SPHERIC-1. Sildenafil and Pulmonary HypERtension In COPD

NCT01441934 | Unknown Phase 3 DMC

• 1 other identifier: ARC209
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 10

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

Outcome Measures

Primary Outcomes (1)

• 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

  16 weeks

Secondary Outcomes (5)

• Arterial blood gas analysis

  16 Weeks

• Pulmonary function - Borg scale

  16 Weeks

• Pulmonary function - Bode Index

  16 Weeks

• Functional capacity - Quality of Life

  16 Weeks

• Functional capacity testing - 6 Minutes walking test

  16 Weeks

Study Arms (2)

Sildenafil citrate

ACTIVE COMPARATOR

20 mg t.i.d.

Drug: Sildenafil citrate

Sugar pill

PLACEBO COMPARATOR

Drug: Sugar pills

Interventions

Sildenafil citrate DRUG

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

Also known as: Revatio

Sildenafil citrate

Sugar pills DRUG

placebo t.i.d.

Sugar pill

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Italian Association of Hospital Pneumologists: lead

Study Sites (10)

Pulmonary Unit - Azienda Ospedaliera Ospedale Niguarda Ca' Granda

Milan, Milano, 20162, Italy

ACTIVE NOT RECRUITING

Pulmonary Diseases Clinic - Azienda Ospedaliera Universitaria - Policlinico di Modena

Modena, Modena, 41100, Italy

ACTIVE NOT RECRUITING

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

Napoli, Napoli, 80131, Italy

RECRUITING

Thoracic Surgery Clinic - Azienda Ospedaliera di Padova

Padua, Padova, 35128, Italy

ACTIVE NOT RECRUITING

Dept. of Medicine - Pulmonary Medicine - IsMeTT

Palermo, Palermo, 90127, Italy

RECRUITING

Pulmonary Diseases Clinic - Fondazione IRCCS Policlinico San Matteo

Pavia, Pavia, 27100, Italy

RECRUITING

Pulmonary Hypertension Center - Policlinico Umberto I

Rome, Rome, 00161, Italy

RECRUITING

University Pulmonary Unit - Azienda Ospedaliera Universitaria Senese

Siena, Siena, 53100, Italy

RECRUITING

Pulmonary Unit - Azienda Ospedaliera Universitaria San Giovanni Battista

Torino, Torino, 10143, Italy

RECRUITING

Pulmonary Unit - Azienda Ospedaliera Universitaria Ospedali Riuniti di Trieste

Trieste, Trieste, 34100, Italy

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Disease, Chronic Obstructive

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• 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)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pulmonary Medicine

Study Record Dates

• First Submitted: July 29, 2011
• First Posted: September 28, 2011
• Study Start: October 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 4, 2013

Record last verified: 2013-02

Locations

IT (10)