Pulmonary HypertensionPhase 3SPHERIC-1NCT01441934
SPHERIC-1. Sildenafil and Pulmonary HypERtension In COPD
A Phase 3 study testing Sildenafil citrate and Sugar pills in people with Pulmonary Hypertension and COPD, run by Italian Association of Hospital Pneumologists at 10 sites in Italy.
Trial summary
Although pulmonary hypertension (PH) is a quite frequent complication of advanced pulmonary diseases, and it is an independent prognostic factor, until now no evidence-based treatment approach exists for those patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension, COPD
- What is being tested?
- Sildenafil citrate and Sugar pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 10 sitesItaly
- Study dates
- Oct 2010to Feb 2013
- Phase
- Phase 3
- 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
- Patient affected by stable COPD under optimal treatment, chronic oxygen therapy in patients with hypoxia, with PaO2 at rest ≥ 60 mmHg and PaCO2≤ 55 mmHg, aged between 18 and 80 years old:
- Group 1: BPCO GOLD I-III (post bronchodilator FEV1 ≥ 30%, FEV1/FVC ≤ 0,7 , TLC ≥ 70%) + PAPm ≥ 30 mmHg and PCP <15 mmHg
- Group 2: BPCO GOLD IV (post bronchodilator FEV1 <30%, FEV1/FVC ≤ 0,7 , TLC ≥ 70%) + PAPm ≥ 35 mmHg and PCP <15 mmHg
Who cannot join
- Different types of pulmonary hypertension (chronic, thromboembolic pulmonary hypertension, pulmonary arterial hypertension etc.)
- Significant left cardiac disease (LVEF <45%, cardiomyopathy, valvulopathy, unstable coronaropathy)
- Treatment with nitrates in the last 10 days, or in need of other nitrate therapy for different diseases
- Treatment with other specific drugs for arterial pulmonary hypertension (less than 4 weeks)
- Significant systemic disease other than COPD
- Recent exacerbations of chronic bronchitis (< 4 weeks)
Show all 14Show fewer
- Pregnancy or breastfeeding, or women without an adequate contraceptive method for the whole study duration
- History of anaphylaxis or allergic reactions to 5-phosphodiesterase inhibitors
- Cancers within the last 5 years with the exception of localized cancers of the skin or of the cervix
- Hepatic insufficiency or chronic renal failure or hemoglobinemia < 10 g/dL during the screening phase
- Contraindications to subministration as per SPC
- Mental disorder, alcohol abuse, chronic alcoholism, drug abuse
- Subjects unable to sign the informed consent form
- Subjects unable to walk
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites, 7 recruiting
- Active, not recruiting
Pulmonary Unit - Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Milan, Milano, 20162
- Active, not recruiting
Pulmonary Diseases Clinic - Azienda Ospedaliera Universitaria - Policlinico di Modena
Modena, Modena, 41100
- Recruiting
Pulmonary Clinic - Federico II University - Azienda Ospedaliera V. Monaldi
Naples, Napoli, 80131
Matteo Sofia, MD, matteo.sofia@unina.it
- Active, not recruiting
Thoracic Surgery Clinic - Azienda Ospedaliera di Padova
Padova, Padova, 35128
- Recruiting
Dept. of Medicine - Pulmonary Medicine - IsMeTT
Palermo, Palermo, 90127
Patrizio Vitulo, MD, 00390912192111, pvitulo@ismett.edu
- Recruiting
Pulmonary Diseases Clinic - Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, 27100
Tiberio Oggionni, MD, t.oggionni@smatteo.pv.it
- Recruiting
Pulmonary Hypertension Center - Policlinico Umberto I
Rome, Rome, 00161
Carmime D. Vizza, MD, 00390649979051, dario.vizza@uniroma1.it
- Recruiting
University Pulmonary Unit - Azienda Ospedaliera Universitaria Senese
Siena, Siena, 53100
Paola Rottoli, MD, rottoli@unisi.it
- Recruiting
Pulmonary Unit - Azienda Ospedaliera Universitaria San Giovanni Battista
Torino, Torino, 10143
Daniela Libertucci, MD, dlibertucci@molinette.piemonte.it
- Recruiting
Pulmonary Unit - Azienda Ospedaliera Universitaria Ospedali Riuniti di Trieste
Trieste, Trieste, 34100
Marco Confalonieri, MD, marco.confalonieri@aots.sanita.fvg.it
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of Sildenafil in the Treatment of Patients With Pulmonary Hypertension Associated to Chronic Obstructive Lung Disease
Although pulmonary hypertension (PH) is a quite frequent complication of advanced pulmonary diseases, and it is an independent prognostic factor, until now no evidence-based treatment approach exists for those patients.
