TrialReader


Copd Exacerbation and Pulmonary Hypertension Trial

NCT04538976 — Phase 4, Completed, 250 participants, Chronic Obstructive Pulmonary Disease Trial Network, Denmark

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT04538976, acronym CODEX-P
StatusCompleted
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment250 (Actual)
SponsorChronic Obstructive Pulmonary Disease Trial Network, Denmark (Other)
ConditionsAcute Exacerbation of COPD
InterventionsSildenafil (Drug)
Datesstart 2020-02-01, primary completion 2024-03-15, completion 2024-03-15, first posted 2020-09-04, last updated 2025-03-13
Locations5 sites in Denmark

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Acute Exacerbation of COPD All trials of Sildenafil

-Summary

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.

Expand all sections  ·  Collapse all

+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
ControlNo interventionPatients in the control group will receive standard care.
SildenafilActive comparatorDrug: SildenafilPatients in the Sildenafil group will receive standard care and targeted Sildenafil-treatment.
  • Sildenafil (Drug), also known as Vizarsin: Sildenafil in standard dosage

+Outcome measures

Primary outcomes

  • Time alive and out of hospital [365 days]

Secondary outcomes

  • Time to "prednisolon and/or antibiotica"-needing exacerbation of COPD or death [365 days]
  • Death within 90 days [90 days]
  • Death within 1 year [365 days]
  • Alive and without exacerbation of COPD on day 365 [365 days]
  • Clinical cure [14 days]
  • Number of readmissions due to exacerbations of COPD [365 days]
  • Number of days with non-invasive ventilation (NIV) or respirator during admittance [14 days]
  • Delta Pa(O2) [4 days]
  • Delta Pa(CO2) [4 days]
  • Delta(pH) [4 days]
  • Change in FEV1 [90 days]
  • Change in COPD Assesment Test (CAT) [29 days]
  • Change in Body Mass Index (BMI) [90 days]
  • Delta(TR-gradient) [4 days]

+Eligibility

Sex: All, ages: 40 Years to any

Inclusion Criteria:

* COPD verified by specialist and spirometry
* Admitted with the diagnosis "acute exacerbation of COPD"
* TR-gradient ≥40 mmHg verified by specialist and echocardiography
* Informed consent

Exclusion Criteria:

* Known pulmonal hypertension
* Known heart disease which affects the pump function of the heart
* Men <40 years
* Women <55 years
* Not-menopauseal women <55 years (Menopause is defined as no menstruation within 12 months.)
* Severe mental illness which significantly complicates cooperation
* Severe language difficulties which significantly complicates cooperation
* known allergy to Sildenafil
* Sildenafil consumption ≥50 mg / week due to other indications

+Locations (5)

FacilityCityCountryStatus
Bispebjerg University HospitalCopenhagenDenmark
Herlev-Gentofte HospitalCopenhagenDenmark
Hvidovre HospitalCopenhagenDenmark
Nordsjællands HospitalHillerødDenmark
Odense UniversitetshospitalOdenseDenmark

My Notes