Effect of the Nasal Provocation on the Breathing Style

Study Overview
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Brief Summary
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The purpose of this study is to find out how the provocation of the nose changes breathing style (specifically, frequency and tidal volume changes)

Detailed Description
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It is intended to clarify on both healthy and birch pollen allergic adults how the provocation of the nose with the birch pollen, dilutant and xylometazoline affect the breathing style (breathing pattern) and how these possible changes could be controlled in the measurement of the breathing with respiratory effort belts. In addition to this, our intention is to clarify the effect of the facial mask on the breathing. The allergic and control subjects undergo nasal provocation in 2 sessions. The first is done with birch pollen extract (should block the nose in allergic subjects) and the second with xylometazoline (should open the nose). The mask group undergo similar measurements without nasal exposures. The second objective of the study is to clarify if there are differences between the allergic and control subjects in the function of the autonomous nervous system during these provocations. This is done with the heart rate variability analysis method.

Official Title
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Effect of the Nasal Provocation on the Breathing Style and on the Calibration of Respiratory Effort Belts

Conditions
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Birch Pollen Allergy, Healthy Control Subjects

Intervention / Treatment
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* Biological: 1. session birch pollen nasal exposure 2. session xylometazoline nasal exposure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Birch pollen allergic subjects must have clear nasal symptoms during the birch pollen season and birch specific IgE >= 0.70 Healthy subjects: birch specific IgE < 0.35 The subjects are not allowed to be under medication that affects the function of their nose during a specific time period before the measurement They have to be free of any acute respiratory symptoms during the prior two weeks to the measurements Before measurement, they are not allowed to have heavy meal or sport They are not allowed to have caffeine or other stimulants for 12 hours or alcohol for 24 hours. Exclusion Criteria: Heart diseases Brain circulatory disorders Surgical operations of nose Chronic nasal symptoms Pregnancy Smoker

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allergen and xylometatsolin<br>Two separate exposure sessions: 1) nasal birch pollen exposure 2) nasal xylometazoline exposure | Biological: 1. session birch pollen nasal exposure 2. session xylometazoline nasal exposure<br>* Aquagen SQ 10 000 SQ/ml nasal exposure Xylometazoline 1 mg/ml nasal exposure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breathing style | frequence and volume of breathing measured with spirometry and respiratory effort belts | continuously during 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thorax - abdomen relation | relation of the movements of the thorax and abdomen as measured with the respiratory belts | continuously during 2 hours | 
| activation of the autonomous nervous system | activity of the autonomous nervous system as measured with heart rate variability | continuously during 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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birch pollen, allergy, breathing, pattern, exposure