Chronic Obstructive Pulmonary DiseasePhase 2NCT01197469
Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Hypertension?
A Phase 2 study testing Tadalafil in people with Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension, run by University of Dundee at 1 site in United Kingdom.
Trial summary
The investigators hypothesise that phosphodiesterase 5A inhibitors will improve exercise capacity in those with Chronic Obstructive Pulmonary Disease and secondary pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension
- What is being tested?
- Tadalafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Sep 2012
- Phase
- Phase 2
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD
- Forced expiratory volume in 1 second (FEV1) <80% (FEV1/FVC <0.70)
- Right ventricular systolic pressure (RVSP) > 30 mmHg or Pulmonary Acceleration time <120 ms
Who cannot join
- Pulmonary stenosis or echo left ventricular outflow tract obstruction
- Left ventricular ejection fraction < 45%
- Patients taking nitrates, nicorandil or doxazosin.
- Drug contraindications:
- Systolic Blood Pressure <90 mmHg
- recent stroke
- unstable angina
- past history of non arteritic anterior ischaemic optic neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension?
The investigators hypothesise that phosphodiesterase 5A inhibitors will improve exercise capacity in those with Chronic Obstructive Pulmonary Disease and secondary pulmonary hypertension.
- Being tested
- Tadalafil, Placebo
- Keywords
- Secondary Pulmonary Hypertension
- 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.
TadalafilDrug
Tadalafil 10mg once daily for 3 months
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Tadalafil | Active comparator | Not described Receives: Drug: Tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walking distance
The investigators will perform a baseline 6 minute walking distance (0 months) and repeat the measure at 2 months and finally at 3 months
Measured: 3 months
Secondary outcomes (4)
Quality of Life
The investigators will measure baseline quality of life (0 months) using St George's Respiratory Questionnaire, SF-36v2, Minnesota Heart Failure Questionnaire. These questionnaires will be repeated at 2 and 3 months (final measurement).
Measured: 3 months
B- Natriuretic Peptide (BNP)
Will be measured at 0, 2 and 3 months
Measured: 3 months
Diffusion lung capacity for carbon monoxide (DLCO)
Will be measured at 0 and 3 months
Measured: 3 months
Echocardiographic measurements
Will be measured at 0 and 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government, NHS Tayside, NHS Fife
- Responsible party
- Principal investigator, A. D. Struthers, University of Dundee
- Investigators
- Allan Struthers, MBChB, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197469
- Sponsor's protocol ID
- 2008CV17
- Status last verified
- Nov 2012
- First submitted
- 1 Sep 2010
- Last updated
- 6 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Goudie AR, Lipworth BJ, Hopkinson PJ, Wei L, Struthers AD. Tadalafil in patients with chronic obstructive pulmonary disease: a randomised, double-blind, parallel-group, placebo-controlled trial. Lancet Respir Med. 2014 Apr;2(4):293-300. doi: 10.1016/S2213-2600(14)70013-X. Epub 2014 Mar 5.
PubMed 24717626
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension?
- ClinicalTrials.gov ID
- NCT01197469
- Acronym / sponsor ID
- 2008CV17
- Keywords
- Secondary Pulmonary Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government, NHS Tayside, NHS Fife
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 9 Sep 2010 (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.
The investigators hypothesise that phosphodiesterase 5A inhibitors will improve exercise capacity in those with Chronic Obstructive Pulmonary Disease and secondary pulmonary hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Tadalafil | Active comparator | Drug: Tadalafil |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COPD
- Forced expiratory volume in 1 second (FEV1) <80% (FEV1/FVC <0.70)
- Right ventricular systolic pressure (RVSP) > 30 mmHg or Pulmonary Acceleration time <120 ms
Key exclusion criteria (8 listed)
- Pulmonary stenosis or echo left ventricular outflow tract obstruction
- Left ventricular ejection fraction < 45%
- Patients taking nitrates, nicorandil or doxazosin.
- Drug contraindications:
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 |
|---|---|---|
| TadalafilTadalafil 10mg once daily for 3 months | Drug | Tadalafil |
| Placebo | Drug | Placebo |
Primary outcome
6 minute walking distance
Time frame: 3 months
The investigators will perform a baseline 6 minute walking distance (0 months) and repeat the measure at 2 months and finally at 3 months
4 secondary outcomes
Quality of Life
Time frame: 3 months
B- Natriuretic Peptide (BNP)
Time frame: 3 months
Diffusion lung capacity for carbon monoxide (DLCO)
Time frame: 3 months
Echocardiographic measurements
Time frame: 3 months
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 6 Nov 2012.
- Derived from this study: PubMed 24717626Goudie AR, Lipworth BJ, Hopkinson PJ, Wei L, Struthers AD. Tadalafil in patients with chronic obstructive pulmonary disease: a randomised, double-blind, parallel-group, placebo-controlled trial. Lancet Respir Med. 2014 Apr;2(4):293-300. doi: 10.1016/S2213-2600(14)70013-X. Epub 2014 Mar 5.
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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.
Allan Struthers, MBChB principal investigator
University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tadalafil in people with Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension, run by University of Dundee at 1 site in United Kingdom.
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 3 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: finished, as of the sponsor's last update on 6 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
6 minute walking distance (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01197469, which also lists 1 linked publication.
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 6 Nov 2012.