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OpenTrials
Completed

NCT Number: NCT02100332

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

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.

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Key information

Conditions

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

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Veruno (Novara), Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Prevalence of Comorbidities of COPD in the Exacerbator Phenotype - A Cross Sectional Disease/Condition Focused Observational Study on COPD

Acronym: PREFER

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 31, 2014
Registry last updated
Dec 5, 2016

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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