CClinicalTrials.gg
Status unknownNCT02146300Updated May 23, 2014

Effect of the Nasal Provocation on the Breathing Style

An interventional study of 1. session birch pollen nasal exposure 2. session xylometazoline nasal exposure in Birch Pollen Allergy and Healthy Control Subjects, sponsored by Oulu University Hospital. Status unknown at 1 site in Finland. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-23.

Sponsored by Oulu University Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified May 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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)

Read the 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.

02

Conditions studied

  • Birch Pollen Allergy
  • Healthy Control Subjects

Keywords

  • birch pollen
  • allergy
  • breathing
  • pattern
  • exposure
03

In context

Rhinitis, Allergic, Seasonal

392 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 25 are open to participants now.

This study's planned enrollment of 30 is below the median of 136 across 356 interventional studies indexed under Rhinitis, Allergic, Seasonal.

Browse Rhinitis, Allergic, Seasonal studies →

Lead sponsor

Oulu University Hospital is the lead sponsor of 39 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Heart diseases
  • Brain circulatory disorders
  • Surgical operations of nose
  • Chronic nasal symptoms
  • Pregnancy
  • Smoker
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

Interventions

  • Biological1. session birch pollen nasal exposure 2. session xylometazoline nasal exposure

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

06

What researchers measure

Primary outcomes

  1. breathing style

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

    Time frame: continuously during 2 hours

Secondary outcomes

  1. thorax - abdomen relation

    relation of the movements of the thorax and abdomen as measured with the respiratory belts

    Time frame: continuously during 2 hours

  2. activation of the autonomous nervous system

    activity of the autonomous nervous system as measured with heart rate variability

    Time frame: continuously during 2 hours

07

Study locations

1 site
  • Oulu University hospital, dept of Otorhinolaryngology
    Oulu, FIN-90120, Finland
    • Olli-Pekka Alho, Professor · Contact · Olli-Pekka.Alho@oulu.fi · +358 8 315 3473
    • Tiina Seppänen, PhD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02146300
Lead sponsor
Oulu University Hospital
Responsible party
Sponsor
First posted
May 23, 2014
Start date
Mar 2014
Primary completion
Jun 2014 (estimated)
Completion
Jun 2016 (estimated)
Last update
May 23, 2014

Study contacts

Tiina Seppänen, MSc
Contact
tiina.seppanen@oulu.fi
+358294488028
Olli-Pekka Alho, Professor
Contact
olli-pekka.alho@oulu.fi
+35883153473
Tiina M Seppänen, PhD
principal investigator · University of Oulu
Miia-Liisa Vakkuri, Med Cand
principal investigator · University of Oulu
Tapio Seppänen, Prof
study chair · University of Oulu
Olli-Pekka Alho, Prof
study chair · University of Oulu

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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