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CompletedNCT02100332PREFERUpdated Dec 5, 2016

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

An observational study in Chronic Obstructive Pulmonary Disease, sponsored by AstraZeneca. Completed at 1 site in Italy. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-12-05.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
860
Ages
45 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • Drug Therapy
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 860 is above the median of 157 across 929 observational studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 85 Years
Sexes eligible
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

Exclusion Criteria:

  • None
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
860 participants (actual)
Patient registry
No

Groups and cohorts

  • Chronic obstructive pulmonary disease

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Comorbidities captured at the index visit and related to 12 Months Prior to Study Index Visit

  2. Percentage of Participants having Annual Spirometric Tests

    Time frame: 12 months prior and up to the Study Index Visit

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Study locations

1 site
  • Veruno (Novara), Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02100332
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Mar 31, 2014
Start date
Nov 2012
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Dec 5, 2016

Study contacts

AstraZeneca AstraZeneca
study director · AstraZeneca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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