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The OPTI Study in Spain Looks at the History Flare-ups in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Inhaled Steroids.

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ClinicalTrials.gov Identifier: NCT03611777
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
This non-Interventional, descriptive, cross-sectional cohort and multicentre study will be conducted with COPD patients attended at Spanish Primary Care offices.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: Inhaled corticosteroid

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Non-interventional, Cross-sectional, Multicenter Study to Describe the Exacerbations Profile of COPD Patients Treated With ICS in a Real-life Primary Care Population in Spain. OPTI Study.
Actual Study Start Date : August 14, 2018
Estimated Primary Completion Date : October 10, 2019
Estimated Study Completion Date : October 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort Intervention/treatment
subjects with Pulmonary Disease, Chronic Obstructive Drug: Inhaled corticosteroid
Drug




Primary Outcome Measures :
  1. proportion of patients currently on ICS who did not have moderate/severe exacerbation in the year prior to the study visit [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. proportion of patients currently on ICS who have had moderate/severe exacerbation in the year prior to the study visit [ Time Frame: 1 year ]


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:   Non-Probability Sample
Study Population
study will be conducted with COPD patients attended at Spanish Primary Care offices.
Criteria

Inclusion Criteria:

  1. Written informed consent prior to participation
  2. Female and male patient ≥ 40 years of age
  3. Chronic Obstructive Pulmonary Disease (COPD) diagnosis more than 2 years before the study visit
  4. Previously confirmed Chronic Obstructive Pulmonary Disease (COPD) diagnosis (post-bronchodilator FEV1/FVC ratio <70%)
  5. Clinical data available 2 years before the study visit
  6. Ability to complete CAT - COPD Assessment Test

Exclusion Criteria:

  1. Current participation in any clinical trial involving a drug or device
  2. A moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) during the study visit or within 4 weeks before the study visit

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): NCT03611777


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

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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Mireia Canals, (+34) 93 404 58 77 mireia.canals@boehringer-ingelheim.com

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03611777     History of Changes
Other Study ID Numbers: 1237-0070
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studiesin products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).Requestors can use the following link http://trials.boehringer-ingelheim.com/ to:

  1. find information in order to request access to clinical study data, for listed studies.
  2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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