COPDPhase 4NCT00730067
Sildenafil for Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension
A Phase 4 study testing sildenafil in people with COPD and Pulmonary Hypertension, run by University of Aarhus at 2 sites in Denmark.
Trial summary
Chronic obstructive pulmonary disease (COPD)can be complicated by an increased pressure in the pulmonary circulation. This worsens the prognosis, but so far it is unknown whether treatment of the increased pulmonary blood pressure betters the patients symptoms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD, Pulmonary Hypertension
- What is being tested?
- sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesDenmark
- Study dates
- Jun 2012to Dec 2012
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A mean pulmonary arterial pressure of 25 mmHg measured by right heart catheterization.
- A diagnosis of COPD-associated pulmonary hypertension, implicating that no other potential cause of pulmonary hypertension is present.
- Stable COPD, defined by no subjective alterations of symptoms or use of short acting beta-antagonists for minimally six weeks. Any exacerbation resulting in admission to hospital or other contacts to a physician must have ceased for at least 6 weeks before entering the study.
- Age > 18
- Informed written consent.
- Reliable anticonception for fertile women.
Who cannot join
- Rheumatic disease limiting walking capacity.
- Exacerbation in COPD during the study.
- Age>80 years
- FEV1 < 25 % of predicted.
- Allergy towards contents of sildenafil or placebo tablets.
- Fall in blood pressure of > 30 mmHg systolic or >20 mmHg diastolic after intake of the first dose of trial medication.
- Fall in peripheral saturation of > 5% after intake of the first dose of trial medication.
- Treatment with nitrous vasodilators or aminophyllamines.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Pulmonary Diseases, Århus Sygehus
Aarhus, Dk-8000
Department of Cardiology, Skejby sygehus
Århus N, DK_8200
About this study
Official title: Sildenafil for COPD-associated Pulmonary Hypertension. A Randomized Double Blinded Placebo Controlled Study.
Chronic obstructive pulmonary disease (COPD)can be complicated by an increased pressure in the pulmonary circulation. This worsens the prognosis, but so far it is unknown whether treatment of the increased pulmonary blood pressure betters the patients symptoms.
In this study 32 patients with increased pulmonary blood pressure due to COPD will be randomized to 3 months treatment with placebo or sildenafil, which is known to lower the pulmonary blood pressure in other types of pulmonary hypertension.
Our hypothesis is that treatment with sildenafil in these patients will improve the functional capacity measured by the distance walked in 6 minutes and life quality.
- Conditions
- COPD, Pulmonary Hypertension
- Being tested
- sildenafil, placebo
- Keywords
- COPD, Pulmonary hypertension, Sildenafil, NT-pro BNP, apelin
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildenafilDrug
Also called Viagra
Sildenafil 50 mg three times daily
placeboDrug
tablet with Laetose mono hydrat, talc,Potato tarch, Gelatin, Magnesium stearate.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sildenafil treatment Receives: Drug: sildenafil |
| 2 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test
Measured: at base line, after 2 hours and after 3 months
Secondary outcomes (4)
assessment of life quality
Measured: At baseline and follow up after three months
Systolic pulmonary pressure
Measured: At baseline and follow-up after three months
Activity of symptoms measured by use of short acting beta agonists
Measured: At baseline and follow-up after three months
Levels of NT-proBNP and apelin
Measured: At baseline and follow-up after three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startJun 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: As a single center, it was not possible to recruit enough patients with pulmonary hypertension
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Charlotte Andersen, University of Aarhus
- Investigators
- Ole Hilberg, MDSC, Principal investigator, Århus SygehusJens Erik Nielsen-Kudsk, MDSC, Principal investigator, Skejby Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730067
- Sponsor's protocol ID
- 2008-002237-73
- Other IDs
- 2008
- Status last verified
- Aug 2012
- First submitted
- 4 Aug 2008
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sildenafil for COPD-associated Pulmonary Hypertension. A Randomized Double Blinded Placebo Controlled Study.
- ClinicalTrials.gov ID
- NCT00730067
- Acronym / sponsor ID
- 2008-002237-73
- Conditions
- COPD, Pulmonary Hypertension
- Keywords
- COPD, Pulmonary hypertension, Sildenafil, NT-pro BNP, apelin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: As a single center, it was not possible to recruit enough patients with pulmonary hypertension
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 8 Aug 2008 (estimated)
- 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.
Chronic obstructive pulmonary disease (COPD)can be complicated by an increased pressure in the pulmonary circulation. This worsens the prognosis, but so far it is unknown whether treatment of the increased pulmonary blood pressure betters the patients symptoms.
In this study 32 patients with increased pulmonary blood pressure due to COPD will be randomized to 3 months treatment with placebo or sildenafil, which is known to lower the pulmonary blood pressure in other types of pulmonary hypertension.
Our hypothesis is that treatment with sildenafil in these patients will improve the functional capacity measured by the distance walked in 6 minutes and life quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: sildenafilSildenafil treatment |
| 2 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A mean pulmonary arterial pressure of 25 mmHg measured by right heart catheterization.
- A diagnosis of COPD-associated pulmonary hypertension, implicating that no other potential cause of pulmonary hypertension is present.
- Stable COPD, defined by no subjective alterations of symptoms or use of short acting beta-antagonists for minimally six weeks. Any exacerbation resulting in admission to hospital or other contacts to a physician must have ceased for at least 6 weeks before entering the study.
- Age > 18
- Informed written consent.
Key exclusion criteria (8 listed)
- Rheumatic disease limiting walking capacity.
- Exacerbation in COPD during the study.
- Age>80 years
- FEV1 < 25 % of predicted.
- Allergy towards contents of sildenafil or placebo tablets.
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: ViagraSildenafil 50 mg three times daily | Drug | 1 |
| placebotablet with Laetose mono hydrat, talc,Potato tarch, Gelatin, Magnesium stearate. | Drug | 2 |
Primary outcome
6 minute walk test
Time frame: at base line, after 2 hours and after 3 months
4 secondary outcomes
assessment of life quality
Time frame: At baseline and follow up after three months
Systolic pulmonary pressure
Time frame: At baseline and follow-up after three months
Activity of symptoms measured by use of short acting beta agonists
Time frame: At baseline and follow-up after three months
Levels of NT-proBNP and apelin
Time frame: At baseline and follow-up after three months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
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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.
Ole Hilberg, MDSC principal investigator
Århus Sygehus
Jens Erik Nielsen-Kudsk, MDSC principal investigator
Skejby Sygehus
2 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 COPD and Pulmonary Hypertension, run by University of Aarhus at 2 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 6 inclusion and 8 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: withdrawn, as of the sponsor's last update on 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
6 minute walk test (time frame: at base line, after 2 hours and after 3 months). 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 23 Aug 2012.