Trial Outcomes & Findings for The ENERGITO® 2 Study Compares 2 Inhaled Medicines for Chronic Obstructive Pulmonary Disease (COPD). One Medicine is a Combination of Tiotropium and Olodaterol (Stiolto®) Taken Using the Respimat® Inhaler and the Other Medicine is a Combination of Fluticasone and Salmeterol Taken Using the Diskus (NCT NCT03240575)
NCT ID: NCT03240575
Last Updated: 2020-04-16
Results Overview
Forced Expiratory Volume in one second (FEV1) Area under the Curve from 0 to 24 hours (AUC0-24) response (change from baseline) \[L\] after 12 weeks of treatment. FEV1 AUC0-24 was calculated as the area under the FEV1-time curve from 0-24 hours post-dose using the trapezoidal rule, divided by the duration (24 hours) and reported in liters. FEV1 AUC0-24 response (change from baseline) was defined as FEV1 AUC0-24 mius baseline FEV1.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
302 participants
Primary outcome timeframe
1 hours (h) and 10 minutes (min) before first dose at day1 of weeks 1 for baseline.10 min before and 30 min, 1 h, 2h, 3h, 4h, 6h, 8h, 10h, 11h 50min, 12h 30 min, 13h, 14h, 22h, 23h, and 24h post morning dose at week 12.
Results posted on
2020-04-16
Participant Flow
The study compares treatment tiotropium+olodaterol (5μg/5μg) once daily FDC to Fluticasone propionate+Salmeterol (250μg/50μg) twice daily FDC over 12 weeks in patients with COPD. A Digital Health (DH)-study has been integrated a site specific study. The patients enrolled in the DH-study are not considered to be part of the main study.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and non of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Tiotropium+Olodaterol (5μg/5μg) - Main Study
2 inhalations of fixed dose combination (FDC) of 2.5 microgram (μg) tiotropium and 2.5μg olodaterol (T+O) (total 5μg/5μg) were administered orally once daily in the morning via RESPIMAT inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the main study were not eligible to participate in the DH study.
|
Fluticasone Propionate+Salmeterol (500μg/100μg) - Main Study
2 inhalations of fixed dose combination (FDC) of 250μg fluticasone propionate and 50μg salmeterol (F+S) (total 500μg/100μg) were administered orally twice daily in the morning and in the evening (12h after morning dose) via Diskus inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the main study were not eligible to participate in the DH study.
|
Tiotropium+Olodaterol (5μg/5μg) - DH-study
2 inhalations of fixed dose combination (FDC) of 2.5 microgram (μg) tiotropium and 2.5μg olodaterol (T+O) (total 5μg/5μg) were administered orally once daily in the morning via RESPIMAT inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the DH study were not eligible to participate in the main study.
|
Fluticasone Propionate+Salmeterol (500μg/100μg) - DH-study
2 inhalations of fixed dose combination (FDC) of 250μg fluticasone propionate and 50μg salmeterol (F+S) (total 500μg/100μg) were administered orally twice daily in the morning and in the evening (12h after morning dose) via Diskus inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the DH study were not eligible to participate in the main study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
146
|
145
|
6
|
5
|
|
Overall Study
COMPLETED
|
144
|
131
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
14
|
0
|
2
|
Reasons for withdrawal
| Measure |
Tiotropium+Olodaterol (5μg/5μg) - Main Study
2 inhalations of fixed dose combination (FDC) of 2.5 microgram (μg) tiotropium and 2.5μg olodaterol (T+O) (total 5μg/5μg) were administered orally once daily in the morning via RESPIMAT inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the main study were not eligible to participate in the DH study.
|
Fluticasone Propionate+Salmeterol (500μg/100μg) - Main Study
2 inhalations of fixed dose combination (FDC) of 250μg fluticasone propionate and 50μg salmeterol (F+S) (total 500μg/100μg) were administered orally twice daily in the morning and in the evening (12h after morning dose) via Diskus inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the main study were not eligible to participate in the DH study.
|
Tiotropium+Olodaterol (5μg/5μg) - DH-study
2 inhalations of fixed dose combination (FDC) of 2.5 microgram (μg) tiotropium and 2.5μg olodaterol (T+O) (total 5μg/5μg) were administered orally once daily in the morning via RESPIMAT inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the DH study were not eligible to participate in the main study.
