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

NCT ID: NCT03431961

Last Updated: 2018-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-07

Study Completion Date

2019-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Allergic Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

0.9% normal saline administered twice daily for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

twice daily for 14 days

Intranasal Corticosteroid

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

Group Type EXPERIMENTAL

Triamcinolone Acetonide

Intervention Type DRUG

220 mcg administered twice daily for 14 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Triamcinolone Acetonide

220 mcg administered twice daily for 14 days

Intervention Type DRUG

Placebo

twice daily for 14 days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nasacort 0.9% Normal Saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gail Gauvreau

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gail Gauvreau

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gail M Gauvreau, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cardio- Respiratory Research Laboratory, Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gail M Gauvreau, PhD

Role: CONTACT

905-525-9140 ext. 22791

Paul M O'Byrne, MB

Role: CONTACT

905-525-9140 ext. 22100

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gail Gauvreau, PhD.

Role: primary

905-525-9140 ext. 22791

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37794659 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DC002544/HIREB3820

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.