Patients with COPD or IIPs (WHO functional class II, III or IV), without hypoxia (PaO2 at rest<
Conditions
Interventions
Treated subgroup In patients with COPD without hypoxia (PaO2<
60mmHg at rest) (WHO functional class II, III or IV), patients with exercise induced elevation of PAP or less severe pulmonary hypertension (mPAP at rest=/>
35mmHg: 15subjects Tracleer, Voriblis or Opsumit Tablets will be administered basically according to the approved dosage and administration. However, in this study conducted in accordance with routi
s condition. Duration of study drug administration: 24 months
Untreated subgroup In patients with COPD without hypoxia (PaO2<
60mmHg at rest) (WHO functional class II, III or IV), patients with exercise induced elevation of PAP or less severe pulmonary hypertension (mPAP at rest=/>
35mmHg: 15subjects Duration of study: 24 months
Treated subgroup In patients with IIPs without hypoxia (PaO2<
60mmHg at rest) (WHO functional class II, III or IV), patients with severe pulmonary hypertension with mPAP at rest=/>
35mmHg : 10subjects Tracleer or Opsumit Tablets will be administered basically according to the approved dosage and administration. However, in this study conducted in accordance with routine clinic
s condition. Duration of study drug administration: 24 months
Treated subgroup In patients with IIPs without hypoxia (PaO2<
25mmH
Sponsors
Department of Respiratory Medicine, Nippon Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients having COPD or IIPs aged 20 years and older (males and females) 2) Patients diagnosed at this hospital as having pulmonary hypertension in patients with COPD or IIPs without hypoxia (PaO2<60mmHg at rest or after 6 minutes walk) (WHO functional class II, III or IV). 3) Patients in a stable disease condition who did not require any change of treatment during the 3 months or more previous to their enrollment. 4) Inpatients and outpatients 5) Patients who provide their written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1) Patients already on Endothelin Receptor Antagonist or other drugs for pulmonary hypertension 2) Patients with any disease that can cause right heart overload 3) Patients with hypoxemia (PaO2<60mmHg at rest ). 4) Women who are pregnant or who may be pregnant, and lactating women 5) Patients with moderate or severe liver disorder 6) Patients under treatment with ciclosporin, tacrolimus, or glibenclamide 6) Other patients judged by the investigator to be inappropriate as a subject of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Influence on survival rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Influence on ADL and Exercise tolerance (2) Influence on cardiac function Change in NT-proBNP or BNP etc, and cardiac function, and these association with ADL, survival rate, or severity of PH. (3) Influence on PFT Change in %DLco and so on, and these association with ADL, survival rate, or severity of PH (4)change from baseline in TEI index and so on (including changes in ICT, ET, IRT,RA size, RV size, and TAPSE etc,) on echocardiography and results of Right heart catheter, and these association with ADL, or severity of PH. (5) Safety of the drug | — |
Countries
Japan
Contacts
Public ContactYosuke Tanaka
Nippon Medical School Department of Respiratory Medicine
Outcome results
None listed