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NCT Number: NCT06252805

Severe Prospective Observational COPD Catalonia

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Ferran Morell

Other

Registry information

Official study title

Severe Prospective Observational Study of COPD in Catalonia

Acronym: SPOCCAT

Important dates

Study start
2024
Primary completion
2025
Study completion
2030
First posted
Feb 12, 2024
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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