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

NCT02100332 | Completed

• 2 other identifiers: RO-2455-402-ITU1111-1152-9289
• Study Type: observational
• Target: 860
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (2)

• 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

• Percentage of Participants having Annual Spirometric Tests

  12 months prior and up to the Study Index Visit

Study Arms (1)

Chronic obstructive pulmonary disease

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

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with COPD will be enrolled at hospital and pulmonology departments in Italy.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Unknown Facility

Veruno (Novara), Italy

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: March 31, 2014
• Study Start: November 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 5, 2016

Record last verified: 2016-09

Locations

IT (1)