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

G

Gail Gauvreau

Status

Unknown

Conditions

Allergic Asthma

Treatments

Drug: Placebo
Drug: Triamcinolone Acetonide

Study type

Interventional

Funder types

Other

Identifiers

NCT03431961
DC002544/HIREB3820

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

20 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
0.9% normal saline administered twice daily for 14 days
Treatment:
Drug: Placebo
Intranasal Corticosteroid
Experimental group
Description:
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
Treatment:
Drug: Triamcinolone Acetonide

Trial contacts and locations

1

Loading...

Central trial contact

Gail M Gauvreau, PhD; Paul M O'Byrne, MB

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems