Acute Exacerbation of COPDPhase 4CODEX-PNCT04538976
Copd Exacerbation and Pulmonary Hypertension Trial
A Phase 4 study testing Sildenafil in people with Acute Exacerbation of COPD, run by Chronic Obstructive Pulmonary Disease Trial Network, Denmark at 5 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Acute Exacerbation of COPD
- What is being tested?
- Sildenafil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 5 sitesDenmark
- Study dates
- 1 Feb 2020to 15 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Severe language difficulties which significantly complicates cooperation
- known allergy to Sildenafil
- Sildenafil consumption ≥50 mg / week due to other indications
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Bispebjerg University Hospital
Copenhagen
Herlev-Gentofte Hospital
Copenhagen
Hvidovre Hospital
Copenhagen
Nordsjællands Hospital
Hillerød
Odense Universitetshospital
Odense
About this study
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.
Read the 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.
- Conditions
- Acute Exacerbation of COPD
- Being tested
- Sildenafil
- Keywords
- COPD, Chronic Obstructive Lung Disease, Increased pulmonary pressure, Acute Exacerbation, AECOPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Also called Vizarsin
Sildenafil in standard dosage
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time alive and out of hospital
Measured: 365 days
Secondary outcomes (14)
Time to "prednisolon and/or antibiotica"-needing exacerbation of COPD or death
Measured: 365 days
Death within 90 days
Measured: 90 days
Death within 1 year
Measured: 365 days
Alive and without exacerbation of COPD on day 365
Measured: 365 days
Clinical cure
Measured: 14 days
Number of readmissions due to exacerbations of COPD
Measured: 365 days
Number of days with non-invasive ventilation (NIV) or respirator during admittance
Measured: 14 days
Delta Pa(O2)
Measured: 4 days
Delta Pa(CO2)
Measured: 4 days
Delta(pH)
Measured: 4 days
Change in FEV1
Measured: 90 days
Change in COPD Assesment Test (CAT)
Measured: 29 days
Change in Body Mass Index (BMI)
Measured: 90 days
Delta(TR-gradient)
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 Feb 2020
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a multicenter controlled, randomized, open-lapel trial.
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chronic Obstructive Pulmonary Disease Trial Network, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538976
- Sponsor's protocol ID
- Study_protocol_CODEX-P_ver2_1
- Acronym
- CODEX-P
- Status last verified
- Feb 2025
- First submitted
- 30 Aug 2020
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have not yet decided to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copd Exacerbation and Pulmonary Hypertension Trial
- ClinicalTrials.gov ID
- NCT04538976
- Acronym / sponsor ID
- CODEX-P / Study_protocol_CODEX-P_ver2_1
- Conditions
- Acute Exacerbation of COPD
- Keywords
- COPD, Chronic Obstructive Lung Disease, Increased pulmonary pressure, Acute Exacerbation, AECOPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Chronic Obstructive Pulmonary Disease Trial Network, DenmarkUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 4 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a multicenter controlled, randomized, open-lapel trial.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in the control group will receive standard care. |
| Sildenafil | Active comparator | Drug: SildenafilPatients in the Sildenafil group will receive standard care and targeted Sildenafil-treatment. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SildenafilAlso: VizarsinSildenafil in standard dosage | Drug | Sildenafil |
Primary outcome
Time alive and out of hospital
Time frame: 365 days
14 secondary outcomes
Time to "prednisolon and/or antibiotica"-needing exacerbation of COPD or death
Time frame: 365 days
Death within 90 days
Time frame: 90 days
Death within 1 year
Time frame: 365 days
Alive and without exacerbation of COPD on day 365
Time frame: 365 days
Clinical cure
Time frame: 14 days
Number of readmissions due to exacerbations of COPD
Time frame: 365 days
Number of days with non-invasive ventilation (NIV) or respirator during admittance
Time frame: 14 days
Delta Pa(O2)
Time frame: 4 days
Delta Pa(CO2)
Time frame: 4 days
Delta(pH)
Time frame: 4 days
Change in FEV1
Time frame: 90 days
Change in COPD Assesment Test (CAT)
Time frame: 29 days
Change in Body Mass Index (BMI)
Time frame: 90 days
Delta(TR-gradient)
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No. We have not yet decided to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sildenafil in people with Acute Exacerbation of COPD, run by Chronic Obstructive Pulmonary Disease Trial Network, Denmark at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time alive and out of hospital (time frame: 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.