This study will address if the drug sildenafil can lower pulmonary vascular resistance in patients with significant pulmonary hypertension (high blood pressure in the lungs) associated to chronic obstructive pulmonary disease (COPD). It will see if this treatment can improve effort capacity, quality of life without causing a deterioration in pulmonary gas exchange (mainly arterial oxygenation).
Read more
Patients 18 years of age and older with moderate COPD and pulmonary hypertension (mean pulmonary arterial pressure >30 mmHg) may be eligible for this study. Participants are randomly assigned to receive sildenafil or placebo (pill with no drug) for 16 weeks.
Before starting treatment (baseline), and a the end of the study, the patients have a comprehensive assessment including:
- a chest x-ray and CT scan (only at baseline);
- pulmonary function tests to measure how much air the patient can breathe in and out, and the capacity of diffusion of gases;
- arterial blood gases analysis (for safety reason this examination is performed at baseline, before the randomization after one hour from the administration of a tablet (20 mg) of sildenafil, and every month)
- an echocardiogram (heart ultrasound) (only at baseline);
- a 6-minute walk test to measure exercise capacity;
- a quality-of-life assessment (SF-36 questionnaire)
- a right heart catheterization to evaluate the severity of hypertension
At the end of the 16-week period, patients may opt to continue to receive sildenafil and monitoring in an open-label phase of the study for up to 1 year.
- Conditions
- Pulmonary Hypertension, COPD
- Being tested
- Sildenafil citrate, Sugar pills
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil citrateDrug
Also called Revatio
sildenafil 20 mg t.i.d. compared to placebo 20 mg t.i.d - 16 weeks treatment
Sugar pillsDrug
placebo t.i.d.
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil citrate | Active comparator | 20 mg t.i.d. Receives: Drug: Sildenafil citrate |
| Sugar pill | Placebo comparator | Not described Receives: Drug: Sugar pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary vascular resistance (PVR)
PVR are measured by right cath study as the following formula:
PVR= (mean pulmonary arterial pressure-pulmonary arterial wedge pressure)/cardiac output
Measured: 16 weeks
Secondary outcomes (5)
Arterial blood gas analysis
Measured: 16 Weeks
Pulmonary function - Borg scale
The dyspnea is assessed by an analogic scale from 0 (no dyspnea) to 10 (very severe dyspnea)
Measured: 16 Weeks
Pulmonary function - Bode Index
The BODE Index is a composite marker of disease taking into consideration the systemic nature of COPD: FEV1% pred = predicted amount as a percentage of the forced expiratory lung volume in one second; 6MWD = six minute walking distance; MMRC = modified medical research council dyspnea scale; BMI = body mass index.
Measured: 16 Weeks
Functional capacity - Quality of Life
Quality of Life is assessed by a standardized questionnaire (SF-36 questionnaire) at baseline and the end of study
Measured: 16 Weeks
Functional capacity testing - 6 Minutes walking test
The six-minute walk test is performed in a straight corridor (length 25-30 meters) in the same environmental conditions
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startOct 2010
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Italian Association of Hospital Pneumologists
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Patrizio Vitulo, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
- Investigators
- Patrizio Vitulo, MD, Study chair, Dept. of Medicine - Pulmonary Medicine - IsMeTT Palermo, ItalyCarmine D. Vizza, MD, Study chair, Pulmonary Hypertension Center - Dept. of Cardiovascular and Respiratory Sciences - I° School of Medicine - Sapienza University of Rome (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441934
- Sponsor's protocol ID
- ARC209
- Acronym
- SPHERIC-1
- Status last verified
- Feb 2013
- First submitted
- 29 Jul 2011
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of Sildenafil in the Treatment of Patients With Pulmonary Hypertension Associated to Chronic Obstructive Lung Disease
- ClinicalTrials.gov ID
- NCT01441934
- Acronym / sponsor ID
- SPHERIC-1 / ARC209
- Conditions
- Pulmonary Hypertension, COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Italian Association of Hospital PneumologistsUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 28 Sep 2011 (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.
Although pulmonary hypertension (PH) is a quite frequent complication of advanced pulmonary diseases, and it is an independent prognostic factor, until now no evidence-based treatment approach exists for those patients.
