AsthmaNCT01286129
Nasal Allergen Challenge in Rhinitic Subjects
A study testing Nasal allergen challenge in people with Asthma and Allergic Rhinitis, run by Laval University at 1 site in Canada.
Trial summary
Background: Nasal allergen challenge (NAC) is useful to study the pathophysiology of rhinitis, and multiple challenges may more adequately approximate natural exposure. Objective: To determine the effect of 4 consecutive daily NAC, on clinical and inflammatory parameters in rhinitics with or without asthma. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Asthma, Allergic Rhinitis
- What is being tested?
- Nasal allergen challenge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2005to Mar 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- To have a positive reaction to one or more allergen on prick tests.
- Non smokers
- No respiratory track infection for at least one month prior to the study.
- Positive reaction to cat hair and/or house dust mite (Dermatophagoides pteronyssinus) aeroallergens on allergy skin prick tests and report rhinitis symptoms when exposed to an environment containing this allergen.
- Asthmatic subjects using only inhaled beta-2 agonists on an as needed basis for their asthma treatment.
- Asthmatic subjects with a history of asthma of at least 6 months.
Show all 9Show fewer
- Asthmatic subjects with PC20 methacholine lower or equal to 8 mg/ml.
- Allergic rhinitic subjects never experienced any asthma symptoms or took any asthma medication in the past.
- Allergic rhinitic subjects with a provocative concentration of methacholine (PC20 higher than 16 mg/ml.
Who cannot join
- Smokers or ex smokers less than 6 months or more than 10 pack-years.
- Asthmatic subjects using or used in the past 3 months inhaled or oral corticosteroids.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5
About this study
Official title: Comparative Responses to Nasal Allergen Challenge in Allergic Rhinitic Subjects With or Without Asthma
Background: Nasal allergen challenge (NAC) is useful to study the pathophysiology of rhinitis, and multiple challenges may more adequately approximate natural exposure.
Objective: To determine the effect of 4 consecutive daily NAC, on clinical and inflammatory parameters in rhinitics with or without asthma.
Read the detailed description
The study will be performed outside the pollen season. On a baseline visit, 2 to 7 days prior to control challenge, allergy skin prick tests and methacholine inhalation test will be done. Prior to first allergen challenge, skin titration will be done using tenfold dilutions of the allergen chosen for nasal challenges. Subsequent to baseline visit, a control challenge will be done, followed, a week later, by repeated NACs. NACs will be done over 4 consecutive days, in the morning. Nasal peak inspiratory flows (NPIF), oral peak expiratory flows (PEF), and symptoms will be recorded at baseline and at regular intervals over 7 hours post-challenge on each challenge day. Induced sputum and nasal lavage specimen will be obtained 7 hours following the control challenge and the first and last NAC.
- Conditions
- Asthma, Allergic Rhinitis
- Being tested
- Nasal allergen challenge
- Medical subject headings
- Asthma, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal allergen challengeProcedure or surgery
Allergen sprayed into nostrils. Allergen used will be house dust mite or cat allergen. Allergens will be given in increasing ten-fold dilutions until a positive response occurs.
| Study group | Role | What they receive |
|---|---|---|
| Allergic asthmatic | Active comparator | Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt. Receives: Procedure: Nasal allergen challenge |
| Allergic rhinitic without asthma | Active comparator | Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt. Receives: Procedure: Nasal allergen challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sputum Eosinophils Following Allergen Challenge
Eosinophil is an inflammatory cell found in the lungs. Sputum is obtained from hypertonic inhalation. patients expectorate in a sterile dish and mucus plugs are selected and treated to obtain cells. cells are transferred on a slide and a differential count is obtained where eosinophils are counted.
Measured: At 7 hours post first and last challenge compared to baseline
Secondary outcomes (1)
Change in Nasal Lavage Eosinophils After Allergen Challenge
Change in nasal lavage eosinophil percentages in allergic asthmatic and allergic non asthmatic at baseline and at 7h post first and last challenge
Measured: At 7 hours post first and last challenge compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startNov 2005
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- AllerGen NCE Inc.
