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OTIVACTO Regional Center Vienna (RCV) Non-Interventional Study (NIS)

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ClinicalTrials.gov Identifier: NCT02719639
Recruitment Status : Completed
First Posted : March 25, 2016
Results First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Prospective
Condition Pulmonary Disease, Chronic Obstructive
Enrollment 7443
Recruitment Details This is an open label observational study in Chronic Obstructive Pulmonary Disease (COPD) patients from 534 investigational sites in 9 countries.
Pre-assignment Details All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be entered to trial if any one of the specific entry criteria were not met.
Arm/Group Title Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
Hide Arm/Group Description Patients with Chronic Obstructive Pulmonary Disease (COPD) included in this group were treated with Spiolto® Respimat®, Tiotropium/ Olodaterol 2.5 microgram/ 2.5 microgram, inhalation solution for 6 weeks.
Period Title: Overall Study
Started 7443
Completed 7443
Not Completed 0
Arm/Group Title Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
Hide Arm/Group Description Patients with Chronic Obstructive Pulmonary Disease (COPD) included in this group were treated with Spiolto® Respimat®, Tiotropium/ Olodaterol 2.5 microgram/ 2.5 microgram, inhalation solution for 6 weeks.
Overall Number of Baseline Participants 7443
Hide Baseline Analysis Population Description
Treated set (TS): All patients enrolled, registered and received at least one dose were included in the treated set.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7443 participants
65.07  (9.33)
[1]
Measure Analysis Population Description: Treated set (TS): All patients enrolled, registered and received at least one dose were included in the treated set.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7443 participants
Female
2349
  31.6%
Male
5094
  68.4%
[1]
Measure Analysis Population Description: Treated set (TS): All patients enrolled, registered and received at least one dose were included in the treated set.
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Percentage of Patients With Therapeutic Success After Approximately 6 Weeks.
Hide Description The therapeutic success was defined as a minimum of 10- point increase in the Physical Functioning (PF-10) score between visit 1 (baseline visit at the start of the study) and visit 2 (final visit approximately 6 weeks after visit 1), having approximately time period of 6 weeks between the evaluated questionnaires. PF-10 score measures changes in physical functioning - serving as a surrogate for physical activity and exercise capacity - in COPD patients.
Time Frame Approximately 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set.
Arm/Group Title Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
Hide Arm/Group Description:
Patients with Chronic Obstructive Pulmonary Disease (COPD) included in this group were treated with Spiolto® Respimat®, Tiotropium/ Olodaterol 2.5 microgram/ 2.5 microgram, inhalation solution for 6 weeks.
Overall Number of Participants Analyzed 7218
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants (%)
67.76
(66.67 to 68.84)
2.Secondary Outcome
Title Change in the Physical Functioning (PF-10) Score From Baseline (visit1) to Approximately 6 Weeks (visit2)
Hide Description Change in PF-10 score was determined by taking into account the individual change of each patient between visit 1 and visit 2. The PF-10 used for assessing the primary outcome is a sub-domain of the validated Short Form (SF)-36 quality of life questionnaire and consists of 10 questions evaluating the experienced restrictions while conducting usual activities. Each question of the PF-10 may be answered with "yes, limited a lot", "yes, limited a little", or "No, not limited at all", with a score of 1, 2, or 3, respectively. The scores will be summed up between 10 and 30. The final sum of the individual scores was standardized to a range of 0 to 100 using the formula: 100*(sum-10)/20. The lower the score the more disability. The higher the score the less disability. If less than half of the scale items were missing, missing values were replaced with the mean of the other values. If half or more than half was missing, no score was calculated.
Time Frame Baseline and week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set.
Arm/Group Title Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
Hide Arm/Group Description:
Patients with Chronic Obstructive Pulmonary Disease (COPD) included in this group were treated with Spiolto® Respimat®, Tiotropium/ Olodaterol 2.5 microgram/ 2.5 microgram, inhalation solution for 6 weeks.
Overall Number of Participants Analyzed 7218
Mean (Standard Deviation)
Unit of Measure: Score on scale
16.62  (17.87)
3.Secondary Outcome
Title General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2).
Hide Description This outcome measures general condition of the patient evaluated by the physician (PGE score) at visit 1 (baseline visit at the start of the study) and visit 2 (final visit approximately 6 weeks after visit 1) evaluated on an 8-point scale with the scores “Poor (1,2)”, “Satisfactory (3, 4)”, “Good (5, 6)” and “Excellent (7, 8)”. More the score, the better is the general condition of patient.
Time Frame Baseline and week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set.
Arm/Group Title Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
Hide Arm/Group Description:
Patients with Chronic Obstructive Pulmonary Disease (COPD) included in this group were treated with Spiolto® Respimat®, Tiotropium/ Olodaterol 2.5 microgram/ 2.5 microgram, inhalation solution for 6 weeks.
