Birch Pollen AllergyNCT02146300
Effect of the Nasal Provocation on the Breathing Style
A study testing 1. session birch pollen nasal exposure 2. session xylometazoline nasal exposure in people with Birch Pollen Allergy and Healthy Control Subjects, run by Oulu University Hospital at 1 site in Finland.
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) Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Birch Pollen Allergy, Healthy Control Subjects
- What is being tested?
- 1. session birch pollen nasal exposure 2. session xylometazoline nasal exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Heart diseases
- Brain circulatory disorders
- Surgical operations of nose
- Chronic nasal symptoms
- Pregnancy
- Smoker
Trial locations and contacts
1 site in 1 country.
Finland1 site
Oulu University hospital, dept of Otorhinolaryngology
Oulu, Oulu, FIN-90120
Olli-Pekka Alho, Professor, +358 8 315 3473, Olli-Pekka.Alho@oulu.fi
Tiina Seppänen, PhD
About this study
Official title: 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)
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.
- Conditions
- Birch Pollen Allergy, Healthy Control Subjects
- Being tested
- 1. session birch pollen nasal exposure 2. session xylometazoline nasal exposure
- Keywords
- birch pollen, allergy, breathing, pattern, exposure
- Medical subject headings
- Hypersensitivity, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. session birch pollen nasal exposure 2. session xylometazoline nasal exposureBiological
Aquagen SQ 10 000 SQ/ml nasal exposure Xylometazoline 1 mg/ml nasal exposure
| Study group | Role | What they receive |
|---|---|---|
| Allergen and xylometatsolin | Experimental | Two separate exposure sessions: 1) nasal birch pollen exposure 2) nasal xylometazoline exposure Receives: Biological: 1. session birch pollen nasal exposure 2. session xylometazoline nasal exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
breathing style
frequence and volume of breathing measured with spirometry and respiratory effort belts
Measured: continuously during 2 hours
Secondary outcomes (2)
thorax - abdomen relation
relation of the movements of the thorax and abdomen as measured with the respiratory belts
Measured: continuously during 2 hours
activation of the autonomous nervous system
activity of the autonomous nervous system as measured with heart rate variability
Measured: continuously during 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2014 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birch Pollen AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiina M Seppänen, PhD, Principal investigator, University of OuluMiia-Liisa Vakkuri, Med Cand, Principal investigator, University of OuluTapio Seppänen, Prof, Study chair, University of OuluOlli-Pekka Alho, Prof, Study chair, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146300
- Sponsor's protocol ID
- Diary number 15/2014
- Status last verified
- May 2014
- First submitted
- 21 May 2014
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Nasal Provocation on the Breathing Style and on the Calibration of Respiratory Effort Belts
- ClinicalTrials.gov ID
- NCT02146300
- Acronym / sponsor ID
- Diary number 15/2014
- Conditions
- Birch Pollen Allergy, Healthy Control Subjects
- Keywords
- birch pollen, allergy, breathing, pattern, exposure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 23 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allergen and xylometatsolin | Experimental | Biological: 1. session birch pollen nasal exposure 2. session xylometazoline nasal exposureTwo separate exposure sessions: 1) nasal birch pollen exposure 2) nasal xylometazoline exposure |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Heart diseases
- Brain circulatory disorders
- Surgical operations of nose
- Chronic nasal symptoms
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1. session birch pollen nasal exposure 2. session xylometazoline nasal exposureAquagen SQ 10 000 SQ/ml nasal exposure Xylometazoline 1 mg/ml nasal exposure | Biological | Allergen and xylometatsolin |
Primary outcome
breathing style
Time frame: continuously during 2 hours
frequence and volume of breathing measured with spirometry and respiratory effort belts
2 secondary outcomes
thorax - abdomen relation
Time frame: continuously during 2 hours
activation of the autonomous nervous system
Time frame: continuously during 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1. session birch pollen nasal exposure 2. session xylometazoline nasal exposure in people with Birch Pollen Allergy and Healthy Control Subjects, run by Oulu University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tiina Seppänen, MSc (+358294488028, tiina.seppanen@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
breathing style (time frame: continuously during 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2014.