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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's enrollment of 250 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Chronic Obstructive Pulmonary Disease Trial Network, Denmark is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Ran from Feb 2020 to primary completion in Mar 2024, 49 months.
Of 86 non-industry phase 4 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 50. This study's 49 months is above that.
Counting every sponsor, half of 157 studies reached it within 19 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Sildenafil
Pulmonary Disease, Chronic Obstructive →
Chronic Obstructive Pulmonary Disease Trial Network, Denmark