Overall Number of Participants Analyzed 7218
Measure Type: Number
Unit of Measure: Participants
Score 1 at visit 1 96
Score 2 at visit 1 754
Score 3 at visit 1 1907
Score 4 at visit 1 2159
Score 5 at visit 1 1317
Score 6 at visit 1 743
Score 7 at visit 1 203
Score 8 at visit 1 39
Score 1 at visit 2 0
Score 2 at visit 2 53
Score 3 at visit 2 261
Score 4 at visit 2 887
Score 5 at visit 2 1772
Score 6 at visit 2 2458
Score 7 at visit 2 1451
Score 8 at visit 2 335
4.Secondary Outcome
Title Patient’s Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Hide Description At visit 2 patients were asked for their overall satisfaction with the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases.
Time Frame Approximately 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set.
Arm/Group Title Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
Hide Arm/Group Description:
Patients with Chronic Obstructive Pulmonary Disease (COPD) included in this group were treated with Spiolto® Respimat®, Tiotropium/ Olodaterol 2.5 microgram/ 2.5 microgram, inhalation solution for 6 weeks.
Overall Number of Participants Analyzed 7218
Measure Type: Number
Unit of Measure: Participants
Very satisfied 2847
Satisfied 2998
Rather satisfied 890
Neither satisfied nor dissatisfied 307
Rather dissatisfied 93
Dissatisfied 52
Very dissatisfied 26
Not answered 5
5.Secondary Outcome
Title Patient’s Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Hide Description At visit 2 patients were asked how satisfied they were with inhaling from the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases.
Time Frame Approximately 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set.
Arm/Group Title Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
Hide Arm/Group Description:
Patients with Chronic Obstructive Pulmonary Disease (COPD) included in this group were treated with Spiolto® Respimat®, Tiotropium/ Olodaterol 2.5 microgram/ 2.5 microgram, inhalation solution for 6 weeks.
Overall Number of Participants Analyzed 7218
Measure Type: Number
Unit of Measure: Participants
Very satisfied 3143
Satisfied 3021
Rather satisfied 716
Neither satisfied nor dissatisfied 228
Rather dissatisfied 48
Dissatisfied 34
Very dissatisfied 11
Not answered 17
6.Secondary Outcome
Title Patient’s Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Hide Description At visit 2 patients were asked how satisfied they were with handling the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases.
Time Frame Approximately 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set.
Arm/Group Title Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
Hide Arm/Group Description:
Patients with Chronic Obstructive Pulmonary Disease (COPD) included in this group were treated with Spiolto® Respimat®, Tiotropium/ Olodaterol 2.5 microgram/ 2.5 microgram, inhalation solution for 6 weeks.
Overall Number of Participants Analyzed 7218
Measure Type: Number
Unit of Measure: Participants
Very satisfied 3086
Satisfied 2988
Rather satisfied 794
Neither satisfied nor dissatisfied 239
Rather dissatisfied 55
Dissatisfied 30
Very dissatisfied 9
Not answered 17
Time Frame From first dose adminstration until 21 days after permanently discontinuation of therapy or end of the study.
Adverse Event Reporting Description An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Analysis of adverse events were done on Treated set, which includes all patients enrolled, registered and received at least one dose.
 
Arm/Group Title Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
Hide Arm/Group Description Patients with Chronic Obstructive Pulmonary Disease (COPD) included in this group were treated with Spiolto® Respimat®, Tiotropium/ Olodaterol 2.5 microgram/ 2.5 microgram, inhalation solution for 6 weeks.
All-Cause Mortality
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
Affected / at Risk (%)
Total   4/7443 (0.05%) 
Show Serious Adverse Events Hide Serious Adverse Events
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
Affected / at Risk (%)
Total   5/7443 (0.07%) 
Cardiac disorders   
Atrial fibrillation  1  1/7443 (0.01%) 
Infections and infestations   
Pneumonia  1  1/7443 (0.01%) 
Sepsis  1  1/7443 (0.01%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasm  1  1/7443 (0.01%) 
Neoplasm progression  1  1/7443 (0.01%) 
1
Term from vocabulary, 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
Affected / at Risk (%)
Total   0/7443 (0.00%) 
The impact and the interpretation of this data are limited due to the non-interventional study concept. No objective assessment was performed. It might be considered that patients may get used to limited activity and overrate their baseline activity
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02719639     History of Changes
Other Study ID Numbers: 1237.44
First Submitted: March 1, 2016
First Posted: March 25, 2016
Results First Submitted: May 29, 2018
Results First Posted: January 9, 2019
Last Update Posted: January 9, 2019