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SPHERIC-1. Sildenafil and Pulmonary HypERtension In COPD

NCT01441934 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2013-02-04

No results posted yet for this study

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

Interventions

DRUG

Sildenafil citrate

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

DRUG

Sugar pills

placebo t.i.d.

Sponsors & Collaborators

  • Italian Association of Hospital Pneumologists

    lead OTHER

Principal Investigators

  • Patrizio Vitulo, MD · Dept. of Medicine - Pulmonary Medicine - IsMeTT Palermo, Italy

  • Carmine D. Vizza, MD · Pulmonary Hypertension Center - Dept. of Cardiovascular and Respiratory Sciences - I° School of Medicine - Sapienza University of Rome (Italy)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01441934 on ClinicalTrials.gov