- Responsible party
- Sponsor
- Investigators
- Louis-Philippe Boulet, MD, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286129
- Sponsor's protocol ID
- FP-2005-3
- Other IDs
- CER1223
- Status last verified
- Jan 2019
- First submitted
- 13 Jan 2011
- Last updated
- 1 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rousseau MC, Boulay ME, Goronfolah L, Denburg J, Keith P, Boulet LP. Comparative responses to nasal allergen challenge in allergic rhinitic subjects with or without asthma. Allergy Asthma Clin Immunol. 2011 Apr 20;7(1):8. doi: 10.1186/1710-1492-7-8.
PubMed 21507261
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Responses to Nasal Allergen Challenge in Allergic Rhinitic Subjects With or Without Asthma
- ClinicalTrials.gov ID
- NCT01286129
- Acronym / sponsor ID
- FP-2005-3
- Conditions
- Asthma, Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- AllerGen NCE Inc.
- Study start
- Nov 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 31 Jan 2011 (estimated)
- Results
- Posted 1 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Nasal allergen challenge (NAC) is useful to study the pathophysiology of rhinitis, and multiple challenges may more adequately approximate natural exposure.
Objective: To determine the effect of 4 consecutive daily NAC, on clinical and inflammatory parameters in rhinitics with or without asthma.
Detailed description
The study will be performed outside the pollen season. On a baseline visit, 2 to 7 days prior to control challenge, allergy skin prick tests and methacholine inhalation test will be done. Prior to first allergen challenge, skin titration will be done using tenfold dilutions of the allergen chosen for nasal challenges. Subsequent to baseline visit, a control challenge will be done, followed, a week later, by repeated NACs. NACs will be done over 4 consecutive days, in the morning. Nasal peak inspiratory flows (NPIF), oral peak expiratory flows (PEF), and symptoms will be recorded at baseline and at regular intervals over 7 hours post-challenge on each challenge day. Induced sputum and nasal lavage specimen will be obtained 7 hours following the control challenge and the first and last NAC.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allergic asthmatic | Active comparator | Procedure: Nasal allergen challengeSubjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt. |
| Allergic rhinitic without asthma | Active comparator | Procedure: Nasal allergen challengeSubjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- To have a positive reaction to one or more allergen on prick tests.
- Non smokers
- No respiratory track infection for at least one month prior to the study.
- Positive reaction to cat hair and/or house dust mite (Dermatophagoides pteronyssinus) aeroallergens on allergy skin prick tests and report rhinitis symptoms when exposed to an environment containing this allergen.
- Asthmatic subjects using only inhaled beta-2 agonists on an as needed basis for their asthma treatment.
Key exclusion criteria (2 listed)
- Smokers or ex smokers less than 6 months or more than 10 pack-years.
- Asthmatic subjects using or used in the past 3 months inhaled or oral corticosteroids.
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 challengeAllergen sprayed into nostrils. Allergen used will be house dust mite or cat allergen. Allergens will be given in increasing ten-fold dilutions until a positive response occurs. | Procedure or surgery | Allergic asthmatic, Allergic rhinitic without asthma |
Primary outcome
Change in Sputum Eosinophils Following Allergen Challenge
Time frame: At 7 hours post first and last challenge compared to baseline
Eosinophil is an inflammatory cell found in the lungs. Sputum is obtained from hypertonic inhalation. patients expectorate in a sterile dish and mucus plugs are selected and treated to obtain cells. cells are transferred on a slide and a differential count is obtained where eosinophils are counted.
1 secondary outcome
Change in Nasal Lavage Eosinophils After Allergen Challenge
Time frame: At 7 hours post first and last challenge compared to baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21507261Rousseau MC, Boulay ME, Goronfolah L, Denburg J, Keith P, Boulet LP. Comparative responses to nasal allergen challenge in allergic rhinitic subjects with or without asthma. Allergy Asthma Clin Immunol. 2011 Apr 20;7(1):8. doi: 10.1186/1710-1492-7-8.
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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.
Louis-Philippe Boulet, MD principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
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 and Allergic Rhinitis, run by Laval 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 9 inclusion and 2 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 1 Feb 2019. 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. 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?
Yes. Results are posted in the registry (first posted 1 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Sputum Eosinophils Following Allergen Challenge (time frame: At 7 hours post first and last challenge compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01286129, which also lists 1 linked publication.
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 Feb 2019.