|
Fluticasone Propionate+Salmeterol (500μg/100μg) - DH-study
2 inhalations of fixed dose combination (FDC) of 250μg fluticasone propionate and 50μg salmeterol (F+S) (total 500μg/100μg) were administered orally twice daily in the morning and in the evening (12h after morning dose) via Diskus inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the DH study were not eligible to participate in the main study.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
11
|
0
|
1
|
|
Overall Study
Other
|
0
|
1
|
0
|
0
|
Baseline Characteristics
The ENERGITO® 2 Study Compares 2 Inhaled Medicines for Chronic Obstructive Pulmonary Disease (COPD). One Medicine is a Combination of Tiotropium and Olodaterol (Stiolto®) Taken Using the Respimat® Inhaler and the Other Medicine is a Combination of Fluticasone and Salmeterol Taken Using the Diskus
Baseline characteristics by cohort
| Measure |
Fluticasone Propionate+Salmeterol (500μg/100μg) - DH-study
n=5 Participants
2 inhalations of fixed dose combination (FDC) of 250μg fluticasone propionate and 50μg salmeterol (F+S) (total 500μg/100μg) were administered orally twice daily in the morning and in the evening (12h after morning dose) via Diskus inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the DH study were not eligible to participate in the main study.
|
Total
n=302 Participants
Total of all reporting groups
|
Tiotropium+Olodaterol (5μg/5μg) - Main Study
n=146 Participants
2 inhalations of fixed dose combination (FDC) of 2.5 microgram (μg) tiotropium and 2.5μg olodaterol (T+O) (total 5μg/5μg) were administered orally once daily in the morning via RESPIMAT inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the main study were not eligible to participate in the DH study.
|
Fluticasone Propionate+Salmeterol (500μg/100μg) - Main Study
n=145 Participants
2 inhalations of fixed dose combination (FDC) of 250μg fluticasone propionate and 50μg salmeterol (F+S) (total 500μg/100μg) were administered orally twice daily in the morning and in the evening (12h after morning dose) via Diskus inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the main study were not eligible to participate in the DH study.
|
Tiotropium+Olodaterol (5μg/5μg) - DH-study
n=6 Participants
2 inhalations of fixed dose combination (FDC) of 2.5 microgram (μg) tiotropium and 2.5μg olodaterol (T+O) (total 5μg/5μg) were administered orally once daily in the morning via RESPIMAT inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the DH study were not eligible to participate in the main study.
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.00 years
STANDARD_DEVIATION 4.58 • n=4 Participants
|
63.44 years
STANDARD_DEVIATION 7.81 • n=21 Participants
|
63.95 years
STANDARD_DEVIATION 8.32 • n=5 Participants
|
64.74 years
STANDARD_DEVIATION 7.33 • n=7 Participants
|
71.00 years
STANDARD_DEVIATION 4.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=4 Participants
|
139 Participants
n=21 Participants
|
72 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=4 Participants
|
163 Participants
n=21 Participants
|
74 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=4 Participants
|
298 Participants
n=21 Participants
|
144 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=4 Participants
|
270 Participants
n=21 Participants
|
132 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 hours (h) and 10 minutes (min) before first dose at day1 of weeks 1 for baseline.10 min before and 30 min, 1 h, 2h, 3h, 4h, 6h, 8h, 10h, 11h 50min, 12h 30 min, 13h, 14h, 22h, 23h, and 24h post morning dose at week 12.Population: Full Analysis Set (FAS): FAS included all patients in the TS who had baseline and at least one post-baseline measurement for at least one efficacy parameter. The Mixed-effects model repeated measurement (MMRM) model defined the participants who contributed to the model.
Forced Expiratory Volume in one second (FEV1) Area under the Curve from 0 to 24 hours (AUC0-24) response (change from baseline) \[L\] after 12 weeks of treatment. FEV1 AUC0-24 was calculated as the area under the FEV1-time curve from 0-24 hours post-dose using the trapezoidal rule, divided by the duration (24 hours) and reported in liters. FEV1 AUC0-24 response (change from baseline) was defined as FEV1 AUC0-24 mius baseline FEV1.
