No registrations found.
ID
Source
Brief title
Health condition
20 healthy volunteers will be exposed to either provocation with xylometazoline nasal spray or placebo.
Sponsors and support
Department of Otolaryngology and Clinical Physiology
Intervention
Outcome measures
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
Background 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.
Study objective
Xylometazoline nasal spray realizes vasoconstricion in the nasal mucosa, which will be assessed and visualized using SDF imaging.
Study design
N/A
Intervention
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.
Room A2-234,
P.O. Box 22660
W.J. Fokkens
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663789
W.J.Fokkens@amc.nl
Room A2-234,
P.O. Box 22660
W.J. Fokkens
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663789
W.J.Fokkens@amc.nl
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 patient’s physician;
4. Written informed consent.
Exclusion criteria
1. Smoking;
2. Severe cardiac or pulmonary disorder;
3. Peripheral vascular disease;
4. Medication:
systemic: â blockers, corticosteroids (local and systemic);
any local nasal treatment;
bronchodilatory inhalation medication for pulmonary diseases > 1000 ìg/day;
5. Cystic fibrosis, Immotile cilia syndrome, Rendu-Osler-Weber disease, vasculitis;
6. Cocaine and/or alcohol abuse.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL710 |
| NTR-old | NTR719 |
| Other | : N/A |
| ISRCTN | ISRCTN67264420 |