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

Chronic Obstructive Pulmonary Disease Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100332
• Other study ID #: RO-2455-402-IT
• Secondary ID: U1111-1152-9289
• Status: Completed
• Phase: N/A
• First received: February 6, 2014
• Last updated: December 2, 2016
• Start date: November 2012
• Est. completion date: July 2014

Study information

• Verified date: September 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency (AIFA: Agenzia Italiana del Farmaco)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 860
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Comorbidities	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.	Comorbidities captured at the index visit and related to 12 Months Prior to Study Index Visit	No
Primary	Percentage of Participants having Annual Spirometric Tests		12 months prior and up to the Study Index Visit	No