Outcome measures
| Measure |
Tiotropium+Olodaterol (5μg/5μg) - Main Study
n=145 Participants
2 inhalations of fixed dose combination (FDC) of 2.5 microgram (μg) tiotropium and 2.5μg olodaterol (T+O) (total 5μg/5μg) were administered orally once daily in the morning via RESPIMAT inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the main study were not eligible to participate in the DH study.
|
Fluticasone Propionate+Salmeterol (500μg/100μg) - Main Study
n=138 Participants
2 inhalations of fixed dose combination (FDC) of 250μg fluticasone propionate and 50μg salmeterol (F+S) (total 500μg/100μg) were administered orally twice daily in the morning and in the evening (12h after morning dose) via Diskus inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the main study were not eligible to participate in the DH study.
|
Tiotropium+Olodaterol (5μg/5μg) - DH-study
n=6 Participants
2 inhalations of fixed dose combination (FDC) of 2.5 microgram (μg) tiotropium and 2.5μg olodaterol (T+O) (total 5μg/5μg) were administered orally once daily in the morning via RESPIMAT inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the DH study were not eligible to participate in the main study.
|
Fluticasone Propionate+Salmeterol (500μg/100μg) - DH-study
n=4 Participants
2 inhalations of fixed dose combination (FDC) of 250μg fluticasone propionate and 50μg salmeterol (F+S) (total 500μg/100μg) were administered orally twice daily in the morning and in the evening (12h after morning dose) via Diskus inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the DH study were not eligible to participate in the main study.
|
|---|---|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 24 Hours (AUC0-24) Response (Change From Baseline) [L] After 12 Weeks of Treatment
|
0.174 Litre*hours (L*h)
Standard Error 0.019
|
0.122 Litre*hours (L*h)
Standard Error 0.019
|
NA Litre*hours (L*h)
Standard Error NA
Due to the small number of subjects and due to the many out of window test assessments, the primary endpoint could not be evaluated.
|
NA Litre*hours (L*h)
Standard Error NA
Due to the small number of subjects and due to the many out of window test assessments, the primary endpoint could not be evaluated.
|
SECONDARY outcome
Timeframe: 1 hours (h) and 10 minutes (min) before first dose at day1 of weeks 1 for baseline. 10 min before and 30 min, 1 h, 2h, 3h, 4h, 6h, 8h, 10h, 11h 50min post morning dose at week 12.Population: Full Analysis Set (FAS): FAS included all patients in the TS who had baseline and at least one post-baseline measurement for at least one efficacy parameter. The Mixed-effects model repeated measurement (MMRM) model defined the participants who contributed to the model.
Forced Expiratory Volume in one second (FEV1) Area under the Curve from 0 to 12 hours (AUC0-12) response (change from baseline) \[L\] after 12 weeks of treatment. FEV1 AUC0-12 was calculated as the area under the FEV1-time curve from 0-12 hours post-dose using the trapezoidal rule, divided by the duration (12 hours) and reported in liters. FEV1 AUC0-12 response (change from baseline) was defined as FEV1 AUC0-12 minus baseline FEV1.
Outcome measures
| Measure |
Tiotropium+Olodaterol (5μg/5μg) - Main Study
n=145 Participants
2 inhalations of fixed dose combination (FDC) of 2.5 microgram (μg) tiotropium and 2.5μg olodaterol (T+O) (total 5μg/5μg) were administered orally once daily in the morning via RESPIMAT inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the main study were not eligible to participate in the DH study.
|
Fluticasone Propionate+Salmeterol (500μg/100μg) - Main Study
n=138 Participants
2 inhalations of fixed dose combination (FDC) of 250μg fluticasone propionate and 50μg salmeterol (F+S) (total 500μg/100μg) were administered orally twice daily in the morning and in the evening (12h after morning dose) via Diskus inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the main study were not eligible to participate in the DH study.
|
Tiotropium+Olodaterol (5μg/5μg) - DH-study
n=6 Participants
2 inhalations of fixed dose combination (FDC) of 2.5 microgram (μg) tiotropium and 2.5μg olodaterol (T+O) (total 5μg/5μg) were administered orally once daily in the morning via RESPIMAT inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the DH study were not eligible to participate in the main study.
|
Fluticasone Propionate+Salmeterol (500μg/100μg) - DH-study
n=3 Participants
2 inhalations of fixed dose combination (FDC) of 250μg fluticasone propionate and 50μg salmeterol (F+S) (total 500μg/100μg) were administered orally twice daily in the morning and in the evening (12h after morning dose) via Diskus inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the DH study were not eligible to participate in the main study.
