Back to resultsCharacterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
fluticasone propionate
salmeterol
placebo
placebo
tiotropium
olodaterol
olodaterol
placebo
placebo
tiotropium
fluticasone propionate
salmeterol
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion criteria:
- Diagnosis of chronic obstructive pulmonary disease
- 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%
- Male or female patients, 40 years of age or older
- Smoking history of more than 10 pack years
- Ability to perform technically acceptable pulmonary function tests and maintain records
- Ability to inhale medication in a competent manner from the RESPIMAT Inhaler, Accuhaler and from a metered dose inhaler (MDI)
Exclusion criteria:
- Significant disease other than COPD
- COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or iv) or hospitalization in the last 3 months.
- Clinically relevant abnormal lab values
- History of asthma
- Diagnosis of thyrotoxicosis
- Diagnosis of paroxysmal tachycardia
- History of myocardial infarction
- Unstable or life-threatening cardiac arrhythmia
- Hospitalization for heart failure within the past year
- Known active tuberculosis
- malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
- History of life-threatening pulmonary obstruction
- History of cystic fibrosis
- Clinically evident bronchiectasis
- History of significant alcohol or drug abuse
- History of thoracotomy with pulmonary resection
- oral or patch ß-adrenergics
- Oral corticosteroid medication within 6 weeks prior to Visit 1
- Regular use daytime oxygen therapy for more than one hour per day
- Pulmonary rehabilitation program in the six weeks prior to the screening visit
- Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
- Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA
- Pregnant or nursing women
Sites / Locations
- 1237.11.32002 Boehringer Ingelheim Investigational Site
- 1237.11.32001 Boehringer Ingelheim Investigational Site
- 1237.11.42003 Boehringer Ingelheim Investigational Site
- 1237.11.42004 Boehringer Ingelheim Investigational Site
- 1237.11.42002 Boehringer Ingelheim Investigational Site
- 1237.11.42001 Boehringer Ingelheim Investigational Site
- 1237.11.45002 Boehringer Ingelheim Investigational Site
- 1237.11.45004 Boehringer Ingelheim Investigational Site
- 1237.11.45001 Boehringer Ingelheim Investigational Site
- 1237.11.45003 Boehringer Ingelheim Investigational Site
- 1237.11.49003 Boehringer Ingelheim Investigational Site
- 1237.11.49005 Boehringer Ingelheim Investigational Site
- 1237.11.49001 Boehringer Ingelheim Investigational Site
- 1237.11.49004 Boehringer Ingelheim Investigational Site
- 1237.11.49002 Boehringer Ingelheim Investigational Site
- 1237.11.36001 Boehringer Ingelheim Investigational Site
- 1237.11.36004 Boehringer Ingelheim Investigational Site
- 1237.11.36003 Boehringer Ingelheim Investigational Site
- 1237.11.36002 Boehringer Ingelheim Investigational Site
- 1237.11.31005 Boehringer Ingelheim Investigational Site
- 1237.11.31002 Boehringer Ingelheim Investigational Site
- 1237.11.31006 Boehringer Ingelheim Investigational Site
- 1237.11.31001 Boehringer Ingelheim Investigational Site
- 1237.11.31007 Boehringer Ingelheim Investigational Site
- 1237.11.31003 Boehringer Ingelheim Investigational Site
- 1237.11.34003 Boehringer Ingelheim Investigational Site
- 1237.11.34001 Boehringer Ingelheim Investigational Site
- 1237.11.34002 Boehringer Ingelheim Investigational Site
- 1237.11.46001 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
T+O FDC dosage 1
T+O FDC dosage 2
ICS/LABA FDC Dosage 1
ICS/LABA FDC Dosage 2
Arm Description
Low dose
High dose
Low dose
High dose
Outcomes
Primary Outcome Measures
FEV1 AUC (0-12h) Change From Patient Baseline After 6 Weeks of Treatment
Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 12hours post-dose (AUC 0-12h) [L] after 6 weeks of treatment. Measured values presented are actually adjusted means.
The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.
Secondary Outcome Measures
FEV1 AUC (0-24h) Change From Patient Baseline After 6 Weeks of Treatment
Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 24 hours post-dose (AUC 0-24h) [L] after 6 weeks of treatment.
Measured values presented are actually adjusted means. The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.
Trough FEV1 Change From Patient Baseline After 6 Weeks of Treatment
Change from patient baseline in Trough Forced Expiratory Volume in one second (FEV1) after 6 weeks of treatment. Trough FEV1 was defined as the mean of the 23h and 23h 50min (minutes) post-dose FEV1 measurements. Measured values presented are actually adjusted means.
