A Phase 4 interventional study of Sildenafil in Acute Exacerbation of COPD, sponsored by Chronic Obstructive Pulmonary Disease Trial Network, Denmark. Completed at 5 sites in Denmark. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by Chronic Obstructive Pulmonary Disease Trial Network, Denmark · Phase 4, Interventional, and Treatment
This trial will investigate whether patiens admitted with an acute exacerbation of chronic obstructive lung disease and pulmonary hypertension will benefit from a targeted pharmacological treatment.
During admittance due to acute exacerbation of chronic obstructive lung disease will patience have an echocardiography to examine their pulmonary pressure. If patient have a tricuspidal return gradient above 40 mmHg, they will receive treatment with a phosphordiesterase-5-inhibitor, Sildenafil.
Exclusion Criteria:
Patients in the control group will receive standard care.
Patients in the Sildenafil group will receive standard care and targeted Sildenafil-treatment.
Drug: Sildenafil
Sildenafil in standard dosage
Also known as: Vizarsin
Time alive and out of hospital
Time frame: 365 days
Time to "prednisolon and/or antibiotica"-needing exacerbation of COPD or death
Time frame: 365 days
Death within 90 days
Time frame: 90 days
Death within 1 year
Time frame: 365 days
Alive and without exacerbation of COPD on day 365
Time frame: 365 days
Clinical cure
Time frame: 14 days
Number of readmissions due to exacerbations of COPD
Time frame: 365 days
Number of days with non-invasive ventilation (NIV) or respirator during admittance
Time frame: 14 days
Delta Pa(O2)
Time frame: 4 days
Delta Pa(CO2)
Time frame: 4 days
Delta(pH)
Time frame: 4 days
Change in FEV1
Time frame: 90 days
Change in COPD Assesment Test (CAT)
Time frame: 29 days
Change in Body Mass Index (BMI)
Time frame: 90 days
Delta(TR-gradient)
Time frame: 4 days
Plan to share: No — We have not yet decided to share IPD.
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Chronic Obstructive Pulmonary Disease Trial Network, Denmark