|
|---|---|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 12 Hours (AUC0-12) Response (Change From Baseline) [L] After 12 Weeks of Treatment
|
0.237 Litre*hours (L*h)
Standard Error 0.019
|
0.147 Litre*hours (L*h)
Standard Error 0.020
|
NA Litre*hours (L*h)
Standard Error NA
Based on the exploratory study design of the DH-study and the small number of patients, Endpoints were planned to be analyzed descriptively.
|
NA Litre*hours (L*h)
Standard Error NA
Based on the exploratory study design of the DH-study and the small number of patients, Endpoints were planned to be analyzed descriptively.
|
SECONDARY outcome
Timeframe: At 23 h and 24 h post dose at baseline and at 23h and 24 h post dose at week 12.Population: Full Analysis Set (FAS): FAS included all patients in the TS who had baseline and at least one post-baseline measurement for at least one efficacy parameter. The Mixed-effects model repeated measurement (MMRM) model defined the participants who contributed to the model.
Trough Forced Expiratory Volume in one second (FEV1) response (change from baseline) \[L\] after 12 weeks treatment. Trough FEV1 was defined as the mean of the FEV1 value measured at 23 hours and at 24 hours after the trial medication administration. Through FEV1 response (change from baseline) was defined as trough FEV1 minus baseline FEV1.
Outcome measures
| Measure |
Tiotropium+Olodaterol (5μg/5μg) - Main Study
n=145 Participants
2 inhalations of fixed dose combination (FDC) of 2.5 microgram (μg) tiotropium and 2.5μg olodaterol (T+O) (total 5μg/5μg) were administered orally once daily in the morning via RESPIMAT inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the main study were not eligible to participate in the DH study.
|
Fluticasone Propionate+Salmeterol (500μg/100μg) - Main Study
n=138 Participants
2 inhalations of fixed dose combination (FDC) of 250μg fluticasone propionate and 50μg salmeterol (F+S) (total 500μg/100μg) were administered orally twice daily in the morning and in the evening (12h after morning dose) via Diskus inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the main study were not eligible to participate in the DH study.
|
Tiotropium+Olodaterol (5μg/5μg) - DH-study
n=6 Participants
2 inhalations of fixed dose combination (FDC) of 2.5 microgram (μg) tiotropium and 2.5μg olodaterol (T+O) (total 5μg/5μg) were administered orally once daily in the morning via RESPIMAT inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the DH study were not eligible to participate in the main study.
|
Fluticasone Propionate+Salmeterol (500μg/100μg) - DH-study
n=3 Participants
2 inhalations of fixed dose combination (FDC) of 250μg fluticasone propionate and 50μg salmeterol (F+S) (total 500μg/100μg) were administered orally twice daily in the morning and in the evening (12h after morning dose) via Diskus inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the DH study were not eligible to participate in the main study.
|
|---|---|---|---|---|
|
Trough Forced Expiratory Volume in One Second (FEV1) Response (Change From Baseline) [L] After 12 Weeks Treatment
|
0.118 Litre (L)
Standard Error 0.019
|
0.114 Litre (L)
Standard Error 0.019
|
NA Litre (L)
Standard Error NA
Based on the exploratory study design of the DH-study and the small number of patients, Endpoints were planned to be analyzed descriptively.
|
NA Litre (L)
Standard Error NA
Based on the exploratory study design of the DH-study and the small number of patients, Endpoints were planned to be analyzed descriptively.
|
SECONDARY outcome
Timeframe: 30 minutes, 1 h, 2h and 3h post dose at baseline and week 12.Population: Full Analysis Set (FAS): FAS included all patients in the TS who had baseline and at least one post-baseline measurement for at least one efficacy parameter. The Mixed-effects model repeated measurement (MMRM) model defined the participants who contributed to the model.
Peak 0-3 hours Forced Expiratory Volume in one second (FEV1) response (change from baseline) \[L\] after 12 weeks treatment. Peak 0-3h was defined as the maximum value measured within the first three hours post doing.
