|- candidate number||2154|
|- NTR Number||NTR719|
|- Date ISRCTN created||21-jul-2006|
|- date ISRCTN requested||19-jul-2006|
|- Date Registered NTR||30-jun-2006|
|- Secondary IDs||N/A |
|- Public Title||Visualization of the microcirculation of the nasal mucosa in vivo in different nasal disorders, using Sidestream Dark-Field (SDF) imaging.
|- Scientific Title||Visualization of the microcirculation of the nasal mucosa in vivo in different nasal disorders, using Sidestream Dark-Field (SDF) imaging.
|- hypothesis||Xylometazoline nasal spray realizes vasoconstricion in the nasal mucosa, which will be assessed and visualized using SDF imaging.|
|- Healt Condition(s) or Problem(s) studied||Nasal disorders, Microcirculation|
|- Inclusion criteria||1. Patients with active allergic rhinitis, idiopathic rhinitis, chronic rhinosinusitis or nasal polyps;|
2. Males or females aged over 18 years with no maximum age;
3. Approval of the patientís physician;
4. Written informed consent.
|- Exclusion criteria||1. Smoking;|
2. Severe cardiac or pulmonary disorder;
3. Peripheral vascular disease;
systemic: ‚ blockers, corticosteroids (local and systemic);
any local nasal treatment;
bronchodilatory inhalation medication for pulmonary diseases > 1000 žg/day;
5. Cystic fibrosis, Immotile cilia syndrome, Rendu-Osler-Weber disease, vasculitis;
6. Cocaine and/or alcohol abuse.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2006|
|- planned closingdate||1-dec-2006|
|- Target number of participants||20|
|- Interventions||The microcirculation of the nasal mucosa of healthy controls will assessed using a non invasive probe, diameter 0.5 cm, which will be placed in the nasal cavity, twice for a period of approximately 10 minutes. Images will be recorded to make off-line analysis possible. In between the two periods of recording/measuring, the healthy volunteers will get a provocation with xylometazoline nasal spray or placebo. After a few minutes the second measurement will be done to assess the possible differences in the microcirculation.|
|- Primary outcome||The following parameters will be used to asses the microcirculatory reaction after provocation:|
Flow in the capillary, venules and arterioles can be scored semi quantitatively or quantitatively:
1. Semi quantitative scoring:
(0 = no flow, 1 = intermittent flow, 2 = sluggish flow and 3 = continuous flow);
2. Quantitative scoring:
(velocity, flow, diameter, length, density).
|- Secondary outcome||N/A|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. W.J. Fokkens|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. W.J. Fokkens|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Otorhinolaryngology|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Amsterdam|
|- Brief summary||The nose, and in particular the nasal mucosa, is a very dynamic organ system. It combines olfactory and respiratory functions and acts as a first defence mechanism against pathogens. The nose maintains a rich neurovascular network to manage the different tasks of which the nasal microcirculation stands out in managing these very diverse physiological processes. However, little is known about abnormalities of the microcirculation and the role it may play in different nasal dysfunctions or disorders. |
In this study we would like to assess the microcirculation of healthy subjects as well as to observe the expected of a widely used nasal spay: xylometazoline.
This over-the-counter availabele nasal spray works as a decongestent and is widely used.
As a sympathicomimeticum its main effect is vasocontriction. The aim is to visualize this reaction in healthy subjects using a double blind placebo controlled setting.
|- Main changes (audit trail)|
|- RECORD||30-jun-2006 - 14-sep-2009|