Effects of Bosentan on Respiratory Mechanics

NCT00679068 | Terminated Phase 4 DMC

• 1 other identifier: 525FSM
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Bosentan has been largely used in the treatment of pulmonary hypertension (PH). It can improve exercise capacity, lower Borg dyspnoea score nad these effects are usually associated with the concomitant improvement in cardiopulmonary haemodynamics. No physiological study has so far verified the hypothesis that Bosentan may laso have an effect on the "respiratory side" of the cadio-pulmonary system (i.e. on pulmonary mechanics and work of breathing)

Conditions

Pulmonary Hypertension

Keywords

respiratory mechanics; bosentan; exercise capacity

Outcome Measures

Primary Outcomes (1)

• Respiratory mechanics (i.e. lung compliance, resistances and work of breathing)

  12 weeks

Secondary Outcomes (1)

• exercise capacity (i.e. 6 mwd), dyspnea, oxygen saturation and cardiac function (i.e. hemodynamic evaluation)

  12 weeks

Study Arms (1)

1

EXPERIMENTAL

treatment with Bosentan

Drug: Bosentan

Interventions

Bosentan DRUG

62.5 mg b.i.d. for 4 weeks, then 125 mg b.i.d.for the remaining 8 weeks (if tolerated)

1

Eligibility Criteria

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

You may qualify if:

• Adult patients with World Health Organization (WHO) functional class II-III.
• PAH confirmed by cardiac catheterization as mean pulmonary arterial pressure greater or equal to25 mm Hg, pulmonary capillary wedge pressure lower 15 mm Hg,

You may not qualify if:

• Patients were excluded if they had patent ductus arteriosus (for hemodynamic assessment difficulties)
• complex congenital heart defect
• left ventricular dysfunction (left ventricular ejection fraction lower 40%)
• restrictive lung disease (total lung capacity lower 70% predicted)
• obstructive lung disease (forced expiratory volume in 1 second \[FEV1\] lower 70% predicted
• with FEV1/forced vital capacity lower 60%)
• or previously diagnosed coronary artery disease.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Respiratory Unit, Fondazione S.Maugeri

Pavia, PV, 27100, Italy

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stefano Nava

  Fondazione S.Maugeri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief ICU

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 16, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: August 20, 2015

Record last verified: 2015-08

Locations

IT (1)