Allergic Rhinitis (Disorder)NPTNCT01436851
Nasal Provocation Testing in Occupational Rhinitis
A study testing Storage mite allergen extracts in people with Allergic Rhinitis (Disorder), run by Haukeland University Hospital at 1 site in Norway.
Trial summary
In a previous study the investigators found that many bakery workers were sensitized to storage mites, and many had rhinitis symptoms. The role of storage mites as an occupational allergen with clinical relevance has been questioned, and the investigators wanted to investigate whether a nasal provocation with a… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Allergic Rhinitis (Disorder)
- What is being tested?
- Storage mite allergen extracts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteNorway
- Study dates
- 24 Nov 2010to Dec 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bakery workers
- > 18 years
- sensitized to a storage mite (A.Siro or L. Destructor)
Who cannot join
- pregnant or breast-feeding
- infection in upper or lower airways the last month
- nasal polyposis
Trial locations and contacts
1 site in 1 country.
Norway1 site
Dept. of Occupational Medicine, Haukeland University Hospital
Bergen, 5021
About this study
Official title: Nasal Provocation Testing With Nasal Lavage in Allergic and Non-allergic Occupational Rhinitis
In a previous study the investigators found that many bakery workers were sensitized to storage mites, and many had rhinitis symptoms. The role of storage mites as an occupational allergen with clinical relevance has been questioned, and the investigators wanted to investigate whether a nasal provocation with a storage mite extract would trigger symptoms and objective signs of rhinitis in bakery workers and a control group.
Read the detailed description
The investigations include allergy testing with skin prick testing, and measuring of specific Immunoglobulin E (IgE) in sera, answering a questionnaire, and symptom scoring before and after provocations. The participants will be investigated one day with a placebo, and another day with the allergen extract of either Acarus Siro or Lepidoglyphus Destructor. As a measurement of nasal patency we use the nasal peak inspiratory flow meter, but also clinical scoring of nasal secretion and blockage. Indices of inflammation (ECP and alfa-Macroglobulin) will be monitored in nasal lavage.
- Conditions
- Allergic Rhinitis (Disorder)
- Being tested
- Storage mite allergen extracts
- Keywords
- rhinitis, allergy, occupational, storage mites, nasal lavage, challenge test, ECP, alfa2Macroglobuline
- Medical subject headings
- Rhinitis, Allergic, Rhinitis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Storage mite allergen extractsBiological
Also called Acarus Siro, Lepidoglyphus Destructor
Nasal provocation with increasing doses of storage mite allergen extracts
| Study group | Role | What they receive |
|---|---|---|
| Storage mite and placebo nasal challenge | Experimental | Provocation in the nose with an allergen extract of a storage mite (A. Siro or L. Destructor) and with placebo allergen extract (physiologic salt water) Receives: Biological: Storage mite allergen extracts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of indices of inflammation in nasal lavage after specific nasal provocation with storage mite allergen
Indices of inflammation (alfa2-macroglobulin, eosinophil cationic protein) in nasal lavage after specific nasal provocation with storage mite allergen (Acarus Siro or Lepidoglyphus Destructor) twice, the second provocation with doubled allergen concentration
Measured: Change from baseline to 10 minutes after nasal provocation
Secondary outcomes (3)
Rhinitis symptoms after specific nasal provocation with storage mite allergen glyphus Destructor)
Rhinitis symptoms measured by symptoms score and visual analog scale, before and after specific nasal provocation with storage mite allergen (Acarus Siro, Lepidoglyphus Destructor) twice, the second time with doubled concentration of allergen
Measured: Change from baseline to 10 minutes after provocation
Reduction in nasal patency measured by peak nasal inspiratory flow meter after specific nasal provocation with storage mite allergen
Reduction in nasal patency measured by peak nasal inspiratory flow meter before and after specific nasal provocation with storage mite allergen (Acarus Siro, Lepidoglyphus Destructor) twice, the second time with doubled concentration of allergen
Measured: Change from baseline to 10 minutes after provocation
Objective signs of rhinitis assessed by rhinoscopy after specific nasal provocation with storage mite allergen
Objective signs of rhinitis assessed by anterior rhinoscopy, and notified as a clinical score before and after specific nasal provocation with storage mite allergen (Acarus Siro, Lepidoglyphus Destructor) twice, second time with the doubled allergen concentration
Measured: Change from baseline to 10 minutes after provocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study start24 Nov 2010
- Primary completion1 Sep 2011
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinitis (Disorder)Studies 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
- Model description
- Participants with storage mite sensitization were challenged with placebo extract and storage mite extract in the nose.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torgeir Storaas, MD PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436851
- Sponsor's protocol ID
- 2009/265
- Acronym
- NPT
- Status last verified
- Aug 2017
- First submitted
- 16 Aug 2011
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Provocation Testing With Nasal Lavage in Allergic and Non-allergic Occupational Rhinitis
- ClinicalTrials.gov ID
- NCT01436851
- Acronym / sponsor ID
- NPT / 2009/265
- Conditions
- Allergic Rhinitis (Disorder)
- Keywords
- rhinitis, allergy, occupational, storage mites, nasal lavage, challenge test, ECP, alfa2Macroglobuline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 24 Nov 2010 (actual)
- Primary completion
- 1 Sep 2011 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Sep 2011 (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.
