Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

SPHERIC-1. Sildenafil and Pulmonary HypERtension In COPD (SPHERIC-1)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Italian Association of Hospital Pneumologists.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Dr. Patrizio Vitulo, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies Identifier:
First received: July 29, 2011
Last updated: February 1, 2013
Last verified: February 2013

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
Drug: Sildenafil citrate
Drug: Sugar pills
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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:

Further study details as provided by Italian Association of Hospital Pneumologists:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Arterial blood gas analysis [ Time Frame: 16 Weeks ]
  • Pulmonary function - Borg scale [ Time Frame: 16 Weeks ]
    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 ]
    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 ]
    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 ]
    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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01441934

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   
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   
Pulmonary Diseases Clinic - Fondazione IRCCS Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Contact: Tiberio Oggionni, MD   
Pulmonary Hypertension Center - Policlinico Umberto I Recruiting
Rome, Italy, 00161
Contact: Carmime D. Vizza, MD    00390649979051   
University Pulmonary Unit - Azienda Ospedaliera Universitaria Senese Recruiting
Siena, Italy, 53100
Contact: Paola Rottoli, MD   
Pulmonary Unit - Azienda Ospedaliera Universitaria San Giovanni Battista Recruiting
Torino, Italy, 10143
Contact: Daniela Libertucci, MD   
Pulmonary Unit - Azienda Ospedaliera Universitaria Ospedali Riuniti di Trieste Recruiting
Trieste, Italy, 34100
Contact: Marco Confalonieri, MD   
Sponsors and Collaborators
Italian Association of Hospital Pneumologists
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

Responsible Party: Dr. Patrizio Vitulo, Head of Pulmonary Medicine, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies Identifier: NCT01441934     History of Changes
Other Study ID Numbers: ARC209
Study First Received: July 29, 2011
Last Updated: February 1, 2013

Additional relevant MeSH terms:
Hypertension, Pulmonary
Pulmonary Disease, Chronic Obstructive
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Sildenafil Citrate
Citric Acid
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Calcium Chelating Agents
Chelating Agents
Sequestering Agents processed this record on April 28, 2017