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OpenTrials
Completed

NCT Number: NCT03419962

Greek NIS Spiolto ELLACTO

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

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Metropolitan, Aegina, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MaxSpiolto® Respimat® 160 Characters...

Drug

as per the approved SmPC

Other names: INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO

Primary outcomes

  1. Percentage of Patients Achieving "Therapeutic Success" Defined as a ≥ 0.4 Point of Decrease in the Clinical COPD Questionnaire (CCQ) Score

    Time frame: Between visit 1 (baseline visit at study start) and visit 2 (final visit after end of study, approximately 6 weeks after visit 1).

    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.

Secondary outcomes

  1. Absolute Change in Clinical COPD Questionnaire (CCQ) Score Between Visit 1 and Visit 2

    Time frame: At visit 1 (baseline visit at study start) and at visit 2 (final visit at end of study, approximately 6 weeks after visit 1).

    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.

  2. Absolute Change in the Functional Status Subdomain of Clinical COPD Questionnaire (CCQ-4) Score Between Visit 1 and Visit 2

    Time frame: 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).

    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.

  3. General Condition of Patient at Visit 1 and Visit 2

    Time frame: 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).

    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).

  4. Patients Satisfaction With Spiolto® Respimat® at Visit 2

    Time frame: At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit).

    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.

  5. Patients Preference for Spiolto® Respimat® at Visit 2

    Time frame: At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit)

    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.

  6. Patient's Willingness to Continue Treatment With Spiolto® Respimat® at Visit 2

    Time frame: At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit).

    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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Changes in Health and Functional Status in Patients With Chronic Obstructive Pulmonary Disease (COPD) During Therapy With Spiolto® Respimat® [ELLACTO]

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Feb 5, 2018
Registry last updated
Apr 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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