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Copd Exacerbation and Pulmonary Hypertension Trial (CODEX-P)

Primary Purpose

Acute Exacerbation of COPD

Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Sildenafil
Sponsored by
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Exacerbation of COPD focused on measuring COPD, Chronic Obstructive Lung Disease, Increased pulmonary pressure, Acute Exacerbation, AECOPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bispebjerg University Hospital
  • Herlev-Gentofte HospitalRecruiting
  • Hvidovre Hospital
  • Nordsjællands Hospital
  • Odense UniversitetshospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Sildenafil

Arm Description

Patients in the control group will receive standard care.

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

Outcomes

Primary Outcome Measures

Time alive and out of hospital

Secondary Outcome Measures

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

Full Information

First Posted
August 30, 2020
Last Updated
August 31, 2023
Sponsor
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04538976
Brief Title
Copd Exacerbation and Pulmonary Hypertension Trial
Acronym
CODEX-P
Official Title
Copd Exacerbation and Pulmonary Hypertension Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chronic Obstructive Pulmonary Disease Trial Network, Denmark

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Exacerbation of COPD
Keywords
COPD, Chronic Obstructive Lung Disease, Increased pulmonary pressure, Acute Exacerbation, AECOPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The study is a multicenter controlled, randomized, open-lapel trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in the control group will receive standard care.
Arm Title
Sildenafil
Arm Type
Active Comparator
Arm Description
Patients in the Sildenafil group will receive standard care and targeted Sildenafil-treatment.
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Other Intervention Name(s)
Vizarsin
Intervention Description
Sildenafil in standard dosage
Primary Outcome Measure Information:
Title
Time alive and out of hospital
Time Frame
365 days
Secondary Outcome Measure Information:
Title
Time to "prednisolon and/or antibiotica"-needing exacerbation of COPD or death
Time Frame
365 days
Title
Death within 90 days
Time Frame
90 days
Title
Death within 1 year
Time Frame
365 days
Title
Alive and without exacerbation of COPD on day 365
Time Frame
365 days
Title
Clinical cure
Time Frame
14 days
Title
Number of readmissions due to exacerbations of COPD
Time Frame
365 days
Title
Number of days with non-invasive ventilation (NIV) or respirator during admittance
Time Frame
14 days
Title
Delta Pa(O2)
Time Frame
4 days
Title
Delta Pa(CO2)
Time Frame
4 days
Title
Delta(pH)
Time Frame
4 days
Title
Change in FEV1
Time Frame
90 days
Title
Change in COPD Assesment Test (CAT)
Time Frame
29 days
Title
Change in Body Mass Index (BMI)
Time Frame
90 days
Title
Delta(TR-gradient)
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pradeesh Sivapalan, PhD
Phone
004538673513
Email
pradeesh.sivapalan.01@regionh.dk
Facility Information:
Facility Name
Bispebjerg University Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Pedersen
Facility Name
Herlev-Gentofte Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens-Ulrik Jensen, MD, PhD
Facility Name
Hvidovre Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Ulrik
Facility Name
Nordsjællands Hospital
City
Hillerød
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Browatzki
Facility Name
Odense Universitetshospital
City
Odense
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian B Laursen, Prof.

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We have not yet decided to share IPD.

Learn more about this trial

Copd Exacerbation and Pulmonary Hypertension Trial

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