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    Summary
    EudraCT Number:2010-020917-97
    Sponsor's Protocol Code Number:ARC209
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-28
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-020917-97
    A.3Full title of the trial
    SPHERIC-1 (Sildenafil in the Chronic Obstructive Pulmonary Disease associated to Chronic Pulmonary Hypertension. Sixteen weeks long, multicentre, randomized, double blind study, in comparison with placebo, for the evaluation of sildenafil in the treatment of patients affected by pulmonary hypertension associated to COPD.
    SPHERIC-1 (Sildenafil nelle Pneumopatie ostruttive cHE pResentano Ipertensione Polmonare Cronica) - Studio multicentrico, randomizzato, a doppio cieco, verso placebo, della durata di 16 settimane che valuta l’effetto del sildenafil nel trattamento di pazienti con ipertensione polmonare associata a BPCO
    A.3.2Name or abbreviated title of the trial where available
    SPHERIC-1
    SPHERIC-1
    A.4.1Sponsor's protocol code numberARC209
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASSOCIAZIONE ITALIANA PNEUMOLOGI OSPEDALIERI
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ITALIA Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/03/178
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSildenafil
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe pulmonary hypertension associated to moderate to mild COPD.
    Ipertensione polmonare moderata-severa associata a BPCO lieve-moderata.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10064911
    E.1.2Term Pulmonary arterial hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate the superiority of sildenafil (20 mg tid) compared to placebo in the reduction of the pulmonary vascular resistance after 16 weeks of treatment.
    Dimostrare la superiorita' del sildenafil (20 mg tid) rispetto al placebo nella riduzione delle resistenze vascolari polmonari di pazienti con ipertensione polmonare associata a BPCO dopo 16 settimane di trattamento.
    E.2.2Secondary objectives of the trial
    Evaluation of sildenafil safety profile in comparison to placebo. Evaluation of sildenafil effect on the exercise capacity, symptoms and quality of life in comparison to placebo.
    Valutare il profilo di sicurezza del sildenafil paragonato al placebo. Valutare l’effetto del sildenafil sulla tolleranza allo sforzo, sintomi e qualita' di vita rispetto al placebo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    LIFE QUALITY:
    Vers:1.0
    Date:2010/05/21
    Title:
    Objectives:

    QUALITA DELLA VITA:
    Vers:1.0
    Data:2010/05/21
    Titolo:Questionario di Qualita' della Vita SF-36 nell'ambito del protocollo: SPHERIC-1 (Sildenafil nelle Pneumopatie ostruttive cHE pResentano Ipertensione Polmonare Cronica) - Studio multicentrico, randomizzato, a doppio cieco, verso placebo, della durata di 16 settimane che valuta l’effetto del sildenafil nel trattamento di pazienti con ipertensione polmonare associata a BPCO
    Obiettivi:Valutazione della qualita' della vita correlata alla salute.

    E.3Principal 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.
    Pazienti con BPCO stabile in ottimale trattamento farmacologico e in O2 terapia a lungo termine se ipossici, con PaO2 a riposo in aria o corretta ≥ 60 mmHg e PaCO2≤ 55 mmHg, di eta' compresa fra i 18 e gli 80 anni: • Gruppo 1: BPCO GOLD I‐III (post broncodilatatore FEV1 ≥ 30%, FEV1/FVC ≤ 0,7 , TLC ≥ 70%) + PAPm ≥ 30 mmHg e PCP &lt;15 mmHg • Gruppo 2: BPCO GOLD IV (post broncodilatatore FEV1 &lt;30%, FEV1/FVC ≤ 0,7 , TLC ≥ 70%) + PAPm ≥ 35 mmHg e PCP &lt;15 mmHg.
    E.4Principal 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 reacutization of chronic bronchitis (< 4 weeks) • Pregnancy or breastfeeding, or women without an adequate contraceptive method for the whole study duration • History of anaphylaxys 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
    • Altre forme di ipertensione polmonare (ipertensione polmonare cronica trombo embolica, ipertensione arteriosa polmonare, ecc.) • Significativa malattia cardiaca sinistra (LVEF &lt;45%, cardiomiopatie, valvulopatie, coronaropatia instabile) • Trattamento con i nitrati negli ultimi 10 giorni, o necessita' di una terapia di nitrato per altre malattie • Trattamento con altri farmaci specifici per l'ipertensione arteriosa polmonare (da meno di 4 settimane) • Significativa malattia sistemica diversa da BPCO • Recente riacutizzazione bronchitica (&lt; 4 settimane) • Donne in gravidanza o in allattamento, oppure donne in eta' fertile che non facciano uso di adeguati metodi anticoncezionali per tutta la durata dello studio • Storia di anafilassi o reazioni allergiche ai derivati degli inibitori della fosfodiesterasi‐5 • Presenza di malattia tumorale entro 5 anni ad eccezione di carcinomi localizzati della cute o della cervice • Insufficienza epatica o insufficienza renale cronica o emoglobinemia &lt; 10 g/dL allo screening • Controindicazioni alla somministrazione del farmaco secondo quanto riportato in scheda tecnica • Instabilita' mentale, abuso di alcool o alcolismo cronico, uso di droghe • Soggetti non in grado di firmare un consenso informato • Soggetti non in grado di deambulare
    E.5 End points
    E.5.1Primary end point(s)
    Significant reduction of basal pulmonary vascular resistance at rest, after 16 weeks of treatment with sildenafil compared with placebo.
    Riduzione significativa delle resistenze vascolari polmonari (RVP) basali a riposo dopo 16 settimane di trattamento con sildenafil rispetto al trattamento con placebo.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months16
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state42
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-23
    P. End of Trial
    P.End of Trial StatusCompleted
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