Skip to main content
OpenTrials
Completed

NCT Number: NCT01657097

Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allergic Rhinitis Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Respiratory Diseases, Aarhus University Hospital

Aarhus, DK-8000 C, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INCS

Drug

Placebo

Drug

Primary outcomes

  1. Serum Eosinophil Cationic Protein (ECP)

    Time frame: 1 month

Secondary outcomes

  1. Serum Eosinophil Peroxidase (EPO)

    Time frame: 1 month

  2. Nasal lavage Eosinophil Cationic Protein (ECP)

    Time frame: 1 month

  3. Nasal lavage Eosinophil Peroxidase (EPO)

    Time frame: 1 month

  4. Blood Eosinophils

    Time frame: 1 month

Other outcomes

  1. Bronchial metacholine challenge

    Time frame: 1 month

  2. Acoustic rhinometry

    Time frame: 1 month

  3. Spirometry (Forced Expiratory Volume 1 second (FEV-1))

    Time frame: 1 month

  4. Nasal symptom score

    Time frame: 1 month

  5. Asthma symptom score

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge. Impact on Bronchial Hyperresponsiveness and the Effect of Intranasal Corticosteroid Treatment

Important dates

Study start
1997
Primary completion
1997
Study completion
1997
First posted
Aug 3, 2012
Registry last updated
Aug 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.