Greek NIS Spiolto ELLACTO

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03419962
Recruitment Status : Active, not recruiting
First Posted : February 2, 2018
Last Update Posted : December 12, 2018
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: MaxSpiolto® Respimat® 160 Characters...

Study Type : Observational
Actual Enrollment : 1363 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Health and Functional Status in Patients With Chronic Obstructive Pulmonary Disease (COPD) During Therapy With Spiolto® Respimat® [ELLACTO]
Actual Study Start Date : March 19, 2018
Actual Primary Completion Date : November 9, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort Intervention/treatment
COPD patients
Chronic obstructive pulmonary disease
Drug: MaxSpiolto® Respimat® 160 Characters...
as per the approved SmPC

Primary Outcome Measures :
  1. the proportion of patients achieving the "therapeutic success" defined as a ≥ 0.4 point of decrease in the Clinical COPD Questionnaire (CCQ) score [ Time Frame: upto week 6 ]

Secondary Outcome Measures :
  1. absolute change in Clinical COPD using COPD questionaire [ Time Frame: upto 6 weeks ]
    Clinical COPD questionaire

  2. absolute change in CCQ-4 (subdomain 4) using COPD questionaire [ Time Frame: upto 6 weeks ]
    subdomain 4

  3. patient's general condition (physician's evaluation) at baseline and end of study [ Time Frame: 1 week- 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
1300 patients with chronic obstructive pulmonary disease (COPD) in whom combination treatment with long-acting bronchodilators is indicated in accordance with the guidelines are to be observed by approx. 100 pulmonologists in the setting of private practice. The NIS will take place in Greece and sites in urban as well as rural areas will be included. The nationwide distribution of the participating pulmonologists as well as the number of patients enrolled are intended to ensure that the data collected are representative.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03419962

Aigina, Greece, 18547
Athens, Greece, 18547
Athens, Greece, 18547
Chania, Greece, 18547
Heraklio, Greece, 18547
Hrakleio, Greece, 18547
Hraklio, Greece, 18547
Ioannina, Greece, 55535
Kavala, Greece, 55535
Larisa, Greece, 55535
Patra, Greece, 18547
Serres, Greece, 55535
Merkouropoulos Markos
Thessaloniki, Greece, 54629
Thessaloniki, Greece, 55535
Volos, Greece, 55535
Sponsors and Collaborators
Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim Identifier: NCT03419962     History of Changes
Other Study ID Numbers: 1237-0073
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes