Copd Exacerbation and Pulmonary Hypertension Trial

NCT04538976 | Completed Phase 4 DMC

• 1 other identifier: Study_protocol_CODEX-P_ver2_1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Acute Exacerbation of COPD

Keywords

COPD; Chronic Obstructive Lung Disease; Increased pulmonary pressure; Acute Exacerbation; AECOPD

Outcome Measures

Primary Outcomes (1)

• Time alive and out of hospital

  365 days

Secondary Outcomes (14)

• 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

Study Arms (2)

Control

NO INTERVENTION

Patients in the control group will receive standard care.

Sildenafil

ACTIVE COMPARATOR

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

Drug: Sildenafil

Interventions

Sildenafil DRUG

Sildenafil in standard dosage

Also known as: Vizarsin

Sildenafil

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chronic Obstructive Pulmonary Disease Trial Network, Denmark: lead

Study Sites (5)

Bispebjerg University Hospital

Copenhagen, Denmark

Location

Herlev-Gentofte Hospital

Copenhagen, Denmark

Location

Hvidovre Hospital

Copenhagen, Denmark

Location

Nordsjællands Hospital

Hillerød, Denmark

Location

Odense Universitetshospital

Odense, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a multicenter controlled, randomized, open-lapel trial.

Study Record Dates

• First Submitted: August 30, 2020
• First Posted: September 4, 2020
• Study Start: February 1, 2020
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5)