Recruiting

Intranasal Corticosteroid

Sponsor:

Gail Gauvreau

Code:

NCT03431961

Conditions

Allergic Asthma

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Triamcinolone Acetonide

Placebo

Study Details

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.

Conditions

Allergic Asthma

Study ID

NCT03431961

Start date

Mar 7, 2018

Status verified date

Aug, 2018

Completion date

Feb, 2019

Anticipated

Primary completion date

Feb, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not 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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

0.9% normal saline administered twice daily for 14 days

experimental: 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

Interventions

Triamcinolone Acetonide

220 mcg administered twice daily for 14 days

Placebo

twice daily for 14 days

Primary outcome measure

  • Cellular inflammation [ Time Frame: 24 hours after nasal allergen challenge ]

Central Contacts and Locations

Central contacts

Gail M Gauvreau, PhD

905-525-9140gauvreau@mcmaster.ca

Paul M O'Byrne, MB

905-525-9140obyrnep@mcmaster.ca

Locations

Cardio- Respiratory Research Laboratory, Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

Gail Gauvreau, PhD.

905-525-9140gauvreau@mcmaster.ca

Principal Investigator:

Gail M Gauvreau, PhD

More Information

Sponsor

Gail Gauvreau

Last update posted

Aug 2, 2018

Last verified

Aug, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gail Gauvreau on 2018-08-02.