Assessment of Physical Functioning and Handling of Spiolto Respimat in Patients With COPD (OTIVACTO)

Terminated

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Spiolto Respimat

• Registration Number: NCT02720757
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this Non Interventional Study is to measure changes in physical functioning, a surrogate for physical activity and exercise capacity, in COPD patients on treatment with Spiolto® Respimat® in routine daily treatment after approximately 6 weeks.

A secondary objective is to evaluate the patient's general condition (physician's evaluation) from Visit 1 (baseline visit at the start of the study) to Visit 2 (final visit at the end of the study, approx. 6 weeks after Visit 1), as well as patient satisfaction with Spiolto® Respimat® at Visit 2.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-03
• Study First Submitted QC: 2016-03-22
• Study First Posted: 2016-03-28
• Study Start: 2016-08-26
• Primary Completion: 2017-12-14
• Study Completion: 2017-12-14
• Results First Submitted: 2018-12-14
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-15
• Last Update Submitted: 2019-04-15
• Results First Posted: 2019-04-16
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spiolto Respimat	Spiolto Respimat	COPD patients requiring a fixed combination therapy of two long-acting bronchodilators (LAMA + LABA) according to approved Summary of Product Characteristics (SmPC) and Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Therapeutic Success After Approximately (Approx.) 6 Weeks After Baseline	Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)	"Therapeutic success" is defined as a 10-point increase of physical functioning (PF)-10 between Visit 1 (baseline) and Visit 2 (approx. 6 weeks later) using a PF questionnaire, which is a subdomain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can 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. The scores over the 10 questions will be summed, resulting in a value between 10 (a patient answering all questions with "yes, limited a lot") and 30 (a patient answering all questions with "No, not limited at all"). The final sum of the individual scores will be standardized to a range of 0 to 100 using the following formula: 100\*(sum-10)/20.; Percentage of patients with therapeutic success after approximately 6 weeks after baseline are presented

Secondary Outcome Measures

Name	Time	Method
General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later)	Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)	The treating physician used the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8(excellent). PGE will be completed before and approx. 6 weeks after treatment initiation.; Count of patients with PGE score 2, 3, 4, 5, 6, 7, 8 are presented for Visit 1 and Visit 2.
Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 (Approx. 6 Weeks Later)	Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)	Change in PF-10 score was determined by taking into account the individual change of each patient between Visit 1 and Visit 2.; PF questionnaire, is a sub-domain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can 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. The scores over the 10 questions will be summed, resulting in a value between 10 (a patient answering all questions with "yes, limited a lot") and 30 (a patient answering all questions with "No, not limited at all"). The final sum of the individual scores will be standardized to a range of 0 to 100 using the following formula: 100\*(sum-10)/20.
Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction	Visit 2 (approx. 6 weeks post baseline)	A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied.; Count of patients with divisions from very dissatisfied to very satisfied are presented.
Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device	Visit 2 (approx. 6 weeks post baseline)	A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied.; Count of patients with divisions from very dissatisfied to very satisfied are presented.
Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device	Visit 2 (approx. 6 weeks post baseline)	A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied.; Count of patients with divisions from very dissatisfied to very satisfied are presented.