This study will address if the drug sildenafil can lower pulmonary vascular resistance in patients with significant pulmonary hypertension (high blood pressure in the lungs) associated to chronic obstructive pulmonary disease (COPD). It will see if this treatment can improve effort capacity, quality of life without causing a deterioration in pulmonary gas exchange (mainly arterial oxygenation).
Patients 18 years of age and older with moderate COPD and pulmonary hypertension (mean pulmonary arterial pressure >30 mmHg) may be eligible for this study. Participants are randomly assigned to receive sildenafil or placebo (pill with no drug) for 16 weeks.
Before starting treatment (baseline), and a the end of the study, the patients have a comprehensive assessment including:
- a chest x-ray and CT scan (only at baseline);
- pulmonary function tests to measure how much air the patient can breathe in and out, and the capacity of diffusion of gases;
- arterial blood gases analysis (for safety reason this examination is performed at baseline, before the randomization after one hour from the administration of a tablet (20 mg) of sildenafil, and every month)
- an echocardiogram (heart ultrasound) (only at baseline);
- a 6-minute walk test to measure exercise capacity;
- a quality-of-life assessment (SF-36 questionnaire)
- a right heart catheterization to evaluate the severity of hypertension
At the end of the 16-week period, patients may opt to continue to receive sildenafil and monitoring in an open-label phase of the study for up to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil citrate | Active comparator | Drug: Sildenafil citrate20 mg t.i.d. |
| Sugar pill | Placebo comparator | Drug: Sugar pills |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient affected by stable COPD under optimal treatment, chronic oxygen therapy in patients with hypoxia, with PaO2 at rest ≥ 60 mmHg and PaCO2≤ 55 mmHg, aged between 18 and 80 years old:
- Group 1: BPCO GOLD I-III (post bronchodilator FEV1 ≥ 30%, FEV1/FVC ≤ 0,7 , TLC ≥ 70%) + PAPm ≥ 30 mmHg and PCP <15 mmHg
- Group 2: BPCO GOLD IV (post bronchodilator FEV1 <30%, FEV1/FVC ≤ 0,7 , TLC ≥ 70%) + PAPm ≥ 35 mmHg and PCP <15 mmHg
Key exclusion criteria (14 listed)
- Different types of pulmonary hypertension (chronic, thromboembolic pulmonary hypertension, pulmonary arterial hypertension etc.)
- Significant left cardiac disease (LVEF <45%, cardiomyopathy, valvulopathy, unstable coronaropathy)
- Treatment with nitrates in the last 10 days, or in need of other nitrate therapy for different diseases
- Treatment with other specific drugs for arterial pulmonary hypertension (less than 4 weeks)
- Significant systemic disease other than COPD
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 |
|---|---|---|
| Sildenafil citrateAlso: Revatiosildenafil 20 mg t.i.d. compared to placebo 20 mg t.i.d - 16 weeks treatment | Drug | Sildenafil citrate |
| Sugar pillsplacebo t.i.d. | Drug | Sugar pill |
Primary outcome
Pulmonary vascular resistance (PVR)
Time frame: 16 weeks
PVR are measured by right cath study as the following formula: PVR= (mean pulmonary arterial pressure-pulmonary arterial wedge pressure)/cardiac output
5 secondary outcomes
Arterial blood gas analysis
Time frame: 16 Weeks
Pulmonary function - Borg scale
Time frame: 16 Weeks
Pulmonary function - Bode Index
Time frame: 16 Weeks
Functional capacity - Quality of Life
Time frame: 16 Weeks
Functional capacity testing - 6 Minutes walking test
Time frame: 16 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
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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.
Pulmonary Clinic - Federico II University - Azienda Ospedaliera V. Monaldi
Naples, Italy
Pulmonary Diseases Clinic - Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Patrizio Vitulo, MD study chair
Dept. of Medicine - Pulmonary Medicine - IsMeTT Palermo, Italy
Carmine D. Vizza, MD study chair
Pulmonary Hypertension Center - Dept. of Cardiovascular and Respiratory Sciences - I° School of Medicine - Sapienza University of Rome (Italy)
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sildenafil citrate and Sugar pills in people with Pulmonary Hypertension and COPD, run by Italian Association of Hospital Pneumologists at 10 sites in Italy.
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 14 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: status not confirmed, as of the sponsor's last update on 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary vascular resistance (PVR) (time frame: 16 weeks). 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 4 Feb 2013.