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A Cross Sectional Disease/Condition Focused Observational Study on Chronic Obstructive Pulmonary Disease (COPD) (PREFER)

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: NCT02100332
Recruitment Status : Completed
First Posted : March 31, 2014
Last Update Posted : December 5, 2016
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to establish the prevalence of comorbidities in Italian patients with chronic bronchitis with at least 2 exacerbations per year, and to document the appropriateness of instrumental diagnostic tests, such as spirometry of these patients.

Condition or disease
Chronic Obstructive Pulmonary Disease

Detailed Description:

This is an observational study so participants will only take medication that is presently prescribed by their regular healthcare provider. No additional study medication will be administered. This study will enroll patients who have been previously diagnosed with COPD. This study will look at the medical history and other diseases that have been diagnosed in people who also have COPD.

The study will enroll approximately 3000 patients.

This multi-centre trial will be conducted in Italy. The overall time to participate in this study is at a single, regularly scheduled visit at the pulmonologists office. There will not be any follow up assessments.

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Study Type : Observational
Actual Enrollment : 860 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Prevalence of Comorbidities of COPD in the Exacerbator Phenotype - A Cross Sectional Disease/Condition Focused Observational Study on COPD
Study Start Date : November 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Chronic obstructive pulmonary disease
Patients with chronic obstructive pulmonary disease will undergo a single visit with the collection of data from his/her records.

Primary Outcome Measures :
  1. Prevalence of Comorbidities [ Time Frame: Comorbidities captured at the index visit and related to 12 Months Prior to Study Index Visit ]
    The following comorbidities were accounted for (from the patient records): arterial hypertension, ischemic heart disease, other cardiac disorders, arrhythmia, congestive heart failure, diabetes, metabolic syndrome, known osteoporosis, depression, and chronic renal insufficiency.

  2. Percentage of Participants having Annual Spirometric Tests [ Time Frame: 12 months prior and up to the Study Index Visit ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with COPD will be enrolled at hospital and pulmonology departments in Italy.

Inclusion Criteria:

  1. Age 45-85, of either gender.
  2. Signed informed consent.
  3. Known COPD documented by spirometric exams showing fixed non reversible respiratory obstruction.
  4. Forced Expired Volume measured after 1 second expiration (FEV-1) < 50% in a previous test (no time limits).
  5. Symptoms of chronic bronchitis : chronic productive cough for 3 months at least in each of the 2 years prior to the index visits.
  6. On treatment of bronchodilators (no restrictions) for the last 12 months at least.
  7. History of at least 2 exacerbations (moderate/severe) in the last 12 months prior to index visit.

Exclusion Criteria:

  • None

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): NCT02100332

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Veruno (Novara), Italy
Sponsors and Collaborators
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Study Director: AstraZeneca AstraZeneca AstraZeneca

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Responsible Party: AstraZeneca Identifier: NCT02100332    
Other Study ID Numbers: RO-2455-402-IT
U1111-1152-9289 ( Registry Identifier: WHO (UTN) )
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: September 2016
Keywords provided by AstraZeneca:
Drug Therapy
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases