This study will investigate treatment of patients with chronic obstructive pulmonary disease (COPD), who experience frequent exacerbations (AECOPD). Only patients with a minimum of 2 moderate AECOPD or 1 severe AECOPD within 12 months will be able to participate. Furthermore they must pulmonary hypertension documented by echocardiography. MedDRA version: 20.0 Level: LLT Classification code 10019203 Term: Head spinning System Organ Class: 100000004854 MedDRA version: 20.1 Level: LLT Classificat
Conditions
Interventions
Trade Name: Vizarsin
Product Name: Vizarsin
Product Code: Sildenafil
Pharmaceutical Form: Tablet
INN or Proposed INN: SILDENAFIL
CAS Number: 139755-83-2
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Chronic Obstructive Pulmonary Disease Trial Network (COP:TRIN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - COPD (verified by respiratory specialist based on clinical assessment and spirometry) - Acute hospitalization with an action diagnosis of “AECOPD” - Tricuspid return (TR) gradient = 40 mmHg assessed by echocardiography done by a cardiolog specialist or a main physician with special interestand adequate training in echocardiography - “Stabile phase” TR gradient =65 years) yes F.1.3.1 Number of subjects for this age range 98
Exclusion criteria
Exclusion criteria: - Diagnosed with any type of pulmonary hypertension - Diagnosed with left or right sided heart failure - Male 55 years* - Severe mental illness or linguistic problems that considerably complicate cooperation - Known allergy to Vizarsin (Sildenafil) - Takes Vizarsin (Sildenafil) with other indication with consumption =50 mg/week *defined as have had = 1 menstruation within the last 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to clarify 1) whether the prognosis (days alive and out of hospital in 12 months) among patients with AECOPD and pulmonary hypertension can be improved by treatment with the phosphodiesterase inhibitor, sildenafil.;Secondary Objective: 2) the prevalence of pulmonary hypertension in patients admitted for AECOPD. 3) if the prognosis in AECOPD combined with pulmonary hypertension worsens the clinical status and prognosis of AECOPD.;Primary end point(s): Time alive and discharged from hospital within 365 days from baseline;Timepoint(s) of evaluation of this end point: 365 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to prednisolone and/or antibiotic-requiring AECOPD or death in primary or secondary care within 365 days - Death within 90 days - Death within 12 months - Number of readmissions with COPD exacerbations within 12 months - A live and without AECOPD on day 365 - Number of days with non-invasive ventilation (NIV) or mechanical ventilation treatment during 365 days - Change in PaO2 from baseline to day 4 - Change in PaCO2 from baseline to day 4 - pH on day 4 - Change in FEV1 from baseline to day 90 months - Change in COPD Assessment Test (CAT) from baseline to day 29 - Change in body mass index (BMI) from baseline to day 90 - Delta TR gradient from baseline to day 90;Timepoint(s) of evaluation of this end point: 365 days | — |
Countries
Denmark
Contacts
Public Contactwww.coptrin.dk
COP:TRIN
Outcome results
None listed