Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
FDC of tiotropium + olodaterol
Placebo
Tiotropium
Olodaterol
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion criteria:
- Male or female patients.
- Patients 40 years of age or older.
- Patients with a smoking history > 10 pack years.
- Diagnostic of COPD with Post-bronchodilator FEV1 (Forced Expiratory Volume in one second) >= 30% and <80% of predicted normal and Post-bronchodilator FEV1/FVC (Forced Vital Capacity) <70% at screening.
- Symptomatic patients with CAT (COPD Assessment Test TM) score >= 10 at screening.
- Further inclusion criteria apply.
Exclusion criteria:
- COPD exacerbation or symptoms of lower respiratory tract infection within 6 weeks prior to screening.
- Patients with a current diagnosis of asthma.
- Further exclusion criteria apply.
Sites / Locations
- Ordination Dr. Robert Voves, 8330 Feldbach
- KH d. Elisabethinen Linz
- Aarhus Universitetshospital
- Hvidovre Hospital
- Regionshospitalet Silkeborg
- Jorvin sairaala
- HYKS Keuhkosairauksien
- TAYS, Keuhkotautien poliklinikka
- TYKS, Keuhkosairauksien klinikka, Turku
- Terveystalo Pulssi, Turku
- HOP Louis Pradel
- CLI du Parc, Pneumo, Castelnau le Lez
- CAB Pigearias B., Pneumo, Nice
- CAB Dupouy J, Pneumo, Nîmes
- HOP Cochin
- HOP Haut-Lévêque
- HOP Maison Blanche
- INS A.Tzanck,Pneumo,St Laurent du Var
- CAB Lejay D, MG, Vieux Condé
- Univ. Clinic of Respiratory and Allergic Diseases, Golnik
- Verboten Kopriva Renata - Private practice, Litija
- Arjana Macek d.o.o.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FDC of tiotropium + olodaterol
Free combination tiotropium + olodaterol
Arm Description
Fixed Dose Combination of tiotropium + olodaterol
Outcomes
Primary Outcome Measures
Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment
This outcome measure presents FEV1 after 28 days of treatment (measurement on Day 29). Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), and was measured at 24 hours (+/- 10 minutes) after trial medication administration at Visit 5.
The FEV1 measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement.
Secondary Outcome Measures
Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment
This outcome measure presents trough FVC after 28 days of treatment (measurement on Day 29).
The FVC measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement for FVC.
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on Day 28
This outcome measure presents COPD assessment test score on Day 28. The COPD Assessment Test™ is a short 8-item questionnaire for assessment and monitoring of COPD health status in routine practice. Its scale is 0-40 (high score = poor health).
The CAT measurement on Visit 4 prior to the first dose of double-blind study drug was the baseline for CAT.
Full Information
NCT ID
NCT02683109
First Posted
February 12, 2016
Last Updated
December 7, 2017
Sponsor
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT02683109
Brief Title
Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD
Official Title
A 4-week, Randomised, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Tiotropium + Olodaterol Fixed Dose Combination (5/5 µg) Delivered by the Respimat® Inhaler Versus the Free Combination of Tiotropium 5 µg and Olodaterol 5 µg Delivered by Separate Respimat® Inhalers in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 8, 2016 (Actual)
Primary Completion Date
January 9, 2017 (Actual)
Study Completion Date
January 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled study.
Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of either FDC (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat® inhaler. The purpose is to show non-inferiority between the FDC and the free combination of tiotropium and olodaterol in patients with COPD.
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 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
221 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FDC of tiotropium + olodaterol
Arm Type
Experimental
Arm Description
Fixed Dose Combination of tiotropium + olodaterol
Arm Title
Free combination tiotropium + olodaterol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
FDC of tiotropium + olodaterol
Intervention Description
Fixed Dose Combination of tiotropium + olodaterol
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Intervention Type
Drug
Intervention Name(s)
Olodaterol
Primary Outcome Measure Information:
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment
Description
This outcome measure presents FEV1 after 28 days of treatment (measurement on Day 29). Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), and was measured at 24 hours (+/- 10 minutes) after trial medication administration at Visit 5.
The FEV1 measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement.
Time Frame
Day 29
Secondary Outcome Measure Information:
Title
Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment
Description
This outcome measure presents trough FVC after 28 days of treatment (measurement on Day 29).
The FVC measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement for FVC.
Time Frame
Day 29
Title
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on Day 28
Description
This outcome measure presents COPD assessment test score on Day 28. The COPD Assessment Test™ is a short 8-item questionnaire for assessment and monitoring of COPD health status in routine practice. Its scale is 0-40 (high score = poor health).
The CAT measurement on Visit 4 prior to the first dose of double-blind study drug was the baseline for CAT.
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Male or female patients.
Patients 40 years of age or older.
Patients with a smoking history > 10 pack years.
Diagnostic of COPD with Post-bronchodilator FEV1 (Forced Expiratory Volume in one second) >= 30% and <80% of predicted normal and Post-bronchodilator FEV1/FVC (Forced Vital Capacity) <70% at screening.
Symptomatic patients with CAT (COPD Assessment Test TM) score >= 10 at screening.
Further inclusion criteria apply.
Exclusion criteria:
COPD exacerbation or symptoms of lower respiratory tract infection within 6 weeks prior to screening.
Patients with a current diagnosis of asthma.
Further exclusion criteria apply.
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
Ordination Dr. Robert Voves, 8330 Feldbach
City
Feldbach
ZIP/Postal Code
8330
Country
Austria
Facility Name
KH d. Elisabethinen Linz
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Aarhus Universitetshospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Regionshospitalet Silkeborg
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
Facility Name
Jorvin sairaala
City
Espoo
ZIP/Postal Code
FI-02740
Country
Finland
Facility Name
HYKS Keuhkosairauksien
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
TAYS, Keuhkotautien poliklinikka
City
Tampere
ZIP/Postal Code
FI-33520
Country
Finland
Facility Name
TYKS, Keuhkosairauksien klinikka, Turku
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Terveystalo Pulssi, Turku
City
Turku
ZIP/Postal Code
FI-20100
Country
Finland
Facility Name
HOP Louis Pradel
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
CLI du Parc, Pneumo, Castelnau le Lez
City
Castelnau Le Lez
ZIP/Postal Code
34170
Country
France
Facility Name
CAB Pigearias B., Pneumo, Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
CAB Dupouy J, Pneumo, Nîmes
City
Nîmes
ZIP/Postal Code
30900
Country
France
Facility Name
HOP Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
HOP Haut-Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
HOP Maison Blanche
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
INS A.Tzanck,Pneumo,St Laurent du Var
City
Saint Laurent du Var
ZIP/Postal Code
06721
Country
France
Facility Name
CAB Lejay D, MG, Vieux Condé
City
Vieux Condé
ZIP/Postal Code
59690
Country
France
Facility Name
Univ. Clinic of Respiratory and Allergic Diseases, Golnik
City
Golnik
ZIP/Postal Code
4204
Country
Slovenia
Facility Name
Verboten Kopriva Renata - Private practice, Litija
City
Litija
ZIP/Postal Code
1270
Country
Slovenia
Facility Name
Arjana Macek d.o.o.
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info
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Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD
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