The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.
FEV1 AUC (12-24h) Change From Patient Baseline After 6 Weeks of Treatment
Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 12 to 24 hours post-dose (AUC 12-24h) [L] after 6 weeks of treatment. Measured values presented are actually adjusted means.
The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.
FEV1 Peak (0-3h) Change From Patient Baseline After 6 Weeks of Treatment
Change from patient baseline in Forced Expiratory Volume in one second (FEV1) peak (0-3 hours) after 6 weeks of treatment. FEV1 peak (0-3 hours) was defined as the maximum FEV1 value measured within the first three hours post dosing. Measured values presented are actually adjusted means.
Full Information
NCT ID
NCT01969721
First Posted
October 22, 2013
Last Updated
January 14, 2016
Sponsor
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT01969721
Brief Title
Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients
Official Title
Randomized, Double-blind, Double-dummy, Active-controlled, 4 Period Complete Cross-over Study to Compare the Effect on Lung Function of 6 Weeks Once Daily Treatment With Orally Inhaled Tiotropium+Olodaterol Fixed Dose Combination Delivered by the Respimat® Inhaler vs. 6 Weeks Twice Daily Treatment With Fluticasone Propionate+Salmeterol Fixed Dose Combination Delivered by the Accuhaler® in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
229 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T+O FDC dosage 1
Arm Type
Experimental
Arm Description
Low dose
Arm Title
T+O FDC dosage 2
Arm Type
Experimental
Arm Description
High dose
Arm Title
ICS/LABA FDC Dosage 1
Arm Type
Active Comparator
Arm Description
Low dose
Arm Title
ICS/LABA FDC Dosage 2
Arm Type
Active Comparator
Arm Description
High dose
Intervention Type
Drug
Intervention Name(s)
fluticasone propionate
Intervention Description
low dose
Intervention Type
Drug
Intervention Name(s)
salmeterol
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo/dummy for blinding purposes
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo/dummy for blinding purposes
Intervention Type
Drug
Intervention Name(s)
tiotropium
Intervention Description
tiotropium high dose
Intervention Type
Drug
Intervention Name(s)
olodaterol
Intervention Type
Drug
Intervention Name(s)
olodaterol
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo/dummy for blinding purposes
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo/dummy for blinding purposes
Intervention Type
Drug
Intervention Name(s)
tiotropium
Intervention Description
tiotropium low dose
Intervention Type
Drug
Intervention Name(s)
fluticasone propionate
Intervention Description
low dose
Intervention Type
Drug
Intervention Name(s)
salmeterol
Primary Outcome Measure Information:
Title
FEV1 AUC (0-12h) Change From Patient Baseline After 6 Weeks of Treatment
Description
Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 12hours post-dose (AUC 0-12h) [L] after 6 weeks of treatment. Measured values presented are actually adjusted means.
The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.
Time Frame
Baseline and 6 weeks.
Secondary Outcome Measure Information:
Title
FEV1 AUC (0-24h) Change From Patient Baseline After 6 Weeks of Treatment
Description
Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 24 hours post-dose (AUC 0-24h) [L] after 6 weeks of treatment.
Measured values presented are actually adjusted means. The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.
Time Frame
Baseline and 6 weeks.
Title
Trough FEV1 Change From Patient Baseline After 6 Weeks of Treatment
Description
Change from patient baseline in Trough Forced Expiratory Volume in one second (FEV1) after 6 weeks of treatment. Trough FEV1 was defined as the mean of the 23h and 23h 50min (minutes) post-dose FEV1 measurements. Measured values presented are actually adjusted means.
The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.
Time Frame
Baseline and 6 weeks.
Title
FEV1 AUC (12-24h) Change From Patient Baseline After 6 Weeks of Treatment
Description
Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 12 to 24 hours post-dose (AUC 12-24h) [L] after 6 weeks of treatment. Measured values presented are actually adjusted means.
The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.
Time Frame
Baseline and 6 weeks.
Title
FEV1 Peak (0-3h) Change From Patient Baseline After 6 Weeks of Treatment
Description
Change from patient baseline in Forced Expiratory Volume in one second (FEV1) peak (0-3 hours) after 6 weeks of treatment. FEV1 peak (0-3 hours) was defined as the maximum FEV1 value measured within the first three hours post dosing. Measured values presented are actually adjusted means.
