OTIVACTO Spain Non Interventional Study

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT02927795
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC. Patients will be enrolled consecutively and will be followed over an observational period of approx. 6 weeks.

Detailed Description

Purpose:

Study Design:

Study Timeline

• Study First Submitted: 2016-10-06
• Study First Submitted QC: 2016-10-06
• Study First Posted: 2016-10-07
• Study Start: 2017-04-26
• Primary Completion: 2018-09-18
• Study Completion: 2018-09-18
• Status Verified: 2019-09
• Results First Submitted: 2019-09-03
• Results First Submitted QC: 2019-09-03
• Last Update Submitted: 2019-09-03
• Results First Posted: 2019-09-30
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2)	After approximately 6 weeks (visit 2)	Therapeutic success defined as at least 10-point increase of Physical functioning questionnaire (PF-10 ) score after approximately 6 weeks of Spiolto® Respimat® treatment. The PF-10 used for assessing the primary outcome "physical functioning" is a subdomain of the validated Short Form 36 (SF-36 ) and 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 sum of the scores of the 10 questions results 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 was standardized to a range of 0 to 100 using the following formula: \[(sum of scale items - 10) \* 100\] / 20.; Higher scores indicate better physical functioning.

Secondary Outcome Measures

Name	Time	Method
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2	Baseline (visit 1) and after approx.week 6 (visit 2)	The patient's general condition was evaluated by means of Physician's Global Evaluation (PGE) score. The PGE score is documented on a scale from 1 (poor) to 8 (excellent) at both visits. 1-2: poor; 3-4: satisfactory; 5-6: good; 7-8: excellent
Patient Satisfaction With Inhaling From the Respimat® Device	After approx. 6 weeks (visit 2) of treatment initiation	A patient satisfaction questionnaire on how satisfied they were by inhaling with the Respimat® device was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied).
Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2	After approx. 6 weeks (visit 2) of treatment initiation	A patient satisfaction questionnaire on how overall satisfied they were with the Spiolto® Respimat® treatment was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied).
The Mean Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2	Baseline (visit 1) and after approx. week 6 (visit 2)	The change in Physical functioning questionnaire (PF-10 ) score was determined by taking into account the individual change of each patient between Baseline (Visit 1) and Week 6 (approx.) (Visit 2) and then the mean for change from baseline values across all patients was calculated.; The PF-10 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 sum of the scores of the 10 questions results 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 was standardized to a range of 0 to 100 using the following formula: \[(sum of scale items - 10) \* 100\] / 20.; Higher scores indicate better physical functioning.
Patient Satisfaction With Handling of the Respimat® Inhalation Device	After approx. 6 weeks (visit 2) of treatment initiation	A patient satisfaction questionnaire on how satisfied they were with handling of the Respimat® inhalation device was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied).

Trial Locations

Locations (78)

Centro de Salud Águilas Sur; 🇪🇸 Aguilas (Murcia), Spain

Consultorio Médico de Albelda; 🇪🇸 Albelda (Huesca), Spain

Centro de Salud Alcantarilla-Sangonera; 🇪🇸 Alcantarilla (Murcia), Spain

Centro de Salud Alquerías Raal; 🇪🇸 Alquerías (Murcia), Spain

Centro de Salud Aranda Norte; 🇪🇸 Aranda De Duero (Burgos), Spain

Centro de Salud La Paz-Cruces; 🇪🇸 Barakaldo (Vizcaya), Spain

Consulta Privada; 🇪🇸 Bizcaia, Spain

Centro de Salud de Beniel; 🇪🇸 Beniel (Murcia), Spain

Zorroza Centro de Salud; 🇪🇸 Bilbao (Vizcaya), Spain

Centro de Salud Gazteleku; 🇪🇸 Bilbao (Vizcaya), Spain

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Centro de Salud Águilas Sur

🇪🇸Aguilas (Murcia), Spain