SPHERIC-1. Sildenafil and Pulmonary HypERtension In COPD
This study is currently recruiting participants.
Verified February 2013 by Italian Association of Hospital Pneumologists
Sponsor:
Italian Association of Hospital Pneumologists
Information provided by (Responsible Party):
Dr. Patrizio Vitulo, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
ClinicalTrials.gov Identifier:
NCT01441934
First received: July 29, 2011
Last updated: February 1, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Hypertension COPD |
Drug: Sildenafil citrate Drug: Sugar pills |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Gas
High Blood Pressure
Pulmonary Hypertension
U.S. FDA Resources
Further study details as provided by Italian Association of Hospital Pneumologists:
Primary Outcome Measures:
- Pulmonary vascular resistance (PVR) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
PVR are measured by right cath study as the following formula:
PVR= (mean pulmonary arterial pressure-pulmonary arterial wedge pressure)/cardiac output
Secondary Outcome Measures:
- Arterial blood gas analysis [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
- Pulmonary function - Borg scale [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]The dyspnea is assessed by an analogic scale from 0 (no dyspnea) to 10 (very severe dyspnea)
- Pulmonary function - Bode Index [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]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.
- Functional capacity - Quality of Life [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]Quality of Life is assessed by a standardized questionnaire (SF-36 questionnaire) at baseline and the end of study
- Functional capacity testing - 6 Minutes walking test [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]The six-minute walk test is performed in a straight corridor (length 25-30 meters) in the same environmental conditions
| Estimated Enrollment: | 32 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Sildenafil citrate
20 mg t.i.d.
|
Drug: Sildenafil citrate
sildenafil 20 mg t.i.d. compared to placebo 20 mg t.i.d - 16 weeks treatment
Other Name: Revatio
|
| Placebo Comparator: Sugar pill |
Drug: Sugar pills
placebo t.i.d.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441934
Locations
| Italy | |
| Pulmonary Unit - Azienda Ospedaliera Ospedale Niguarda Ca' Granda | Active, not recruiting |
| Milano, Italy, 20162 | |
| Pulmonary Diseases Clinic - Azienda Ospedaliera Universitaria - Policlinico di Modena | Active, not recruiting |
| Modena, Italy, 41100 | |
| Pulmonary Clinic - Federico II University - Azienda Ospedaliera V. Monaldi | Recruiting |
| Napoli, Italy, 80131 | |
| Contact: Matteo Sofia, MD matteo.sofia@unina.it | |
| Thoracic Surgery Clinic - Azienda Ospedaliera di Padova | Active, not recruiting |
| Padova, Italy, 35128 | |
| Dept. of Medicine - Pulmonary Medicine - IsMeTT | Recruiting |
| Palermo, Italy, 90127 | |
| Contact: Patrizio Vitulo, MD 00390912192111 pvitulo@ismett.edu | |
| Pulmonary Diseases Clinic - Fondazione IRCCS Policlinico San Matteo | Recruiting |
| Pavia, Italy, 27100 | |
| Contact: Tiberio Oggionni, MD t.oggionni@smatteo.pv.it | |
| Pulmonary Hypertension Center - Policlinico Umberto I | Recruiting |
| Rome, Italy, 00161 | |
| Contact: Carmime D. Vizza, MD 00390649979051 dario.vizza@uniroma1.it | |
| University Pulmonary Unit - Azienda Ospedaliera Universitaria Senese | Recruiting |
| Siena, Italy, 53100 | |
| Contact: Paola Rottoli, MD rottoli@unisi.it | |
| Pulmonary Unit - Azienda Ospedaliera Universitaria San Giovanni Battista | Recruiting |
| Torino, Italy, 10143 | |
| Contact: Daniela Libertucci, MD dlibertucci@molinette.piemonte.it | |
| Pulmonary Unit - Azienda Ospedaliera Universitaria Ospedali Riuniti di Trieste | Recruiting |
| Trieste, Italy, 34100 | |
| Contact: Marco Confalonieri, MD marco.confalonieri@aots.sanita.fvg.it | |
Sponsors and Collaborators
Italian Association of Hospital Pneumologists
Investigators
| Study Chair: | Patrizio Vitulo, MD | Dept. of Medicine - Pulmonary Medicine - IsMeTT Palermo, Italy |
| Study Chair: | Carmine D. Vizza, MD | Pulmonary Hypertension Center - Dept. of Cardiovascular and Respiratory Sciences - I° School of Medicine - Sapienza University of Rome (Italy) |
More Information
No publications provided
| Responsible Party: | Dr. Patrizio Vitulo, Head of Pulmonary Medicine, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies |
| ClinicalTrials.gov Identifier: | NCT01441934 History of Changes |
| Other Study ID Numbers: | ARC209 |
| Study First Received: | July 29, 2011 |
| Last Updated: | February 1, 2013 |
| Health Authority: | Italy: Ethics Committee Italy: The Italian Medicines Agency |
Additional relevant MeSH terms:
|
Hypertension Hypertension, Pulmonary Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Sildenafil |
Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013