Effect of the Nasal Provocation on the Breathing Style

NCT02146300 | Unknown

• 1 other identifier: Diary number 15/2014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Conditions

Birch Pollen Allergy; Healthy Control Subjects

Keywords

birch pollen; allergy; breathing; pattern; exposure

Outcome Measures

Primary Outcomes (1)

• breathing style

  frequence and volume of breathing measured with spirometry and respiratory effort belts

  continuously during 2 hours

Secondary Outcomes (2)

• thorax - abdomen relation

  continuously during 2 hours

• activation of the autonomous nervous system

  continuously during 2 hours

Study Arms (1)

Allergen and xylometatsolin

EXPERIMENTAL

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

Interventions

1. session birch pollen nasal exposure 2. session xylometazoline nasal exposure BIOLOGICAL

Aquagen SQ 10 000 SQ/ml nasal exposure Xylometazoline 1 mg/ml nasal exposure

Allergen and xylometatsolin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Heart diseases
• Brain circulatory disorders
• Surgical operations of nose
• Chronic nasal symptoms
• Pregnancy
• Smoker

Sponsors & Collaborators

• Oulu University Hospital: lead

Study Sites (1)

Oulu University hospital, dept of Otorhinolaryngology

Oulu, Oulu, FIN-90120, Finland

Location

MeSH Terms

Conditions

Hypersensitivity; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Immune System Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tiina M Seppänen, PhD

  University of Oulu

  PRINCIPAL INVESTIGATOR

• Miia-Liisa Vakkuri, Med Cand

  University of Oulu

  PRINCIPAL INVESTIGATOR

• Tapio Seppänen, Prof

  University of Oulu

  STUDY CHAIR

• Olli-Pekka Alho, Prof

  University of Oulu

  STUDY CHAIR

Central Study Contacts

Tiina Seppänen, MSc

CONTACT

+358294488028; tiina.seppanen@oulu.fi

Olli-Pekka Alho, Professor

CONTACT

+35883153473; olli-pekka.alho@oulu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 23, 2014
• Study Start: March 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2016
• Last Updated: May 23, 2014

Record last verified: 2014-05

Locations

FI (1)