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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00513487
First received: August 6, 2007
Last updated: July 14, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention
Allergic Rhinitis
Drug: Dust mite extract, Fluticasone, Methacholine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Estimated Enrollment: 18
Study Start Date: July 2007
Study Completion Date: November 2007
Intervention Details:
    Drug: Dust mite extract, Fluticasone, Methacholine
    Dust mite extract, Fluticasone, Methacholine
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513487

Locations
Australia
Novartis Investigative site
Sydney, Australia
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigative site
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00513487     History of Changes
Other Study ID Numbers: CPJMR0052107
Study First Received: August 6, 2007
Last Updated: July 14, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Novartis:
Allergic Rhinitis
dust mites
IgE
IL-13
nasal
inflammation

Additional relevant MeSH terms:
Inflammation
Rhinitis
Pathologic Processes
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Methacholine Chloride
Fluticasone
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Therapeutic Uses
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 29, 2014