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

Allergic Asthma Clinical Trial

— NACHO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03431961
• Other study ID #: DC002544/HIREB3820
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2018
• Est. completion date: February 2019

Study information

• Verified date: August 2018
• Source: Hamilton Health Sciences Corporation
• Contact: Gail M Gauvreau, PhD
• Phone: 905-525-9140
• Email: gauvreau[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. One cohort will have intranasal corticosteroid intervention.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Asthma

Intervention

Drug:
• Triamcinolone Acetonide
220 mcg administered twice daily for 14 days
• Placebo
twice daily for 14 days

Locations

Country	Name	City	State
Canada	Cardio- Respiratory Research Laboratory, Hamilton Health Sciences	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Gail Gauvreau

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cellular inflammation	Nasal eosinophils	24 hours after nasal allergen challenge