Effect of the Nasal Provocation on the Breathing Style

Birch Pollen Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02146300
• Other study ID #: Diary number 15/2014
• Status: Not yet recruiting
• Phase: N/A
• First received: May 21, 2014
• Last updated: May 22, 2014
• Start date: March 2014
• Est. completion date: June 2016

Study information

• Verified date: May 2014
• Source: Oulu University Hospital
• Contact: Tiina Seppänen, MSc
• Phone: +358294488028
• Email: tiina.seppanen[@]oulu.fi
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2016
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Birch Pollen Allergy
• Healthy Control Subjects
• Rhinitis, Allergic, Seasonal

Intervention

Biological:
• 1. session birch pollen nasal exposure 2. session xylometazoline nasal exposure
Aquagen SQ 10 000 SQ/ml nasal exposure Xylometazoline 1 mg/ml nasal exposure

Locations

Country	Name	City	State
Finland	Oulu University hospital, dept of Otorhinolaryngology	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	breathing style	frequence and volume of breathing measured with spirometry and respiratory effort belts	continuously during 2 hours	No
Secondary	thorax - abdomen relation	relation of the movements of the thorax and abdomen as measured with the respiratory belts	continuously during 2 hours	No
Secondary	activation of the autonomous nervous system	activity of the autonomous nervous system as measured with heart rate variability	continuously during 2 hours	No