Exploring the link between small airway disease and cardiovascular disease in patients with chronic obstructive pulmonary disease

Not Applicable

• Conditions: Cardiovascular disease (CVD) and small airway disease (SAD) in patients with chronic obstructive pulmonary disease (COPD); Respiratory

• Registration Number: ISRCTN49392136
• Lead Sponsor: niversity of Rome Tor Vergata

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37414133/ (added 07/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-15
• Last Update Posted: 18 July 2023
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Clinical and functional diagnosis of COPD
2. Forced expiratory volume in the 1st second (FEV1)/forced vital capacity (FVC) ratio <0.7 and/or FEV1/FVC (or FEV1/vital capacity [VC]) < lower limit of normal (LLN)
3. Clinical stability =3 months (no mild moderate or severe exacerbations)
4. Both genders
5. Age =40 years
6. Smoking history =10 p/y

Exclusion Criteria

1. Previous or current history of bronchial asthma
2. Restrictive lung disease or interstitial lung disease
3. Active or under treatment neoplasms
4. Shift of inhalation therapy in the 3 months prior to study entry
5. Inability to perform reliable and repeatable pulmonary function tests
6. Oxygen therapy >18 hours a day
7. Diagnosed with clinically significant bronchiectasis (overt diagnosis of bronchiectasis on chest computed tomography [CT] which is the patient's primary diagnosis)
8. Severe obstructive sleep apnea syndrome (apnea/hypopnea index >30/h)
9. Pregnancy

Study & Design

• Study Type: Observational
• Study Design: Not specified