Copd Exacerbation and Pulmonary Hypertension Trial

Acute Exacerbation of COPD Clinical Trial

— CODEX-P  

Official title:

Copd Exacerbation and Pulmonary Hypertension Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04538976
• Other study ID #: Study_protocol_CODEX-P_ver2_1
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2020
• Est. completion date: October 31, 2025

Study information

• Verified date: August 2023
• Source: Chronic Obstructive Pulmonary Disease Trial Network, Denmark
• Contact: Pradeesh Sivapalan, PhD
• Phone: 004538673513
• Email: pradeesh.sivapalan.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Exacerbation of COPD
• Hypertension
• Hypertension, Pulmonary

Intervention

Drug:
• Sildenafil
Sildenafil in standard dosage

Locations

Country	Name	City	State
Denmark	Bispebjerg University Hospital	Copenhagen
Denmark	Herlev-Gentofte Hospital	Copenhagen
Denmark	Hvidovre Hospital	Copenhagen
Denmark	Nordsjællands Hospital	Hillerød
Denmark	Odense Universitetshospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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