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Greek NIS Spiolto ELLACTO

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ClinicalTrials.gov Identifier: NCT03419962
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : May 25, 2018
Sponsor:
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
Estimated Enrollment : 1300 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
Estimated Primary Completion Date : September 21, 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
Other Name: INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO




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 ]


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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03419962


Contacts
Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Greece
Metropolitan Recruiting
Athens, Greece, 18547
Contact: Konstantinos Fragkos    36977976787    fragosk@yahoo.gr   
Metropolitan Recruiting
Athens, Greece, 18547
Contact: Gerasimos Apolonatos    36937239800    gapollon1@yahoo.gr   
Metropolitan Recruiting
Athens, Greece, 18547
Contact: Eleni Iliadi charmezokova    36948877712    iliadie@hotmail.com   
Metropolitan Recruiting
Athens, Greece, 18547
Contact: Charalampos Papagoras    36944 713302    hpapagoras@gmail.com   
Metropolitan Recruiting
Athens, Greece, 18547
Contact: Nikolaos Chainis    36944 641664    info@hainis.gr   
Metropolitan Recruiting
Athens, Greece, 18547
Contact: Maria Vounatsi    36944 538301    mariavounatsi@yahoo.com   
Metropolitan Recruiting
Athens, Greece, 18547
Contact: Alexandra Thomopoulou Katsika    36970837183    thalex70@otenet.gr   
Metropolitan Recruiting
Athens, Greece, 18547
Contact: Alexios Krokidis    3210 2637370    krokidis@otenet.gr   
Metropolitan Recruiting
Athens, Greece, 18547
Contact: Georgios Kromidas    36972770334    geokrommidas@yahoo.gr   
Metropolitan Recruiting
Athens, Greece, 18547
Contact: Konstantinos Nikas    36932 207184    konstantinosnikas5@gmail.com   
Metropolitan Recruiting
Athens, Greece, 18547
Contact: Eleni Pipini    36944 537603    epipini@hygeia.gr   
Metropolitan Recruiting
Athens, Greece, 18547
Contact: Violeta Talou    36932652681    violeta_talou@hotmail.com   
Metropolitan Recruiting
Athens, Greece, 18547
Contact: Chrisoula Trampari    36932280637    trabarixr@yahoo.gr   
Metropolitan Recruiting
Athens, Greece, 18547
Contact: Anna Kontogianni    36977 850311    annakontogiani@gmail.com   
Metropolitan Recruiting
Athens, Greece, 18547
Contact: Dimosthenis Papapetrou    36934381578    dimospapapetroudsa@hotmail.com   
Metropolitan Recruiting
Athens, Greece, 18547
Contact: Makrina Michailidou Tsagari    36977085520    mak_rina@otenet.gr   
Metropolitan Recruiting
Chania, Greece, 18547
Contact: Grigoris Georgoudakis    36974790028    gregory@georgoudakis.gr   
Metropolitan Recruiting
Heraklio, Greece, 18547
Contact: Michalis Arvanitakis    36945976696    arvanitakism@hotmail.gr   
Metropolitan Recruiting
Hrakleio, Greece, 18547
Contact: Kostas Chatzakis    36932732135    xatzakis@gmail.com   
Diavalkaniko Recruiting
Ioannina, Greece, 55535
Contact: Christina Leontaridi    32651077144    cl2651@gmail.com   
Diavalkaniko Recruiting
Larisa, Greece, 55535
Contact: Georgios Kalfountzos    36937 332332    gkalfoun@yahoo.gr   
Diavalkaniko Recruiting
Larisa, Greece, 55535
Contact: Maria Kouri    36937 233001    kourimaria@ymail.com   
Diavalkaniko Recruiting
Larisa, Greece, 55535
Contact: Konstantinos Perifanos    36977917056    perifanosk@hotmail.gr   
Metropolitan Recruiting
Patra, Greece, 18547
Contact: Michalis Kitrou    36936655762    mkitrou@otenet.gr   
Metropolitan Recruiting
Patra, Greece, 18547
Contact: Antonis Christopoulos    36977983808    asthmaclinics@outlook.com   
Diavalkaniko Recruiting
Serres, Greece, 55535
Contact: Babalis Christos    36945989821    cbabalis@otenet.gr   
Merkouropoulos Markos Recruiting
Thessaloniki, Greece, 54629
Contact: Markos Merkouropoulos    36976809491    markosmer@gmail.com   
Diavalkaniko Recruiting
Thessaloniki, Greece, 55535
Contact: Markos Merkouropoulos    36976809491    markosmer@gmail.com   
Diavalkaniko Recruiting
Thessaloniki, Greece, 55535
Contact: Drosos Tsavlis    36945540502    dr.tsavlis@yahoo.com   
Diavalkaniko Recruiting
Thessaloniki, Greece, 55535
Contact: Panagiotis Chatziapostolou    36945266126    panoshatziapostolou@gmail.com   
Diavalkaniko Recruiting
Thessaloniki, Greece, 55535
Contact: Kapetagiorgis Athanasios    36937018967    atkapet@gmail.com   
Diavalkaniko Recruiting
Thessaloniki, Greece, 55535
Contact: Athanasios Kiriakakis    36944 731317    ath_kyriakakis@hotmail.com   
Diavalkaniko Recruiting
Thessaloniki, Greece, 55535
Contact: Dimosthenis Vlaikos    36973617494    vlaikosdim@yahoo.gr   
Diavalkaniko Recruiting
Thessaloniki, Greece, 55535
Contact: Dimitris Vlachopoulos    36937123067    vlahopoulosd@yahoo.gr   
Diavalkaniko Recruiting
Thessaloniki, Greece, 55535
Contact: Lemonia Mendonidou    36944597254    mendolenia@live.com   
Diavalkaniko Recruiting
Thessaloniki, Greece, 55535
Contact: Prodromos Chatzivlasiou    36944144414    phatzivlassiou@gmail.com   
Diavalkaniko Recruiting
Volos, Greece, 55535
Contact: Konstantinos Christou    36972 245424    koschr@mail.com   
Sponsors and Collaborators
Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03419962     History of Changes
Other Study ID Numbers: 1237-0073
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

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