Back to resultsEffect of the Nasal Provocation on the Breathing Style
Primary Purpose
Birch Pollen Allergy, Healthy Control Subjects
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
1. session birch pollen nasal exposure 2. session xylometazoline nasal exposure
Sponsored by
About this trial
This is an interventional diagnostic trial for Birch Pollen Allergy focused on measuring birch pollen, allergy, breathing, pattern, exposure
Eligibility Criteria
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
Sites / Locations
- Oulu University hospital, dept of Otorhinolaryngology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Allergen and xylometatsolin
Arm Description
Two separate exposure sessions: 1) nasal birch pollen exposure 2) nasal xylometazoline exposure
Outcomes
Primary Outcome Measures
breathing style
frequence and volume of breathing measured with spirometry and respiratory effort belts
Secondary Outcome Measures
thorax - abdomen relation
relation of the movements of the thorax and abdomen as measured with the respiratory belts
activation of the autonomous nervous system
activity of the autonomous nervous system as measured with heart rate variability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02146300
Brief Title
Effect of the Nasal Provocation on the Breathing Style
Official Title
Effect of the Nasal Provocation on the Breathing Style and on the Calibration of Respiratory Effort Belts
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oulu University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birch Pollen Allergy, Healthy Control Subjects
Keywords
birch pollen, allergy, breathing, pattern, exposure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Allergen and xylometatsolin
Arm Type
Experimental
Arm Description
Two separate exposure sessions: 1) nasal birch pollen exposure 2) nasal xylometazoline exposure
Intervention Type
Biological
Intervention Name(s)
1. session birch pollen nasal exposure 2. session xylometazoline nasal exposure
Intervention Description
Aquagen SQ 10 000 SQ/ml nasal exposure Xylometazoline 1 mg/ml nasal exposure
Primary Outcome Measure Information:
Title
breathing style
Description
frequence and volume of breathing measured with spirometry and respiratory effort belts
Time Frame
continuously during 2 hours
Secondary Outcome Measure Information:
Title
thorax - abdomen relation
Description
relation of the movements of the thorax and abdomen as measured with the respiratory belts
Time Frame
continuously during 2 hours
Title
activation of the autonomous nervous system
Description
activity of the autonomous nervous system as measured with heart rate variability
Time Frame
continuously during 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiina Seppänen, MSc
Phone
+358294488028
Email
tiina.seppanen@oulu.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Olli-Pekka Alho, Professor
Phone
+35883153473
Email
olli-pekka.alho@oulu.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiina M Seppänen, PhD
Organizational Affiliation
University of Oulu
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Miia-Liisa Vakkuri, Med Cand
Organizational Affiliation
University of Oulu
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tapio Seppänen, Prof
Organizational Affiliation
University of Oulu
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Olli-Pekka Alho, Prof
Organizational Affiliation
University of Oulu
Official's Role
Study Chair
Facility Information:
Facility Name
Oulu University hospital, dept of Otorhinolaryngology
City
Oulu
ZIP/Postal Code
FIN-90120
Country
Finland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olli-Pekka Alho, Professor
Phone
+358 8 315 3473
Email
Olli-Pekka.Alho@oulu.fi
First Name & Middle Initial & Last Name & Degree
Tiina Seppänen, PhD
12. IPD Sharing Statement
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Effect of the Nasal Provocation on the Breathing Style
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