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OpenTrials
Completed

NCT Number: NCT04538976

Copd Exacerbation and Pulmonary Hypertension Trial

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.

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Key information

Conditions

Acute Exacerbation of COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bispebjerg University Hospital, Copenhagen, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sildenafil

Drug

Sildenafil in standard dosage

Other names: Vizarsin

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

Sponsors and collaborators

Lead sponsor

Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Other

Registry information

Acronym: CODEX-P

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 4, 2020
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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