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NCT01987219 · ClinicalTrials.gov registry record · Phase 3
The Effects Of Bronchodilator Therapy On Respiratory And Autonomic Function In Patients With Familial Dysautonomia
A Phase 3 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 3
- Development phase
- 15
- Enrollment target
NCT01987219 is a Phase 3 study that has completed, run by NYU Langone Health. The registered enrollment target is 15 participants.
The verdict
NCT01987219, a Phase 3 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 15 participants
- Enrollment target
Study Summary
Evaluate the effects of bronchodilator therapy on respiratory function. Our overall goal is to determine whether, in patients with familial dysautonomia (FD), there is a component of airway obstruction that is reversible. To this end, we will evaluate airway resistance before and after receiving the anti-cholinergic ipratropium (Atrovent ®) and the beta-2-agonist albuterol (ProVentil®/Ventolin®). We predict that the response to either drug will depend on the underlying level of sympathetic and parasympathetic activity and airway tone. We will then determine the cardiovascular effects of inhaled ipratropium and albuterol in patients with FD. Because patients with FD have fewer sympathetic neurons and denervation supersenstivity, we predict that following albuterol inhalation, there will be non-selective activation of alpha-1-adrenergic receptors. Furthermore, because of a congenital defect in the afferent baroreceptor neurons that sense blood pressure, we suspect that the resulting vasoconstriction will be unopposed leading to a pressor effect. We hypothesize that inhalation of the anti-cholinergic ipratopium will produce little rise in heart rate, due to the extent of parasympathetic denervation to the heart.
Interventions
- OTHER placebo
- DRUG Albuterol-sulphate
- DRUG Ipratropium-bromide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2013-03 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01987219
The ClinicalTrials.gov registry entry for NCT01987219 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01987219 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01987219 about?
NCT01987219 is a clinical study titled "The Effects Of Bronchodilator Therapy On Respiratory And Autonomic Function In Patients With Familial Dysautonomia". Evaluate the effects of bronchodilator therapy on respiratory function. Our overall goal is to determine whether, in patients with familial dysautonomia (FD), there is a component of airway obstruction that is reversible. To this end, we will evaluate airway resistance before and after receiving the...
What is the current status of trial NCT01987219?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2013-03. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01987219?
The interventions under investigation include: placebo (OTHER), Albuterol-sulphate (DRUG), Ipratropium-bromide (DRUG).
Who is sponsoring clinical trial NCT01987219?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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