Effect of the Nasal Provocation on the Breathing Style

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

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

Study Overview

• Status: Unknown
• Conditions: Birch Pollen Allergy; Healthy Control Subjects
• Intervention / Treatment: Biological: 1. session birch pollen nasal exposure 2. session xylometazoline nasal exposure

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tiina Seppänen, MSc; Phone Number: +358294488028; Email: tiina.seppanen@oulu.fi
• Study Contact Backup: Name: Olli-Pekka Alho, Professor; Phone Number: +35883153473; Email: olli-pekka.alho@oulu.fi

Study Locations

• Finland
  • Oulu, Finland, FIN-90120
    • Oulu University hospital, dept of Otorhinolaryngology
    • Contact: Olli-Pekka Alho, Professor; Phone Number: +358 8 315 3473; Email: Olli-Pekka.Alho@oulu.fi
    • Principal Investigator: Tiina Seppänen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Allergen and xylometatsolin; 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; Aquagen SQ 10 000 SQ/ml nasal exposure Xylometazoline 1 mg/ml nasal exposure

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oulu University Hospital
• Investigators: Principal Investigator: Tiina M Seppänen, PhD, University of Oulu; Principal Investigator: Miia-Liisa Vakkuri, Med Cand, University of Oulu; Study Chair: Tapio Seppänen, Prof, University of Oulu; Study Chair: Olli-Pekka Alho, Prof, University of Oulu

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: May 21, 2014
• First Submitted That Met QC Criteria: May 22, 2014
• First Posted (Estimate): May 23, 2014

Study Record Updates

• Last Update Posted (Estimate): May 23, 2014
• Last Update Submitted That Met QC Criteria: May 22, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: breathing; exposure; allergy; birch pollen; pattern
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis, Allergic; Rhinitis; Respiratory Aspiration; Rhinitis, Allergic, Seasonal; Respiratory System Agents; Vasoconstrictor Agents; Nasal Decongestants; Xylometazoline
• Other Study ID Numbers: Diary number 15/2014