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Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge

University of Aarhus logo

University of Aarhus

Status and phase

Completed
Phase 4

Conditions

Asthma
Allergic Rhinitis

Treatments

Drug: Placebo
Drug: INCS

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01657097
RHINO97

Details and patient eligibility

About

Allergic rhinitis is a common condition caused by inflammation of nasal mucosa. The study was performed to gain information on this inflammation, including effect of intranasal corticosteroid treatment hereupon and potential influence on the lower airways, ie asthma.

The study was randomised, placebo-controlled double-blind in patients, monoallergic to grasspollen, presenting symptoms of rhinitis and asthma during season.

Treatment,ie intranasal corticosteroid or placebo, were given four weeks. After two weeks of treatment intranasal allergen challenge was performed. Measurements were performed during the full study period.

The study was performed out of pollen season.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • monoallergy to grass
  • symptoms of allergic rhinitis for at least the two most recent grasspollen seasons
  • asthma symptoms of asthma for at least two of the four most recent grasspollen seasons
  • age 18 or older

Exclusion criteria

  • pregnancy or lactation
  • fertile women, not sterilised or using sufficient anticonception
  • Corticosteroid treatment (parenteral, oral, inhaled or intranasal) within two months prior to enrolment
  • Any other disease, condition or treatment, which to the discretion of the investigator has the potential to interfere with study results

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

24 participants in 2 patient groups, including a placebo group

INCS
Experimental group
Description:
Fluticasone propionate 400 microgram daily
Treatment:
Drug: INCS
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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