CODEX-P: Copd Exacerbation and Pulmonary Hypertension Trial

Sponsor

Chronic Obstructive Pulmonary Disease Trial Network, Denmark (Other)

Overall Status

Recruiting

CT.gov ID

NCT04538976

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

0.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Exacerbation of COPD	Drug: Sildenafil	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Copd Exacerbation and Pulmonary Hypertension Trial

Actual Study Start Date :

Feb 1, 2020

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Oct 31, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Time alive and out of hospital [365 days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Bispebjerg University Hospital	Copenhagen	Denmark
2	Herlev-Gentofte Hospital	Copenhagen	Denmark
3	Hvidovre Hospital	Copenhagen	Denmark
4	Nordsjællands Hospital	Hillerød	Denmark
5	Odense Universitetshospital	Odense	Denmark