Severe Prospective Observational COPD Catalonia

Not yet recruiting

• Conditions: Severe Chronic Obstructive Pulmonary Disease

• Registration Number: NCT06252805
• Lead Sponsor: Ferran Morell

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-10-02
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-01
• Last Update Submitted: 2024-02-01
• Study First Posted: 2024-02-12
• Last Update Posted: 2024-02-12
• Study Start: 2024-03-10
• Primary Completion: 2025-03-31
• Study Completion: 2030-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 450

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Importance of comorbidities in the evolution of COPD	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
Impact of exacerbations and chronic bronchial infection on the evolution of COPD	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
Assess effect of the different treatments, both inhaled and non-inhaled, on the disease progression and according to the patient's phenotype.	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