Copd Exacerbation and Pulmonary Hypertension Trial (CODEX-P)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Exacerbation of COPD
• Intervention / Treatment: Drug: Sildenafil

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.

• Study Type: Interventional
• Enrollment (Estimated): 2
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Pradeesh Sivapalan, PhD; Phone Number: 004538673513; Email: pradeesh.sivapalan.01@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • Herlev-Gentofte Hospital
    • Contact: Jens-Ulrik Jensen, MD, PhD
  • Copenhagen, Denmark
    • Not yet recruiting
    • Bispebjerg University Hospital
    • Contact: Lars Pedersen
  • Copenhagen, Denmark
    • Not yet recruiting
    • Hvidovre Hospital
    • Contact: Charlotte Ulrik
  • Hillerød, Denmark
    • Not yet recruiting
    • Nordsjællands Hospital
    • Contact: Andrea Browatzki
  • Odense, Denmark
    • Recruiting
    • Odense Universitetshospital
    • Contact: Christian B Laursen, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Sildenafil in standard dosage; Other Names: Vizarsin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time alive and out of hospital	365 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: August 30, 2020
• First Submitted That Met QC Criteria: August 30, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: COPD; AECOPD; Acute Exacerbation; Chronic Obstructive Lung Disease; Increased pulmonary pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: Study_protocol_CODEX-P_ver2_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We have not yet decided to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No