In a previous study the investigators found that many bakery workers were sensitized to storage mites, and many had rhinitis symptoms. The role of storage mites as an occupational allergen with clinical relevance has been questioned, and the investigators wanted to investigate whether a nasal provocation with a storage mite extract would trigger symptoms and objective signs of rhinitis in bakery workers and a control group.
Detailed description
The investigations include allergy testing with skin prick testing, and measuring of specific Immunoglobulin E (IgE) in sera, answering a questionnaire, and symptom scoring before and after provocations. The participants will be investigated one day with a placebo, and another day with the allergen extract of either Acarus Siro or Lepidoglyphus Destructor. As a measurement of nasal patency we use the nasal peak inspiratory flow meter, but also clinical scoring of nasal secretion and blockage. Indices of inflammation (ECP and alfa-Macroglobulin) will be monitored in nasal lavage.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants with storage mite sensitization were challenged with placebo extract and storage mite extract in the nose.
| Arm | Type | Receives |
|---|---|---|
| Storage mite and placebo nasal challenge | Experimental | Biological: Storage mite allergen extractsProvocation in the nose with an allergen extract of a storage mite (A. Siro or L. Destructor) and with placebo allergen extract (physiologic salt water) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- bakery workers
- > 18 years
- sensitized to a storage mite (A.Siro or L. Destructor)
Key exclusion criteria (3 listed)
- pregnant or breast-feeding
- infection in upper or lower airways the last month
- nasal polyposis
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 |
|---|---|---|
| Storage mite allergen extractsAlso: Acarus Siro, Lepidoglyphus DestructorNasal provocation with increasing doses of storage mite allergen extracts | Biological | Storage mite and placebo nasal challenge |
Primary outcome
Measurements of indices of inflammation in nasal lavage after specific nasal provocation with storage mite allergen
Time frame: Change from baseline to 10 minutes after nasal provocation
Indices of inflammation (alfa2-macroglobulin, eosinophil cationic protein) in nasal lavage after specific nasal provocation with storage mite allergen (Acarus Siro or Lepidoglyphus Destructor) twice, the second provocation with doubled allergen concentration
3 secondary outcomes
Rhinitis symptoms after specific nasal provocation with storage mite allergen glyphus Destructor)
Time frame: Change from baseline to 10 minutes after provocation
Reduction in nasal patency measured by peak nasal inspiratory flow meter after specific nasal provocation with storage mite allergen
Time frame: Change from baseline to 10 minutes after provocation
Objective signs of rhinitis assessed by rhinoscopy after specific nasal provocation with storage mite allergen
Time frame: Change from baseline to 10 minutes after provocation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
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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.
Torgeir Storaas, MD PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Storage mite allergen extracts in people with Allergic Rhinitis (Disorder), run by Haukeland University Hospital at 1 site in Norway.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 16 Aug 2017. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurements of indices of inflammation in nasal lavage after specific nasal provocation with storage mite allergen (time frame: Change from baseline to 10 minutes after nasal provocation). 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 16 Aug 2017.