SPHERIC-1. Sildenafil and Pulmonary HypERtension In COPD

NCT ID: NCT01441934

Last Updated: 2013-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-02-28

Brief 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.

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.

Conditions

Pulmonary Hypertension; COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sildenafil citrate

20 mg t.i.d.

Group Type: ACTIVE_COMPARATOR

Sildenafil citrate

Intervention Type: DRUG

sildenafil 20 mg t.i.d. compared to placebo 20 mg t.i.d - 16 weeks treatment

Sugar pill

Group Type: PLACEBO_COMPARATOR

Sugar pills

Intervention Type: DRUG

placebo t.i.d.

Interventions

Sildenafil citrate

sildenafil 20 mg t.i.d. compared to placebo 20 mg t.i.d - 16 weeks treatment

Intervention Type: DRUG

Sugar pills

placebo t.i.d.

Intervention Type: DRUG

Other Intervention Names

Revatio

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Italian Association of Hospital Pneumologists

OTHER

Sponsor Role: lead

Responsible Party

Dr. Patrizio Vitulo

Head of Pulmonary Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrizio Vitulo, MD

Role: STUDY_CHAIR

Dept. of Medicine - Pulmonary Medicine - IsMeTT Palermo, Italy

Carmine D. Vizza, MD

Role: STUDY_CHAIR

Pulmonary Hypertension Center - Dept. of Cardiovascular and Respiratory Sciences - I° School of Medicine - Sapienza University of Rome (Italy)

Locations

Pulmonary Unit - Azienda Ospedaliera Ospedale Niguarda Ca' Granda

Milan, Milano, Italy

Site Status: ACTIVE_NOT_RECRUITING

Pulmonary Diseases Clinic - Azienda Ospedaliera Universitaria - Policlinico di Modena

Modena, Modena, Italy

Site Status: ACTIVE_NOT_RECRUITING

Pulmonary Clinic - Federico II University - Azienda Ospedaliera V. Monaldi

Napoli, Napoli, Italy

Site Status: RECRUITING

Thoracic Surgery Clinic - Azienda Ospedaliera di Padova

Padua, Padova, Italy

Site Status: ACTIVE_NOT_RECRUITING

Dept. of Medicine - Pulmonary Medicine - IsMeTT

Palermo, Palermo, Italy

Site Status: RECRUITING

Pulmonary Diseases Clinic - Fondazione IRCCS Policlinico San Matteo

Pavia, Pavia, Italy

Site Status: RECRUITING

Pulmonary Hypertension Center - Policlinico Umberto I

Rome, Rome, Italy

Site Status: RECRUITING

University Pulmonary Unit - Azienda Ospedaliera Universitaria Senese

Siena, Siena, Italy

Site Status: RECRUITING

Pulmonary Unit - Azienda Ospedaliera Universitaria San Giovanni Battista

Torino, Torino, Italy

Site Status: RECRUITING

Pulmonary Unit - Azienda Ospedaliera Universitaria Ospedali Riuniti di Trieste

Trieste, Trieste, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Matteo Sofia, MD

Role: primary

matteo.sofia@unina.it

Patrizio Vitulo, MD

Role: primary

pvitulo@ismett.edu

00390912192111

Tiberio Oggionni, MD

Role: primary

t.oggionni@smatteo.pv.it

Carmime D. Vizza, MD

Role: primary

dario.vizza@uniroma1.it

00390649979051

Paola Rottoli, MD

Role: primary

rottoli@unisi.it

Daniela Libertucci, MD

Role: primary

dlibertucci@molinette.piemonte.it

Marco Confalonieri, MD

Role: primary

marco.confalonieri@aots.sanita.fvg.it

Other Identifiers

ARC209

Identifier Type: -

Identifier Source: org_study_id