AsthmaNCT01204060
Effect of Allergen Challenge on Inflammation Induced by Toll-like Receptor Stimulation in a Nasal Model
A study testing Nasal allergen challenge in people with Asthma, run by McMaster University at 1 site in Canada.
Trial summary
Asthma is one of the most common diseases affecting about 2.5 million Canadians, and can result in reduced quality of life and difficulties with work and school. Once the disease has become established with irreversible changes in the lungs it can be very difficult to treat. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Nasal allergen challenge
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Sep 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
- 1 Subjects over the age of 18 2 Subjects able to give written informed consent 3 Subjects able to comply with study procedures and protocol 4 Subjects with a history of allergic asthma 5 Subjects with a positive skin prick test to a common aeroallergen 6 Subjects who are otherwise healthy with no other health problems
Who cannot join
- Subjects with a viral URTI within 2 weeks prior to screening.
- Subjects with a TNSS> 2 at screening
- Subjects with a structural nasal abnormality or nasal polyps on examination, a history of frequent nose bleeding, nasal surgery within the previous 3 months.
- Subjects who are a current smoker or have a history of smoking within the previous 3 months.
- Subjects who have used a medication that could affect responses to nasal challenge (eg corticosteroids, decongestants, anti-histamines) or any other nasally applied medication within 2 weeks prior to screening.
- Subjects who have participated in any other clinical trials within the previous 3 months.
- -
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Melanie Kjarsgaard, BSc RRT, 905 522 1155 ext. 33024, mkjarga@stjoes.ca
About this study
Official title: Effect of Allergen Challenge on Inflammation Induced by Toll-like Receptor Stimulation in a Nasal Model.
Asthma is one of the most common diseases affecting about 2.5 million Canadians, and can result in reduced quality of life and difficulties with work and school. Once the disease has become established with irreversible changes in the lungs it can be very difficult to treat. Severe asthma although less common than mild asthma uses more healthcare resources.
The objective of this project is to find out how the changes in the lung develop in severe asthma. Once this is known then new treatments can be developed to prevent irreversible damage to the lungs.
Read more
Volunteers will have substances sprayed up their nose and then samples collected from their nose. Levels of proteins and cells can be measured in these samples. This will give an indication of the type of inflammation that occurs.
The usual method of investigating the changes that occur in asthma is to challenge the lungs. Samples have to then be collected from the lungs. This can be in the form of sputum which must be treated to break it down to a liquid or washed out during a camera test. These methods cause problems with measuring proteins and they are broken down or diluted. Because the nose is easily accessible samples can be obtained at many time points. Because the samples can be collected directly from the nose the problems with obtaining samples from the lung are avoided.
- Conditions
- Asthma
- Being tested
- Nasal allergen challenge, Nasal placebo challenge
- Keywords
- Nasal Allergen Lipopolysaccharide Inflammation Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal allergen challengeOther
Subjects will receive a nasal spray containing an allergen to which they are allergic
Nasal placebo challengeOther
Subjects will receive a nasal spray with allergen diluent
| Study group | Role | What they receive |
|---|---|---|
| Nasal allergen challenge | Active comparator | Not described Receives: Other: Nasal allergen challenge |
| Nasal placebo challenge | Placebo comparator | Not described Receives: Other: Nasal placebo challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of eosinophils in nasal lavage
Measured: Assessed 4 hours after challenge
Secondary outcomes (3)
Change in level of IL-4, IL-5 and IL-13 in nasal secretions
Measured: Assessed 4 hours after challenge
Change in nasal symptom score
Measured: Assessed 4 hours after challenge
Change in FIZZ1 levels in nasal tissue
Measured: Assessed 4 hours after challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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 PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204060
- Sponsor's protocol ID
- #10-3322
- Status last verified
- Oct 2012
- First submitted
- 15 Sep 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
- Effect of Allergen Challenge on Inflammation Induced by Toll-like Receptor Stimulation in a Nasal Model.
- ClinicalTrials.gov ID
- NCT01204060
- Acronym / sponsor ID
- #10-3322
- Conditions
- Asthma
- Keywords
- Nasal Allergen Lipopolysaccharide Inflammation Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- Sep 2010
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 17 Sep 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.
Asthma is one of the most common diseases affecting about 2.5 million Canadians, and can result in reduced quality of life and difficulties with work and school. Once the disease has become established with irreversible changes in the lungs it can be very difficult to treat. Severe asthma although less common than mild asthma uses more healthcare resources.
The objective of this project is to find out how the changes in the lung develop in severe asthma. Once this is known then new treatments can be developed to prevent irreversible damage to the lungs.
Volunteers will have substances sprayed up their nose and then samples collected from their nose. Levels of proteins and cells can be measured in these samples. This will give an indication of the type of inflammation that occurs.
The usual method of investigating the changes that occur in asthma is to challenge the lungs. Samples have to then be collected from the lungs. This can be in the form of sputum which must be treated to break it down to a liquid or washed out during a camera test. These methods cause problems with measuring proteins and they are broken down or diluted. Because the nose is easily accessible samples can be obtained at many time points. Because the samples can be collected directly from the nose the problems with obtaining samples from the lung are avoided.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal allergen challenge | Active comparator | Other: Nasal allergen challenge |
| Nasal placebo challenge | Placebo comparator | Other: Nasal placebo challenge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1 Subjects over the age of 18 2 Subjects able to give written informed consent 3 Subjects able to comply with study procedures and protocol 4 Subjects with a history of allergic asthma 5 Subjects with a positive skin prick test to a common aeroallergen 6 Subjects who are otherwise healthy with no other health problems
Key exclusion criteria (7 listed)
- Subjects with a viral URTI within 2 weeks prior to screening.
- Subjects with a TNSS> 2 at screening
- Subjects with a structural nasal abnormality or nasal polyps on examination, a history of frequent nose bleeding, nasal surgery within the previous 3 months.
- Subjects who are a current smoker or have a history of smoking within the previous 3 months.
- Subjects who have used a medication that could affect responses to nasal challenge (eg corticosteroids, decongestants, anti-histamines) or any other nasally applied medication within 2 weeks prior to screening.
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 |
|---|---|---|
| Nasal allergen challengeSubjects will receive a nasal spray containing an allergen to which they are allergic | Other | Nasal allergen challenge |
| Nasal placebo challengeSubjects will receive a nasal spray with allergen diluent | Other | Nasal placebo challenge |
Primary outcome
Level of eosinophils in nasal lavage
Time frame: Assessed 4 hours after challenge
3 secondary outcomes
Change in level of IL-4, IL-5 and IL-13 in nasal secretions
Time frame: Assessed 4 hours after challenge
Change in nasal symptom score
Time frame: Assessed 4 hours after challenge
Change in FIZZ1 levels in nasal tissue
Time frame: Assessed 4 hours after 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 Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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 PhD 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 Nasal allergen challenge in people with Asthma, 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 1 inclusion and 7 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 Melanie Kjarsgaard, BSc RRT (905 522 1155 ext. 33024, mkarsga@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of eosinophils in nasal lavage (time frame: Assessed 4 hours after challenge). 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.