 Boehringer Ingelheim Investigational Site

Debrecen, , Hungary

Site Status

1237.11.36004 Boehringer Ingelheim Investigational Site

Pécs, , Hungary

Site Status

1237.11.36003 Boehringer Ingelheim Investigational Site

Szeged, , Hungary

Site Status

1237.11.36002 Boehringer Ingelheim Investigational Site

Szombathely, , Hungary

Site Status

1237.11.31005 Boehringer Ingelheim Investigational Site

Almelo, , Netherlands

Site Status

1237.11.31002 Boehringer Ingelheim Investigational Site

Breda, , Netherlands

Site Status

1237.11.31006 Boehringer Ingelheim Investigational Site

Eindhoven, , Netherlands

Site Status

1237.11.31001 Boehringer Ingelheim Investigational Site

Heerlen, , Netherlands

Site Status

1237.11.31007 Boehringer Ingelheim Investigational Site

Hoorn, , Netherlands

Site Status

1237.11.31003 Boehringer Ingelheim Investigational Site

Zutphen, , Netherlands

Site Status

1237.11.34003 Boehringer Ingelheim Investigational Site

Alicante, , Spain

Site Status

1237.11.34001 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1237.11.34002 Boehringer Ingelheim Investigational Site

Pozuelo de Alarcón, , Spain

Site Status

1237.11.46001 Boehringer Ingelheim Investigational Site

Lund, , Sweden

Site Status

Countries

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Belgium Czechia Denmark Germany Hungary Netherlands Spain Sweden

Other Identifiers

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2013-000808-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1237.11

Identifier Type: -

Identifier Source: org_study_id

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