Time Frame
Baseline and 6 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Diagnosis of chronic obstructive pulmonary disease
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%
Male or female patients, 40 years of age or older
Smoking history of more than 10 pack years
Ability to perform technically acceptable pulmonary function tests and maintain records
Ability to inhale medication in a competent manner from the RESPIMAT Inhaler, Accuhaler and from a metered dose inhaler (MDI)
Exclusion criteria:
Significant disease other than COPD
COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or iv) or hospitalization in the last 3 months.
Clinically relevant abnormal lab values
History of asthma
Diagnosis of thyrotoxicosis
Diagnosis of paroxysmal tachycardia
History of myocardial infarction
Unstable or life-threatening cardiac arrhythmia
Hospitalization for heart failure within the past year
Known active tuberculosis
malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
History of life-threatening pulmonary obstruction
History of cystic fibrosis
Clinically evident bronchiectasis
History of significant alcohol or drug abuse
History of thoracotomy with pulmonary resection
oral or patch ß-adrenergics
Oral corticosteroid medication within 6 weeks prior to Visit 1
Regular use daytime oxygen therapy for more than one hour per day
Pulmonary rehabilitation program in the six weeks prior to the screening visit
Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA
Pregnant or nursing women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1237.11.32002 Boehringer Ingelheim Investigational Site
City
Genk
Country
Belgium
Facility Name
1237.11.32001 Boehringer Ingelheim Investigational Site
City
Gent
Country
Belgium
Facility Name
1237.11.42003 Boehringer Ingelheim Investigational Site
City
Kyjov
Country
Czech Republic
Facility Name
1237.11.42004 Boehringer Ingelheim Investigational Site
City
Rokycany
Country
Czech Republic
Facility Name
1237.11.42002 Boehringer Ingelheim Investigational Site
City
Tabor
Country
Czech Republic
Facility Name
1237.11.42001 Boehringer Ingelheim Investigational Site
City
Trebic
Country
Czech Republic
Facility Name
1237.11.45002 Boehringer Ingelheim Investigational Site
City
Hvidovre
Country
Denmark
Facility Name
1237.11.45004 Boehringer Ingelheim Investigational Site
City
Kolding
Country
Denmark
Facility Name
1237.11.45001 Boehringer Ingelheim Investigational Site
City
Odense C
Country
Denmark
Facility Name
1237.11.45003 Boehringer Ingelheim Investigational Site
City
Silkeborg
Country
Denmark
Facility Name
1237.11.49003 Boehringer Ingelheim Investigational Site
City
Großhansdorf
Country
Germany
Facility Name
1237.11.49005 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
1237.11.49001 Boehringer Ingelheim Investigational Site
City
Mannheim
Country
Germany
Facility Name
1237.11.49004 Boehringer Ingelheim Investigational Site
City
Mönchengladbach
Country
Germany
Facility Name
1237.11.49002 Boehringer Ingelheim Investigational Site
City
Wiesbaden
Country
Germany
Facility Name
1237.11.36001 Boehringer Ingelheim Investigational Site
City
Debrecen
Country
Hungary
Facility Name
1237.11.36004 Boehringer Ingelheim Investigational Site
City
Pecs
Country
Hungary
Facility Name
1237.11.36003 Boehringer Ingelheim Investigational Site
City
Szeged
Country
Hungary
Facility Name
1237.11.36002 Boehringer Ingelheim Investigational Site
City
Szombathely
Country
Hungary
Facility Name
1237.11.31005 Boehringer Ingelheim Investigational Site
City
Almelo
Country
Netherlands
Facility Name
1237.11.31002 Boehringer Ingelheim Investigational Site
City
Breda
Country
Netherlands
Facility Name
1237.11.31006 Boehringer Ingelheim Investigational Site
City
Eindhoven
Country
Netherlands
Facility Name
1237.11.31001 Boehringer Ingelheim Investigational Site
City
Heerlen
Country
Netherlands
Facility Name
1237.11.31007 Boehringer Ingelheim Investigational Site
City
Hoorn
Country
Netherlands
Facility Name
1237.11.31003 Boehringer Ingelheim Investigational Site
City
Zutphen
Country
Netherlands
Facility Name
1237.11.34003 Boehringer Ingelheim Investigational Site
City
Alicante
Country
Spain
Facility Name
1237.11.34001 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1237.11.34002 Boehringer Ingelheim Investigational Site
City
Pozuelo de Alarcón
Country
Spain
Facility Name
1237.11.46001 Boehringer Ingelheim Investigational Site
City
Lund
Country
Sweden
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info
Learn more about this trial
Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients
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