Allergic RhinitisNCT01110837
Repeat Dose Nasal Allergen Challenge
A study testing Allergen in people with Allergic Rhinitis, run by McMaster University at 1 site in Canada.
Trial summary
What happens in the nose during an allergic reaction? Are there changes that a new drug could treat? What is the best way to test new drugs?The response of the nose to being exposed to cat allergen in someone who is allergic to cats. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Allergen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Apr 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged over 18 able to understand and sign the written consent form.
- Able to comply with study procedures and protocol.
- Positive skin prick test (wheal difference ≥ 3mm compared to negative control) to cat at or within 12 months preceding the screening visit.
- Clear history of nasal symptoms on exposure to cats.
- Otherwise healthy with no other health problems, other than mild asthma controlled by intermittent β2-agonist use, that may prevent the subject participating in the study.
Who cannot join
- Presence of perennial rhinitis or seasonal allergic rhinitis.
- TNSS < 2 at screening
- Viral URTI within the 2 weeks prior to screening.
- Current smoker or history of smoking within the previous 3 months.
- Presence of any structural nasal abnormalities or nasal polyps on examination, a history of frequent nose bleeding, nasal surgery within the previous 3 months.
- Use of concomitant medication that could affect responses to nasal challenge (e.g. corticosteroids, decongestants, anti-histamines) or any other nasally applied medication within 2 weeks prior to screening.
- Participation in any other clinical trials within the previous 3 months.
- Use of inhaled corticosteroids within the 2 months prior to screening.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St Joseph's Healthcare
Hamitlon, Ontario, L8N 4A6
About this study
Official title: Repeat Dose Nasal Allergen Challenge: Development of a Model to Investigate the Cellular and Inflammatory Changes That Occur in Allergic Rhinitis
What happens in the nose during an allergic reaction? Are there changes that a new drug could treat? What is the best way to test new drugs?The response of the nose to being exposed to cat allergen in someone who is allergic to cats. Symptoms, level of nasal blockage and cell and chemical changes that occur in the nose will be studied before and after being exposed to cat allergen. The investigators will also to see if giving repeated doses of allergen increases the response.Allergic rhinitis is a very common illness. There are over 500 million patients worldwide. It can increase the severity of associated asthma. Currently available drugs do not completely treat the symptoms. New treatments need to be found. A way of testing these drugs is very important. This study will investigate causes of the symptoms that occur in allergic rhinitis. It will also validate a proposed model to test new drugs. the Study Hypothesis is that a model of nasal allergen challenge shows an increased response (priming) with repeat challenges as determined by changes in nasal peak inspiratory flow.
- Conditions
- Allergic Rhinitis
- Being tested
- Allergen, Placebo challenge
- Keywords
- Allergic rhinitis, Allergen
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllergenOther
Allergen nasal challenge
Placebo challengeOther
Placebo nasal challenge
| Study group | Role | What they receive |
|---|---|---|
| Allergen | Active comparator | Not described Receives: Other: Allergen |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak nasal inspiratory flow following repeat allergen challenge
The peak nasal inspiratory flow will be measured using a hand-held peak flow meter, and changes will be measured following repeated allergen challenge.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor
- Investigators
- Helen Neighbour, MB BS, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110837
- Sponsor's protocol ID
- #09-3232
- Status last verified
- Oct 2012
- First submitted
- 23 Apr 2010
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeat Dose Nasal Allergen Challenge: Development of a Model to Investigate the Cellular and Inflammatory Changes That Occur in Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01110837
- Acronym / sponsor ID
- #09-3232
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic rhinitis, Allergen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- Apr 2010
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 27 Apr 2010 (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.
What happens in the nose during an allergic reaction? Are there changes that a new drug could treat? What is the best way to test new drugs?The response of the nose to being exposed to cat allergen in someone who is allergic to cats. Symptoms, level of nasal blockage and cell and chemical changes that occur in the nose will be studied before and after being exposed to cat allergen. The investigators will also to see if giving repeated doses of allergen increases the response.Allergic rhinitis is a very common illness. There are over 500 million patients worldwide. It can increase the severity of associated asthma. Currently available drugs do not completely treat the symptoms. New treatments need to be found. A way of testing these drugs is very important. This study will investigate causes of the symptoms that occur in allergic rhinitis. It will also validate a proposed model to test new drugs. the Study Hypothesis is that a model of nasal allergen challenge shows an increased response (priming) with repeat challenges as determined by changes in nasal peak inspiratory flow.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allergen | Active comparator | Other: Allergen |
| Placebo | Placebo comparator | Other: Placebo challenge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects aged over 18 able to understand and sign the written consent form.
- Able to comply with study procedures and protocol.
- Positive skin prick test (wheal difference ≥ 3mm compared to negative control) to cat at or within 12 months preceding the screening visit.
- Clear history of nasal symptoms on exposure to cats.
- Otherwise healthy with no other health problems, other than mild asthma controlled by intermittent β2-agonist use, that may prevent the subject participating in the study.
Key exclusion criteria (8 listed)
- Presence of perennial rhinitis or seasonal allergic rhinitis.
- TNSS < 2 at screening
- Viral URTI within the 2 weeks prior to screening.
- Current smoker or history of smoking within the previous 3 months.
- Presence of any structural nasal abnormalities or nasal polyps on examination, a history of frequent nose bleeding, nasal surgery within the previous 3 months.
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 |
|---|---|---|
| AllergenAllergen nasal challenge | Other | Allergen |
| Placebo challengePlacebo nasal challenge | Other | Placebo |
Primary outcome
Change in peak nasal inspiratory flow following repeat allergen challenge
Time frame: 1 year
The peak nasal inspiratory flow will be measured using a hand-held peak flow meter, and changes will be measured following repeated allergen challenge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2012.
Related trials for Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
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RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
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Allergy, Asthma, and Atopic Eczema in Finland
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Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
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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.
Helen Neighbour, MB BS principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allergen in people with Allergic Rhinitis, run by McMaster University at 1 site in Canada.
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 5 inclusion and 8 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 1 Nov 2012. 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 Canada. 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. Some participants in this study may receive a placebo. 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 Helen Neighbour, MB BS PhD (905-522-1155 ext. 32145, neighbh@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak nasal inspiratory flow following repeat allergen challenge (time frame: 1 year). 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 1 Nov 2012.