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CompletedNCT04538976CODEX-PUpdated Mar 13, 2025

Copd Exacerbation and Pulmonary Hypertension Trial

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

Phase
Phase 4
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Exacerbation of COPD

Keywords

  • COPD
  • Chronic Obstructive Lung Disease
  • Increased pulmonary pressure
  • Acute Exacerbation
  • AECOPD
03

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
250 participants (actual)

Study arms

  • No intervention
    Control

    Patients in the control group will receive standard care.

  • Active comparator
    Sildenafil

    Patients in the Sildenafil group will receive standard care and targeted Sildenafil-treatment.

    Drug: Sildenafil

Interventions

  • DrugSildenafil

    Sildenafil in standard dosage

    Also known as: Vizarsin

05

What researchers measure

Primary outcomes

  1. Time alive and out of hospital

    Time frame: 365 days

Secondary outcomes

  1. Time to "prednisolon and/or antibiotica"-needing exacerbation of COPD or death

    Time frame: 365 days

  2. Death within 90 days

    Time frame: 90 days

  3. Death within 1 year

    Time frame: 365 days

  4. Alive and without exacerbation of COPD on day 365

    Time frame: 365 days

  5. Clinical cure

    Time frame: 14 days

  6. Number of readmissions due to exacerbations of COPD

    Time frame: 365 days

  7. Number of days with non-invasive ventilation (NIV) or respirator during admittance

    Time frame: 14 days

  8. Delta Pa(O2)

    Time frame: 4 days

  9. Delta Pa(CO2)

    Time frame: 4 days

  10. Delta(pH)

    Time frame: 4 days

  11. Change in FEV1

    Time frame: 90 days

  12. Change in COPD Assesment Test (CAT)

    Time frame: 29 days

  13. Change in Body Mass Index (BMI)

    Time frame: 90 days

  14. Delta(TR-gradient)

    Time frame: 4 days

06

Study locations

5 sites
  • Bispebjerg University Hospital
    Copenhagen, Denmark
  • Herlev-Gentofte Hospital
    Copenhagen, Denmark
  • Hvidovre Hospital
    Copenhagen, Denmark
  • Nordsjællands Hospital
    Hillerød, Denmark
  • Odense Universitetshospital
    Odense, Denmark
07

References and documents

Individual participant data

Plan to share: No — We have not yet decided to share IPD.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04538976
Lead sponsor
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Responsible party
Sponsor
First posted
Sep 4, 2020
Start date
Feb 1, 2020
Primary completion
Mar 15, 2024
Completion
Mar 15, 2024
Last update
Mar 13, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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