COPDPhase 4SIL-COPD-02NCT01055405
Study of Sildenafil Effects in Combination With Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Associated Pulmonary Hypertension
A Phase 4 study testing Sildenafil in people with COPD and Pulmonary Hypertension, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric oxide (NO) pathway in the vessel wall. Read more about this study
- Who is it for?
- Ages 40 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
- 65 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2008to Jan 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD, FEV1 < 80% ref. and FEV1/FVC < 0.7 post bronchodilator
- Age 40-80 years
- Pulmonary hypertension
- Consent to participate in the study
Who cannot join
- Pulmonary or extrapulmonary disease that modifies gas exchange or pulmonary hemodynamics
- Recent exacerbation (<4 weeks) (temporally)
- Patients treated with nitrates or CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir)
- Ischemic optic neuropathy
- Patients treated with phosphodiesterase-5 inhibitors
- Patients with ischemic cardiopathy
- Systemic disease that could modified the results
- Patients unable to practise exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study on the Effects of Sildenafil in Combination With Pulmonary Rehabilitation Program on Exercise Tolerance in Patients With COPD and Pulmonary Hypertension
Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric oxide (NO) pathway in the vessel wall. Since this pathway is impaired in pulmonary arteries of patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD), the investigators hypothesized that sildenafil might improve pulmonary hemodynamics and increase exercise tolerance in this condition.
Read the detailed description
It is a prospective, randomized, double-blind, placebo controlled trial to assess the effect of 3 months treatment with sildenafil (20 mg/8 h), added to a pulmonary rehabilitation program, on exercise tolerance. Subjects: 60 patients (30 by treatment group). Main end-point variable: endurance time in constant work exercise test (CWET). Other measurements: 6 min walk distance, performance in incremental exercise test, physiological and metabolic response at iso-time and iso-load in CWET, dyspnea, and health-related quality of life.
- Conditions
- COPD, Pulmonary Hypertension
- Being tested
- Sildenafil, Placebo
- Keywords
- Exercise tolerance, COPD, Pulmonary hypertension, Sildenafil
- 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 Revatio
Sildenafil 20mg TID orally
PlaceboOther
Placebo TID orally
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil plus pulmonary rehabilitation | Experimental | Not described Receives: Drug: Sildenafil |
| Placebo plus pulmonary rehabilitation | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance time
Measured: 3 months
Secondary outcomes (1)
6 min walk distance, performance in incremental exercise test, physiological and metabolic response at iso-time and iso-load in CWET, dyspnea, and health-related quality of life
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 posted25 Jan 2010 (estimated)
- Study startAug 2008
- Primary completionMar 2011
- Study completionJan 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 COPDStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Albert Barbera Mir, Hospital Clinic of Barcelona
- Investigators
- Joan Albert Barbera, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055405
- Sponsor's protocol ID
- JA Barbera
- Acronym
- SIL-COPD-02
- Status last verified
- Apr 2012
- First submitted
- 22 Jan 2010
- Last updated
- 4 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Blanco I, Santos S, Gea J, Guell R, Torres F, Gimeno-Santos E, Rodriguez DA, Vilaro J, Gomez B, Roca J, Barbera JA. Sildenafil to improve respiratory rehabilitation outcomes in COPD: a controlled trial. Eur Respir J. 2013 Oct;42(4):982-92. doi: 10.1183/09031936.00176312. Epub 2013 Feb 21.
PubMed 23429918
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study on the Effects of Sildenafil in Combination With Pulmonary Rehabilitation Program on Exercise Tolerance in Patients With COPD and Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT01055405
- Acronym / sponsor ID
- SIL-COPD-02 / JA Barbera
- Conditions
- COPD, Pulmonary Hypertension
- Keywords
- Exercise tolerance, COPD, Pulmonary hypertension, Sildenafil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 25 Jan 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.
Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric oxide (NO) pathway in the vessel wall. Since this pathway is impaired in pulmonary arteries of patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD), the investigators hypothesized that sildenafil might improve pulmonary hemodynamics and increase exercise tolerance in this condition.
Detailed description
It is a prospective, randomized, double-blind, placebo controlled trial to assess the effect of 3 months treatment with sildenafil (20 mg/8 h), added to a pulmonary rehabilitation program, on exercise tolerance. Subjects: 60 patients (30 by treatment group). Main end-point variable: endurance time in constant work exercise test (CWET). Other measurements: 6 min walk distance, performance in incremental exercise test, physiological and metabolic response at iso-time and iso-load in CWET, dyspnea, and health-related quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil plus pulmonary rehabilitation | Experimental | Drug: Sildenafil |
| Placebo plus pulmonary rehabilitation | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD, FEV1 < 80% ref. and FEV1/FVC < 0.7 post bronchodilator
- Age 40-80 years
- Pulmonary hypertension
- Consent to participate in the study
Key exclusion criteria (8 listed)
- Pulmonary or extrapulmonary disease that modifies gas exchange or pulmonary hemodynamics
- Recent exacerbation (<4 weeks) (temporally)
- Patients treated with nitrates or CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir)
- Ischemic optic neuropathy
- Patients treated with phosphodiesterase-5 inhibitors
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: RevatioSildenafil 20mg TID orally | Drug | Sildenafil plus pulmonary rehabilitation |
| PlaceboPlacebo TID orally | Other | Placebo plus pulmonary rehabilitation |
Primary outcome
Endurance time
Time frame: 3 months
1 secondary outcome
6 min walk distance, performance in incremental exercise test, physiological and metabolic response at iso-time and iso-load in CWET, dyspnea, and health-related quality of life
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 4 Apr 2012.
- Derived from this study: PubMed 23429918Blanco I, Santos S, Gea J, Guell R, Torres F, Gimeno-Santos E, Rodriguez DA, Vilaro J, Gomez B, Roca J, Barbera JA. Sildenafil to improve respiratory rehabilitation outcomes in COPD: a controlled trial. Eur Respir J. 2013 Oct;42(4):982-92. doi: 10.1183/09031936.00176312. Epub 2013 Feb 21.
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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.
Joan Albert Barbera, MD principal investigator
Hospital Clinic of Barcelona
1 site 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 Hospital Clinic of Barcelona at 1 site in Spain.
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 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 4 Apr 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 Spain. 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 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?
Endurance time (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 NCT01055405, 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 4 Apr 2012.