Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Registration Number
- NCT02296138
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7903
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tiotropium + olodaterol high dose tiotropium Once daily 2 puffs solution for inhalation Respimat tiotropium + olodaterol high dose olodaterol Once daily 2 puffs solution for inhalation Respimat tiotropium tiotropium Once daily 2 puffs solution for inhalation Respimat
- Primary Outcome Measures
Name Time Method Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period. From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days Annualised rate of moderate to severe COPD exacerbations during the actual treatment period was calculated per treatment per patient-year. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. Least Squares Means are actually exponentiated.
- Secondary Outcome Measures
Name Time Method Annualised Rate of Exacerbations Leading to Hospitalisation During the Actual Treatment Period. From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days Annualised rate of exacerbations leading to hospitalisation during the actual treatment period was calculated per treatment per patient-year. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication.
Number of Patients With at Least One Moderate to Severe COPD Exacerbation During the Actual Treatment Period. From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days Key secondary endpoint: Number of patients with at least one moderate to severe COPD exacerbation during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with at least one moderate to severe COPD exacerbation is presented.
Number of Patients With at Least One COPD Exacerbation Leading to Hospitalisation During the Actual Treatment Period. From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days Number of patients with at least one COPD exacerbation leading to hospitalisation during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with at least one moderate to severe COPD exacerbation leading to hospitalisation is presented.
Number of Patients With All-cause Mortality Occurring During the Actual Treatment Period. From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days Number of patients with all-cause mortality occurring during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with all-cause mortality is presented.
Trial Locations
- Locations (818)
1237.19.10039 Boehringer Ingelheim Investigational Site
🇺🇸Andalusia, Alabama, United States
1237.19.10009 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
1237.19.10077 Boehringer Ingelheim Investigational Site
🇺🇸Florence, Alabama, United States
1237.19.10115 Boehringer Ingelheim Investigational Site
🇺🇸Jasper, Alabama, United States
1237.19.10069 Boehringer Ingelheim Investigational Site
🇺🇸Flagstaff, Arizona, United States
1237.19.10085 Boehringer Ingelheim Investigational Site
🇺🇸Peoria, Arizona, United States
1237.19.10110 Boehringer Ingelheim Investigational Site
🇺🇸Lincoln, California, United States
1237.19.10118 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
1237.19.10074 Boehringer Ingelheim Investigational Site
🇺🇸Poway, California, United States
1237.19.10157 Boehringer Ingelheim Investigational Site
🇺🇸Lafayette, Colorado, United States
Scroll for more (808 remaining)1237.19.10039 Boehringer Ingelheim Investigational Site🇺🇸Andalusia, Alabama, United States