Severe Prospective Observational COPD Catalonia (SPOCCAT)

February 1, 2024 updated by: Ferran Morell

Severe Prospective Observational Study of COPD in Catalonia

Multicenter observational study to characterize and follow-up a cohort of patients with severe chronic obstructive pulmonary disease (COPD) in Catalonia

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Creation of the first multicenter observational study in Catalonia to characterize and follow-up of patients with severe chronic obstructive pulmonary disease. The follow-up will be up to 5 years, with a first initial visit and control visits every year. All patients will be recruited from respiratory departments from major hospitals from Catalonia, a region with approximately 8 million inhabitants and a wide web of public hospitals.

Study Type

Observational

Enrollment (Estimated)

450

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

COPD subjects from respiratory departments in Hospitals from Catalonia

Description

Inclusion Criteria:

  • Informed consent: a signed and dated written informed consent prior to study participation
  • Age: Subjects 35 years of age or order at visit 1.

  • Severe COPD diagnosis: an established severe COPD defined by spirometry values:

    • A post-albuterol/salbutamol FEV1/FVC ratio of <0.70 at visit 1. FEV1: forced expiratory volume at one second FVC: forced vital capacity.
    • A post-bronchodilator FEV1 < 50% predicted normal
  • Smoking history: ≥ 10 pack-years at visit 1
  • Stable phase of the disease (not less than 4 weeks of stability prior visit 1)

Exclusion Criteria:

  • Subjects not giving written informed consent.
  • Subjects at risk of non-compliance, or unable to comply with the scheduled visits.
  • Subjects affected mainly by another severe chronic respiratory disease that justifies the ventilatory alteration, for example pulmonary fibrosis or severe bronchiectasis
  • Subjects with carcinoma that has not been in complete remission for at least 5 years.
  • Subjects with α1-antitrypsin deficiency as the underlying cause of COPD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
SPOCCAT
Severe Chronic Obstructive Pulmonary Disease patients in Catalonia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort creation in Catalonia
Time Frame: Up to 5 years
Creation of a long follow-up (5 years) cohort of severe COPD patients in Catalonia
Up to 5 years
Describe the demographic and clinical characteristics of patients with severe COPD in Catalonia.
Time Frame: Up to 5 years
Identify the distribution of sex, age, severity of lung function impairment, treatment administered and comorbidities of severe COPD patients
Up to 5 years
Assess the natural history and prognosis of severe COPD
Time Frame: Up to 5 years
Assess the decline in lung function, frequency and severity of exacerbations and survival over a period of 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess effect of the different treatments, both inhaled and non-inhaled, on the disease progression and according to the patient's phenotype.
Time Frame: Up to 5 years
Compare the evolution in terms of decline in lung function, exacerbations and survival in patients treated with inhaled corticosteroids versus patients treated without inhaled corticosteroids
Up to 5 years
Impact of exacerbations and chronic bronchial infection on the evolution of COPD
Time Frame: Up to 5 years
Compare the evolution in terms of decline in lung function, frequency and severity of exacerbations and survival according to the presence and severity of exacerbations and the presence of chronic bronchial infection during follow-up
Up to 5 years
Importance of comorbidities in the evolution of COPD
Time Frame: Up to 5 years
Compare the evolution in terms of decline in lung function, frequency and severity of exacerbations and survival according to the presence and severity of different comorbidities and according to the scores on the Chrlson comorbidity index
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferran Morell

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 10, 2024

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2030

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUC-SPOCCAT-2023-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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