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Completed

NCT Number: NCT00513487

Effects of Multiple Nasal Exposures to House Dust Mite Allergen on Nasal and Body Inflammation and Airway Sensitivity

This study will evaluate whether multiple nasal antigen challenges with dust mite allergen produces increases in nasal symptoms and local allergic inflammatory cells in the nose and the blood.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Inflammation Nose Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Novartis Investigative site

Sydney, Australia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy non-smoking subjects with a history of allergic rhinitis consistent with dust mite allergy showing
  • A positive skin prick test to dust mite at or within the 12 months before study start
  • Demonstrate symptomatic worsening after graded nasal allergen challenge

Exclusion criteria

  • Subjects found to be very sensitive to house dust mites (if the skin prick test produces a wheal of mean with a diameter greater than 11 mm).
  • Presence of any respiratory disease other than a history of mild stable asthma not requiring regular treatment.
  • Any known contraindications for methacholine challenge testing

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Dust mite extract, Fluticasone, Methacholine

Drug

Dust mite extract, Fluticasone, Methacholine

Primary outcomes

  1. Total nasal symptom score recorded at baseline, and at pre-challenge,15 mins, 30 mins,and at 1,2,3,4,8 hours

    Time frame: throughout the study

Secondary outcomes

  1. Peak nasal inspiratory flow at time points of total nasal symptom score. Mechanistic markers during challenge days. Exhaled nitric oxide,forced expiratory vol in 1 second & airway resistance at baseline, first & last day

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Assessment of the Effects of Multiple Nasal Antigen Challenges With Dust Mite Allergen on Local and Systemic Allergic Inflammation and Bronchoreactivity in Subjects With Allergic Rhinitis Sensitive to House Dust Mite - a Feasibility and Site Evaluation Study

Important dates

Study start
2007
Study completion
2007
First posted
Aug 8, 2007
Registry last updated
Jul 15, 2008

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.

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