Severe Prospective Observational COPD Catalonia (SPOCCAT)

Ferran Morell

Status: Not yet enrolling

Conditions: Severe Chronic Obstructive Pulmonary Disease

Study type: Observational

Funder types: Other

Identifiers

NCT06252805

FUC-SPOCCAT-2023-10

Details and patient eligibility

About

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

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

450 participants in 1 patient group

SPOCCAT

Description:

Severe Chronic Obstructive Pulmonary Disease patients in Catalonia