Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Changes in Health and Functional Status in Patients With Chronic Obstructive Pulmonary Disease (COPD) During Therapy With Spiolto® Respimat® [ELLACTO]
NCT number | NCT03419962 |
Other study ID # | 1237-0073 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 19, 2018 |
Est. completion date | April 3, 2019 |
Verified date | April 2020 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Open-label observational study: including COPD patients receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations
Status | Completed |
Enrollment | 1360 |
Est. completion date | April 3, 2019 |
Est. primary completion date | November 9, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Therapeutic indication before entering the enrollment face is patients diagnosed with COPD requiring a combination therapy of two long-acting bronchodilators (LAMA + LABA) according to approved SmPC and guidelines, COPD GOLD 2017 groups B to D - Female and male patients =40 years of age - Treatment with Spiolto ® Respimat® acc. to SmPC and at the discretion of the physician - Written informed consent prior to participation Exclusion Criteria: - Patients with contraindications according to Spiolto® Respimat® SmPC - Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 weeks or patients already on a combination of LAMA and LABA therapy; either as a fixed combination product or as separate components Note: Patients previously treated with LABA or LAMA (with or without ICS) are eligible to be included in the study - Patients continuing LABA-ICS treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists - Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks - Pregnancy and lactation - Patients currently listed for lung transplantation - Current participation in any clinical trial or any other non-interventional study of a drug or device |
Country | Name | City | State |
---|---|---|---|
Greece | Metropolitan | Aigina | |
Greece | Metroplitan | Athens | |
Greece | Metropolitan | Athens | |
Greece | Metropolitan | Chania | |
Greece | Metropolitan | Heraklio | |
Greece | Metropolitan | Hrakleio | |
Greece | Metropolitan | Hraklio | |
Greece | Diavalkaniko | Ioannina | |
Greece | Diavalkaniko | Kavala | |
Greece | Diavalkaniko | Larisa | |
Greece | Metropolitan | Patra | |
Greece | Diavalkaniko | Serres | |
Greece | Diavalkaniko | Thessaloniki | |
Greece | Merkouropoulos Markos | Thessaloniki | |
Greece | Diavalkaniko | Volos |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Patients Achieving "Therapeutic Success" Defined as a = 0.4 Point of Decrease in the Clinical COPD Questionnaire (CCQ) Score | Therapeutic success was defined as =0.4 point decrease in the Clinical COPD Questionnaire (CCQ) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The sum of the scores divided by 10 gives the CCQ score. A higher CCQ score is indicative of worse status. A decrease of 0.4 points is considered to be the minimal clinically important difference (MCID) for CCQ score. |
Between visit 1 (baseline visit at study start) and visit 2 (final visit after end of study, approximately 6 weeks after visit 1). | |
Secondary | Absolute Change in Clinical COPD Questionnaire (CCQ) Score Between Visit 1 and Visit 2 | Absolute change in Clinical COPD Questionaire (QQC) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale between 0 and 6. The sum of the scores divided by 10 gives the CCQ score which measured the health and functional status. A higher CCQ score is indicative of worse status. |
At visit 1 (baseline visit at study start) and at visit 2 (final visit at end of study, approximately 6 weeks after visit 1). | |
Secondary | Absolute Change in the Functional Status Subdomain of Clinical COPD Questionnaire (CCQ-4) Score Between Visit 1 and Visit 2 | Absolute change in the functional status subdomain of Clinical COPD Questionnaire (CCQ-4) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ-4 score is a subdomain of the CCQ-score. It contains 4 questions about the functional status of patients. Each questions was scored by the patient on a 7-point scale, (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The QQC-4 score was calculated by the sum of 4 questions divided by 4. A higher CCQ-4 score was indicative of worse status. |
At visit 1 (baseline visit at study start) and at visit 2 (final visit at the end of study, approximately 6 weeks after visit 1). | |
Secondary | General Condition of Patient at Visit 1 and Visit 2 | General condition of the patient, evaluated by Physician´s Global Evaluation (PGE) score at visit 1 and visit 2. The PGE score uses a eight-point ordinal scale, ranging from poor (1,2) to excellent (7,8). |
At visit 1 (baseline visit at study start) and at visit 2 (final visit at the end of study, approximately 6 weeks after visit 1). | |
Secondary | Patients Satisfaction With Spiolto® Respimat® at Visit 2 | The patients satisfaction with Respimat was assessed at end of study (visit 2) by the Patient Satisfaction and Preference Questionnaire (PASAPQ) Part 1. PASAPQ Part 1 uses a 7-point ordinal scale, ranging from very dissatisfied to very satisfied, to rate the satisfaction with inhaler attributes. The patients were requested to describe their satisfaction level answering three questions. | At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit). | |
Secondary | Patients Preference for Spiolto® Respimat® at Visit 2 | Patients preference for Respimat® Inhaler vs. Spiriva HandiHaler (HH) was assessed using the abbreviated Patient Satisfaction and Preference Questionnaire (PASAPQ) Part 2 survey. Patients were requested to describe their preference for each inhaler device by answering 2 additional questions. | At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit) | |
Secondary | Patient's Willingness to Continue Treatment With Spiolto® Respimat® at Visit 2 | Patients' reported willingness to continue using either of the inhalers was measured with a scale score ranking from 0 to 100. 0 indicates not willing to continue using this inhaler and 100 indicates definitely willing to continue using it. | At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit). |
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