Allergic AsthmaNACHONCT03431961
Nasal Allergen Challenge - Reproducibility of Biomarkers and Effect of Topical Steroid Treatment
A study testing Triamcinolone Acetonide in people with Allergic Asthma, run by Gail Gauvreau at 1 site in Canada.
Trial summary
Subjects with allergic asthma developing the required nasal symptoms in response to nasal allergen titration during a screening period will be randomized 1:1 to one of 2 cohorts. All subjects will have repeated nasal challenges with allergen. One cohort will have nasal saline challenge as control. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- Triamcinolone Acetonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 7 Mar 2018to Feb 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- allergic rhinitis + mild asthma
Who cannot join
- other respiratory disease
- any medication for treatment of asthma/allergic rhinitis with the exception of infrequent beta-2 agonist.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Cardio- Respiratory Research Laboratory, Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
Gail Gauvreau, PhD., 905-525-9140 ext. 22791, gauvreau@mcmaster.ca
Gail M Gauvreau, PhD
About this study
Subjects with allergic asthma developing the required nasal symptoms in response to nasal allergen titration during a screening period will be randomized 1:1 to one of 2 cohorts. All subjects will have repeated nasal challenges with allergen. One cohort will have nasal saline challenge as control. One cohort will have intranasal corticosteroid intervention.
Read the detailed description
Eligible subjects will be randomized 1:1 to Cohort A or Cohort B. Each cohort will undergo 3 nasal challenges, each separated by 3 weeks. Cohort A will undergo 2 nasal allergen challenges, and 1 nasal diluent challenge. TNSS, PNIF, spirometry, and samples of blood, urine and nasal secretions will be collected until 24h post-challenge to assess reproducibility. Cohort B will undergo 3 nasal allergen challenges; one of the challenge will be conducted after 14 days treatment with placebo, and one challenge will be conducted after 14 days treatment with triamcinolone acetonide aqueous nasal spray at a dose of 220 mcg administered twice daily for a total daily dose of 440 mcg. TNSS, PNIF, spirometry, and samples of blood, urine, nasal secretions will be collected until 24h post-challenge to determine reproducibility, and nasal tissue will be collected 24h post-challenge to determine effect of steroid treatment.
- Conditions
- Allergic Asthma
- Being tested
- Triamcinolone Acetonide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
Also called Nasacort
220 mcg administered twice daily for 14 days
PlaceboDrug
Also called 0.9% Normal Saline
twice daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 0.9% normal saline administered twice daily for 14 days Receives: Drug: Placebo |
| Intranasal Corticosteroid | Experimental | Triamcinolone acetonide aqueous nasal spray at a dose of 220 mcg administered twice daily (for a total daily dose of 440 mcg) for 14 days Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellular inflammation
Nasal eosinophils
Measured: 24 hours after nasal allergen challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start7 Mar 2018
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gail Gauvreau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gail Gauvreau, Hamilton Health Sciences Corporation
- Investigators
- Gail M Gauvreau, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431961
- Sponsor's protocol ID
- DC002544/HIREB3820
- Acronym
- NACHO
- Status last verified
- Aug 2018
- First submitted
- 7 Feb 2018
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bauer RN, Xie Y, Beaudin S, Wiltshire L, Wattie J, Munoz C, Alsaji N, Oliveria JP, Ju X, MacLean J, Sommer DD, Keith PK, Satia I, Cusack RP, O'Byrne PM, Sperinde G, Hokom M, Li O, Banerjee P, Chen C, Staton T, Sehmi R, Gauvreau GM. Evaluation of the reproducibility of responses to nasal allergen challenge and effects of inhaled nasal corticosteroids. Clin Exp Allergy. 2023 Nov;53(11):1187-1197. doi: 10.1111/cea.14406. Epub 2023 Oct 4.
PubMed 37794659
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Allergen Challenge - Reproducibility of Biomarkers and Effect of Topical Steroid Treatment
- ClinicalTrials.gov ID
- NCT03431961
- Acronym / sponsor ID
- NACHO / DC002544/HIREB3820
- Conditions
- Allergic Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Gail GauvreauUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 13 Feb 2018 (actual)
- 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.
Subjects with allergic asthma developing the required nasal symptoms in response to nasal allergen titration during a screening period will be randomized 1:1 to one of 2 cohorts. All subjects will have repeated nasal challenges with allergen. One cohort will have nasal saline challenge as control. One cohort will have intranasal corticosteroid intervention.
Detailed description
Eligible subjects will be randomized 1:1 to Cohort A or Cohort B. Each cohort will undergo 3 nasal challenges, each separated by 3 weeks. Cohort A will undergo 2 nasal allergen challenges, and 1 nasal diluent challenge. TNSS, PNIF, spirometry, and samples of blood, urine and nasal secretions will be collected until 24h post-challenge to assess reproducibility. Cohort B will undergo 3 nasal allergen challenges; one of the challenge will be conducted after 14 days treatment with placebo, and one challenge will be conducted after 14 days treatment with triamcinolone acetonide aqueous nasal spray at a dose of 220 mcg administered twice daily for a total daily dose of 440 mcg. TNSS, PNIF, spirometry, and samples of blood, urine, nasal secretions will be collected until 24h post-challenge to determine reproducibility, and nasal tissue will be collected 24h post-challenge to determine effect of steroid treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo0.9% normal saline administered twice daily for 14 days |
| Intranasal Corticosteroid | Experimental | Drug: Triamcinolone AcetonideTriamcinolone acetonide aqueous nasal spray at a dose of 220 mcg administered twice daily (for a total daily dose of 440 mcg) for 14 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- allergic rhinitis + mild asthma
Key exclusion criteria (2 listed)
- other respiratory disease
- any medication for treatment of asthma/allergic rhinitis with the exception of infrequent beta-2 agonist.
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 |
|---|---|---|
| Triamcinolone AcetonideAlso: Nasacort220 mcg administered twice daily for 14 days | Drug | Intranasal Corticosteroid |
| PlaceboAlso: 0.9% Normal Salinetwice daily for 14 days | Drug | Placebo |
Primary outcome
Cellular inflammation
Time frame: 24 hours after nasal allergen challenge
Nasal eosinophils
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Derived from this study: PubMed 37794659Bauer RN, Xie Y, Beaudin S, Wiltshire L, Wattie J, Munoz C, Alsaji N, Oliveria JP, Ju X, MacLean J, Sommer DD, Keith PK, Satia I, Cusack RP, O'Byrne PM, Sperinde G, Hokom M, Li O, Banerjee P, Chen C, Staton T, Sehmi R, Gauvreau GM. Evaluation of the reproducibility of responses to nasal allergen challenge and effects of inhaled nasal corticosteroids. Clin Exp Allergy. 2023 Nov;53(11):1187-1197. doi: 10.1111/cea.14406. Epub 2023 Oct 4.
- Individual participant dataSharing planned: No
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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.
Gail M Gauvreau, 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 Triamcinolone Acetonide in people with Allergic Asthma, run by Gail Gauvreau 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 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: status not confirmed, as of the sponsor's last update on 2 Aug 2018. 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 Gail M Gauvreau, PhD (905-525-9140 ext. 22791, gauvreau@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cellular inflammation (time frame: 24 hours after nasal allergen challenge). 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 NCT03431961, 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 2 Aug 2018.