Effect of the Nasal Provocation on the Breathing Style

Not Applicable

• Conditions: Birch Pollen Allergy; Healthy Control Subjects
• Interventions: Biological: 1. session birch pollen nasal exposure 2. session xylometazoline nasal exposure

• Registration Number: NCT02146300
• Lead Sponsor: Oulu University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-03
• Status Verified: 2014-05
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-22
• Last Update Submitted: 2014-05-22
• Study First Posted: 2014-05-23
• Last Update Posted: 2014-05-23
• Primary Completion: 2014-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Allergen and xylometatsolin	1. session birch pollen nasal exposure 2. session xylometazoline nasal exposure	Two separate exposure sessions: 1) nasal birch pollen exposure 2) nasal xylometazoline exposure

Primary Outcome Measures

Name	Time	Method
breathing style	continuously during 2 hours	frequence and volume of breathing measured with spirometry and respiratory effort belts

Secondary Outcome Measures

Name	Time	Method
thorax - abdomen relation	continuously during 2 hours	relation of the movements of the thorax and abdomen as measured with the respiratory belts
activation of the autonomous nervous system	continuously during 2 hours	activity of the autonomous nervous system as measured with heart rate variability

Trial Locations

Locations (1)

Oulu University hospital, dept of Otorhinolaryngology; 🇫🇮 Oulu, Finland