Bronchodilator's Effects on Exertional Dyspnoea in Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02782052
• Date of registration: 17/05/2016
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Bronchodilator's Effects on Exertional Dyspnoea in Pulmonary Arterial Hypertension BD-HTAP
• Scientific title: Bronchodilator's Effects on Exertional Dyspnoea in Pulmonary Arterial Hypertension
• Date of first enrolment: July 2016
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02782052
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Adult (> 18 years old);

2. With signed informed consent;

3. Affiliated to social security system;

4. With idiopathic or heritable PAH , diagnosed according to the current evidence-based
clinical practice guidelines;

5. Irrespective of the treatment received;

6. Clinically stable during the 3 preceding months and the entire duration of the
project;

7. With CPET scheduled within the frame of their clinical follow-up at the reference
center.

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;

4. A FEF75% >60% of predicted normal values at spirometry;

5. A TLC below the 5th percentile of the predicted value;

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;

10. Chronic thromboembolic pulmonary hypertension;

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;

13. Specific contraindications (precautions and drug interactions) to the administration
of IB or IB+SALB.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Nebulized Placebo

Drug: Nebulized ipratropium bromide

Drug: Nebulized combination ipratropium bromide with salbutamol

Primary Outcome(s)

Reduction of 1.0 unit of dyspnoea intensity (on a Borg scale) between pre-dose and post-dose BD measured at a standardized time (iso-time) or V'E (iso-V'E) [Time Frame: At two month (V3), three month (V4) and three months (V5)]

Secondary Outcome(s)

Difference (BDs versus placebo) in CWR endurance time (60 seconds difference) will be also evaluated as potential index of improved exercise tolerance [Time Frame: At two month (V3), three month (V4) and three months (V5)]

Secondary ID(s)

2014-002590-10

P130906

Source(s) of Monetary Support

Please refer to primary and secondary sponsors