Clinical trial NCT06252805: Severe Prospective Observational COPD Catalonia
Official title: Severe Prospective Observational Study of COPD in Catalonia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Severe Chronic Obstructive Pulmonary Disease
Keywords: Severe COPD
Cohort
Catalonia
Prospective
Multicenter
5 year follow-up
characterisation
COPD comorbidities
COPD phenotypes
Lead sponsor: Fundacio Catalana de Pneumologia
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 450
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD subjects from respiratory departments in Hospitals from Catalonia

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cohort creation in Catalonia
timeFrame: Up to 5 years
measure: Describe the demographic and clinical characteristics of patients with severe COPD in Catalonia.
timeFrame: Up to 5 years
measure: Assess the natural history and prognosis of severe COPD
timeFrame: Up to 5 years
Secondary outcomes:
measure: Assess effect of the different treatments, both inhaled and non-inhaled, on the disease progression and according to the patient's phenotype.
timeFrame: Up to 5 years
measure: Impact of exacerbations and chronic bronchial infection on the evolution of COPD
timeFrame: Up to 5 years
measure: Importance of comorbidities in the evolution of COPD
timeFrame: Up to 5 years
Other outcomes:
Locations:
Study officials:
References:
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