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Nasal Allergen Challenge - Reproducibility of Biomarkers and Effect of Topical Steroid Treatment

Nasal Allergen Challenge - Reproducibility of Biomarkers and Effect of Topical Steroid Treatment

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03431961
Acronym
NACHO
Enrollment
20
Registered
2018-02-13
Start date
2018-03-07
Completion date
2019-02-28
Last updated
2018-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Asthma

Brief 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. 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.

Interventions

DRUGTriamcinolone Acetonide

220 mcg administered twice daily for 14 days

DRUGPlacebo

twice daily for 14 days

Sponsors

Gail Gauvreau
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* allergic rhinitis + mild asthma

Exclusion criteria

* other respiratory disease * any medication for treatment of asthma/allergic rhinitis with the exception of infrequent beta-2 agonist.

Design outcomes

Primary

MeasureTime frameDescription
Cellular inflammation24 hours after nasal allergen challengeNasal eosinophils

Countries

Canada

Contacts

Primary ContactGail M Gauvreau, PhD
gauvreau@mcmaster.ca905-525-9140
Backup ContactPaul M O'Byrne, MB
obyrnep@mcmaster.ca905-525-9140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026