Outcome measures
| Measure |
Tiotropium+Olodaterol (5μg/5μg) - Main Study
n=144 Participants
2 inhalations of fixed dose combination (FDC) of 2.5 microgram (μg) tiotropium and 2.5μg olodaterol (T+O) (total 5μg/5μg) were administered orally once daily in the morning via RESPIMAT inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the main study were not eligible to participate in the DH study.
|
Fluticasone Propionate+Salmeterol (500μg/100μg) - Main Study
n=138 Participants
2 inhalations of fixed dose combination (FDC) of 250μg fluticasone propionate and 50μg salmeterol (F+S) (total 500μg/100μg) were administered orally twice daily in the morning and in the evening (12h after morning dose) via Diskus inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the main study were not eligible to participate in the DH study.
|
Tiotropium+Olodaterol (5μg/5μg) - DH-study
n=6 Participants
2 inhalations of fixed dose combination (FDC) of 2.5 microgram (μg) tiotropium and 2.5μg olodaterol (T+O) (total 5μg/5μg) were administered orally once daily in the morning via RESPIMAT inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the DH study were not eligible to participate in the main study.
|
Fluticasone Propionate+Salmeterol (500μg/100μg) - DH-study
n=3 Participants
2 inhalations of fixed dose combination (FDC) of 250μg fluticasone propionate and 50μg salmeterol (F+S) (total 500μg/100μg) were administered orally twice daily in the morning and in the evening (12h after morning dose) via Diskus inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the DH study were not eligible to participate in the main study.
|
|---|---|---|---|---|
|
Peak 0-3 Hours Forced Expiratory Volume in One Second (FEV1) Response (Change From Baseline) [L] After 12 Weeks Treatment
|
0.341 Litre (L)
Standard Error 0.021
|
0.243 Litre (L)
Standard Error 0.021
|
NA Litre (L)
Standard Error NA
Based on the exploratory study design of the DH-study and the small number of patients, Endpoints were planned to be analyzed descriptively.
|
NA Litre (L)
Standard Error NA
Based on the exploratory study design of the DH-study and the small number of patients, Endpoints were planned to be analyzed descriptively.
|
Adverse Events
Tiotropium+Olodaterol (5μg/5μg)
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Fluticasone Propionate+Salmeterol (500μg/100μg)
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tiotropium+Olodaterol (5μg/5μg)
n=152 participants at risk
Once daily treatment of orally inhaled tiotropium + olodaterol (T+O) (5μg/5μg) fixed dose combination (FDC) over 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients from Main and DH-study combined.
|
Fluticasone Propionate+Salmeterol (500μg/100μg)
n=150 participants at risk
Twice daily treatment of orally inhaled fluticasone propionate + salmeterol (F+S) (250μg/50μg) fixed dose combination (FDC) over 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients from Main and DH-study combined.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.66%
1/152 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
0.00%
0/150 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.66%
1/152 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
0.00%
0/150 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
|
Infections and infestations
Pneumonia
|
0.66%
1/152 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
0.00%
0/150 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
|
Infections and infestations
Sepsis
|
0.66%
1/152 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
0.00%
0/150 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/152 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
0.67%
1/150 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/152 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
0.67%
1/150 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.66%
1/152 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
0.00%
0/150 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.66%
1/152 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
0.00%
0/150 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.66%
1/152 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
0.00%
0/150 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.66%
1/152 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
0.00%
0/150 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.00%
0/152 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
0.67%
1/150 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.66%
1/152 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
0.00%
0/150 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.0%
3/152 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
0.67%
1/150 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.66%
1/152 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
0.00%
0/150 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
Other adverse events
| Measure |
Tiotropium+Olodaterol (5μg/5μg)
n=152 participants at risk
Once daily treatment of orally inhaled tiotropium + olodaterol (T+O) (5μg/5μg) fixed dose combination (FDC) over 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients from Main and DH-study combined.
|
Fluticasone Propionate+Salmeterol (500μg/100μg)
n=150 participants at risk
Twice daily treatment of orally inhaled fluticasone propionate + salmeterol (F+S) (250μg/50μg) fixed dose combination (FDC) over 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients from Main and DH-study combined.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.3%
8/152 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
10.0%
15/150 • From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).
Safety analysis is reported for TS of both studies. Participants of each particular treatment arm in main and DH-study were combined in one particular treatment arm for adverse event reporting.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER