Effect of bronchodilators on effort induced dyspnoea in lung hypertension patients

Effect of bronchodilators on effort induced dyspnoea in patients suffering lung hypertension - BD-HTAP

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002590-10-FR

Enrollment

Registered

2016-03-02

Start date

2016-02-11

Completion date

Unknown

Last updated

2020-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic or heritable patients with pulmonary arterial hypertension (PAH). MedDRA version: 18.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Bromure d'Ipratropium Product Name: Bromure d'Ipratropium Pharmaceutical Form: Nebuliser solution INN or Proposed INN: Bromure d'Ipratropium Concentration unit: mg/ml milligram(s)/millilit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Idiopathic or heritable PAH patients, clinically stable during the 3 preceding months, non/never smokers, with normal FEV1/VC ratio but FEF75% ? 60% predicted. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3

Exclusion criteria

Exclusion criteria: 1. Pregnant women 2. Past or current tobacco-smoking history, 3. A spirometric evidence of an obstructive ventilatory defect as defined by a reduced FEV1/VC ratio below the 5th percentile of the predicted value [43], 4. A FEF75% >60% of predicted normal values at spirometry, 5. A TLC below the 5th percentile of the predicted value [43], 6. A body mass index >30 kg.m-2, 7. Use of supplemental oxygen, 8. PAH induced by drugs and toxins, 9. PAH associated with other conditions, including connective tissue diseases, congenital heart diseases, portal hypertension, and HIV infection [42], 10. Chronic thromboembolic pulmonary hypertension [42], 11. Other respiratory, cardiac and other diseases that could contribute to dyspnoea or exercise limitation, 12. Contraindications to clinical exercise testing, such as NYHA functional class IV, syncope and others, as detailed page 28 elsewhere [26, 44]. 1. NYHA functional class IV 2. Syncope 3. Acute myocardial infarction (3-5 days) 4. Unstable angina 5. Uncontrolled arrhythmias causing symptoms or hemodynamic compromise 6. Uncontrolled heart failure 7. Active endocarditis 8. Acute myocarditis or pericarditis 9. Symptomatic severe aortic stenosis 10. Suspected dissecting aneurysm 11. Acute pulmonary embolus or pulmonary infarction 12. Thrombosis of lower extremities 13. Uncontrolled asthma 14. Pulmonary edema 15. Room air desaturation at rest 200 mm Hg systolic, >120 mm Hg diastolic) 4. Tachyarrhythmias or bradyarrhythmias 5. High-degree atrioventricular block 6. Hypertrophic cardiomyopathy 7. Electrolyte abnormalities 8. Orthopedic impairment that compromises exercise performance 13. Specific contraindications (precautions and drug interactions) to the administration of IB or IB+SALB (please refer to section 7).

Design outcomes

Primary

Measure	Time frame
Main Objective: To test the hypothesis that administration of inhaled BDs (?2-agonist and/or anticholinergic), as add-ons to vasodilators, would be beneficial to PAH patients by reducing and/or delaying the rate of onset of DH-induced critical ventilatory constraints, thus ameliorating the exertional symptoms in patients with stable PAH undergoing high-intensity constant work-rate (CWR) cycle endurance test.;Secondary Objective: Difference (BD versus placebo) in CWR endurance time (60 seconds difference) will be also evaluated as potential index of improved exercise tolerance (secondary evaluation criterion).;Primary end point(s): primary endpoint: ameliorating the exertional symptoms in patients with stable PAH undergoing high-intensity constant work-rate (CWR) cycle endurance test. secondary endpoint: potential index of improved exercise tolerance (secondary evaluation criterion).;Timepoint(s) of evaluation of this end point: LSLV	—

Measure

Time frame

Main Objective: To test the hypothesis that administration of inhaled BDs (?2-agonist and/or anticholinergic), as add-ons to vasodilators, would be beneficial to PAH patients by reducing and/or delaying the rate of onset of DH-induced critical ventilatory constraints, thus ameliorating the exertional symptoms in patients with stable PAH undergoing high-intensity constant work-rate (CWR) cycle endurance test.;Secondary Objective: Difference (BD versus placebo) in CWR endurance time (60 seconds difference) will be also evaluated as potential index of improved exercise tolerance (secondary evaluation criterion).;Primary end point(s): primary endpoint: ameliorating the exertional symptoms in patients with stable PAH undergoing high-intensity constant work-rate (CWR) cycle endurance test. secondary endpoint: potential index of improved exercise tolerance (secondary evaluation criterion).;Timepoint(s) of evaluation of this end point: LSLV

—

Secondary

Measure	Time frame
Secondary end point(s): Change (increase) of at least 60 seconds in CWR-CPET endurance time between pre-dose and post-dose BD measured at the end of CWR bouts. This criterion will be used to evaluate the potential improvement in exercise tolerance.;Timepoint(s) of evaluation of this end point: LSLV	—

Countries

France

Contacts

Public ContactDRCD Hôpital St Louis

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

didier.bouton@aphp.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026