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

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT02719639
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Real-world data on the effects of a fixed-dose combination Long-acting beta agonists + long-acting antimuscarinic agent (LABA+LAMA) therapy with tiotropium and olodaterol administered in a single device, in COPD patients who need treatment with two long-acting bronchodilators, is not available. This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto Respimat according to the approved Summary of Product Characteristics (SmPC).

Detailed Description

Purpose:

Study Design:

Study Timeline

• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-03-21
• Study First Posted: 2016-03-25
• Study Start: 2016-04-01
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Results First Submitted: 2018-05-29
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-08
• Last Update Submitted: 2019-01-08
• Results First Posted: 2019-01-09
• Last Update Posted: 2019-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7443

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Therapeutic Success After Approximately 6 Weeks.	Approximately 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in the Physical Functioning (PF-10) Score From Baseline (visit1) to Approximately 6 Weeks (visit2)	Baseline and week 6	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.
General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2).	Baseline and week 6	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.
Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)	Approximately 6 weeks	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.
Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)	Approximately 6 weeks	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.
Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)	Approximately 6 weeks	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.